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(b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits premarket notification submission for a device under part 807 may not show merely that the device is accurately described by the section title and identification provisions of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required by $ 807.87.

(c) To avoid duplicative listings, a cardiovascular device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic device) is listed only in one subpart.

(d) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted. [52 FR 17735, May 11, 1987) $ 870.3 Effective dates of requirement

for premarket approval. A device included in this part that is classified into class III (premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer has an approval under section 515 of the act (unless an exemption has been granted under section 520(g)(2) of the act). An approval under section 515 of the act consists of FDA's issuance of an order approving an application for premarket approval (PMA) for the device or declaring completed a product development protocol (PDP) for the device.

(a) Before FDA requires that a device commercially distributed before the enactment date of the amendments, or a device that has been found substantially equivalent to such a device, has an approval under section 515 of the act FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as provided in paragraph (b) of this section. Such a regulation under section 515(b) of the act shall not be effective during the grace period ending on the 90th day after its promulgation or on the last day of the 30th full calendar month after the regulation that classifies the device into class III is effective, whichever is later. See section 501(f)(2)(B) of

the act. Accordingly, unless an effective date of the requirement for premarket approval is shown in the regulation for a device classified into class III in this part, the device may be commercially distributed without FDA's issuance of an order approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act requiring premarket approval for a device, section 501(1)(1)(A) of the act ap plies to the device.

(b) Any new, not substantially equivalent, device introduced into commercial distribution on or after May 28, 1976, including a device formerly marketed that has been substantially altered, is classified by statute (section 513(f) of the act) into class III without any grace period and FDA must have issued an order approving a PMA or declaring completed a PDP for the device before the device is commercially distributed unless it is reclassified. If FDA knows that a device being commercially distributed may be a "new". device as defined in this section because of any new intended use or other reasons, FDA may codify the statutory classification of the device into class III for such new use. Accordingly, the regulation for such a class III device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution.

(52 FR 17735, May 11, 1987)

$ 870.9 Limitations of exemptions from

section 510(k) of the Federal Food,

Drug, and Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of

(8) For noninvasive testing as defined in 8812.3(k) of this chapter; and

(9) For near patient testing (point of care).

[65 FR 2314, Jan. 14, 2000]

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Subpart B-Cardiovascular

Diagnostic Devices $ 870.1025 Arrhythmia detector and

alarm. (a) Identification. An arrhythmia detector and alarm is a system that monitors the electrocardiogram and is designed to produce a visible or audible signal or alarm when an atrial or ventricular arrhythmia, such as a premature contraction or ventricular fibrillation, exists.

(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 $ 870.3. [45 FR 7907–7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987]

premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:

(a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;

(b) The modified device operates using different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or

(c) The device is an in vitro device that is intended:

(1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices;

(2) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism;

(3) For measuring an analyte that serves

a surrogate marker for screening, diagnosis, monitoring life-threatening diseases such as quired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy;

(4) For assessing the risk of cardiovascular diseases;

(5) For use in diabetes management;

(6) For identifying or inferring the identity of a microorganism directly from clinical material;

(7) For detection of antibodies to microorganisms other

than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma;

$ 870.1100 Blood pressure alarm.

(a) Identification. A blood pressure alarm is a device that accepts the signal from a blood pressure transducer amplifier, processes the signal, and emits an alarm when the blood pressure falls outside a pre-set upper or lower limit.

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

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$ 870.1110 Blood pressure computer.

(a) Identification. A blood pressure computer is a device that accepts the electrical signal from a blood pressure transducer amplifier and indicates the systolic, diastolic, or mean pressure based on the input signal.

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

$ 870.1120 Blood pressure cuff.

(a) Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject’s blood pressure.

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

8870.1130 Noninvasive blood pressure

measurement system. (a) Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

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

platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.

(b) Classification. Class II (performance standards). § 870.1230 Fiberoptic oximeter cath.

eter. (a) Identification. A fiberoptic oximeter catheter is a device used to estimate the oxygen saturation of the blood. It consists of two fiberoptic bundles that conduct light at a desired wavelength through blood and detect the reflected and scattered light at the distal end of the catheter.

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

$ 870.1140 Venous blood pressure ma

nometer. (a) Identification. A venous blood pressure manometer is a device attached to a venous catheter to indicate manometrically the central or peripheral venous pressure.

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

$ 870.1240 Flow-directed catheter.

(a) Identification. A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.

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

8 870.1200 Diagnostic intravascular

catheter. (a) Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

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

8870.1250 Percutaneous catheter.

(a) Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

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

8 870.1210 Continuous flush catheter.

(a) Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

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

$ 870.1270 Intracavitary phonocatheter

system. (a) Identification. An intracavitary phonocatheter system is a system that includes a catheter with an acoustic transducer and the associated device that processes the signal from the transducer; this device records bioacoustic phenomena from a transducer placed within the heart, blood vessels, or body cavities.

