PERFORMAX SE TOTAL FACE MASK

K072588 · Respironics Inc., Sleep & Home Respiratory Group · CBK · Dec 18, 2007 · Anesthesiology

Device Facts

• Record ID: K072588
• Device Name: PERFORMAX SE TOTAL FACE MASK
• Applicant: Respironics Inc., Sleep & Home Respiratory Group
• Product Code: CBK · Anesthesiology
• Decision Date: Dec 18, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Performax SE Total 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 ventilator 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 multi-patient reuse on patients weighing > 30 kg), who are appropriate candidates for noninvasive ventilation, in the hospital/institutional environment only.

Device Story

The Respironics Performax SE Total Face Mask is a patient interface for noninvasive ventilation; it connects to a ventilator circuit to deliver CPAP or positive pressure ventilation. The device consists of a polycarbonate faceplate and a silicone cushion seal; it features headgear hooks for attachment. It is designed for multi-patient reuse in hospital or institutional environments. The mask is available in two sizes (small and large). It functions as an accessory to ventilators equipped with appropriate alarms and safety systems. The device helps treat respiratory failure, respiratory insufficiency, or obstructive sleep apnea by providing a secure seal for air delivery. Clinicians select the mask for patients weighing over 30 kg who are candidates for noninvasive ventilation.

Clinical Evidence

Bench testing only.

Technological Characteristics

Polycarbonate faceplate; silicone cushion seal; polycarbonate standard elbow interface. Two sizes available (small, large). Designed for multi-patient reuse. Non-powered, passive interface device.

Indications for Use

Indicated for patients > 30 kg requiring noninvasive ventilation for respiratory failure, respiratory insufficiency, or obstructive sleep apnea. For use in hospital/institutional settings only.

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

• Respironics Total Face Mask (K992969)
• Image 3 SE Face Mask (K023135)

Submission Summary (Full Text)

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Traditional 510(k) Tab 5 – 510(k) summary

K072588

Respironics Performax SE Total Face Mask

# TAB 5

| 510(K) SUMMARY | |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Submission | 12 September 2007 |
| Official Contact | Zita A. Yurko<br>Director, Regulatory Affairs<br>Respironics, Inc.<br>1001 Murry Ridge Lane<br>Murrysville, PA 15668<br>[e-mail]<br>724-387-4120 t<br>724-882-4120 c<br>724-387-4216 f<br>DEC 1 8 2007 |
| Classification Reference | 21 CFR 868.5895; 21CFR 858.5905 |
| Product Code | CBK - Continuous Ventilator; BZD - non-continuous ventilator |
| Common/Usual Name | Ventilator, continuous, facility use; ventilator, non-continuous (respirator) |
| Proprietary Name | Respironics Performax SE Total Face Mask |
| Predicate Device(s) | Respironics Total Face Mask (K992969) - BZD<br>Image 3 SE Face Mask (K023135) - CBK |
| Reason for submission | new device |

## Substantial Equivalence

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

- Same intended use.
- Same operating principle. ப
- Same technology. D
- Same manufacturing process. ා

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This premarket notification submission demonstrates that the Performax SE Total Face Mask is substantially equivalent to the Respironics Total Face Mask (K992969). Design modifications have been made to the Total Face Mask for this submission. These modifications are described here in. Based on the testing performed, none of the design modification affect the safety or effectiveness of the device.

The following changes have been made:

- 프 The change in the face plate design to contour the face
- I The change in the sealing cushion design
- r The addition of a standard elbow without exhalation similar to the standard elbow used on the Image 3 SE. This design is intended for use with a ventilator that has an integral safety valve.
- ı The addition of the claim for multi-patient use to be included.

### Intended Use

The Performax SE Total 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 ventilator 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 multi-patient reuse on patients weighing > 30 kg), who are appropriate candidates for noninvasive ventilation, in the hospital/institutional environment only.

#### Device Description

The Respironics Performax SE Total Face Mask consists of a polycarbonate faceplate with silicon cushion seal for the face. Like the device predicate, Image 3SE full face mask (K023135), the interface to the patient circuit is a polycarbonate standard elbow. The design of the standard elbow (SE) is the same as the SE used on the Image 3SE Full Face mask. The mask when used with the standard elbow has one integrated exhalation feature, which includes one port on the faceplate. Similar to the device predicate, Total Face Mask (K992969), the mask faceplate contains headgear hooks upon which the premium headgear is attached. The mask is available in two sizes - small and large.

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The Respironics Performax SE 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.

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(End of Tab.)

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DEC 1 8 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Zita Yurko Director, Regulatory Affairs Respironics Incorporated, Sleep & Home Respiratory Group 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668

Re: K072588

Trade/Device Name: Respironics Performax SE Total Face Mask Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: November 21, 2007 Received: November 23, 2007

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. 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): ________________

:

Device Name: ____Respironics Performax SE Total Face Mask_____________________________________________________________________________________________________________________

The Performax SE Total 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 ventilator 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 multi-patient reuse on patients weighing > 30 kg, who are appropriate candidates for noninvasive ventilation, in the hospital/institutional environment only.

Prescription Use ____________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aut J. Wate

K072588