The RespCare Hybrid AV Mask is intended for use by adults (> 30 kg) as a patient interface for CPAP or Bi-Level positive-pressure ventilation devices for treatment of respiratory insufficiencies and obstructive sleep apnea.

(Applies to the standard version):

For homecare applications, the Hybrid AV Mask may be reused multiple times by a single patient. For institutional applications (i.e. hospital or other clinical settings), this interface may be reused multiple times by multiple patients.

(Applies to the Disposable version): The Hybrid AV Disposable Mask is a single patient, single use interface.

Device Description

The RespCare Hybrid AV Mask is a patient interface accessory to a positive pressure ventilator intended for treatment of respiratory insufficiencies and obstructive sleep apnea. The device delivers positive airway pressure from a CPAP or bi-level device to the patient's oral and nasal passages. Connection to the ventilator device is made by a standard 22 mm fitting. The mask is held in place on the face by headgear worn around the head. The device includes anti-asphyxia valve and oxygen entrainment port features.

AI/ML Overview

This device is a RespCare Hybrid AV Mask, a patient interface accessory for positive pressure ventilators. The submission is a Special 510(k) and focuses on modifications to an existing predicate device (K052227). As such, the presented information does not include a traditional study with acceptance criteria and device performance as typically expected for novel or substantially altered devices. Instead, the submission relies on demonstrating substantial equivalence to the predicate device.

Here's an analysis based on the provided text, addressing the requested points:

Table of acceptance criteria and the reported device performance:

Not applicable in the conventional sense for this Special 510(k). The submission relies on demonstrating substantial equivalence to a predicate device (K052227, RespCare Face Mask). The "performance" is implicitly tied to the predicate device's established safety and effectiveness.

Acceptance Criterion (Implicit)	Reported Device Performance (Implicit/Claimed)
Same Intended Use and Indications: The modified device must serve the same purpose and be indicated for the same patient population and conditions as the predicate device.	"The intended use and indications of the modified device are the same as the intended uses and indications as the predicate device."
Same Fundamental Scientific Technology: The underlying principles of operation and design should be consistent with the predicate.	"The modified device uses the same fundamental scientific technology as the predicate device."
No New Issues of Safety and Effectiveness: Design changes should not introduce new risks or compromise existing safety/effectiveness.	"Changes to the design do not raise new issues of safety and effectiveness..."
Safety and Effectiveness Verified by Same Methods as Predicate: For any changes, their impact should be assessed using methods comparable to those used for the predicate.	"...and safety and effectiveness are verified using the same methods as reviewed in the K052227 clearance."
Design Modifications: Specific changes related to exhalation ports and coupling adapters must be properly addressed and not negatively impact performance when used as intended (i.e., with a separate exhalation device and appropriate male hose fitting).	The exhalation ports are removed from the mask shell to accommodate systems with built-in exhalation devices. The male coupling adaptor is eliminated, using a female coupling for a separate exhalation device. Labeling specifies use with a separate exhalation device and connection to a male hose fitting. This implies the device performs as intended when these conditions are met, mirroring the predicate's overall function in its respective system. The phrase "Other than these differences, the Hybrid AV Mask is essentially similar to the predicate device" underscores the claim of comparable performance.

Sample size used for the test set and the data provenance:

No specific test set or sample size is explicitly mentioned for this Special 510(k) submission. The submission states that "safety and effectiveness are verified using the same methods as reviewed in the K052227 clearance." This implies a reliance on the data and testing that supported the original predicate device clearance, rather than new, independent testing for this specific modification. Therefore, details about data provenance (e.g., country of origin, retrospective/prospective) are not provided in this document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Since no new test set is explicitly described for this modification, there's no mention of experts establishing a ground truth for a test set in this document. The assessment relies on the regulatory review (FDA's evaluation of the K052227 clearance) that validated the predicate device's safety and effectiveness.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. No new test set requiring adjudication is described for this submission.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a passive respiratory mask, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant here.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a passive respiratory mask and does not involve an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not explicitly stated for the modified device. The claim is that "safety and effectiveness are verified using the same methods as reviewed in the K052227 clearance." This implies that whatever ground truth (e.g., performance testing against established engineering standards, clinical observations for safety and comfort, or other relevant data) was used for the predicate device, it is considered sufficient for the modified device given the nature of the changes.
The sample size for the training set:

Not applicable. As a physical medical device (mask), it does not involve a "training set" in the context of machine learning or AI.
How the ground truth for the training set was established:

Not applicable for the same reason as point 8.

Summary

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K06224

510(k) SUMMARY Special 510(k) - RespCare Hybrid AV Mask

Submitter's Name:	RespCare Inc.
Submitter's Address:	6601 Lyons Road, Suites B1-B4Coconut Creek, FI 33073, USA	AUG 17 2006
Telephone Number:	(561) 208-3778
Fax Number:	(561) 892-2350
Contact Person:	Frank Pelc
Date:	August 1, 2006
Proprietary Name:	RespCare Hybrid AV Mask
Common/Usual Name:	Face Mask
Classification:	Class II, CFR 868.5905, BZD
Classification Name:	Accessory to Noncontinuous Ventilator
Predicate Device:	K052227, RespCare Face Mask

Device Description

Comparison to Predicate Devices

Modifications relate to providing a mask for use with systems that incorporate built-in exhalation devices. The exhalation ports are removed from the mask shell. Also, the optional male coupling adaptor is eliminated, as a female coupling is appropriate for connecting to a separate exhalation device. Labeling changes relate only to the above changes. The instructions specify that the Hybrid AV must be used with a separate exhalation device, and specify that the mask connects to a male hose fitting.

Other than these differences, the Hybrid AV Mask is essentially similar to the predicate device.

Substantial Equivalence

The information provided in this Special 510(k) demonstrates that the proposed device is substantially equivalent to the identified predicate device. The intended use and indications of the modified device are the same as the intended uses and indications as the predicate device. The modified device uses the same fundamental scientific technology as the predicate device. Changes to the design do not raise new issues of safety and effectiveness, and safety and effectiveness are verified using the same methods as reviewed in the K052227 clearance.

510(k) Summary Page 1 of 1

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 7 2006

Mr. Frank Pelc Director, Regulatory Affairs Pespcare, Incorporated 6601 Lyons Road, Suites B1-B4 Coconut Creek, Florida 33073

Re: K062224

Trade/Device Name: RespCare Hybrid AV Mask Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: August 1, 2006 Received: August 3, 2006

Dear Mr. Pelc:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Pelc

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies, You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 .CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Hcalth

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known):

Device Name: RespCare Hybrid AV Mask

Indications for Use:

(Applies to the standard version):

(Applies to the Disposable version): The Hybrid AV Disposable Mask is a single patient, single use interface.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cover Son
(Sign-Off)
rion of Anesthesiology, General Hospital,
ion Control, Dental Devices
) Number: K062224

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).