PerforMax Pediatric EE Total Face Mask is intended to provide an interface for application of non-invasive positive airway pressure delivered to patients by a device such as a CPAP or bilevel system. 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) for whom positive airway pressure therapy has been prescribed.

Device Description

PerforMax Pediatric EE Total Face Mask is intended to provide an interface for application of non-invasive positive airway pressure delivered to patients by a device such as a CPAP or bi-level system. 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 high-level disinfection process for multi-patient use.

The PerforMax Pediatric EE Total Face Mask consists of a faceplate with a bonded silicone seal for the face and an elbow with an integral entrainment valve. The mask features an interchangeable elbow hub which accepts an EE Leak 1 and EE Leak 2 elbow. The EE Leak 2 elbow includes built-in exhalation, an entrainment valve, a flexible tube, and a 22 mm connection. The EE Leak 1 elbow includes an entrainment valve and a 22 mm connection. The 22 mm elbow is used to 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

The provided document is a 510(k) summary for the PerforMax Pediatric EE Total Face Mask. It describes the device, its intended use, and compares its technological characteristics to predicate devices. It also outlines the non-clinical testing performed to demonstrate safety and efficacy.

However, this document does not contain information on "acceptance criteria" for a study in the context of device performance metrics (e.g., sensitivity, specificity, accuracy, etc.) nor does it describe a study that proves the device meets such criteria in the way typically associated with AI/software devices.

This submission is for a medical device (a face mask) and the "study" referred to is primarily bench testing to demonstrate performance and functionality under various conditions, particularly after cleaning and disinfection processes, and against established material safety standards.

Therefore, many of the requested fields cannot be filled as they are not applicable to the type of device and submission described in the input.

Here's an attempt to answer the questions based only on the provided text, flagging where information is not present or not applicable:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" with specific numerical targets for performance metrics like accuracy, sensitivity, or specificity. Instead, the acceptance criteria are implicitly stated as meeting "performance specifications" and raising "no new issues of safety or effectiveness."

Acceptance Criteria (Implicit from document)	Reported Device Performance
Meets performance specifications (e.g., inspiratory/expiratory resistance, mask leak, functionality pre and post disinfection)	"Results from this testing demonstrate that the PerforMax Pediatric EE Total Face Mask meets its performance specifications..." (Specific numerical results are not provided in this summary.)
Raises no new issues of safety or effectiveness	"...raises no new issues of safety or effectiveness..." (This is a conclusion drawn from the testing, not a direct measurement.)
Substantially equivalent to identified predicate devices	"...and is substantially equivalent to the identified device predicates." (This is the overarching conclusion of the 510(k) submission based on the comparisons and testing.)
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."
High-level disinfection efficacy	Tested for high-level disinfection in accordance with AAMI TIR No. 12-2004, AAMI TIR 30-2003, ASTM E1837-96 (2007), and FDA guidance. (The summary states it was tested, implying it met the criteria, but specific results are not detailed.)

2. 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. The testing described is "bench testing," meaning physical tests on the device itself, not on a human or animal population.
Data provenance: Not applicable in the context of clinical data for this type of bench testing. The testing was performed pre and post institutional cleaning and disinfection treatments.

3. 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. Ground truth as typically understood for diagnostic algorithms (e.g., expert consensus on images) is not relevant for this physical device's bench testing. The "ground truth" would be the established engineering and safety standards/specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are used in clinical studies, particularly for interpreting ambiguous findings or assessing reader agreement, which is not relevant for the bench testing of a medical mask.

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

No. An MRMC study is not mentioned and is not applicable to the evaluation of a non-AI medical mask. The document explicitly states: "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 EE Total Face Mask, as was the case with the predicate devices."

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

This refers to an algorithm's performance. The device is a physical face mask, not an algorithm. Therefore, this question is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for this device would be its ability to meet specified engineering performance metrics (e.g., mask leak, resistance) and material safety standards when subjected to various environmental and cleaning conditions. It is based on engineering specifications and established regulatory standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. This is not an AI/ML device, so there is no "training set" or ground truth established in that context.

Summary

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510(K) SUMMARY	K120562
Date of Submission	21 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 EE Total Face Mask
Common/Usual Name	Face Mask
Classification Name /Product Code	BZD - Ventilator, Non-Continuous (Respirator)
Predicate Device(s)	Respironics PerforMax Youth EE Total Face Mask (K092043)
	Respironics Small Child Profile Lite Nasal Mask (K093416)

Device Description

PerforMax Pediatric EE Total Face Mask is intended to provide an interface for application of non-invasive positive airway pressure delivered to patients by a device such as a CPAP or bi-level system. 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 high-level disinfection process for multi-patient use.

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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.

Intended Use

PerforMax Pediatic EE Total Face Mask is intended to provide an interface for application of non-invasive positive airway pressure delivered to patients by a device such as a CPAP or bi-level system. 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) for whom positive airway pressure therapy has been prescribed.

Summary of Technological Characteristics of Device Compared to the Predicate Devices

The PerforMax Pediatric EE Total Face Mask has the following similarities in the technological characteristics to the previously cleared devices (Respironics PerforMax Youth EE Total Face Mask, K092043, and Respironics Small Child Profile Lite Nasal Mask, K093416):

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

The PerforMax Pediatric EE Total Face Mask has the following differences in the technological characteristics to the previously cleared devices (Respironics PerforMax Youth EE Total Face Mask, K092043, and Respironics Small Child Profile Lite Nasal Mask, K093416):

1. Faceplate and cushion have been reduced in size.
1. Elbow modified
Operating pressure range has been modified. 3.
Addition of inspiratory and expiratory resistance performance specification. 4.
Mask leak specifications has been modified. 5.
The elbow body, elbow hub, and headgear materials have been modified. 6.

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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 hospitallinstitutional 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 EE Total Face Mask meets 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 EE 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 shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

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 17 2012

Re: K120562

Trade/Device Name: PerforMax Pediatric EE Total Face Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: July 9, 2012 Received: July 10, 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 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,

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): L 12 Q 5 6 レ

PerforMax Pediatric EE Total Face Mask Device Name: ___

PerforMax Pediatric EE Total Face Mask is intended to provide an interface for application of non-invasive positive airway pressure delivered to patients by a device such as a CPAP or bilevel system. 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) for whom positive airway pressure therapy has been prescribed.

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

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. Schulte

(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).