This 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 alams and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory insufficiency or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients (>40lbs/20kg) who are appropriate candidates for noninvasive ventilation.

Device Description

The AF541 SE Full Face Mask is an oral-nasal full face mask that is available in two cushion configurations. The AF541 SE Full Face has two cushion configurations, an Over the Nose (OTN) cushion and an Under the Nose (UTN) cushion. The AF541 SE Full Face Mask will have interchangeable cushions that attach to a common frame. There will be four sizes available for the over the nose option (S, M, L, XL). The UTN option will have three sizes available (A, B, C). The AF541 SE will include a 4 point headgear and capstrap to allow for oral access with either headgear option.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called the "AF541 SE Full Face Mask." This type of document is for demonstrating substantial equivalence to a predicate device, not for proving that a device meets specific clinical performance acceptance criteria in the way an AI diagnostic device would.

Therefore, the document does not contain the information requested in your prompt regarding:

A table of acceptance criteria and reported device performance for an AI model.
Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, or standalone performance for an AI model.
Ground truth details for test or training sets of an AI model.

The document describes non-clinical performance and biocompatibility tests for a physical medical device (a mask) and compares it to a predicate device.

However, to address some elements from your prompt based on the provided text, and distinguish them from what is not present (AI-specific criteria):

Acceptance Criteria and Device Performance (Non-Clinical for a Physical Mask Device):

The document states that "Design verification tests were performed on the AF541 SE Full Face Mask. All tests were verified to meet the required acceptance criteria." It also notes that "Performance testing was performed before and after cleaning treatments to verify that the device modifications did not raise new safety and effectiveness concerns of the subject device."

The specific acceptance criteria values or the reported performance data are not provided in this summary. It only states that the tests met the required acceptance criteria.

Types of Non-Clinical Performance Testing Performed:

Total Mask Pressure Drop: The device was tested to ensure the pressure drop across the mask meets certain specifications for proper ventilation. (Specific criteria/results not provided).
Total Mask Leak: The device was tested for leakage to ensure effective delivery of ventilatory pressure. (Specific criteria/results not provided).
Deadspace: The dead space within the mask was measured to ensure it is within acceptable limits for effective ventilation. (Specific criteria/results not provided).

Biocompatibility Testing (for materials in contact with tissue):

New materials used in the mask were classified as external communicating, tissue contact, with a contact duration C (> 30 days cumulative). The following biocompatibility tests were completed and presumably met their acceptance criteria:

Muscle Implantation Study in Rabbits (4 Weeks)
Muscle Implantation Study in Rabbits (12 Weeks)
Genotoxicity: Bacterial Reverse Mutation Study
Genotoxicity: Mouse Lymphoma Assay
Genotoxicity: Mouse Peripheral Blood Micronucleus Study
Intracutaneous Injection Test
Kligman Maximization Test
Agar Diffusion Test (Direct Contact)

Regarding the AI-specific questions from your prompt:

Table of acceptance criteria and the reported device performance: Not applicable/Not present. This document is for a physical medical device (mask), not an AI diagnostic/analytic device. It states non-clinical tests met acceptance criteria, but no specific values or a table are provided.
Sample size used for the test set and the data provenance: Not applicable/Not present. No test set for an AI model.
Number of experts used to establish the ground truth... and qualifications: Not applicable/Not present. No ground truth for an AI model.
Adjudication method: Not applicable/Not present. No adjudication method for an AI model.
If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable/Not present. No MRMC study for an AI model.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/Not present. No algorithm performance.
The type of ground truth used: Not applicable/Not present.
The sample size for the training set: Not applicable/Not present.
How the ground truth for the training set was established: Not applicable/Not present.

Conclusion from the document:

The manufacturer concluded that the new AF541 SE Full Face Mask is substantially equivalent to the predicate device (AF531 SE Full Face Mask - K101129) based on similar intended use, operating principle, design, materials (with biocompatibility testing for new materials), and manufacturing process, and that non-clinical performance and design verification tests (Total Mask Pressure Drop, Total Mask Leak, Deadspace) were successfully met, raising no new safety or effectiveness concerns. Clinical tests were explicitly stated as "not required."

Summary

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

September 18, 2015

Respironics, Inc. Ms. Shaylee Masilunas Regulatory Affairs Engineer 1001 Murry Ridge Lane Murrysville, PA 15668

Re: K150638

Trade/Device Name: AF541 SE Full Face Mask Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK Dated: August 14, 2015 Received: August 17, 2015

Dear Ms. Shaylee Masilunas:

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.

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

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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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K150638

Device Name AF541 SE Full Face Mask

Indications for Use (Describe)

This 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 alams and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory insufficiency or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients (>401bs/20kg) who are appropriate candidates for noninvasive ventilation.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishing Services (Jul) 443-6740 EB

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510(k) Summary

Date	March 9, 2015
510(k) Owner	Respironics, Inc.1001 Murry Ridge LaneMurrysville, PA 15668
	(724) 387-7729(724) 387-3999 (fax)
Official Contact	Shaylee Masilunas
	Regulatory Affairs Engineer
EstablishmentRegistration #	2518422
Proprietary Name	AF541 SE Full Face Mask
Common/Usual Name	Mask Accessory to a Continuous Ventilator
Classification Panel	Anesthesiology Devices
ClassificationReference	21 CFR 868.5895
Classification Name /Product Code	CBK - Continuous Ventilator (Anesthesiology)
Predicate Device(s)	AF531 SE Full Face Mask (K101129)

Indication for Use

The AF541 SE Full 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 ventilation 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 single use in the hospital/institutional environment only. The mask is to be used on patients (>40lbs/20kg) who are appropriate candidates for noninvasive ventilation.

