MODEL 7410 VOYAGER

K974879 · Healthdyne Technologies, Inc. · BZD · Jun 29, 1998 · Anesthesiology

Device Facts

• Record ID: K974879
• Device Name: MODEL 7410 VOYAGER
• Applicant: Healthdyne Technologies, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Jun 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Model 7410 series CPAP system is a device that is intended to provide continuous positive airway pressure to adults who experience obstructive sleep apnea (OSA). The device will automatically adjust and maintain airway pressure based on the continuing needs of the patient. The device may be used in either the home or hospital environment.

Device Story

Model 7410 Series CPAP System provides continuous positive airway pressure to treat obstructive sleep apnea in adults. Device operates by automatically adjusting and maintaining airway pressure based on patient needs. Used in home or hospital settings; operated by patients or healthcare providers. Output consists of regulated airflow delivered via mask interface to maintain airway patency. Clinical benefit includes management of OSA symptoms through pressure support.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on 510(k) regulatory review.

Technological Characteristics

Continuous positive airway pressure system; automatic pressure adjustment mechanism; intended for home or hospital use; electrical power source.

Indications for Use

Indicated for adults with obstructive sleep apnea (OSA) requiring continuous positive airway pressure therapy. Suitable for home or 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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## The 5 3 Jass

Mr. Timothy Y. Cowart Healthdyne Technologies 1850 Parkway Place Marietta, GA 30067-8274

K974879 Re: Model 7410 Voyager Regulatory Class: II (two) 73 BZD Product Code: March 30, 1998 Dated: Received: April 7, 1998

Dear Mr. Cowart:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Timothy Y. Cowart

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Model 7410 Series CPAP System

The Model 7410 series CPAP system is a device that is intended Indications For Use: to provide continuous positive airway pressure to adults who experience obstructive sleep apnea (OSA). The device will automatically adjust and maintain airway pressure based on the continuing needs of the patient. The device may be used in either the home or hospital environment.

**CONFIDENTIAL**

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---------------|-------------------------------------------------------------------|
| | Mark Kreme |
| | (Division Sign-Off) |
| | Division of Cardiovascular, Respiratory, and Neurological Devices |
| 510(k) Number | K974879 |

| Prescription Use | X |
|----------------------|---|
| (Per 21 CFR 801.109) | |

OR

| Over-The-Counter Use | |
|----------------------|--|
|----------------------|--|

(Optional Format 1-2-96)