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

8870.1220 Electrode recording cath

eter or electrode recording probe. (a) Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a

$ 870.1280 Steerable catheter.

(a) Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.

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

$870.1290 Steerable catheter control completion of a PDP is required to be system.

filed with the Food and Drug Adminis(a) Identification. A steerable catheter tration on or before December 26, 1996 control system is a device that is con- for any catheter balloon repair kit that nected to the proximal end of a steer- was in commercial distribution before able guide wire that controls the mo- May 28, 1976, or that has, on or before tion of the steerable catheter.

December 26, 1996 been found to be sub(b) Classification. Class II (perform- stantially equivalent to a catheter balance standards).

loon repair kit that was in commercial

distribution before May 28, 1976. Any $870.1300 Catheter cannula.

other catheter balloon repair kit shall (a) Identification. A catheter cannula

have an approved PMA or a declared is a hollow tube which is inserted into

completed PDP in effect before being a vessel or cavity; this device provides

placed in commercial distribution. a rigid or semirigid structure which can be connected to a tube or con- (45 FR 7907–7971, Feb. 5, 1980, as amended at nector.

52 FR 17736, May 11, 1987; 61 FR 50706, Sept. (b) Classification. Class II (perform- 27, 1996) ance standards).

$ 870.1360 Trace microsphere. 8 870.1310 Vessel dilator for

(a) Identification. A trace microsphere percutaneous catheterization.

is a radioactively tagged nonbiodegrad(a) Identification. A vessel dilator for able particle that is intended to be inpercutaneous catheterization is a de

jected into an artery or vein and vice which is placed over the guide wire

trapped in the capillary bed for the to enlarge the opening in the vessel,

purpose of studying blood flow within and which is then removed before slid

or to an organ. ing the catheter over the guide wire. (b) Classification. Class II (perform

(b) Classification. Class III (premarket ance standards).

approval).

(c) Date PMA or notice of completion of $ 870.1330 Catheter guide wire.

a PDP is required. A PMA or notice of (a) Identification. A catheter guide completion of a PDP is required to be wire is a coiled wire that is designed to filed with the Food and Drug Adminisfit inside a percutaneous catheter for tration on or before December 26, 1996 the purpose of directing the catheter for any trace microsphere that was in through a blood vessel.

commercial distribution before May 28, (b) Classification. Class II (perform- 1976, or that has, on or before Decemance standards).

ber 26, 1996 been found to be substan

tially equivalent to a trace micro$ 870.1340 Catheter introducer.

sphere that was in commercial dis(a) Identification. A catheter intro- tribution before May 28, 1976. Any ducer is a sheath used to facilitate

other trace microsphere shall have an placing a catheter through the skin

approved PMA or a declared completed into a vein or artery.

PDP in effect before being placed in (b) Classification. Class II (perform

commercial distribution. ance standards).

(45 FR 7907-7971, Feb. 5, 1980, as amended at $ 870.1350 Catheter balloon repair kit. 52 FR 17736, May 11, 1987; 61 FR 50706, Sept. (a) Identification. A catheter balloon

27, 1996) repair kit is a device used to repair or replace the balloon of a balloon cath

8 870.1370 Catheter tip occluder. eter. The kit contains the materials, (a) Identification. A catheter tip such as glue and balloons, necessary to occluder is a device that is inserted effect the repair or replacement.

into certain catheters to prevent flow (b) Classification. Class III (premarket through one or more orifices. approval).

(b) Classification. Class II (perform(c) Date PMA or notice of completion of

ance standards). a PDP is required. A PMA or notice of

the heart and vessels by x-ray photography.

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

$870.1660 Indicator injector.

(a) Identification. An indicator injector is an electrically or gas-powered device designed to inject accurately an indicator solution into the blood stream. This device may be used in conjuction with a densitometer or thermodilution device to determine cardiac output.

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

8870.1380 Catheter stylet.

(a) Identification. A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.

(b) Classification. Class II (performance standards). 8870.1390 Trocar.

(a) Identification. A trocar is a sharppointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.

(b) Classification. Class II (performance standards). $ 870.1425 Programmable diagnostic

computer. (a) Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

(b) Classification. Class II (performance standards). 8870.1435 Single-function,

preprogrammed diagnostic com

puter. (a) Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.

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

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8 870.1450 Densitometer.

(a) Identification. A densitometer is a device used to measure the transmission of light through an indicator in a sample of blood.

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

8870.1800 Withdrawal-infusion pump.

(a) Identification. A withdrawal-infusion pump is a device designed to inject accurately drugs into the bloodstream and to withdraw blood samples for use in determining cardiac output.

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

$ 870.1650 Angiographic injector and

syringe. (a) Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study

8870.1875 Stethoscope.

(a) Manual stethoscope—(1) Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

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