WEINMANNCOMFORT 2, MODEL WM 27600 AND WEINMANNAQUA, MODEL WM 27603

K071163 · Weinmann Gerate Fur Medizin GmbH + Co. KG · BZD · Jul 18, 2007 · Anesthesiology

Device Facts

• Record ID: K071163
• Device Name: WEINMANNCOMFORT 2, MODEL WM 27600 AND WEINMANNAQUA, MODEL WM 27603
• Applicant: Weinmann Gerate Fur Medizin GmbH + Co. KG
• Product Code: BZD · Anesthesiology
• Decision Date: Jul 18, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The WEINMANNcomfort 2 is for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The optional integrated humidifier (WEINMANNaqua) is indicated for the humidification and warming of air from the WEINMANNcomfort 2 flow generator device. The WEINMANNcomfort 2 and WEINMANNaqua are for home and hospital use.

Device Story

Microprocessor-controlled, blower-based CPAP device; generates continuous positive airway pressure (4-20 cmH2O) for OSA treatment. Radial compressor draws ambient air through filter; delivers pressurized air via hose and mask. Features include fixed-pressure mode, automatic start/stop (breath-triggered), and softstart ramp function. Optional pass-over humidifier (WEINMANNaqua) attaches to unit for air warming/humidification. Used in home or hospital settings; operated by patient or clinician. Clinician sets fixed pressure; device maintains pressure to keep airway open, improving patient sleep quality.

Clinical Evidence

Bench testing only. Design verification testing confirmed device met specifications and risk analysis requirements. Biocompatibility testing performed on materials.

Technological Characteristics

Microprocessor-controlled radial compressor; CPAP fixed-pressure mode (4-20 cmH2O); external power supply; optional pass-over humidifier. Biocompatible materials used. Software-controlled blower system.

Indications for Use

Indicated for treatment of Obstructive Sleep Apnea (OSA) in adult patients. Optional humidifier indicated for humidification and warming of air. For home and hospital use.

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

• ResMed S7 Elite CPAP System (K013909)

Submission Summary (Full Text)

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WEINMANN
medical technology

#### 5. 510(k) Summary

## WEINMANNcomfort 2

April 20, 2007

JUL 1 8 2007

# Submitter Information:

Weinmann Gerate fur Medizin GmbH+Co. KG Kronsaalsweg 40 22525 Hamburg / Germany

| Submitter's Name: | Eckhardt Albers |
|-------------------|-------------------------|
| Phone: | 011 49 40 54 70 2 - 180 |
| Fax: | 011 49 40 54 70 2 - 468 |

#### Device Name:

| Proprietary name: | WEINMANNcomfort 2 |
|----------------------|--------------------------|
| Common Name: | CPAP Device |
| Classification Name: | Noncontinuous ventilator |

## Device Classification:

.

21 CFR 868.5905, Class II, Product Code BZD

### Predicate Device Equivalence:

Substantial equivalence is claimed to ResMed S7 Elite CPAP System, cleared for commercial distribution per K013909.

### Device Description:

The WEINMANNcomfort 2 is a microprocessor controlled blower-based device that generates a Continuous Positive Airway Pressure (CPAP) from 4 to 20 cmH2O for the treatment of Obstructive Sleep Apnea (OSA).

The system includes the flow generator, patient tubing, external power supply, and an optional heated humidifier WEINMANNaqua.

A radial compressor draws in ambient air via a filter and conveys it to the unit outlet. From here the air flows through the hose system and the mask to the patient.

The WEINMANNcomfort 2 has one mode of operation (CPAP fixed-pressure mode). In this mode the flow generator provides a single fixed-pressure as set by the clinician. Automatic

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Image /page/1/Picture/0 description: The image shows the logo for Weinmann Medical Technology. The logo is in black and white. The word "WEINMANN" is in large, bold letters, and the words "medical technology" are in smaller letters below it. There are two diagonal lines above the second N in Weinmann.

switch on/off can be activated on WEINMANNcomfort 2. The unit can then be switched on by breathing into the mask and will switch off when the mask is removed. The softstart automatic system is installed to help the patient fall asleep more easily.

The optional breath humidifier WEINMANNaqua can be snapped onto the therapy unit. The air from the flow generator is directed over a water surface in the humidifier, which functions according to the pass-over principle.

## Intended Use:

The WEINMANNcomfort 2 is for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The optional integrated humidifier (WEINMANNaqua) is indicated for the humidification and warming of air from the WEINMANNcomfort 2 flow generator device. The WEINMANNcomfort 2 and WEINMANNaqua are for home and hospital use.

## Comparison of Technological Characteristics

The WEINMANNcomfort 2 has the same technological characteristics as the predicate device.

The new device has the following similarities to the previously cleared predicate device:

- . Same intended use
- . Same operating principle
- � Same technology
- Same manufacturing process .

The new device differs in having an external power supply. This change, as well as other minor changes, do not affect safety and effectiveness.

## Summary of Device Testing:

Design verification testing was performed to ensure that the WEINMANNcomfort 2 based on risk analysis and product requirements met its specifications. All tests were verified to meet acceptance criteria. Biocompatibility testing was performed to verify the equivalent safety of the materials that are used.

### Conclusion:

Based on the above, we concluded that the WEINMANNcomfort 2 is substantially equivalent to the legally marketed predicate device and is safe and effective for its intended use, and performs as well as or better than the predicate device.

End of section.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 8 2007

Mr. Eckhardt Albers Quality Assurance Manager Weinmann Gerate Fur Medizin GmbH + CO. KG Kronsaalsweg 40 22525 Hamburg, GERMANY

Re: K071163

Trade/Device Name: WEINMANNcomfort 2, Model WM 27600 and Weinmann Aqua Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: July 6, 2007 Received: July 11, 2007

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. Alberts

Please be advised that FDA'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); 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chih-Lin, Ph.D.

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

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#### 4. Indications for Use Statement

510(k) Number (if known):

Device Name: WEINMANNcomfort 2

Indications For Use:

The WEINMANNcomfort 2 is for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The optional integrated humidifier (WEINMANNaqua) is indicated for the humidification and warming of air from the WEINMANNcomfort 2 flow generator device. The WEINMANNcomfort 2 and WEINMANNaqua are for home and hospital use.

Prescription Use × 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)

Null R. Roff

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K071163