The small size AF531 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 7 years or older (>40lbs/20kg) who are appropriate candidates for noninvasive ventilation.

Device Description

The Respironics AF531 SE Full Face Mask consists of a silicone cushion, polycarbonate faceplate with a standard elbow with no exhalation, requiring the use of a separate exhalation device. This mask is an accessory for use with ventilators in the hospital/institutional environment only. The small size AF531 SE Full Face Mask will be used on patients 7 years or older (> 40 lbs/20kg).

AI/ML Overview

The Respironics AF531 SE Full Face Mask is a medical device for noninvasive ventilation. The provided text describes its acceptance criteria and the study conducted to prove it meets them.

1. Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Intended Use	The mask is intended to provide a patient interface for application of noninvasive ventilation in a hospital/institutional environment for patients aged 7 years or older (>40lbs/20kg).
Environment of Use	Hospital/institutional environment only.
Patient Population	Patients 7 years or older (> 40 lbs/20kg).
Ventilator Compatibility	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 insufficiency or obstructive sleep apnea.
Performance Testing	- Pressure Performance: Not explicitly detailed, but implied to be sufficient for non-invasive ventilation.- Waveform Performance: Not explicitly detailed, but implied to be compliant with ventilation requirements.- Triggering, Cycling, and Alarm Functionality: Implied to be compatible and functioning correctly with ventilators.- Safety and Effectiveness: No new issues of safety or effectiveness identified.
Material/Design	Silicone cushion, polycarbonate faceplate, standard elbow (requiring separate exhalation device), uses Four Points Headgear design (CapStrap headgear also compatible).
Usage	Single use only.

Reported Device Performance:
The document states: "The modified device has been performance tested with passing results. Test protocols including pressure performance, waveform performance, triggering, cycling and alarm functionality testing along with the results of these tests are provided in Tab 8 of this submission." And, "The small size AF531 SE Full Face Mask was performance tested and verified to meet the required acceptance criteria. Results of this testing concluded that the verification testing raises no new issues of safety or effectiveness."

2. Sample Size and Data Provenance

The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The testing described appears to be technical bench testing of the device's physical and functional properties rather than clinical data from human subjects.

3. Number and Qualifications of Experts for Ground Truth

This information is not provided in the document. Given that the testing focuses on the device's physical and functional performance (pressure, waveform, triggering, etc.), it's likely that engineers and technical experts in ventilation equipment would have been involved, rather than medical experts establishing ground truth for diagnostic accuracy.

4. Adjudication Method

The document does not specify any adjudication method for a test set. This type of method is typically used in studies involving subjective interpretation (e.g., image analysis for diagnosis), which is not the nature of the described testing for this device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being conducted involving human readers with or without AI assistance. This type of study is not relevant to the evaluation of a face mask for non-invasive ventilation.

6. Standalone Algorithm Performance

This device is a physical medical device (a face mask), not an algorithm or AI system. Therefore, the concept of a "standalone (i.e., algorithm only without human-in-the-loop performance)" study is not applicable.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established by technical specifications and functional output (e.g., measured pressure, waveform characteristics, appropriate triggering/cycling, alarm functionality) as per engineering and regulatory standards for ventilator accessories. It is not based on expert consensus, pathology, or outcomes data in the clinical sense, but rather on whether the device meets its defined technical performance parameters.

8. Sample Size for the Training Set

The concept of a "training set" is typically associated with machine learning or AI algorithm development. Since this is a physical medical device and not an AI system, there is no training set in the conventional sense. The "training" for such devices involves design, prototyping, and iterative testing to ensure it meets specifications.

9. How Ground Truth for the Training Set was Established

As there is no "training set" for this physical device, the question of how its ground truth was established is not applicable. The design and development process for such a device relies on engineering principles, material science, and established standards for medical device safety and performance.

Summary

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510(K) SUMMARY OF SAFETY & EFFECTIVENE

Date of Submission

510(k) Owner

TAB 3

April 21, 2010

Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668

Official Contact

Zita Yurko Director, Regulatory Affairs (724) 387-4120 (724) 882-4120 (cell) (724) 387-4216 (fax)

Anesthesiology Devices

Proprietary Name

Common/Usual Name Face mask

Class II Device Classification

Classification Panel

Product Code CBK - Continuous ventilator

Respironics PerforMax SE Total Face Mask (K072588/K092648) Predicate Devices

Respironics AF531 SE Full Face Mask

Draft labeling can be found in Tab 5 Labeling

Modified device Reason for submission

Device Description

Intended Use

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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 7 years or older (>40lbs/20kg) who are appropriate candidates for noninvasive ventilation.

Predicate Comparison

Comparison of the AF531 SE Full Face Mask (modified mask) with the predicate Respironics PerforMax SE Total Face Mask (K072588/K092648);

. The intended use and the environment of use is the same. Both masks are for the hospital/institutional use only on patients 7 years or older and > 40lbs/20kg.
Both masks contain a silicone cushion, polycarbonate faceplate and standard elbow, . requiring the use of an additional exhalation device. The same elbow is on both masks.
. Both masks use the same headgear (Four Points Headgear design) and headgear attachment clips. The CapStrap headgear may also be used with the AF531 mask.
The difference between the modified device and the Respironics PerforMax SE Total Face . Mask predicate is the shape of the faceplate and cushion. The modified device is a full face mask with a faceplate and cushion covering the nose and mouth, whereas the predicate device is a total face mask with a faceplate and cushion covering the nose, mouth and eyes.

The modified device has been performance tested with passing results. Test protocols including pressure performance, waveform performance, triggering, cycling and alarm functionality testing along with the results of these tests are provided in Tab 8 of this submission.

Substantial Equivalence

The AF531 SE Full Face Mask has the following similarities to the previously cleared predicate device:

O Same intended use.
o Same operating principle.
D Same technology.
D Same manufacturing process.

There is no change to the intended use, operating principle, technology or manufacturing process for the AF531 SE Full Face Mask. The small size AF531 SE Full Face Mask was performance tested

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and verified to meet the required acceptance criteria. Results of this testing concluded that the verification testing raises no new issues of safety or effectiveness.

Respironics has followed the FDA's Guidance for Industry and FDA Staff document "pre-market assessment of pediatric medical devices" and applied the principle of FDA's Least Burdensome Approach to demonstrate the Substantial Equivalence of the mask.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. 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 or bird-like figure, represented by three curved lines that suggest wings and a head.

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

Respironics, Incorporated Ms. Zita A. Yurko Director, Regulatory Affairs Sleep & Home Respiratory Group 1740 Golden Mile Highway Monroeville, Pennsylvania 15146

SEP 1 32010

Re: K101129

Trade/Device Name: AF531 SE Full Face Mask Regulation Number: 21 CFR 868.5895 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: CBK Dated: August 12, 2010 Received: August 18, 2010

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. 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. 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 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/Medica]Devices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jm. I. D. So. A.

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

K/01129
SEP 1 3 2010

510(k) Number (if known):

Device Name: AF531 SE Full Face Mask

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 Devide Evaluation (ODE)

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

510(k) Number: K101129

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).