DEVILBISS DV5M SMARTLINK SYSTEM

K082209 · Sunrise Medical · BZD · Oct 28, 2008 · Anesthesiology

Device Facts

• Record ID: K082209
• Device Name: DEVILBISS DV5M SMARTLINK SYSTEM
• Applicant: Sunrise Medical
• Product Code: BZD · Anesthesiology
• Decision Date: Oct 28, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The DeVilbiss SmartLink System can only be used in conjunction with the DV51 and DV54 Series CPAP Systems for follow up of obstructive sleep apnea patients weighing above 30 kg on nasal CPAP therapy.

Device Story

DeVilbiss SmartLink System functions as an accessory to DV51 and DV54 Series CPAP systems; collects therapy data from CPAP device; enables clinician follow-up of obstructive sleep apnea patients. System facilitates data transfer for review by healthcare providers to monitor therapy compliance and efficacy. Used in clinical or home settings; operated by clinicians or patients under physician guidance. Output allows providers to assess patient adherence and adjust treatment parameters as necessary.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Accessory system for CPAP devices (DV51/DV54 series); data management and monitoring functionality; intended for use with obstructive sleep apnea patients >30 kg.

Indications for Use

Indicated for follow-up of obstructive sleep apnea patients weighing >30 kg undergoing nasal CPAP therapy using DV51 or DV54 Series CPAP systems.

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 & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

OCT 2 8 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Joseph E. Olsavsky Vice President-Global Quality & Regulatory Affairs DeVilbiss Healthcarc 100 DeVilbiss Drive Somerset, Pennsylvania 15501

Re: K082209

Trade/Device Name: DeVilbiss DV5M Smartlink System Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: October 9, 2008 Received: October 10, 2008

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 (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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric' s (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Thannelis-Led-and-forein

Chiu S. Lin, Ph. D Division 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): K082209

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use: The DeVilbiss SmartLink System can only be used in conjunction with the DV51 and DV54 Series CPAP Systems for follow up of obstructive sleep apnea patients weighing above 30 kg on nasal CPAP therapy.

Prescription Use ਮ (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)

L. Hilliard

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

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510(k) Number: Ko 82209