SOYALA FULL FACE MASK GEL VENTED

K073673 · Weinmann Gerate Fur Medizin GmbH + Co. KG · BZD · Mar 28, 2008 · Anesthesiology

Device Facts

• Record ID: K073673
• Device Name: SOYALA FULL FACE MASK GEL VENTED
• Applicant: Weinmann Gerate Fur Medizin GmbH + Co. KG
• Product Code: BZD · Anesthesiology
• Decision Date: Mar 28, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Full Face Mask is intended for adult patients (>30kg) prescribed continuous positive airway pressure (CPAP) or bi-level therapy for multiple patient use in a hospital or clinic anway prood after high-level disinfection and for single-patient use in a home environment.

Device Story

SOYALA Full Face Mask GEL vented is a molded plastic mask used to deliver CPAP or bi-level positive pressure therapy. It features a gel mask cushion, gel forehead cushion, mask frame, adjustable components, headgear, and an exhalation system. The device connects to therapy equipment via a swivel elbow and tubing. It is intended for use by adult patients in clinical or home settings. The mask facilitates the delivery of pressurized air to the patient's airway to support respiratory therapy.

Clinical Evidence

Bench testing only. Biocompatibility testing and performance bench testing were conducted to verify that the device meets acceptance criteria and performs equivalently to the predicate.

Technological Characteristics

Molded plastic mask with gel cushions (mask and forehead). Includes exhalation system, frame, adjustment components, headgear, and swivel elbow. Non-powered, passive interface for CPAP/bi-level ventilators. No software or electronic components.

Indications for Use

Indicated for adult patients (>30kg) prescribed CPAP or bi-level therapy for use in hospital, clinic, or home environments.

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

• SOYALA Full Face Mask (K061653)

Submission Summary (Full Text)

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# 11. 510(k) Summary

# SOYALA Full Face Mask GEL vented

MAR 2 8 2008

December 12, 2007

### Submitter Information:

Weinmann - Geräte fur Medizin GmbH+Co. KG Kronsaalsweg 40 22525 Hamburg Germany

| Submitter's Name: | Dr. Ralf Egenolf |
|-------------------|-------------------------|
| Phone: | 011 49 40 54 70 2 - 370 |
| Fax: | 011 49 40 54 70 2 - 468 |

#### Device Name:

| Proprietary name: | SOYALA Full Face Mask GEL vented |
|----------------------|----------------------------------------|
| Common Name: | Full Face Mask |
| Classification Name: | Accessory to non-continuous ventilator |

### Device Classification:

21 CFR 868.5905, Class II, Product Code BZD

## Predicate Device Equivalence:

Substantial equivalence is claimed to SOYALA Full Face Mask, cleared for commercial distribution per K061653.

#### Device Description:

The SOYALA Full Face Mask GEL vented is a molded plastic mask, including an exhalation system, for the delivery of CPAP or Bi-level Positive Pressure therapy.

It consists of a gel mask cushion, gel forehead cushion, mask frame, coarse adjustment it component, fine adjustment, forehead support, headgear, headgear clip, ports for pressure measurement, port cap, rotating sleeve, elbow, and retaining ring.

The mask provides a swivel and securely attached elbow connection for simple and secure handling of the tubing between the mask and the therapy device.

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Image /page/1/Picture/0 description: The image shows the logo for WEINMANN medical technology. The logo is in black and white. The word "WEINMANN" is in large, bold letters, and the words "medical technology" are in smaller letters below. There are two diagonal lines above the letters "ANN".

#### Intended Use:

The Full Face Mask is intended for adult patients (>30kg) prescribed continuous positive airway pressure (CPAP) or bi-level therapy for multiple patient use in a hospital or clinic anway prood after high-level disinfection and for single-patient use in a home environment.

# Comparison of Technological Characteristics

The SOYALA Full Face Mask GEL vented has the same technological characteristics as the predicate device.

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

- . Same intended use
- Same operating principle .
- Same fundamental scientific technology .
- Same mask design .

Some materials of the modified device are changed. Safety and effectiveness are not affected by these changes.

### Summary of Device Testing:

Biocompatibility testing was performed to verify the equivalent safety of the materials that are used. Bench testing was performed to verify equivalent performance. All tests were verified to meet acceptance criteria.

#### Conclusion:

Based on the above, we concluded that the SOYALA Full Face Mask GEL vented is substantially equivalent to legally marketed predicate device and is safe and effective for its intended use, and performs as well as the predicate device.

End of section.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird-like figure. The symbol is composed of several curved lines that come together to form the shape of the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAR 2 8 2008

Dr. Ralf Egenolf Head of Quality Management and Regulatory Affairs Department Weinmann Gerate fur Medizin GmbH + Company KG Kronsaalsweg 40 22525 Hamburg GERMANY

Re: K073673

Trade/Device Name: SOYALA Full Face Mask GEL Vented Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: February 28, 2008 Received: March 4, 2008

Dear Dr. Egenolf:

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 - Dr. Egenolf

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 (QS) 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,

Sutie y. Michie Dmd

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 6.

510(k) Number (if known):

K073673

Device Name: SOYALA Full Face Mask GEL vented

Indications For Use:

The Full Face Mask is intended for adult patients (>30kg) prescribed continuous positive The Full Pace Mask is intended for addit patient use in a hospital on clinic airway pressure (CPAP) of blevel therepy for makiple patient use in a home environment.

AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Min Thul

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

510(k) Number:________________________________________________________________________________________________________________________________________________________________