The PerforMax Total Face Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. For multi-use in the hospital/institutional environment or single patient reuse in the home. The mask is to be used on patients 7 years or older (>40 lbs/18.2 kg) for whom CPAP or bi-level therapy has been prescribed.

Device Description

The PerforMax Total Face Mask is intended to be used with positive airway pressure devices such as CPAP or bi-level systems. The small size mask is intended for use on patients 7 years or older (>40 lbs/20kg) and the large size mask is intended for use on patients (>66 lbs/30 kg) for whom CPAP or bilevel therapy has been prescribed.

The PerforMax Total Face Mask consists of a polycarbonate faceplate and a silicone cushion seal for the face. The PerforMax Total Face Mask can utilize a bronchoscopy elbow. This elbow will allow physicians to perform bronchoscopy procedures on a patient while the patient is receiving non-invasive ventilation. A pressure-pick off port is located on the elbow. A separate exhalation device is required when using the Respironics PerforMax Total Face Mask with bronchoscopy elbow because exhalation is not built into the mask. The mask is available in two sizes: small and large.

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

AI/ML Overview

This document describes a 510(k) submission for the Respironics PerforMax Total Face Mask. The submission focuses on a modification to an existing device, specifically the introduction of a bronchoscopy elbow, and asserts substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Unintentional leak	Completed and passed during extensive performance testing.
Pressure drop	Completed and passed during extensive performance testing.
CO2 rebreathing	Completed and passed during extensive performance testing.
Mask deadspace	Completed and passed during extensive performance testing.
Therapy device compatibility	Completed and passed during extensive performance testing.
Biocompatibility (new skin-contacting and air path-contacting materials)	Biocompatibility assessment completed in accordance with ISO 10993-1, including irritation, sensitization (ISO 10993-10), and cytotoxicity (ISO 10993-5) tests, and passed.

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

The document does not explicitly state the sample sizes used for each specific test (unintentional leak, pressure drop, CO2 rebreathing, mask deadspace, therapy device compatibility, biocompatibility). The testing described appears to be retrospective in the sense that it evaluates a modification to an existing device against established performance benchmarks for that device. The provenance of the data is internal testing conducted by Respironics, Inc. There is no indication of external data sources or specific countries of origin beyond the company's location.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The testing described focuses on engineering and biocompatibility benchmarks, not on clinical interpretation or expert consensus regarding performance.

4. Adjudication method for the test set:

This information is not applicable as the evaluation is based on objective performance metrics and compliance with engineering standards, rather than subjective expert adjudication.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a medical mask for CPAP/bi-level therapy, not an AI-assisted diagnostic tool or imaging system. Therefore, the concept of human readers improving with AI assistance is not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

A standalone algorithm performance study was not done. This device is a physical medical mask, not an algorithm.

7. The type of ground truth used:

The ground truth used for this product is based on engineering performance specifications and biocompatibility standards. Specifically:

For performance tests (leak, pressure drop, CO2 rebreathing, deadspace, compatibility), the ground truth is established by the pre-defined performance specifications for the device, consistent with the predicate device tests.
For biocompatibility, the ground truth is established by international standards such as ISO 10993-1, ISO 10993-10, and ISO 10993-5.

8. The sample size for the training set:

There is no training set in the context of this device, as it is a physical medical device and not a machine learning model.

9. How the ground truth for the training set was established:

This question is not applicable as there is no training set for this device.

Summary

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Date of Submission	November 17, 2010
510(k) Owner	Respironics, Inc.1001 Murry Ridge LaneMurrysville, PA 15668(724) 387-4146(724) 387-3999 (fax)
Official Contact	Michelle BrinkerRegulatory Affairs Manager, Patient Interface
Proprietary Name	PerforMax Total Face Mask
Common/Usual Name	Face Mask
Classification Name /Product Code	BZD - Ventilator, non-continuous (respirator)
Predicate Device(s)	Respironics PerforMax Total Face Mask (K072592)Respironics PerforMax Total Face Mask/BiPAP Synchrony 2(K092043)

Device Description

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Intended Use

Summary of Technological Characteristics of Device Compared to the Predicate Device

The modified mask has the following similarities in the technological characteristics to the previously cleared device Respironics PerforMax Total Face Mask (K072592/K092043):

『 Same intended use
매 Same operating principle
Same technology
체 Similar device design
트 Similar physical properties
Similar material used
Same scientific concepts that form the basis for the device .

The modified mask has the following differences in the technological characteristics to the previously cleared device Respironics PerforMax Total Face Mask (K072592/K092043):

The bronchoscopy elbow is being utilized instead of the entrainment elbow.
배 The bronchoscopy elbow will be for single use only in the hospital/institutional environment.
홍 The bronchoscopy elbow material is being tinted green to differentiate between elbows.

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Respironics PerforMax Total Face Mask

Summary of the Non-Clinical Test Submitted, Referenced or Relied on in the 510(k)

To demonstrate performance and functionality was unaffected as a result of this modification, extensive performance testing, including unintentional leak, pressure drop, CO2 rebreathing, mask deadspace and therapy device compatibility tests were completed on the modified PerforMax Total Face Mask. These tests are consistent with the tests that were completed on the predicate device, PerforMax Total Face Mask (K072592/K092043). A biocompatibility assessment in accordance with ISO 10993-1 was completed for all new skin-contacting and air path-contacting materials. As required by the standard, the test suite included irritation and sensitization (ISO 10993-10) and cytotoxicity (ISO 10993-5) biocompatibility tests.

Results from this verification testing concluded that the modified PerforMax Total Face its performance specifications, raises no new issues of safety or effectiveness, and is substantially equivalent to the identified device predicates.

Clinical Data

Use of full face masks with CPAP or bi-level therapy is proven technology and is well accepted by the medical community. Bench testing is sufficient to demonstrate safety and efficacy of the modified PerforMax Total Face Mask, as was the case with the predicate devices.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes on its wing, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Michelle Brinker Regulatory Affairs Manager, Patient Interface Respironics, Incorporated 365 Plum Industrial Court Pittsburgh, Pennsylvania 15239

MAR 2 4 2011

Re: K103395

Trade/Device Name: Respironics PerforMax Total Face Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: February 18, 2011 Received: February 22, 2011

Dear Ms. Brinker:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Ms. Brinker

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital,

Infection Control and Dental Devices

Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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Page __ 1_ of__1

Indications for Use

510(k) Number (if known): __ 103395

Device Name: ___ Respironics PerforMax Total Face Mask

The PerforMax Total Face Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. For multi-patient, multi-use in the hospital/institutional environment or single patient reuse in the home. The mask is to be used on patients 7 years or older (>40 Ibs/18.2 kg) for whom CPAP or bi-level therapy has been prescribed.

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)

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

K103395 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).