AF541 SE Full Face Mask

K150638 · Respironics, Inc. · CBK · Sep 18, 2015 · Anesthesiology

Device Facts

• Record ID: K150638
• Device Name: AF541 SE Full Face Mask
• Applicant: Respironics, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Sep 18, 2015
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Oral-nasal full face mask; provides patient interface for noninvasive ventilation; accessory to ventilators administering CPAP or positive pressure; used in hospital/institutional environments. Features interchangeable Over-the-Nose (OTN) and Under-the-Nose (UTN) cushions on a common frame; includes 4-point headgear and capstrap for oral access. Clinician-operated; facilitates respiratory support for patients with respiratory failure or obstructive sleep apnea. Benefits include patient-specific fit via multiple cushion sizes and configurations, ensuring effective pressure delivery and patient comfort during ventilation therapy.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via non-clinical bench testing, including biocompatibility (muscle implantation, genotoxicity, intracutaneous injection, Kligman maximization, agar diffusion) and performance testing (pressure drop, leak, deadspace).

Technological Characteristics

Materials: Silicone (cushion), Polycarbonate (frame), Polypropylene (elbow), Nylon/Spandex/Polyurethane foam (headgear). Design: Oral-nasal mask with interchangeable OTN/UTN cushions. Standards: ISO 17510-2, ISO 10993-1, ISO 14971. Non-sterile, single-use. No software or electronic components.

Indications for Use

Indicated for patients >40lbs/20kg requiring noninvasive ventilation, CPAP, or positive pressure ventilation for respiratory failure, respiratory insufficiency, or obstructive sleep apnea in hospital/institutional settings.

Regulatory Classification

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.

Predicate Devices

• AF531 SE Full Face Mask (K101129)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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.

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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.<br>1001 Murry Ridge Lane<br>Murrysville, PA 15668 |
| | [phone]<br>[phone] (fax) |
| Official Contact | Shaylee Masilunas |
| | Regulatory Affairs Engineer |
| Establishment<br>Registration # | 2518422 |
| Proprietary Name | AF541 SE Full Face Mask |
| Common/Usual Name | Mask Accessory to a Continuous Ventilator |
| Classification Panel | Anesthesiology Devices |
| Classification<br>Reference | 21 CFR 868.5895 |
| Classification Name /<br>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

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.

### 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 Device<br>AF531 with Standard Elbow (SE) –<br>Small Size (K101129) | Subject Device<br>AF541 SE Full Face Mask |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | The AF531 SE is intended to provide<br>a patient interface for application of<br>noninvasive ventilation. The mask is<br>to be used as an accessory to<br>ventilators which have adequate<br>alarms and safety systems for<br>ventilation failure, and which are<br>intended to administer CPAP or<br>positive pressure ventilation for<br>treatment of respiratory failure,<br>respiratory insufficiency or<br>obstructive sleep apnea. The mask is<br>for single use in the<br>hospital/institutional environment | This AF541 SE Full Face Mask is<br>intended to provide a patient interface<br>for application of noninvasive<br>ventilation. The mask is to be used as<br>an accessory to ventilators which have<br>adequate alarms and safety systems<br>for ventilation failure, and which are<br>intended to administer CPAP or positive<br>pressure ventilation for treatment of<br>respiratory failure, respiratory<br>insufficiency or obstructive sleep<br>apnea. The mask is for single use in<br>the hospital/institutional environment |

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| Area | Predicate Device<br>AF531 with Standard Elbow (SE) -<br>Small Size (K101129) | Subject Device<br>AF541 SE Full Face Mask |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| | only. The mask is to be used on<br>patients 7 years or older<br>(>40lbs/20kg) who are appropriate<br>candidates for noninvasive<br>ventilation. | only. The mask is to be used on<br>patients (>40lbs/20kg) who are<br>appropriate candidates for noninvasive<br>ventilation. |
| Patient<br>Population | 7 years or older (>40lbs/20kg) | Similar to K101129.<br>(>40lbs/20kg) |
| Patient<br>Usage Type /<br>Environment<br>of Use | Single use in the hospital/institutional | Unchanged from K101129. |
| Product Code | CBK | Unchanged from K101129. |
| Provided<br>Sterile or<br>Non-Sterile | Non-Sterile | Unchanged from K101129. |
| Anatomical<br>Sites | Nose and Mouth | Unchanged from K101129. |
| Device<br>Design | 1. Faceplate/frame<br>2. Cushion<br>3. Elbow<br>4. Headgear<br>5. Headgear clips | 1. Frame<br>2. Cushion<br>3. Elbow<br>4. Headgear<br>5. Headgear talon clips |
| Sizes | One size - Small | Over the Nose (OTN) version has four<br>sizes (S, M, L, XL)<br>Under the Nose (UTN) version has<br>three sizes (A, B, C) |

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| Component | Primary Predicate: | Subject Device: |
|-------------------|---------------------------------------|-------------------------------------|
| | Device: | Device: |
| | AF531 SE Mask - Small Size<br>K101129 | AF541 SE Full Face Mask |
| | Manufacturer: | Manufacturer: |
| | Respironics, Inc. | Respironics, Inc. |
| Cushion | Silicone | Silicone |
| Frame | Polycarbonate | Polycarbonate |
| Elbow | Polycarbonate | Polypropylene |
| Headgear/Capstrap | Nylon/Spandex, Polyurethane<br>Foam | Nylon/Spandex, Polyurethane<br>Foam |

#### 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.