WEINMANNCOMPACT, MODEL WM 27380; WEINMANNCLICK2, MODEL WM 27340

K072009 · Weinmann Gerate Fur Medizin GmbH + Co. KG · BZD · Dec 14, 2007 · Anesthesiology

Device Facts

• Record ID: K072009
• Device Name: WEINMANNCOMPACT, MODEL WM 27380; WEINMANNCLICK2, MODEL WM 27340
• Applicant: Weinmann Gerate Fur Medizin GmbH + Co. KG
• Product Code: BZD · Anesthesiology
• Decision Date: Dec 14, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

WEINMANNcompact is for the treatment of Obstructive Sleep Apnea (OSA) in adult patients (>30kg). The device delivers a fixed treatment pressure within the range of 4 to 20 cmH2O. (Fooly). The oction action and click 2) is indicated for the humidification and warming of air from the WEINMANNcompact flow generator device. The WEINMANNcompact and WEINMANNclick 2 are for home and hospital use.

Device Story

Microprocessor-controlled, blower-based CPAP device; generates fixed positive airway pressure (4-20 cmH2O) for OSA treatment. Radial compressor draws ambient air through filter; delivers pressurized air via hose and mask to patient. Features 'softstart' automatic system to assist sleep onset. Optional WEINMANNclick 2 humidifier attaches to unit front; uses pass-over principle to warm/humidify air. Used in home and hospital settings; operated by patients or clinicians. Clinician sets fixed pressure; device maintains pressure during use. Benefits patient by providing consistent airway support to prevent apnea events.

Clinical Evidence

Bench testing only. Design verification testing performed based on risk analysis and product requirements to ensure specifications met. Biocompatibility testing performed to verify material safety.

Technological Characteristics

Microprocessor-controlled blower; radial compressor; fixed-pressure CPAP mode; 4-20 cmH2O pressure range; external power supply; optional pass-over humidifier; home/hospital use.

Indications for Use

Indicated for adult patients (>30kg) with Obstructive Sleep Apnea (OSA) requiring fixed-pressure CPAP therapy (4-20 cmH2O). Optional humidifier indicated for warming/humidifying air.

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)
• WEINMANNcomfort 2 (K071163)

Submission Summary (Full Text)

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# 5. 510(k) Summary

## WEINMANNcompact

November 26, 2007

DEC 1 4 2007

## Submitter Information:

Weinmann Gerate für 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:

| Proprietary name: | WEINMANNcompact |
|-------------------|-----------------|
| Common Name: | CPAP Device |

#### Noncontinuous ventilator Classification Name:

## 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 and WEINMANNcomfort 2, cleared for commercial distribution (since the original submittal) per K071163.

## Device Description:

The WEINMANNcompact 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 WEINMANNclick 2.

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 WEINMANNcompact 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. A softstart automatic system is installed to help the patient fall asleep more easily.

The optional breath humidifier WEINMANNclick 2 can be snapped onto the therapy unit at the front. The air from the flow generator is directed over a water surface in the humidifier, which functions according to the pass-over principle.

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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, with the word "WEINMANN" in large, bold letters. Below the word "WEINMANN" are the words "medical technology" in a smaller font. There are two diagonal lines between the two N's in WEINMANN.

### Intended Use:

WEINMANNcompact is for the treatment of Obstructive Sleep Apnea (OSA) in adult patients (>30kg). The device delivers a fixed treatment pressure within the range of 4 to 20 cmH2O. (Fooly). The oction action and click 2) is indicated for the humidification and warming of air from the WEINMANNcompact flow generator device. The WEINMANNcompact and WEINMANNclick 2 are for home and hospital use.

# Comparison of Technological Characteristics

The WEINMANNcompact has the same technological characteristics as the predicate devices.

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

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

The new device differs to Resmed S7 Elite CPAP System in having an external power supply. This change, as well as other minor changes, does not affect safety and effectiveness.

## Summary of Device Testing:

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

#### Conclusion:

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

End of section.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OEC 1 4 2007

Dr. Ralf Egenolf Head of Quality Management and Regulatory Affairs Department Weinmann Gerate fur Medizin GmbH + Company KG Kronsaalsweg 40 Hamburg GERMANY 22525

Re: K072009

Trade/Device Name: WEINMANNcompact Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: November 26, 2007 Received: November 29, 2007

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.

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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 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,

Cintan, U.d.d. ter
Chiu 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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Image /page/4/Picture/0 description: The image shows the logo for WEINMANN medical technology. The word "WEINMANN" is in large, bold, black letters. Below it, in smaller letters, are the words "medical technology."

# 4. Indications for Use Statement

510(k) Number (if known): K072009

Device Name: __ WEINMANNcompact

Indications For Use:

WEINMANNcompact is for the treatment of Obstructive Sleep Apnea (OSA) in adult patients (>30kg). The device delivers a fixed therapy pressure within the range of 4 to 20 cmH2O. The ( - only). THO done CEINMANNclick 2) is indicated for the humidification and warming of air optional namian (vice to the generator device. The WEINMANNcompact and WEINMANNclick 2 are for home and hospital use.

Prescription Use × (Part 21 CFR 801 Subpart D)

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AND/OR

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)

Min Vuchul

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

510(k) Number: K072009

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