§ 876.5310 Nonimplanted, peripheral electrical continence device.

(a) Identification. A nonimplanted, peripheral electrical continence device is a device that consists of an electrode that is connected by an electrical cable to a battery-powered pulse source. The electrode is placed onto or inserted into the body at a peripheral location and used to stimulate the nerves associated with pelvic floor function to maintain urinary continence. When necessary, the electrode may be removed by the user.

(b) Classification. Class II, subject to the following special controls:

(1) That sale, distribution, and use of this device are restricted to prescription use in accordance with §801.109 of this chapter.

(2) That the labeling must bear all information required for the safe and effective use of the device as outlined in § 801.109(c) of this chapter, including a detailed summary of the clinical information upon which the instructions are based.

[65 FR 18237, Apr. 7, 2000]

§ 876.5320 Nonimplanted

continence device.

electrical

(a) Identification. A nonimplanted electrical continence device is a device

that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).

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

§ 876.5365 Esophageal dilator.

(a) Identification. An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).

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

§ 876.5450 Rectal dilator.

(a) Identification. A rectal dilator is a device designed to dilate the anal sphincter and canal when the size of the anal opening may interfere with its function or the passage of an examining instrument.

(b) Classification. Class I. The device is 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]

§ 876.5470 Ureteral dilator.

(a) Identification. A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.

(b) Classification. Class II (performance 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]

§876.5540 Blood access device and accessories.

(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, implanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.

non

(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

or hollow needles, which are inserted into appropriate blood vessels or a vascular graft prosthesis (§§ 870.3450 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 III (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.

non

(4) Class I for the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and implanted 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]

§ 876.5600 Sorbent

regenerated dialysate delivery system for hemodialysis.

(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

this cartridge and the dialysate compartment of the dialyzer. The device is used with the extracorporeal blood system and the dialyzer of the hemodialysis system and accessories (§ 876.5820). The device includes the means to maintain the temperature, conductivity, electrolyte balance, flow rate and pressure of the dialysate, and alarms to indicate abnormal dialysate conditions. The sorbent cartridge may include absorbent, ion exchange and catalytic materials.

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

§ 876.5630 Peritoneal dialysis system and accessories.

(a) Identification. (1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.

(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula

in the abdominal wall between treatments.

(3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles.

(4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or "cycler systems") or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or "reverse osmosis" systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.

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

§ 876.5665 Water purification system for hemodialysis.

(a) Identification. A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.

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

§ 876.5820 Hemodialysis system and accessories.

(a) Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment,

the

undesirable substances in the blood pass through the semipermeable membrane into the dialysate in 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 (§876.5540) 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 an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§876.5830) or dialyzers of high permeability (§ 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 (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§876.5630), 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

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 delivery 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]

§ 876.5830 Hemodialyzer with disposable 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 (§ 876.5820).

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

[48 FR 53023, Nov. 23, 1983, as amended at 53 FR 11253, Apr. 6, 1988]

§ 876.5860 High permeability hemodialysis system.

as

(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 a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§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

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 (Kuf) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or 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 (§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 system.

a

(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 (§ 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 § 876.3.

[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987]

§ 876.5880 Isolated kidney perfusion and transport system and accessories.

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