§ 866.5880 Transferrin immunological test system. (a) Identification. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia. (b) Classification. Class II (performance standards). § 866.5890 Inter-alpha trypsin inhibitor immunological test system. (a) Identification. An inter-alpha trypsin inhibitor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the inter-alpha trypsin inhibitor (a protein) in serum and other body fluids. Measurement of inter-alpha trypsin inhibitor may aid in the diagnosis of acute bacterial infection and inflammation. (b) Classification. Class I (general controls). [47 FR 50823, Nov. 9, 1982, as amended at 53 FR 11253, Apr. 6, 1988] Subpart B-Diagnostic Devices 868.1030 Manual algesimeter. 868.1040 Powered algesimeter. 868.1075 Argon gas analyzer. 868.1100 Arterial blood sampling kit. 868.1120 Indwelling blood oxyhemoglobin concentration analyzer. 868.1150 Indwelling blood carbon dioxide partial pressure (Pco2) analyzer. 868.1170 Indwelling blood hydrogen ion concentration (pH) analyzer. 868.1200 Indwelling blood oxygen partial pressure (Poz) analyzer. 868.1400 Carbon dioxide gas analyzer. 868.1690 Nitrogen gas analyzer. 868.1700 Nitrous oxide gas analyzer. 868.1720 Oxygen gas analyzer. 868.1730 Oxygen uptake computer. 868.1750 Pressure plethysmograph. 868.1760 Volume plethysmograph. 868.1780 Inspiratory airway meter. pressure Sec. 868.6885 Medical gas yoke assembly. AUTHORITY: Secs. 501, 510, 513, 515, 520, 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 371). SOURCE: 42 FR 31142, July 16, 1982, unless otherwise noted. Subpart A-General Provisions § 868.1 Scope. (a) This part sets forth the classification of anesthesiology devices intended for human use that are in commercial distribution. a (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 a premarket notification submission for 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, an anesthesiology 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 17734, May 11, 1987]) § 868.3 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(f)(1)(A) of the act applies 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 17734, May 11, 1987] distributed § 868.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). The Food and Drug Administration's (FDA's) decision to grant an exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I device is based upon the existing and reasonably foreseeable characteristics of commercially devices within that generic type. Because FDA cannot anticipate every change in intended use or characteristic that could significantly affect a device's safety or effectiveness, manufacturers of any commercially distributed class I device for which FDA has granted an exemption from the requirement of 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 its intended use before May 28, 1976, or the device is intended for a use different from the intended use of a preamendments device to which it had been determined to be substantially equivalent; 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; or (b) The modified device operates using a different fundamental scientific technology than that in use in the device before May 28, 1976, 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 a deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology. [54 FR 25047, June 12, 1989] Subpart B-Diagnostic Devices § 868.1030 Manual algesimeter. (a) Identification. A manual algesimeter is a mechanical device intended to determine a patient's sensitivity to pain after administration of an anes thetic agent, e.g., by pricking with a sharp point. (b) Classification. Class I. The device is exempt from the premarket notification procedures in Subpart E of Part 807 of this chapter. The device is also exempt from the current good manufacturing practice regulations in Part 820 of this chapter, with the exception of § 820.180, with respect to general concerning requirements records, and § 820.198, with respect to complaint files. [54 FR 25048, June 12, 1989] § 868.1040 Powered algesimeter. (a) Identification. A powered alge simeter is a device using electrical stimulation intended to determine a patient's sensitivity to pain after administration of an anesthetic agent. (b) Classification. Class II (performance standards). § 868.1075 Argon gas analyzer. (a) Identification. An argon gas analyzer is a device intended to measure the concentration of argon in a gas mixture to aid in determining the patient's ventilatory status. The device? may use techniques such as mass spectrometry or thermal conductivity. (b) Classification. Class II (performance standards). § 868.1100 Arterial blood sampling kit. (a) Identification. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. The kit may include a syringe, needle, cork, and heparin. (b) Classification. Class II (performance standards). § 868.1120 Indwelling blood oxyhemoglo bin concentration analyzer. (a) Identification. An indwelling blood oxyhemoglobin concentration analyzer is a photoelectric device used to measure, in vivo, the oxygen-carrying capacity of hemoglobin in blood to aid in determining the patient's physiological status. (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 868.3. [47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987; 52 FR 22577, June 12, 1987] 8868.1150 Indwelling blood carbon dioxide partial pressure (Pcoa) analyzer. (a) Identification. An indwelling blood carbon dioxide partial pressure Poo2 analyzer is a device that consists of a catheter-tip Pco2 transducer (e.g., Pco electrode) and that is used to measure, in vivo, the partial pressure of carbon dioxide in blood to aid in determining the patient's circulatory, ventilatory, and metabolic status. (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 § 868.3. [47 FR 31142, July 16, 1982; 47 FR 40410, Sept. 14, 1982, as amended at 52 FR 17735, May 11, 1987] § 868.1170 Indwelling blood hydrogen ion concentration (pH) analyzer. (a) Identification. An indwelling blood hydrogen ion concentration (pH) analyzer is a device that consists of a catheter-tip pH electrode and that is used to measure, in vivo, the hydrogen ion concentration (pH) in blood to aid in determining the patient's acidbase balance. (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 § 868.3. [47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987] § 868.1200 Indwelling blood oxygen partial pressure (Po2) analyzer. (a) Identification. An indwelling blood oxygen partial pressure (P。2) analyzer is a device that consists of a catheter-tip Po transducer (e.g., Po2 electrode) and that is used to measure, in vivo, the partial pressure of oxygen in blood to aid in determining the pa tient's circulatory, ventilatory, and metabolic status. (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 § 868.3. [47 FR 31142, July 16, 1982; 47 FR 40410, Sept. 14, 1982, as amended at 52 FR 17735, May 11, 1987] § 868.1400 Carbon dioxide gas analyzer. (a) Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry. (b) Classification. Class II (performance standards). § 868.1430 Carbon monoxide gas analyzer. (a) Identification. A carbon monoxide gas analyzer is a device intended to measure the concentration of carbon monoxide in a gas mixture to aid in determining the patient's ventilatory status. The device may use techniques such as infrared absorption or gas chromatography. (b) Classification. Class II (performance standards). § 868.1500 Enflurane gas analyzer. (a) Identification. An enflurane gas analyzer is a device intended to measure the concentration of enflurane anesthetic in a gas mixture. (b) Classification. Class II (performance standards). § 868.1575 Gas collection vessel. (a) Identification. A gas collection vessel is a container-like device intended to collect a patient's exhaled gases for subsequent analysis. It does not include a sampling pump. (b) Classification. Class II (performance standards). |