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(b) Classification. Class III (premarket that consists of a pair of electrodes on approval).

a plug or a pessary that are connected (c) Date PMA or notice of completion of by an electrical cable to a battery-powa PDP is required. A PMA or a notice of ered pulse source. The plug or pessary completion of a PDP is required to be

is inserted into the rectum or into the filed with the Food and Drug Adminis

vagina and used to stimulate the mustration on or before December 26, 2000,

.cles of the pelvic floor to maintain urifor any implanted mechanical/hydrau

nary or fecal continence. When neclic urinary continence device that was

essary, the plug or pessary may be rein commercial distribution before May 28, 1976, or that has, on or before De

moved by the user. This device excember 26, 2000, been found to be sub

cludes an AC-powered nonimplanted stantially equivalent to an implanted

electrical continence device and the mechanical/hydraulic urinary con

powered vaginal muscle stimulator for tinence device that was in commercial

therapeutic use (§ 884.5940). distribution before May 28, 1976. Any (b) Classification. Class II (performother implanted mechanical/hydraulic ance standards). urinary continence device shall have an approved PMA or a declared com- $ 876.5365 Esophageal dilator. pleted PDP in effect before being

(a) Identification. An esophageal dilaplaced in commercial distribution.

tor is a device that consists of a cylin[48 FR 53023, Nov. 23, 1983, as amended at 52 drical instrument that may be hollow FR 17738, May 11, 1987; 65 FR 57731, Sept. 26, and weighted with mercury or a metal 2000]

olive-shaped weight that slides on a $876.5310 Nonimplanted, peripheral

guide, such as a string or wire and is electrical continence device.

used to dilate a stricture of the esoph

agus. This generic type of device in(a) Identification. A nonimplanted, pe

cludes esophageal or gastrointestinal ripheral electrical continence device is

bougies and the esophageal dilator a device that consists of an electrode

(metal olive). that is connected by an electrical cable to a battery-powered pulse source. The

(b) Classification. Class II (performelectrode is placed onto or inserted

ance standards). into the body at a peripheral location

$ 876.5450 Rectal dilator. and used to stimulate the nerves associated with pelvic floor function to (a) Identification. A rectal dilator is a maintain urinary continence. When device designed to dilate the anal necessary, the electrode may be re- sphincter and canal when the size of moved by the user.

the anal opening may interfere with its (b) Classification. Class II, subject to function or the passage of an examthe following special controls:

ining instrument. (1) That sale, distribution, and use of

(b) Classification. Class I. The device this device are restricted to prescrip

is exempt from the premarket notification use in accordance with $ 801.109 of

tion procedures in subpart E of part 807 this chapter.

of this chapter. (2) That the labeling must bear all information required for the safe and ef- [48 FR 53023, Nov. 23, 1983, as amended at 61 fective use of the device as outlined in FR 1122, Jan. 16, 1996) $ 801.109(c) of this chapter, including a detailed summary of the clinical infor

8 876.5470 Ureteral dilator. mation upon which the instructions (a) Identification. A ureteral dilator is are based.

a device that consists of a specially [65 FR 18237, Apr. 7, 2000]

shaped catheter or bougie and is used

to dilate the ureter at the place where $876.5320 Nonimplanted electrical a stone has become lodged or to dilate continence device.

a ureteral stricture. (a) Identification. Anonimplanted (b) Classification. Class II (performelectrical continence device is a device ance standards).

$876.5520 Urethral dilator.

(a) Identification. A urethral dilator is a device that consists of a slender hollow or solid instrument made of metal, plastic, or other suitable material in a cylindrical form and in a range of sizes and flexibilities. The device may include a mechanism to expand the portion of the device in the urethra and indicate the degree of expansion on a dial. It is used to dilate the urethra. This generic type of device includes the mechanical urethral dilator, urological bougies, metal or plastic urethral sound, urethrometer, filiform, and filiform follower.

(b) Classification. (1) Class II (performance standards).

(2) Class I for the urethrometer, urological bougie, filiform and filiform follower, and metal or plastic urethral sound. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996)

or hollow needles, which are inserted into appropriate blood vessels or a vascular graft prosthesis ($8870.3450 and 870.3460), and are intended to remain in the body for less than 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle).

(3) Accessories common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents).

(b) Classification. (1) Class II (premarket approval) for the implanted blood access device.

(2) Class II (performance standards) for the nonimplanted blood access device.

(3) Class II (performance standards) for accessories for both the implanted and the nonimplanted blood access devices not listed in paragraph (b)(4) of this section.

(4) Class I for the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device. The devices subject to this paragraph (b)(4) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

(c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval for the device described in paragraph (b)(1). See $ 876.3. [48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 61 FR 1122, Jan. 16, 1996)

8 876.5540 Blood access device and ac

cessories. (a) Identification. A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.

(1) The implanted blood access device consists of various flexible or rigid tubes, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes various shunts and connectors specifically designed to provide access to blood, such as the arteriovenous (A-V) shunt cannula and vessel tip.

