SOYALA SILKGEL FULL FACE MASK

K112167 · Weinmann Gerate Fur Medizin GmbH + Co. KG · BZD · Nov 16, 2011 · Anesthesiology

Device Facts

• Record ID: K112167
• Device Name: SOYALA SILKGEL FULL FACE MASK
• Applicant: Weinmann Gerate Fur Medizin GmbH + Co. KG
• Product Code: BZD · Anesthesiology
• Decision Date: Nov 16, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SOYALA SilkGel Full Face Mask is intended for adult patients (>66 pounds or 30kg) prescribed continuous positive airway pressure (CPAP) or bi-level therapy for multiple patient use in a hospital or clinic environment after high-level disinfection and for single-patient use in a home environment.

Device Story

The SOYALA SilkGel Full Face Mask is a molded plastic interface designed to deliver CPAP or bi-level positive pressure therapy. It comprises a mask cushion, mask body, forehead cushion, adjustment components, headgear, and a swivel elbow connection for tubing. The device is used in clinical settings (hospital/clinic) or home environments. It is operated by the patient or healthcare provider to facilitate airway pressure delivery. The mask connects to a therapy device to provide respiratory support, aiding in the treatment of conditions requiring positive pressure ventilation. It is intended for multiple-patient use in clinical settings following high-level disinfection and single-patient use in home settings.

Clinical Evidence

Bench testing only.

Technological Characteristics

Molded plastic mask assembly including cushion, body, forehead support, adjustment components, and swivel elbow. Non-continuous ventilator accessory. No electronic components or software.

Indications for Use

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

• SOYALA FULL FACE MASK GEL vented (K073673)

Submission Summary (Full Text)

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# 11. 510(k) Summary

NOV 1 6 2011

# SOYALA SilkGel Full Face Mask

July 26, 2011

# 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 SilkGel Full Face Mask |
|----------------------|----------------------------------------|
| 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 GEL vented, cleared for commercial distribution per K073673.

#### Device Description:

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

It consists of a mask cushion, mask body, forehead cushion, rough adjustment component, fine adjustment component, headgear, headgear clips, pressure measurement connection, tube anchoring strap, 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 word "WEINMANN" is in large, bold, black letters. Below it, in smaller letters, are the words "medical technology". There are two diagonal lines above the "A" and "N" in "WEINMANN".

## Intended Use:

The SOYALA SilkGel Full Face Mask is intended for adult patients (>66 pounds or 30kg) prescribed continuous positive airway pressure (CPAP) or bi-level therapy for multiple patient use in a hospital or clinic environment after high-level disinfection and for single-patient use in a home environment.

### Comparison of Technological Characteristics

The SOYALA SilkGel Full Face Mask 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 and mechanical details are changed in the modified device. Safety and effectiveness are not affected by these changes.

#### Summary of Device Testing:

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 SilkGel Full Face Mask is substantially equivalent to the 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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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

# NOV 1 6 2011

Re: K112167

Trade/Device Name: SOYALA SilkGel Full Face Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: BZD Dated: October 14, 2011 Received: October 18, 2011

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 ITDA'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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Nh far

Anthony D. Watson, B.S., M.S., M.B.A. 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):

Device Name: SOYALA SilkGel Full Face Mask

Indications for Use:

The SOYALA SilkGel Full Face Mask is intended for adult patients (>66 pounds or 30kg) prescribed continuous positive airway pressure (CPAP) or bi-level therapy for multiple patient use in a hospital or clinic environment after high-level disinfection and for single-patient use in a home environment.

K112167

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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) :

Y. Schultheis

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

4112167 510(k) Number:

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