REUSABLE CONTOUR II NASAL MASK

K991648 · Respironics, Inc. · BZD · May 28, 1999 · Anesthesiology

Device Facts

• Record ID: K991648
• Device Name: REUSABLE CONTOUR II NASAL MASK
• Applicant: Respironics, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: May 28, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Respironics Reusable Contour II Nasal Mask is intended to provide an interface for application of Respironics bi-level or CPAP therapy to patients. For single patient use in the home or hospital/institutional environment. The mask is to be used on adult patients (>30kg) for whom bi-level or CPAP therapy has been prescribed using a Respironics bi-level or CPAP system.

Device Story

Reusable nasal mask interface for CPAP or bi-level therapy; delivers pressurized air to patient airways. Components: silicone cushion, polycarbonate faceplate, polycarbonate elbow with integrated exhalation ports, gel forehead spacer. Elbow swivels 360 degrees at faceplate and tubing connection; 22 mm flexible tubing attachment. Used in home or hospital settings by adult patients. Device provides secure seal via variable-thickness cushion and force-distributing gel spacer; allows for increased strap tension without compromising comfort. Fixed exhalation ports eliminate need for separate exhalation device. Streamlined faceplate reduces mask volume.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: silicone (cushion), polycarbonate (faceplate, elbow). Design: nasal mask with integrated exhalation ports, gel forehead spacer, and dual-swivel elbow. Connectivity: 22 mm flexible tubing interface. Energy source: none (passive interface).

Indications for Use

Indicated for adult patients (>30 kg) requiring CPAP or bi-level therapy prescribed for use with Respironics systems.

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

• Reusable Contour Nasal Mask (K991648)

Submission Summary (Full Text)

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Reusable Contour II Nasel Mask

8

K 91648

P.04

Premarket Notification - Special 610(K)

#### & EFFECT 30MMAH

Image /page/0/Picture/4 description: The image shows the logo for Respironics Inc. The logo features a stylized graphic above the company name, with the address "1001 Murry Ridge Lane, Murrysville, PA 15668" printed below. The logo is in black and white and appears to be from a printed document.

### Official Contact

David J, Vanella Manager, Regulatory Affairs Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668

Classification Reference

21 CFR 868.5895

**Product Code**

BZD - noncontinuous ventilator

Common/Usual Name nasal mask

Proprietary Namp

Reusable II Contour Nasal Mask

**Predicate Device**

Reusable Contour Nasal Mask Hausable Conton Nasal Mask

Change in design; change in materials Reason for submission,

## Substantial Equivalence

Verlineation testing has shown the modified mask has the following similarities to the previously cleared predicate device:

- Same indicated use.
- Same operating principle.
- Same skin-contacting mask cushion materials.
- Same technology.
- Same manufacturing process

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P.05

fire summary, the mask described in this submission is, in our opinion, 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.

# evice Description/Intended Use

The Reusable Contour II Nasal Mask is intended to provide a single-patient use interface for adult patients (>30 kg) receiving Respironics CPAP or bi-level therapy. It consists of a silicone skincontacting cushion, a polycarbonate faceplate and a polycarbonate elbow (to which 22 mm flexible tubing is attached). The mask elbow swivels 360 degrees relative to the faceplate.

Image /page/1/Figure/7 description: This image shows a diagram of a medical mask and its components. The mask includes a faceplate, gel forehead spacer, mask cushion, pressure pickoff port, modified elbow, exhalation ports, accessory swivel, and 22 mm flexible tubing. The exhalation ports are located on each side of the elbow.

eusable Contour II Nasal Mask.

The Reusable Contour II Nasal mask has two permanently fixed exhalation ports (vent holes), one on each side of the mask elbow, which eliminate the need for a separate exhalation device. An accessory swivel allows rotation of the flexible tubing about its center axis. Thus the elbow swivels at both the faceplate and the tubing connection. The mask cushion material varies in thickness for hetter seal and fit. The cushion material is thinnest where the cushion contacts the nose.

The faceplate has a streamlined, compact shape to reduce mask volume. The gel forehead spacer is mounted on the mask's forehead extension. Because it distributes force more evenly than the current foam spacer, it allows the patient or caregiver to increase strap tension without jeopardizing patient comfort. The Reusable Contour II Nasal Mask (with an optional headstrap) is available in three sizes (End of Section.) fit a broad range of facial structures.

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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 features a stylized eagle or bird-like symbol with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 8 1999

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

Re: K991648 Reusable Contour Nasal Mask Regulatory Class: II (two) 73 BZD Product Code: May 12, 1999 Dated: Received: May 13, 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 reqistration, 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 regulations 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 Reqister. 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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Paqe 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,

Sincerely yours,

Thomas J. Callahon

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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510(k) Number (if known): K991 to 4

Device Name: Reusable Contour II Nasal Mask

#### Intended Use/Indications for Use

The Respironics Reusable Contour II Nasal Mask is intended to provide an interface for application of Respironics bi-level or CPAP 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 (>30kg) for whom bi-level or CPAP therapy has been prescribed using a Respironics bi-level or CPAP system.

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Concurrence of CDRH, Office of Device Evaluation (ODE) OR Prescription Use Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K991648