SOYALA GEL VENTED

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for WEINMANN medical technology. The logo is in black and white, with the word "WEINMANN" in large, bold letters. Below the word "WEINMANN" is the phrase "medical technology" in smaller letters. The logo is simple and modern, and it conveys a sense of professionalism and expertise. K081014 MAY - 9 2008 # 11. 510(k) Summary SOYALA GEL vented April 8, 2008 ## 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: SOYALA GEL vented Proprietary name: Common Name: Nasal 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, cleared for commercial distribution per K060405. ### Device Description: The SOYALA 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 component, fine adjustment component, forehead support, 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. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. (USA)" in a circular arrangement. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY - 9 2008 Dr. Ralf Egenolf Quality Assurance Manager Weinmänn- Gerate Für Medizin GmbH Company KG Kronsaalsweg 40 22525 Hamburg GERMANY Re: K081014 Trade/Device Name: SOYALA GEL Vented Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: April 8, 2008 Received: April 9, 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. {2}------------------------------------------------ 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 complics 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 (240) 276-0120 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, 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 {3}------------------------------------------------ #### Indications for Use 6. 510(k) Number (if known): Device Name: SOYALA GEL vented Indications For Use: The nasal mask is intended for prescription use to be used during nasal CPAP or Bi-level Positive Pressure therapy for adult patients (>30 kg). Prescription Use X AND/OR (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) Thal (Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices 1681014 510(k) Number: