(30 days)
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or analytical capabilities that would suggest AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No
This device is a nasal mask, which is an accessory used during therapy. It does not exert a therapeutic effect itself. The input specifies it's for the "delivery of CPAP or Bi-level Positive Pressure therapy," implying it's a component of a larger therapeutic system, not the therapeutic device itself.
No
The device description indicates it is a nasal mask for delivering CPAP or Bi-level Positive Pressure therapy, which is a treatment, not a diagnostic procedure.
No
The device description clearly outlines multiple physical components (molded plastic mask, gel cushions, frame, etc.), indicating it is a hardware 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 clearly states the mask is for "nasal CPAP or Bi-level Positive Pressure therapy." This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical mask and its components used for delivering air pressure. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or any other typical components of an IVD.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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).
Product codes
BZD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal
Indicated Patient Age Range
Adult patients (>30 kg)
Intended User / Care Setting
Not Found
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)
Not Found
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
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. 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.
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: