DEVILBISS INTELLIPAP MODEL DV 5 SERIES

K071689 · Sunrise Medical · BZD · Sep 7, 2007 · Anesthesiology

Device Facts

• Record ID: K071689
• Device Name: DEVILBISS INTELLIPAP MODEL DV 5 SERIES
• Applicant: Sunrise Medical
• Product Code: BZD · Anesthesiology
• Decision Date: Sep 7, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DeVilbiss IntelliPAP Model DV5 Series is intended for use in treating obstructive sleep apnea in patients 30 Kg and above.

Device Story

DeVilbiss IntelliPAP Model DV5 Series is a noncontinuous ventilator (IPPB) for obstructive sleep apnea treatment. Device delivers positive airway pressure to patients weighing 30 kg or more. Used in home or clinical settings; operated by patient or clinician. Provides therapeutic pressure to maintain airway patency during sleep. Healthcare providers use device output to manage sleep apnea therapy; benefits include improved breathing and reduced apnea events.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and regulatory review.

Technological Characteristics

Noncontinuous ventilator (IPPB); Class II; Product Code BZD; Regulation 868.5905. Device provides positive airway pressure therapy.

Indications for Use

Indicated for treatment of obstructive sleep apnea in patients weighing 30 kg or more. Prescription use only.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 7 2007

Mr. Joseph E. Olsavsky Director, Regulatory Affairs Sunrise Medical 100 DeVilbiss Drive Somerset, Pennsylvania 15501-2125

Re: K071689

Trade/Device Name: DeVilbiss IntelliPAP Model DV5 Series Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: June 19, 2007 Received: June 20, 2007

Dear Mr. Olsavsky:

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. Olsavsky

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 (OS) 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 vours.

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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Indications for Use

510(k) Number: (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use: The DeVilbiss IntelliPAP Model DV5 Series is intended for use in treating obstructive sleep apnea in patients 30 Kg and above.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

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)

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(ession Sign-Off)

L'ivision of Anesthesiology, General Hospital, Intection Control, Dental Devices

510(k) Number: K071689

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