21 CFR 868.5480 — Isocapnic Ventilation Device
General Hospital (HO) · Part 868 Subpart F—Therapeutic Devices · § 868.5480
Identification
An isocapnic ventilation device is a prescription device used to administer a blend of carbon dioxide and oxygen gases to a patient to induce hyperventilation. This device may be labeled for use with breathing circuits made of reservoir bags (§ 868.5320), oxygen cannulas (§ 868.5340), masks (§ 868.5550), valves (§ 868.5870), resuscitation bags (§ 868.5915), and/or tubing (§ 868.5925).
Classification Rationale
Class II (special controls). The special controls for this device are:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QFB | Isocapnic Ventilation Device | 2 | 1 |
Special Controls
QFB — Isocapnic Ventilation Device
In combination with the general controls of the FD&C Act. the isocapnic ventilation device is subject to the following special controls:
De Novo Order DEN170044
QFB — Isocapnic Ventilation Device
*Classification.* Class II (special controls). The special controls for this device are:(1) Nonclinical performance testing data must demonstrate that the device performs as intended under anticipated conditions of use, including the following performance characteristics: (i) Gas concentration accuracy testing for the range of intended concentrations; (ii) Airway pressure delivery accuracy testing; (iii) Supplemental O 2 flowrate accuracy testing;(iv) Alarm testing; and (v) Use life testing. (2) The patient-contacting components of the device must be demonstrated to be biocompatible. (3) Labeling must include the following: (i) Instructions for use; (ii) A precaution that monitoring of capnography is necessary during treatment with non-spontaneously breathing patients; and (iii) Use life specification.
eCFR
QFB — Isocapnic Ventilation Device
(1) Nonclinical performance testing data must demonstrate that the device performs as intended under anticipated conditions of use, including the following performance characteristics: (i) Gas concentration accuracy testing for the range of intended concentrations; (ii) Airway pressure delivery accuracy testing; (iii) Supplemental O 2 flowrate accuracy testing;(iv) Alarm testing; and (v) Use life testing. (2) The patient-contacting components of the device must be demonstrated to be biocompatible. (3) Labeling must include the following: (i) Instructions for use; (ii) A precaution that monitoring of capnography is necessary during treatment with non-spontaneously breathing patients; and (iii) Use life specification.
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