RESPIRONICS PERFORMAX TOTAL FACE MASK

K091271 · Respironics Inc., Sleep & Home Respiratory Group · BZD · May 29, 2009 · Anesthesiology

Device Facts

• Record ID: K091271
• Device Name: RESPIRONICS PERFORMAX TOTAL FACE MASK
• Applicant: Respironics Inc., Sleep & Home Respiratory Group
• Product Code: BZD · Anesthesiology
• Decision Date: May 29, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Performax Total Face Mask is intended to provide an interface for application of CPAP or BiPAP therapy to patients. The mask is for multi-patient reuse on adult patients in the home or hospital/institutional environment.

Device Story

Performax Total Face Mask serves as patient interface for CPAP/BiPAP therapy; delivers pressurized air to patient. Device consists of polycarbonate faceplate, silicone cushion seal, and integrated entrainment valve with silicone flapper for exhalation. Used in home or hospital/institutional environments; operated by clinicians or patients. Modification adds autoclaving as disinfection method for multi-patient reuse and updates swivel torque specification. Mask connects to patient circuit (22mm tubing) for gas delivery. Integrated exhalation features on faceplate and elbow eliminate need for separate exhalation device. Benefits include secure seal and therapy delivery for adult patients.

Clinical Evidence

Bench testing only. No clinical data provided. Testing validated the safety and effectiveness of the new autoclaving disinfection method and the modified swivel torque specification.

Technological Characteristics

Materials: Polycarbonate faceplate, silicone cushion seal, silicone flapper. Form factor: Total face mask, available in small and large sizes. Connectivity: Connects to standard 22mm patient circuit tubing. Disinfection: Supports autoclaving (newly added) and multi-patient reuse. No software or electronic components.

Indications for Use

Indicated for adult patients requiring CPAP or BiPAP therapy in home or hospital/institutional settings. Multi-patient reuse permitted.

Regulatory Classification

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.

Predicate Devices

• Respironics Performax Total Face Mask (K072592)

Reference Devices

• K992969

Submission Summary (Full Text)

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K09127

#### Special 510(k) Attachment 4 - 510(k) summary

Respironics Performax Total Face Mask

| Date of Submission | 29 April 2009 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | MAY 29 2009<br>Andrew P. Zeltwanger<br>Manager, Regulatory Affairs<br>Respironics, Inc.<br>1001 Murry Ridge Lane<br>Murrysville, PA 15668<br>[e-mail]<br>724-387-7442 t<br>724-448-0543 c<br>724-387-7490 f |
| Classification Reference | 21 CFR 868.5905 |
| Product Code | BZD - Ventilator, Non-Continuous (respirator) |
| Common/Usual Name | Ventilator, continuous, non-life supporting |
| Proprietary Name | Respironics Performax Total Face Mask |
| Predicate Device(s) | Respironics Performax Total Face Mask (K072592) - BZD |
| Reason for submission | Modification to add autoclaving |

# Substantial Equivalence

The Respironics Performax Total Face Mask has the following similarities to the previously cleared predicate device:

- ロ: Same intended use.
- Same operating principle. ට
- Same technology. 0
- Same manufacturing process.

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This premarket notification submission demonstrates that the Performax Total Face Mask is substantially equivalent to the design of the Respironics Performax Total Face Mask (K072592). The Performax Total Face Mask has been modified to add a new method of disinfection for multi-patient use in the hospital or institution. These modifications are described herein. Based on the testing performed, the additional cleaning and disinfection method has no effect on the safety or effectiveness of the device.

The following changes have been made:

- The addition of autoclaving as an approved method of disinfection
- The modification to the Swivel torque specification

### Intended Use

The Performax Total Face Mask is intended to provide an interface for application of CPAP or BiPAP therapy to patients. The mask is for multi-patient reuse on adult patients in the home or hospital/institutional environment.

### Device Description

The Respironics Performax Total Face Mask has the exact same design as the previously cleared Performax Total Face Mask (K072592). The Performax Mask consists of a polycarbonate faceplate with silicon cushion seal for the face. An integrated entrainment valve is provided for exhalation. The integrated entrainment valve elbow is polycarbonate with a silicone flapper. The function of the entrainment valve is unchanged from K992969. The mask when used with the integrated entrainment valve has two integrated exhalation features, which includes the one port on the faceplate and an exhalation site on the elbow. A separate exhalation device is not required for the integrated entrainment valve design. The mask faceplate contains headgear hooks upon which the premium headgear is attached. The mask is available in two sizes - small and large.

The Respironics Performax Total Face Mask is intended for use with a patient circuit that is used to connect the device to the patient interface device (mask). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen 22mm tubing, a method of venting exhaled gases.

(End of Tab.)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 9 2009

Mr. Andrew P. Zeltwanger Manager, Regulatory Affairs Respironics, Incorporated Home Respiratory Group 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668

Re: K091271

Trade/Device Name: Respironics Performax Total Face Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: BZD Dated: April 29, 2009 Received: April 30, 2009

Dear Mr. Zeltwanger:

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.

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 - Mr. Zeltwanger

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/cdrh/comp/ 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/cdrh/mdr/ 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Runge

Susan Runner, D.D.S., MA Acting Division 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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Indications for Use

510(k) Number (if known): _KCN 27 |

Device Name: ____Respironics Performax Total Face Mask

The Performax Total Face Mask is intended to provide an interface for application of CPAP or BiPAP therapy to patients. The mask is for multi-patient reuse on adult patients in the home or hospital/institutional environment.

Prescription Use ____________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schett

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

510(k) Number. K091271