GALEMED CPAP MASK

K072755 · Galemed Corp. · BZD · Nov 16, 2007 · Anesthesiology

Device Facts

• Record ID: K072755
• Device Name: GALEMED CPAP MASK
• Applicant: Galemed Corp.
• Product Code: BZD · Anesthesiology
• Decision Date: Nov 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GaleMed CPAP masks are intended to be used in a home, hospital or institutional environment for patients who have been prescribed CPAP/VPAP therapy. This device is intended to be used under the specific direction of a physician. Disposable and Single patient, multi-use styles.

Device Story

GaleMed CPAP mask is a patient interface for CPAP/VPAP therapy; available in full face and nasal styles. Device includes headgear for attachment and an integral anti-asphyxia valve. Used in home, hospital, or sub-acute care settings under physician direction. Functions as a passive delivery interface to maintain airway pressure; does not involve active sensing or electronic processing. Benefits patient by facilitating prescribed positive airway pressure therapy for OSA management.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing comparing flow, leak, pressure, and dead space characteristics against the predicate device.

Technological Characteristics

Materials: Polycarbonate and silicone. Components: Headgear, anti-asphyxia valve. Form factor: Full face and nasal masks. Disposable and single-patient multi-use configurations. No electronic components, software, or energy source.

Indications for Use

Indicated for adult patients with Obstructive Sleep Apnea (OSA) prescribed CPAP/VPAP therapy. No contraindications reported.

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

• Hsiner Co., Ltd. (K063268)

Submission Summary (Full Text)

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K072755

GaleMed CPAP mask

## Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 26-Sept-07

| 87, Li-gong, 2nd Road | | |
|-------------------------------------------------------------------|----------------------------------------------------|--|
| Wu-jia, I-Lan, 268, Taiwan<br>Tel – 011-3-990-8618 | | |
| Official Contact:<br>Thomas Loescher | NOV 】 6 200 | |
| Proprietary or Trade Name:<br>CPAP masks | | |
| Common/Usual Name:<br>Patient interface for use with CPAP systems | | |
| Classification Name:<br>BZD - 868.5905 | Ventilator. non-continuous (respirator), accessory | |
| Device:<br>CPAP masks | | |
| Predicate Devices:<br>Hsiner Co., Ltd. - K063268 | | |

#### Device Description:

The proposed CPAP masks incorporate a number of features, which are designed to maximize seal and comfort, and maintain the mask in the correct position throughout use.

- . Full face and Nasal style
- . Integral anti-asphyxia valve
- Headgear for attachment .
- . Single use disposable and Single patient, multi-use

| Indications for Use: | The GaleMed CPAP masks are intended to be used in a home,<br>hospital or institutional environment for patients who have been<br>prescribed CPAP/VPAP therapy. This device is intended to be<br>used under the specific direction of a physician. Disposable and<br>Single patient, multi-use styles. |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient Population: | Adults with OSA |
| Environment of Use: | Hospitals, Home, sub-acute care settings |
| Contraindications: | None |

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# Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 26-Sept-07

#### Comparative table:

| Features | Predicate Hsiner<br>K063268 | Proposed Device |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Indications for use | The Hsiner CPAP masks are<br>intended to be used in a home,<br>hospital or institutional environment<br>for patients who have been<br>prescribed CPAP/VPAP therapy.<br>This device is intended to be used<br>under the specific direction of a<br>physician. Disposable and Single<br>patient, multi-use styles. | Identical |
| Environment of Use | Home, Hospital, Sub-acute<br>Institutions | Same |
| Patient Population | Adult | Same |
| Contraindications | None | None |
| Single patient,<br>Multi-use | Yes | Yes |
| Components | Headgear<br>Anti-asphyxia valve | Headgear<br>Anti-asphyxia valve |
| Anti-asphyxia valve | Yes | Yes |
| Materials | Polycarbonate<br>Silicone | Identical K063268 |
| Comparative testing<br>for safety and<br>efficacy | Flow vs. Leak / Pressure<br>Dead space | Identical |

### Differences Between Other Legally Marketed Predicate Devices:

The proposed device is identical to the predicate device, K063268.

There are no differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus.

NOV 1 6 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Galemed Corporation C/O Mr. Paul Dryden President ProMedic, Incorporated 3460 Pointe Creek Court, # 102 Bonita Springs, Florida 34134-2015

Re: K072755

Trade/Device Name: CPAP Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: September 26, 2007 Received: September 27, 2007

Dear Mr. Dryden:

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 - Mr. Dryden

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,

Neil R.C. dyl
for

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 Statement

Page 1 of 1

(To be assigned) 510(k) Number: CPAP mask Device Name: The GaleMed CPAP masks are intended to be used in a Indications for Use: home, hospital or institutional environment for patients who have been prescribed CPAP/VPAP therapy. This device is intended to be used under the specific direction of a physician. Disposable and Single patient, multi-use styles.

Prescription Use XX (Part 21 CFR 801 Subpart D) or

Over-the-counter use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Müll Thul

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

510(k) Number: _______________________________________________________________________________________________________________________________________________________________