The ComfortGel Full Face Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for multi-patient use in the home or hospital/institutional environment. The mask is to be used on patients (>66 Ibs/30 kg) for whom CPAP or bi-level therapy has been prescribed using a CPAP or bi-level system.

Device Description

The Respironics ComfortGel Full Face Mask consists of a polycarbonate faceplate with a gel cushion encapsulated in a urethane seal for the face. The mask includes exhalation ports and an entrainment valve that allows the patient to breath room air if positive pressure is discontinued. The integrated entrainment valve elbow is polycarbonate with a silicone flapper. The function of the entrainment valve is unchanged from K002465 and K954207, based on performance data. The mask with the integrated entrainment valve has integrated exhalation features that are located on the top of the valve. A separate exhalation device is not required for the integrated entrainment valve design. The mask faceplate contains a socket for attachment of the headgear via use of a mushroom-shaped "quick clip" mechanism. The mask is available in three sizes - small, medium and large.

The Respironics ComfortGel Full Face Mask is intended for use with a patient circuit that is used to connect a therapy device to the patient interface device (mask). A typical patient circuit consists of a sixfoot disposable or reusable smooth lumen 22mm tubing, a method of venting exhaled gases.

AI/ML Overview

This document describes the Respironics ComfortGel Full Face Mask. It is a 510(k) submission which demonstrates substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria for a new and novel clinical claim. Therefore, much of the requested information regarding clinical studies, ground truth, expert adjudication, and statistical measures like effect size is not applicable in this context.

However, based on the provided text, we can infer some details related to the "acceptance criteria" in the context of substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are not quantitative performance metrics in a clinical study but rather a demonstration that the new device shares fundamental characteristics with predicate devices and that design modifications do not negatively affect safety or effectiveness. The reported "device performance" relies on demonstrating these similarities and the safety of the modifications.

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance (as demonstrated by the submission)
Intended Use: Same as predicate devices.	The ComfortGel Full Face Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients, for multi-patient use in home or hospital/institutional environment, on patients (>66 lbs./30 kg) for whom CPAP or bi-level therapy has been prescribed. This is stated to be the same intended use as the predicate device.
Operating Principle: Same as predicate devices.	Stated as same operating principle.
Technology: Same as predicate devices.	Stated as same technology.
Manufacturing Process: Same as predicate devices.	Stated as same manufacturing process.
Safety and Effectiveness: Design modifications do not affect these.	"Based on the testing performed, none of the design modification affect the safety or effectiveness of the device." (Specific test results are not detailed in this excerpt but would have been part of the full 510(k) submission). The document mentions functional equivalence of the entrainment valve to predicate devices based on "performance data."
Functional equivalence of specific components (e.g., entrainment valve).	"The function of the entrainment valve is unchanged from K002465 and K954207, based on performance data."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated. The document refers to "testing performed" for design modifications and "performance data" for the entrainment valve, but the number of devices or subjects tested is not provided.
Data Provenance: The context implies internal testing by Respironics, Inc. The data would be specific to their new device and its components, likely performed in a controlled laboratory setting or in a limited user study, rather than a large-scale clinical trial. It is an internal report prepared for regulatory submission. The document does not specify country of origin for test data, but the company is US-based. It is retrospective for the purpose of this submission, meaning the tests were completed before the submission date.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable for this type of submission. Ground truth, in a clinical diagnostic sense, is not being established here. The "truth" is whether the device functions as intended and is safe and effective compared to predicates, which is determined through engineering and performance testing.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring expert adjudication of clinical outcomes or interpretations.

5. 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 medical mask for CPAP/bi-level therapy, not an AI diagnostic tool or imaging device that would involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this substantial equivalence submission is based on engineering performance specifications and comparison to the established safety and effectiveness of predicate devices. This means that test data (e.g., pressure measurements, material properties, airflow characteristics, sealing properties, dead space, intentional leak rates) would be compared against predetermined specifications derived from regulatory standards, internal design requirements, and the characteristics of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning study that would involve a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image shows a close-up of a document with some handwritten text at the top. The text appears to be a series of numbers, specifically "1073600". The rest of the image is filled with a dark, grainy texture, obscuring any other potential content on the document. The handwritten numbers are the most prominent and legible feature in the image.

Date of Submission	20 December 2007		APR 2 5 2008
Official Contact	Zita A. YurkoDirector, Regulatory AffairsRespironics, Inc.1001 Murry Ridge LaneMurrysville, PA 15668Zita.yurko@respironics.com724-387-4120 t724-882-4120 c724-387-4216 f
Classification Reference	21 CFR 868.5905
Product Code	BZD - Ventilator, Non-Continuous (respirator)
Common/Usual Name	Ventilator, continuous, non-life supporting
Proprietary Name	Respironics ComfortGel Full Face Mask
Predicate Device(s)	Respironics Spectrum 2 Full Face Mask (K002465) - BZDRespironics Gel Mask (K954207) - BZD
Reason for submission	new device

Substantial Equivalence

The Respironics ComfortGel Full Face Mask has the following similarities to the previously cleared predicate device:

□ Same intended use.
Same operating principle. o
Same technology. ට
Same manufacturing process. a

{1}------------------------------------------------

This premarket notification submission demonstrates that the ComfortGel Full Face Mask is substantially equivalent to the design of the Respironics Spectrum 2 Full Face Mask (K002465) and the Respironics Gel Mask (K954207 for the gel cushion feature only). Design modifications have been made to the ComfortGel Full Face Mask for this submission. These modifications are described here in. Based on the testing performed, none of the design modification affect the safety or effectiveness of the device.

The following changes have been made:

1. The addition of gel to the mask cushion design of the full face mask

The change in the dimensional specifications of the mask, including the change to the size and shape of the mask faceplate and cushion

1. The addition of available mask sizes
1. The addition of the claim for multi-patient use to be added
1. Change to the headgear clip design
1. The change to add a removable cushion
1. The change to the forehead support mechanism
1. The addition of a pressure pick-off port to the faceplate of the mask
1. The increased weight of the mask cushion due to use of gel
1. The change to the mask materials
1. Change to the dead space of the mask
1. Change to the intentional leak of the mask

Intended Use

The ComfortGel Full Face Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for multi-patient use in the home or hospital/institutional environment. The mask is to be used on patients (>66 lbs./30 kg) for whom CPAP or bi-level therapy has been prescribed using a CPAP or bi-level system.

Device Description

The Respironics ComfortGel Full Face Mask consists of a polycarbonate faceplate with a gel cushion encapsulated in a urethane seal for the face. The mask includes exhalation ports and an entrainment

{2}------------------------------------------------

valve that allows the patient to breath room air if positive pressure is discontinued. The integrated entrainment valve elbow is polycarbonate with a silicone flapper. The function of the entrainment valve is unchanged from K002465 and K954207, based on performance data. The mask with the integrated entrainment valve has integrated exhalation features that are located on the top of the valve. A separate exhalation device is not required for the integrated entrainment valve design. The mask faceplate contains a socket for attachment of the headgear via use of a mushroom-shaped "quick clip" mechanism. The mask is available in three sizes - small, medium and large.

(End of Tab.)

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 5 2008

Ms. Zita A. Yurko Director, Regulatory Affairs Respironics Incorporated, Sleep & Home Respiratory Group 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668

Re: K073600

Trade/Device Name: Respironics ComfortGel Full Face Mask Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: April 18, 2008 Received: April 21, 2008

Dear Ms. Yurko:

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.

{4}------------------------------------------------

Page 2 - Ms. Yurko

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device 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 (QS) 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,

Sybil y. Michie Oms.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Minh Hung

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510{k} Number:

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).