STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964

K990574 · Respironics, Inc. · MNT · May 24, 1999 · Anesthesiology

Device Facts

• Record ID: K990574
• Device Name: STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964
• Applicant: Respironics, Inc.
• Product Code: MNT · Anesthesiology
• Decision Date: May 24, 1999
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Respironics Stick-On Disposable Nasal Mask is intended to provide an interface for application of Respironics BiPAP and CPAP support therapy to patients.

Device Story

Disposable nasal mask providing interface for BiPAP/CPAP therapy; consists of thermoplastic elastomer faceplate with integrated exhalation port and 22mm extendible inlet tube; features pressure-sensitive adhesive foam seal for skin contact; used in hospital/institutional environments; applied by clinicians to adult patients; facilitates delivery of prescribed respiratory support; single-use device.

Clinical Evidence

Bench testing only. Performance-related testing verified safety and effectiveness in the intended environment.

Technological Characteristics

Materials: Thermoplastic elastomer faceplate; three-layer foam seal (pressure-sensitive adhesive, closed-cell foam, bonding layer). Dimensions: 22mm inlet tube. Connectivity: Attaches to standard 22mm circuits. Single-use, non-sterile.

Indications for Use

Indicated for adult patients (> 30 kg) in hospital or institutional settings requiring BiPAP or CPAP therapy. Contraindicated for use on non-intact skin.

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

• Disposable Contour Nasal Mask (K951264)

Submission Summary (Full Text)

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Premarket Notification Section 510(k) Section 1 - Summary of Safety and Effectiveness isposable Nasal Mask

## SECTION 1

# SUMMARY OF SAFETY & EFFECTIVENESS

Image /page/0/Picture/5 description: The image shows the logo for Respironics Inc. The logo consists of a triangle with a stylized figure inside, followed by the text "RESPIRONICS INC." Below the company name is the address "1001 Murry Ridge Drive, Murrysville, PA 15668".

| 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 868.5895 |
| Product Code | MNT - continuous ventilator, minimal ventilatory support |
| Common/Usual Name | nasal mask |
| Proprietary Name | Stick-On Disposable Nasal Mask |
| Predicate Device | Disposable Contour Nasal Mask<br>As cleared with Respironics BiPAP S/T-D System (K951264) |
| Reason for submission | New Device |

### Substantial Equivalence

This premarket notification section 510(k) submission demonstrates that the Stick-On Disposable Nasal Mask is substantially equivalent to, and has the same intended use as, the Respironics Disposable Contour Nasal Mask, as cleared with the Respironics BiPAP S/T-D System.

Testing was performed to demonstrate that the performance of the Stick-On Disposable Nasal Mask in its intended environment is as safe and effective as that of the legally marketed predicate device. The safety and effectiveness of the Stick-On Disposable Nasal Mask were verified through performance-related testing. The Stick-On Disposable Nasal Mask was tested and found compliant

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

## Device Description/Intended Use/Indications for Use

The Disposable Nasal Stick-On Mask is intended to provide an interface for application of Respironics BiPAP and CPAP therapy to patients. The mask consists of a faceplate with a contoured skincontacting foam seal. The inlet connector of the faceplate has a pre-assembled, 22mm extendible inlet tube that attaches to a Respironics 22mm circuit. The faceplate has an integrated supplemental exhalation port and strap tabs to accommodate a strap that facilitates holding the mask in place under pressure. The mask is single use, however it can be repositioned on a patient during application and use.

The Stick-On Mask is molded of a soft thermoplastic elastomer, allowing it to flex to fit most adults. The skin-contacting portion is a soft foam material that is bonded to the faceplate of the mask. The foam seal is a laminate of three layers: a skin-contacting layer of a pressure sensitive adhesive material, a center contouring layer made of a soft, mostly closed cell foam, and an interfacing bonding the foam to the faceplate.

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Image /page/2/Figure/2 description: This image shows a diagram of a medical mask and its components. The mask has a head strap, strap tabs, a secondary exhalation port, proximal pressure tubing, mask flex tubing, an exhalation port, and circuit tubing. There is also a paper label that says "Remove".

Figure 1-1. Stick-On Disposable Nasal Mask.

#### Environment of Use/Patient Population

The Stick-On Disposable Nasal Mask is intended for short-term, single use in a hospital or institutional environment. The mask is to be used on adult patients (> 30 kg) under the following conditions:

- Patients for whom BiPAP or CPAP has been prescribed, using a Respironics BiPAP or CPAP 0 system.
- 口 Intact, external skin surfaces only.

(End of Section.)

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned in the center of a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 4 1999

Mr. David J. Vanella Manager, Regulatory Affairs Respironics, Inc. 1001 Murrv Ridge Lane Murrysville, Pennsylvania 15668-8550

K990574 Re: Stick-On Disposable Nasal Mask Requlatory Class: II (two) Product Code: MNT Dated: February 22, 1999 Received: February 23, 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 Requlations, 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 requlation (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

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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.

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, 2 Misbranding by reference to premarket notification² (21CFR 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,

Thomas J. Callahan

Thomas J.Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _1_of_1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Stick-On Disposable Nasal Mask

#### Intended Use/Indications for Use

The Respironics Stick-On Disposable Nasal Mask is intended to provide an interface for application of Respironics BiPAP and CPAP support therapy to patients.

#### Environment of Use/Patient Population

For short-term, single use in a hospital or institutional environment. The mask is to be used on adult patients (> 30kg) under the following conditions:

- [ Patients for whom BiPAP or CPAP has been prescribed, using a Respironics BiPAP or CPAP system.
- Intact, external skin surfaces only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

ice of Device Evaluation (ODE)

Over-The-Counter Use (Optional Format 1-2-96)

A. A. Ciarkowski