(2) The nonimplanted blood access device consists of various flexible or rigid tubes, such as catheters, cannulae

$ 876.5600 Sorbent

regenerated dialysate delivery system for hemo

dialysis. (a) Identification. A sorbent regenerated dialysate delivery system for hemodialysis is a device that is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a sorbent cartridge and the means to circulate dialysate through

source

this cartridge and the dialysate com- in the abdominal wall between treatpartment of the dialyzer. The device is ments. used with the extracorporeal blood sys- (3) The disposable administration set tem and the dialyzer of the hemo- for peritoneal dialysis consists of tubdialysis system and accessories ing, an optional reservoir bag, and ap($ 876.5820). The device includes the propriate connectors. It may include a means to maintain the ten erature, peritoneal dialysate filter to trap and conductivity, electrolyte balance, flow remove contaminating particles. rate and pressure of the dialysate, and (4) The source of dialysate may be alarms to indicate abnormal dialysate sterile prepackaged dialysate (for semiconditions. The sorbent cartridge may automatic peritoneal dialysate delivinclude absorbent, ion exchange and ery systems or “cycler systems”) or catalytic materials.

dialysate prepared from dialysate con(b) Classification. Class II (perform- centrate and sterile purified water (for ance standards).

automatic peritoneal dialysate deliv

ery systems or “reverse osmosis” sys$876.5630 Peritoneal dialysis system tems). Prepackaged dialysate intended and accessories.

for use with either of the peritoneal (a) Identification. (1) A peritoneal di- dialysate delivery systems is regulated alysis system and accessories is a de- by FDA as a drug. vice that is used as an artificial kidney (b) Classification. Class II (performsystem for the treatment of patients ance standards). with renal failure or toxemic conditions, and that consists of a peritoneal

$876.5665 Water Purification system access device, an administration set for

for hemodialysis. peritoneal dialysis, a

of (a) Identification. A water purification dialysate, and, in some cases, a water system for hemodialysis is a device purification mechanism. After the that is intended for use with a hemodialysate is instilled into the patient's dialysis system and that is intended to peritoneal cavity, it is allowed to dwell remove organic and inorganic subthere so that undesirable substances stances and microbial contaminants from the patient's blood pass through from water used to dilute dialysate the lining membrane of the peritoneal concentrate to form dialysate. This gecavity into this dialysate. These sub- neric type of device may include a stances are then removed when the water softener, sediment filter, carbon dialysate is drained from the patient. filter, and water distillation system. The peritoneal dialysis system may (b) Classification. Class II (performregulate and monitor the dialysate ance standards). temperature, volume, and delivery rate together with the time course of each 8876.5820 Hemodialysis system and ac

cessories. cycle of filling, dwell time, and draining of the peritoneal cavity or manual (a) Identification. A hemodialysis syscontrols may be used. This generic de- tem and accessories is a device that is vice includes the semiautomatic and used as an artificial kidney system for the automatic peritoneal delivery sys- the treatment of patients with renal tem.

failure or toxemic conditions and that (2) The peritoneal access device is a consists of an extracorporeal blood sysflexible tube that is implanted through tem, а conventional dialyzer, a the abdominal wall into the peritoneal dialysate delivery system, and accescavity and that may have attached sories. Blood from a patient flows cuffs to provide anchoring and a skin through the tubing of the seal. The device is either a single use extracorporeal blood system and accesperitioneal catheter, intended to re- sories to the blood compartment of the main in the peritoneal cavity for less dialyzer, then returns through further than 30 days, or a long term peritoneal tubing of the extracorporeal blood syscatheter. Accessories include stylets tem to the patient. The dialyzer has and trocars to aid in the insertion of two compartments that are separated the catheter and an obturator to main- by a semipermeable membrane. While tain the patency of the surgical fistula the blood is in the blood compartment,

sociated with the extracorporeal blood system and the dialysate delivery system.

(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate del system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25050, June 12, 1989)

an

re

undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.

(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (8876.5540) to the blood compartment of the dialyzer and back to the patient.

(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that ultrafiltration controller is not quired to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (8 876.5830) or dial ers of high permeability (8 876.5860).

(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (8 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (8876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system $ 876.5860).

(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.

(b) Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly as

$ 876.5830 Hemodialyzer with dispos

able insert (Kiil type). (a) Identification. A hemodialyzer with disposable inserts (Kiil type) is a device that is used as a part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that includes disposable inserts consisting of layers of semipermeable membranes which are sandwiched between support plates. The device is used with the extracorporeal blood system and the dialysate delivery system of the hemodialysis system and accessories (8 876.5820).

(b) Classification. Class II (performance standards). [48 FR 53023, Nov. 23, 1983, as amended at 53 FR 11253, Apr. 6, 1988]

as

$ 876.5860 High permeability hemo

dialysis system. (a) Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies

hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (8 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration

a a

or

rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:

(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (Kur) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.

(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (8 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).

(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).

(b) Classification. Class II. The special controls for this device are FDA's:

(1) “Use of International Standard ISO 10993 "Biological Evaluation of Medical Device-Part I: Evaluation and Testing,'

(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,"

(3) "Guidance for Industry and CDRH Reviewers on the Content of Pre

market Notifications for Hemodialysis Delivery Systems,'

(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis," and

(5) "Guidance for Hemodialyzer Reuse Labeling.' [65 FR 17145, Mar. 31, 2000) $876.5870 Sorbent hemoperfusion sys

tem. (a) Identification. A sorbent hemoperfusion system is a device that consists of an extracorporeal blood system similar to that identified in the hemodialysis system and accessories (8 876.5820) and a container filled with adsorbent material that removes wide range of substances, both toxic and normal, from blood flowing through it. The adsorbent materials are usually activated-carbon or resins which may be coated or immobilized to prevent fine particles entering the patient's blood. The generic type of device may include lines and filters specifically designed to connect the device to the extracorporeal blood system. The device is used in the treatment of poisoning, drug overdose, hepatic coma, or metabolic disturbances.

(b) Classification. Class III (premarket approval).

(c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See 8876.3. [48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987) 8 876.5880 Isolated kidney perfusion

and transport system and acces

sories. (a) Identification. An isolated kidney perfusion and transport system and accesssories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a nearnormal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with

without bag preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set.

or

or

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