(70 days)
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).
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.
This document (K013738) describes a 510(k) premarket notification for the Weinmann SOMNOmask, a nasal mask intended for use during CPAP or Bi-level Positive Pressure therapy. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific performance acceptance criteria through clinical studies.
Based on the provided information, the following answers are generated:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided 510(k) summary does not specify quantifiable acceptance criteria for clinical performance in a table format. The study described focuses on technical characteristics and safety, rather than effectiveness metrics against pre-defined thresholds.
| Acceptance Criteria (Not Explicitly Stated for Performance) | Reported Device Performance (Summary) |
|---|---|
| Clinical effectiveness for CPAP/Bi-level Positive Pressure therapy | Substantially equivalent to legally marketed predicate devices (Respironics Reusable Contour II Nasal Mask and Puritan-Bennett Breeze SleepGear with DreamSeal). Concluded to be "safe and effective for its intended use" based on technical testing and comparison to predicates. |
| Technical Specifications: | |
| Drop Test | Performed, results indicate device met specifications. |
| Operating Temperature | Performed, results indicate device met specifications. |
| Storage Temperature | Performed, results indicate device met specifications. |
| Flow Resistance | Performed, results indicate device met specifications. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. This submission does not describe a clinical performance test set with human subjects or a dataset for algorithm evaluation. The "testing" referred to is laboratory-based technical testing of the physical mask.
- Data Provenance: Not applicable. The "testing" mentioned is technical testing of the device itself (drop test, temperature, flow resistance) rather than data from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth establishment by experts is mentioned as part of this 510(k) submission, as it focuses on technical equivalence and laboratory testing, not clinical performance or diagnostic accuracy.
4. Adjudication method for the test set:
Not applicable. No adjudication method is mentioned as part of this 510(k) submission, as it does not involve a clinical performance test set or data requiring expert review.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a physical medical device (nasal mask), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human reader performance with or without AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used:
Not applicable. The relevant "truth" in this submission relates to the device meeting its technical specifications and being substantially equivalent to predicate devices, rather than ground truth for diagnostic accuracy or clinical outcomes.
8. The sample size for the training set:
Not applicable. This submission does not describe a machine learning algorithm or a training set.
9. How the ground truth for the training set was established:
Not applicable. This submission does not describe a machine learning algorithm or a training set.
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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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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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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.
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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
Pres. 1 minn 1 lse ( 1. 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).