The PerforMax Pediatric SE Total Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilator failure and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The mask is for multi-patient use in the hospital/institutional environment only. The mask is to be used on patients 1 year or older (> 7 kg) who are appropriate candidates for noninvasive ventilation.

Device Description

The PerforMax Pediatric SE Total Face Mask is intended to provide a patient interface for application of noninvasive ventilation when used as an accessory to ventilators which have adequate alarms and safety systems for ventilator failure and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. It provides a seal such that positive pressure from the positive pressure source is directed into the patient's nose and mouth. It is held in place with an adjustable bonnet headgear. It may be cleaned by the professional in the hospital/institutional environment through a thermal high-level disinfection process or a chemical highlevel disinfection process for multi-patient use.

The PerforMax Pediatric SE Total Face Mask consists of a faceplate with a bonded silicone seal for the face. A 22 mm standard elbow is connected to the elbow hub on the faceplate. The 22 mm elbow is used to connect a conventional air delivery hose between the mask and the positive airway pressure source. The bonnet headgear is connected to the mask through slots in the upper part of the frame and clips that attach to the lower part of the frame. The mask is designed in such a way that it can be easily disassembled for disinfection or to replace several of the mask components, such as the headgear and elbow.

AI/ML Overview

This document describes the PerforMax Pediatric SE Total Face Mask, a patient interface for noninvasive ventilation. The submission declares that the device is substantially equivalent to predicate devices based on non-clinical performance testing.

Here's an analysis of the acceptance criteria and study information provided:

Acceptance Criteria and Reported Device Performance

The submission does not explicitly list acceptance criteria in a table format with corresponding performance metrics. Instead, it states that "extensive performance testing was completed" to demonstrate functionality was unaffected by changes from predicate devices. The overarching acceptance criterion implicitly is that the device "meets its performance specifications" and "raises no new issues of safety or effectiveness."

Implicit Acceptance Criteria and Performance:

Acceptance Criterion (Implicit)	Reported Device Performance Statement
Functionality unaffected by design changes	"Extensive performance testing was completed. Testing was performed pre and post hospital/institutional cleaning and disinfection treatments." "Results from this testing demonstrate that the PerforMax Pediatric SE Total Face [Mask] meets its performance specifications, raises no new issues of safety or effectiveness, and is substantially equivalent to the identified device predicates."
Compatibility with high-level disinfection processes	"Additionally, the mask was tested for high level disinfection in accordance with AAMI TIR No. 12-2004, AAMI TIR 30-2003, ASTM E1837-96 (2007), and the 'Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants' -FDA CDRH, January 3, 2000." "Results from this testing demonstrate that the PerforMax Pediatric SE Total Face [Mask] meets its performance specifications..."
Biocompatibility of patient-contacting materials	"All patient contacting or gas path materials used in the mask have been previously cleared by the FDA or evaluated in accordance with the guidance provided by ISO 10993-1."
Maintenance of safety and effectiveness compared to predicates	"Results from this testing demonstrate that the PerforMax Pediatric SE Total Face [Mask] meets its performance specifications, raises no new issues of safety or effectiveness, and is substantially equivalent to the identified device predicates."

Study Details

Based on the provided text, this submission relies on non-clinical bench testing rather than clinical studies involving human subjects or AI algorithms. As such, many of the requested fields are not applicable to this type of regulatory submission.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not specified quantitatively. The document refers to "extensive performance testing" but does not give specific numbers of masks or test cycles.
- Data Provenance: Not specified. The testing was likely conducted in a lab environment by the manufacturer (Respironics, Inc. based in Murrysville, PA). The testing appears to be prospective as it was performed specifically for this 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. This was a non-clinical bench test. "Ground truth" would refer to established engineering and material science standards, and the expertise would be in test engineers and quality assurance personnel rather than medical experts for clinical ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This relates to clinical studies and expert review for ground truth establishment.
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 is a medical device for ventilation, not an AI-assisted diagnostic or imaging device. No AI component is mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. No AI algorithm is involved.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" was established by recognized industry standards and FDA guidance documents for medical device performance, disinfection, and biocompatibility. Examples cited include AAMI TIR No. 12-2004, AAMI TIR 30-2003, ASTM E1837-96 (2007), FDA CDRH guidance on sterilants/disinfectants, and ISO 10993-1 for biocompatibility.
The sample size for the training set:
- Not applicable. This is not a machine learning device; therefore, there is no "training set."
How the ground truth for the training set was established:
- Not applicable. There is no training set.

Summary

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TAB 5
510(K) SUMMARY	K120639
Date of Submission	29 February 2012
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 Pediatric SE Total Face Mask
Common/Usual Name	Face Mask
Classification Name /Product Code	CBK - Ventilator, continuous, facility use
Predicate Device(s)	Respironics PerforMax Youth SE Total Face Mask (K092648)Respironics Small Child Profile Lite Nasal Mask (K093416)JUL 10 2012

Device Description

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clips that attach to the lower part of the frame. The mask is designed in such a way that it can be easily disassembled for disinfection or to replace several of the mask components, such as the headgear and elbow.

Intended Use

Summary of Technological Characteristics of Device Compared to the Predicate Devices

The PerforMax Pediatric SE Total Face Mask has the following similarities in the technological characteristics to the previously cleared devices (Respironics PerforMax Youth SE Total Face Mask, K092648, and Respironics Small Child Profile Lite Nasal Mask, K093416):

Same intended use 1.
1. Same operating principle
1. Same technology
1. Similar device design
Similar physical properties 5.
Similar materials used 6.
1. Same scientific concepts that form the basis for the device

The PerforMax Pediatric SE Total Face Mask has the following differences in the technological characteristics to the previously cleared devices (Respironics PerforMax Youth SE Total Face Mask, K092648, and Respironics Small Child Profile Lite Nasal Mask, K093416):

1. Faceplate and cushion have been reduced in size.
Operating pressure range has been modified. 2.
Mask leak specifications has been modified. 3.
The elbow hub and headgear materials have been modified. 4.

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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 these changes, extensive performance testing was completed. Testing was performed pre and post hospital/institutional cleaning and disinfection treatments. Additionally, the mask was tested for high level disinfection in accordance with AAMI TIR No. 12-2004, AAMI TIR 30-2003, ASTM E1837-96 (2007), and the "Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants" -FDA CDRH, January 3, 2000. All patient contacting or gas path materials used in the mask have been previously cleared by the FDA or evaluated in accordance with the guidance provided by ISO 10993-1.

Results from this testing demonstrate that the PerforMax Pediatric SE 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 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 PerforMax Pediatric SE Total Face Mask, as was the case with the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an 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 Sleep and Home Respiratory Group 365 Plum Industrial Court Pittsburg, Pennsylvania 15239

JUL 10 2012

Re: K120639

Trade/Device Name: PerforMax Pediatric SE Total Face Mask Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: June 28, 2012 Received: June 29, 2012

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 (1 vice 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,

Nh 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): ____________________________________________________________________________________________________________________________________________________

PerforMax Pediatric SE Total Face Mask Device Name:

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

Over-The-Counter 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)

L. Schuldthen

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

510(k) Number: 4120639

Regulation Number and Section

§ 868.5895 Continuous ventilator.

(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).