RESPIRONICS TOTAL FACE MASK

K992969 · Respironics, Inc. · BZD · Nov 10, 1999 · Anesthesiology

Device Facts

• Record ID: K992969
• Device Name: RESPIRONICS TOTAL FACE MASK
• Applicant: Respironics, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Nov 10, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Respironics® Total™ Face Mask is intended to provide an interface for application of Respironics CPAP or BiPAP therapy to patients. For single patient use in the home or hospital/institutional environment. The mask is to be used on adult patients (>30 kg) for whom CPAP or BiPAP therapy has been prescribed using a Respironics CPAP or BiPAP system.

Device Story

Respironics Total Face Mask is a single-patient-use interface for CPAP/BiPAP therapy. Device covers entire face, framing hairline and jawline. Components include polycarbonate faceplate, silicone cushion, headgear, and entrainment valve. Input is pressurized air from CPAP/BiPAP system; output is delivered therapy to patient airway. Used in home or hospital by adult patients. Modified design features smaller, rounder faceplate (1550 ml volume) compared to predicate; includes integrated entrainment valve for ambient air access if pressure ceases and built-in exhalation ports. Healthcare providers use device to facilitate non-invasive ventilation; patient benefits from improved seal and therapy delivery.

Clinical Evidence

Bench testing only. Design verification tests performed per risk analysis assessment; acceptance criteria met.

Technological Characteristics

Polycarbonate faceplate; silicone cushion. 22-mm entrainment valve; integrated exhalation ports; pressure pickoff port. Volume: 1550 ml. Single-patient-use. Non-invasive interface for CPAP/BiPAP. Complies with 1993 FDA Draft Reviewer Guidance for Premarket Notifications.

Indications for Use

Indicated for adult patients (>30 kg) requiring CPAP or BiPAP therapy prescribed for use with Respironics systems in home or hospital settings.

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

• Total Face Mask (K925920)

Submission Summary (Full Text)

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## TACHMENT 4

# SUMMARY OF SAFETY & EFFE

| Official Contact | David J. Vanella<br>Manager, Regulatory Affairs<br>Respironics, Inc.<br>1001 Murry Ridge Lane<br>Murrysville, PA 15668 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------|
| Classification Reference | 21 CFR 868.5905 |
| Product Code | BZD - noncontinuous ventilator |
| Common/Usual Name | nasal mask |
| Proprietary Name | Respironics® Total™ Face Mask |
| Predicate Device | Total Face Mask (K925920) |
| Reason for submission | Modified design; modified materials |

### Substantial Equivalence

The modified mask has the following similarities to the previously cleared predicate device:

- 0 Same intended use.
- ପ Same operating principle.
- Same technology.
- O Same manufacturing process.

Design verification tests were performed on the Total Face Mask as a result of the risk analysis assessment, and acceptance criteria were met. Respironics has determined that the modifications have no impact on the safety and effectiveness of the device. In summary, the mask described in this submission is substantially equivalent to the predicate device.

The modified mask complies with the applicable standards referenced in the "Draft FDA Reviewer Guidance for Premarket Notifications," November 1993.

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## Device Description/Intended Use

The Total Face Mask is intended to provide a single-patient-use interface for adult patients (>30 kg) receiving Respironics CPAP or BiPAP therapy. The mask (Figure 1) fits over the entire face, with the rim of the mask framing the face along the hairline and jawline. The mask consists of a polycarbonate faceplate and a thin silicone cushion that folds inward, creating a flap on the inner perimeter of the mask to improve seal. The faceplate has four Velcro® hooks to which the headgear tabs attach.

Image /page/1/Figure/4 description: The image contains two figures of a Respironics Total Face Mask. Figure 1 shows the face mask being worn with headgear and flexible tubing. Figure 2 shows the face mask with the total face mask faceplate, entrainment valve, accessory swivel, exhalation ports, pressure pickoff port cap, and headgear hooks.

The modified faceplate (Figure 2) is smaller, rounder, and has a streamlined profile. (Predicate mask is larger, primarily round, with the exception of the eye area, which is squared off.) Modified mask volume is smaller at 1550 ml. (Predicate volume is 2300 ml.) Modified mask cushion material is silicone. (Predicate cushion is urethane.)

Modified faceplate (Figure 2) has a nosepiece with 22-mm entrainment valve, whose accessory swivel connects to patient circuit. (Predicate faceplate has a 22-mm elbow, to which patient circuit is connected.) Entrainment valve opens to ambient air if pressure should cease. (Predicate requires use of a non-rebreathing valve (NRV).) Two built-in exhalation ports are located on the nosepiece. (Predicate's ports are located on the mask.) Nosepiece has one pressure pickoff port. (Predicate elbow has two.) The headgear consists of Velcro® straps. (Predicate headgear is a cap with Velcro straps.)

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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure in profile, with three overlapping heads suggesting a sense of community or interconnectedness.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 0 1999

Mr. David J. Vanella Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668-8550

K992969 Re : Total Face Mask Regulatory Class: II (two) Product Code: 73 BZD October 8, 1999 Dated: Received: October 12, 1999

Dear Mr. Vanella:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. David J. Vanella

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Jeanne M. Wentworth for;

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K992969

Device Name: Respironics® Total™ Face Mask

#### Intended Use/Indications for Use

The Respironics® Total™ Face Mask is intended to provide an interface for application of Respironics CPAP or BiPAP therapy to patients.

#### Environment of Use/Patient Population

For single patient use in the home or hospital/institutional environment. The mask is to be used on adult patients (>30 kg) for whom CPAP or BiPAP therapy has been prescribed using a Respironics CPAP or BiPAP system.

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| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |
|------------------------------------------|----|--------------------------------------------------|
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| (Division Sign-Off) | |
|----------------------------------------------------------------------|----------|
| Division of Cardiovascular, Respiratory,<br>and Neurological Devices | |
| 510(k) Number | K 992969 |