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Device Description

Similarities and Differences of the Subject Device Compared to the Predicate Devices

The AF541 SE Full Face Mask has the following similarities to the previously cleared predicate devices AF531 SE Full Face Mask (K101129):

Similar intended use ●
Same operating principle ●
Similar design ●
Similar materials
Similar manufacturing process

The AF541 SE Full Face Mask has the following differences in the technological characteristics to the previously cleared predicate devices AF531 SE Full Face Mask (K101129):

Patient population ●
Patient usage type ●
Interchangeable cushion design
. Mask materials

Table 1: Comparison Table of Respironics AF541 EE Full Face Mask and predicate device

Area	Predicate DeviceAF531 with Standard Elbow (SE) –Small Size (K101129)	Subject DeviceAF541 SE Full Face Mask
IntendedUse	The AF531 SE is intended to providea patient interface for application ofnoninvasive ventilation. The mask isto be used as an accessory toventilators which have adequatealarms and safety systems forventilation failure, and which areintended to administer CPAP orpositive pressure ventilation fortreatment of respiratory failure,respiratory insufficiency orobstructive sleep apnea. The mask isfor single use in thehospital/institutional environment	This AF541 SE Full Face Mask isintended to provide a patient interfacefor application of noninvasiveventilation. The mask is to be used asan accessory to ventilators which haveadequate alarms and safety systemsfor ventilation failure, and which areintended to administer CPAP or positivepressure ventilation for treatment ofrespiratory failure, respiratoryinsufficiency or obstructive sleepapnea. The mask is for single use inthe hospital/institutional environment

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Area	Predicate DeviceAF531 with Standard Elbow (SE) -Small Size (K101129)	Subject DeviceAF541 SE Full Face Mask
	only. The mask is to be used onpatients 7 years or older(>40lbs/20kg) who are appropriatecandidates for noninvasiveventilation.	only. The mask is to be used onpatients (>40lbs/20kg) who areappropriate candidates for noninvasiveventilation.
PatientPopulation	7 years or older (>40lbs/20kg)	Similar to K101129.(>40lbs/20kg)
PatientUsage Type /Environmentof Use	Single use in the hospital/institutional	Unchanged from K101129.
Product Code	CBK	Unchanged from K101129.
ProvidedSterile orNon-Sterile	Non-Sterile	Unchanged from K101129.
AnatomicalSites	Nose and Mouth	Unchanged from K101129.
DeviceDesign	1. Faceplate/frame2. Cushion3. Elbow4. Headgear5. Headgear clips	1. Frame2. Cushion3. Elbow4. Headgear5. Headgear talon clips
Sizes	One size - Small	Over the Nose (OTN) version has foursizes (S, M, L, XL)Under the Nose (UTN) version hasthree sizes (A, B, C)

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Component	Primary Predicate:	Subject Device:
	Device:	Device:
	AF531 SE Mask - Small SizeK101129	AF541 SE Full Face Mask
	Manufacturer:	Manufacturer:
	Respironics, Inc.	Respironics, Inc.
Cushion	Silicone	Silicone
Frame	Polycarbonate	Polycarbonate
Elbow	Polycarbonate	Polypropylene
Headgear/Capstrap	Nylon/Spandex, PolyurethaneFoam	Nylon/Spandex, PolyurethaneFoam

Table 2: Material comparison for the Respironics AF541 SE Full Face Mask and its predicate device

New materials used in this mask are classified as external communicating, tissue contact, with a contact duration C (> 30 days cumulative). The following biocompatibility tests were completed:

Muscle Implantation Study in Rabbits 4 Weeks ●
Muscle Implantation Study in Rabbits 12 Weeks ●
Genotoxicity: Bacterial Reverse Mutation Study .
. Genotoxicity: Mouse Lymphoma Assay
. Genotoxicity: Mouse Peripheral Blood Micronucleus Study
. Intracutaneous Injection Test
Kligman Maximization Test
Agar Diffusion Test (Direct Contact)

Design verification tests were performed on the AF541 SE Full Face Mask. All tests were verified to meet the required acceptance criteria. Respironics has determined that the modifications have not raised new safety and effectiveness concerns of the device. In summary, the device described in this submission is substantially equivalent to the predicate device.

Clinical Tests

Clinical tests were not required to demonstrate the substantial equivalence of the AF541 SE Full Face Mask. Product functionality has been adequately assessed by non-clinical tests.

Non-Clinical Tests

Performance testing was performed before and after cleaning treatments to verify that the device modifications did not raise new safety and effectiveness concerns of the subject device. Performance testing included:

Total Mask Pressure Drop .
Total Mask Leak ●

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. Deadspace
The AF541 SE Full Face Mask has been designed per the following standards:
. ISO 17510-2 Sleep Apnoea Devices Part 2: Masks and Application Accessories
. ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
. ISO 14971 Medical devices – Application of risk management to medical devices

Conclusion

The performance and technological characteristics of the AF541 SE Full Face Mask are substantially equivalent to those of the AF531 SE Full Face Mask (K101129) and raise no new types of safety or effectiveness questions.

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).