WEINMANN SOMNOMASK

K013738 · Gottlieb Weinmann Geraete Fuer Medizin Und Arbeits · BZD · Jan 22, 2002 · Anesthesiology

Device Facts

• Record ID: K013738
• Device Name: WEINMANN SOMNOMASK
• Applicant: Gottlieb Weinmann Geraete Fuer Medizin Und Arbeits
• Product Code: BZD · Anesthesiology
• Decision Date: Jan 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

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).

Device Story

Nasal mask interface for CPAP or Bi-level Positive Pressure therapy; used by adult patients (>30 kg) in clinical or home settings. Device consists of mask body in three sizes (small, medium, large) with removable seal and 4-point headgear (SOMNOstrap). Lacks integrated CO2 exhaust ports; requires external exhalation device for operation. Delivers pressurized air to patient airway to support respiratory therapy. Healthcare provider prescribes device; patient wears mask during therapy sessions.

Clinical Evidence

Bench testing only. Testing included drop test, operating and storage temperature testing, and flow resistance testing to verify device specifications.

Technological Characteristics

Nasal mask interface; three sizes (S, M, L); removable mask seal; 4-point headgear (SOMNOstrap). Lacks integrated CO2 venting. Non-powered, passive accessory to non-continuous ventilators.

Indications for Use

Indicated for adult patients (>30 kg) requiring nasal CPAP or Bi-level Positive Pressure therapy.

Regulatory Classification

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.

Predicate Devices

• Respironics Reusable Contour II Nasal Mask (K991648)
• Puritan-Bennett Breeze SleepGear with DreamSeal (K002001)

Submission Summary (Full Text)

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K013738

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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 [phone]. 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 [phone] or [phone] 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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