(70 days)
Not Found
No
The summary describes a physical mask and headgear for CPAP/Bi-level therapy and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No.
The SOMNOmask is a nasal mask used in conjunction with CPAP/Bi-level Positive Pressure therapy; it is an accessory to the therapeutic device (CPAP/Bi-level Positive Pressure device), but not a therapeutic device itself.
No
The device is a mask used for CPAP/Bi-level Positive Pressure therapy, which is a treatment method, not a diagnostic one. Its intended use statement and device description do not mention any diagnostic functions.
No
The device description clearly outlines physical components like a mask, seal, and headgear, and performance studies include physical tests like drop testing and flow resistance. This indicates a hardware medical device, not a software-only one.
Based on the provided information, the Weinmann SOMNOmask is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for use during nasal CPAP or Bi-level Positive Pressure therapy for adult patients. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a mask used for delivering positive pressure, which is a treatment method.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide information about a patient's health status or disease.
- Predicate Devices: The predicate devices listed are also nasal masks used for respiratory therapy, not diagnostic devices.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The Weinmann SOMNOmask's function is to facilitate the delivery of positive airway pressure, which is a treatment for conditions like sleep apnea.
N/A
Intended Use / Indications for Use
The Weinmann SOMNOmask is intended for prescription use to be used during nasal CPAP or Bi-level Positive Pressure therapy for adult patients (>30 KG).
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The Weinmann SOMNOmask comes in three sizes, small, medium and large. It has a removable mask seal. Because the Weinmann SOMNOmask does not contain any ports or vents for removing the CO2 buildup, an external exhalation device must be used. The SOMNOmask is secured to the patient's head with a 4-point headgear called the SOMNOstrap.
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)
A drop test, operating and storage temperature testing and flow resistance testing were performed to ensure that the SOMNOmask met its specifications.
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/1 description: The image shows the word "WEINMANN" in a bold, sans-serif font. A diagonal line cuts through the middle of the word, separating the two "N"s. The text is black against a white background.
JAN 2 2 2002
510(k) SUMMARY
Weinmann SOMNOmask
October 31, 2001
Submitter Information:
Gottlieb Weinmann Geraete für Medizin und Arbeitsschutz GmbH+Co. Kronsaalsweg 40 22525 Hamburg Germany
| Submitter's Name: | Eckhardt Albers |
|---|---|
| Phone: | 011 49 40 54 70 2 - 180 |
Device Name:
| Proprietary name: | Weinmann SOMNOmask |
|---|---|
| ------------------- | -------------------- |
Common Name: Nasal mask
Classification Name: Accessory to non-continuous ventilator
Predicate Device Equivalence:
Substantial equivalence is claimed to the Respironics Reusable Contour II Nasal Mask and to the Puritan-Bennett Breeze SleepGear with DreamSeal, cleared for commercial distribution per K991648 and K002001, respectively.
Device Description:
The Weinmann SOMNOmask comes in three sizes, small, medium and large. It has a removable mask seal.
Because the Weinmann SOMNOmask does not contain any ports or vents for removing the CO2 buildup, an external exhalation device must be used.
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Image /page/1/Picture/0 description: The image shows the word "WEINMANN" in a bold, sans-serif font. There are two diagonal lines that intersect the letters "M" and "A", creating a unique visual element. The text is black and the background is white, providing a clear contrast. The overall design is simple and modern.
The SOMNOmask is secured to the patient's head with a 4-point headgear called the SOMNOstrap.
Intended Use:
The Weinmann SOMNOmask is intended for prescription use to be used during nasal CPAP or Bi-level Positive Pressure therapy for adult patients (>30 KG).
Comparison of Technological Characteristics:
The Weinmann SOMNOmask has the same technological characteristics as the predicate devices.
Summary of Device Testing:
A drop test, operating and storage temperature testing and flow resistance testing were performed to ensure that the SOMNOmask met its specifications.
Conclusions:
Based on the above, we concluded that the Weinmann SOMNOmask is substantially equivalent to legally marketed predicate devices and is safe and effective for its intended use.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form, with three overlapping profiles suggesting unity and cooperation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 2002
Mr. Eckhardt Albers Gottlieb Weinmann Geräte für Medizin und Arbeitsschutz GmbH + Co. Kronsaalsweg 40 D-22525 Hamburg, Germany
Re: K013738
Weinmann SOMNOmask Regulation Number: 868.5905 Regulation Name: Non-continuous ventilator, Accessory Regulatory Class: Class II (two) Product Code: BZD Dated: October 31, 2001 Received: November 13, 2001
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.
3
Page 2 - Mr. Eckhardt Albers
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that I Dri has Intacted and regulations administered by other Federal agencies. You must or any I odotar states and see and see and the mot limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality byevelions (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) I mis lotter writing in you'll cognituding of substantial equivalence of your device to a legally premation in the 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 and 11 you dostre spoolite art.809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 OF IC For at 646. Additionally, for questions on the promotion and advertising of Compinance at (301) 591 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation onlined, "Thisoranang of esponsibilities under the Act may be obtained from the Oiner general 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/dsma/dsmamain.html
Sincerely yours,
Deahtull
B.R. Tuller, M.D.
ram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Device Name: K013738
Weinmann SOMNOmask
Indications for Use:
:
The Weinmann SOMNOmask is intended for prescription use to be used during nasal CPAP or Bilevel Positive Pressure therapy for adult patients (>30 Kg).
Qaitul
Division of Cardiovascular & Respiratory Devices
510(k) Number K013738
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