(149 days)
The SOYALA Full Face Mask is intended for adult patients (>30kg) prescribed continuous positive airway pressure (CPAP) or bi-level therapy for multiplepatient use in a hospital or clinic environment after high-level disinfection and for single-patient use in a home environment.
The SOYALA Full Face Mask is a molded plastic face mask covering the patient's nose and mouth and including an exhalation system, for the delivery of CPAP or Bi-level Positive Pressure therapy. It consists of a mask cushion, mask frame, forehead cushion, coarse adjustment component, fine adjustment component, forehead support, headgear, headgear clip, ports for pressure measurement, port cap, rotating sleeve, elbow with anti asphyxia valve, 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. The Weinmann SOYALA Full Face Mask comes in three sizes, small, medium and large. It has a removable mask cushion. An anti-asphyxia valve is integrated into the elbow of the mask. It functions as a safety mechanism, which allows the patient to breathe fresh air if the therapy device ceases operation. SOYALA Full Face Mask is secured to the patient's head with a 4-point headgear called the SOYALAstrap. An alternate headgear model is also available.
The provided text is a 510(k) summary for the Weinmann SOYALA Full Face Mask. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain the detailed acceptance criteria and study information typically found for AI/ML device evaluations.
Instead, the document states:
- "Bench testing was performed to ensure that the SOYALA Full Face Mask met its specifications. All tests were verified to meet acceptance criteria."
- "Biocompatibility testing was performed to verify the equivalent safety of the materials that are used."
This indicates that acceptance criteria and testing were done, but the specifics are not provided in this regulatory submission. This type of submission (510(k) in 2006) for a physical medical device like a face mask typically relies on engineering and biocompatibility testing against established standards, rather than complex clinical studies with AI/ML systems.
Therefore, I cannot provide the requested information regarding acceptance criteria, reported performance, sample sizes, expert ground truth, MRMC studies, standalone performance, or training set details because these specific elements are not present in the provided text, as it describes a hardware device not an AI/ML diagnostic system.
{0}------------------------------------------------
K.061653
Image /page/0/Picture/1 description: The image shows the word "WEINMANN" in a bold, sans-serif font. A diagonal line slashes through the middle of the word, starting from the top right of the first "N" and extending to the bottom left of the first "A". The text is black against a white background.
5. 510(k) Summary
Weinmann SOYALA Full Face Mask
November 06, 2006
NOV - 9 2006
Submitter Information:
Weinmann Gerate fur Medizin GmbH+Co. KG Kronsaalsweg 40 22525 Hamburg / Germany
| Submitter's Name: | Eckhardt Albers |
|---|---|
| Phone: | 011 49 40 54 70 2 - 180 |
| Fax: | 011 49 40 54 70 2 - 468 |
Device Name:
| Proprietary name: | Weinmann SOYALA Full Face Mask |
|---|---|
| Common Name: | 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 ResMed Mirage Full Face Mask Series 2, cleared for commercial distribution per K023244, Weinmann SOMNOmask, K013738, Weinmann SOYALA, K060405, and Fisher & Paykel Flexifit Series HC431 Full Face Mask, K040506.
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the word "WEINMANN" in all caps. A diagonal line goes through the middle of the word, starting at the top right of the "I" and ending at the bottom left of the second "N". The font is a bold sans-serif font.
Device Description:
The SOYALA Full Face Mask is a molded plastic face mask covering the patient's nose and mouth and including an exhalation system, for the delivery of CPAP or Bi-level Positive Pressure therapy.
It consists of a mask cushion, mask frame, forehead cushion, coarse adjustment component, fine adjustment component, forehead support, headgear, headgear clip, ports for pressure measurement, port cap, rotating sleeve, elbow with anti asphyxia valve, 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.
The Weinmann SOYALA Full Face Mask comes in three sizes, small, medium and large. It has a removable mask cushion.
An anti-asphyxia valve is integrated into the elbow of the mask. It functions as a safety mechanism, which allows the patient to breathe fresh air if the therapy device ceases operation.
SOYALA Full Face Mask is secured to the patient's head with a 4-point headgear called the SOYALAstrap. An alternate headgear model is also available.
Intended Use:
The SOYALA Full Face Mask is intended for adult patients (>30kg) prescribed continuous positive airway pressure (CPAP) or bi-level therapy for multiplepatient 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 Weinmann SOYALA Full Face Mask has the same technological characteristics as the predicate device.
The new device has the following similarities to the previously cleared predicate device:
- · Same intended use
- · Same operating principle
- · Same technology
- · Same manufacturing process
Some materials of the new device are different from the predicate device. The changed materials represent secondary support or incidental contact. Safety and effectiveness are not affected by these changes.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the word "WEINMANN" in all caps. A diagonal line goes through the middle of the word, starting at the top of the first N and ending at the bottom of the second N. The font is sans-serif and bold.
Summary of Device Testing:
Bench testing was performed to ensure that the SOYALA Full Face Mask met its specifications. All tests were verified to meet acceptance criteria. Biocompatibility testing was performed to verify the equivalent safety of the materials that are used.
Conclusion:
Based on the above, we concluded that the Weinmann SOYALA 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 or better than the predicate device.
End of section.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
NOV - 9 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Eckhardt Albers Quality Assurance Manager Weinmann Gerate Fur Medizin GmbH + Company KG Kronsaalsweg 40 Hamburg GERMANY 22525
Re: K061653
Trade/Device Name: SOYALA Full Face Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: October 17, 2006 Received: October 24, 2006
Dear Mr. Albers:
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.
{4}------------------------------------------------
Page 2 - Mr. Albers
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 (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
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
{5}------------------------------------------------
Indications for Use
510(k) Number (if known): K061653
Device Name: SOYALA Full Face Mask
Indications For Use:
The SOYALA Full Face Mask is intended for adult patients (>30kg) prescribed continuous positive airway pressure (CPAP) or bi-level therapy for multiplepatient use in a hospital or clinic environment after high-level disinfection and for single-patient use in a home environment.
Prescription Use_ × 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)
Amy Nelson
Jon Control, Dental De
n of Anesthesiology, General Hospital,
Page 1 of __ 1___
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
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.(b)
Classification. Class II (performance standards).