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Isocapnic Ventilation Device

Page Type
Product Code
Definition
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 (21 CFR 868.5320), oxygen cannulas (21 CFR 868.5340), masks (21 CFR 868.5550), valves (21 CFR 868.5870), resuscitation bags (21 CFR 868.5915), and/or tubing (21 CFR 868.5925).
Physical State
Device controls gas concentration, flowrate, and output pressures. Gases are delivered via breathing circuits.
Technical Method
Device administers blend of oxygen and carbon dioxide via a patient breathing circuit to enable isocapnic breathing.
Target Area
Lungs
Regulation Medical Specialty
General Hospital
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5480
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 868.5480 Isocapnic ventilation device

§ 868.5480 Isocapnic ventilation device.

(a) 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).

(b) 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 O2 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.

[86 FR 68397, Dec. 2, 2021]

Isocapnic Ventilation Device

Page Type
Product Code
Definition
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 (21 CFR 868.5320), oxygen cannulas (21 CFR 868.5340), masks (21 CFR 868.5550), valves (21 CFR 868.5870), resuscitation bags (21 CFR 868.5915), and/or tubing (21 CFR 868.5925).
Physical State
Device controls gas concentration, flowrate, and output pressures. Gases are delivered via breathing circuits.
Technical Method
Device administers blend of oxygen and carbon dioxide via a patient breathing circuit to enable isocapnic breathing.
Target Area
Lungs
Regulation Medical Specialty
General Hospital
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5480
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 868.5480 Isocapnic ventilation device

§ 868.5480 Isocapnic ventilation device.

(a) 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).

(b) 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 O2 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.

[86 FR 68397, Dec. 2, 2021]