(111 days)
Not Found
No
The device description and intended use are solely focused on the physical components and function of a CPAP mask, with no mention of AI or ML capabilities.
Yes
The device is a full face mask intended for patients prescribed continuous positive airway pressure (CPAP) or bi-level therapy, which are forms of medical treatment.
No
Explanation: The device is a full face mask intended for delivering CPAP or bi-level therapy, which are forms of treatment, not diagnosis. It is used in conjunction with a therapy device.
No
The device description clearly outlines multiple physical components (molded plastic mask, cushion, body, headgear, etc.), indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for delivering CPAP or bi-level therapy to patients for respiratory support. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a mask and its components for delivering air pressure, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting diseases, conditions, or states of health through in vitro examination.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to provide respiratory support, which is a treatment, not a diagnostic process.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
BZD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult patients (>66 pounds or 30kg)
Intended User / Care Setting
multiple patient use in a hospital or clinic environment after high-level disinfection and for single-patient use in a home environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed to verify equivalent performance. All tests were verified to meet acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo for WEINMANN medical technology. Above the logo is the handwritten number K112167. The logo is in black and white and features the company name in bold letters.
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.
1
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.
2
Image /page/2/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The caduceus is positioned to the right of the circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
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.
3
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 (800) 638-2041 or (301) 796-7100 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
4
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.
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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