NASAL INTERFACE MODEL 7910

K974453 · Healthdyne Technologies, Inc. · BZD · Aug 4, 1998 · Anesthesiology

Device Facts

• Record ID: K974453
• Device Name: NASAL INTERFACE MODEL 7910
• Applicant: Healthdyne Technologies, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Aug 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nasal Interface is intended for use with nasal CPAP and bilevel devices for the treatment of adult patients with Obstructive Sleep Apnea. The Nasal Interface may be used in the home, hospital, nursing home, sub-acute care center or other location where nasal CPAP or bilevel therapy is applied. The Nasal Interface will facilitate nasal CPAP or bilevel therapy via a silicone seal which makes contact solely with the patient's nose on the external aspects of the nares. This device is further supported by padded protuberances, which rest on the patient's cheeks below the zygomatic processes. The device is held in place with headgear, which extends back from the nasal interface around the back and top of the patient's head.

Device Story

Nasal interface device designed to deliver CPAP or bilevel therapy to adult patients with Obstructive Sleep Apnea. Device consists of a silicone seal contacting external nares and padded protuberances resting on cheeks below zygomatic processes; secured by headgear. Used in home, hospital, nursing home, or sub-acute care settings. Facilitates airflow delivery from external CPAP/bilevel units to patient airways. Benefits include non-invasive respiratory support for sleep apnea management.

Clinical Evidence

bench testing only

Technological Characteristics

Silicone seal interface; padded cheek protuberances; headgear attachment system. Non-powered, passive respiratory accessory.

Indications for Use

Indicated for adult patients with Obstructive Sleep Apnea requiring nasal CPAP or bilevel therapy.

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)

{0}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

AUG 4 1998

Ms. Betsy Cortelloni
Respironics, Inc.
1255 Kennestone Circle
Marietta, GA 30066

Re: K974453
Nasal Interface Model 7910
Regulatory Class: II (two)
Product Code: 73 BZD
Dated: June 9, 1998
Received: June 10, 1998

Dear Ms. Cortelloni:

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.

{1}

Page 2 - Ms. Betsy Cortelloni

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 regulation (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,

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

Enclosure

{2}

JUL-31-98 17:16 FROM: HEALTHDYNE. TECH ID: 7704991139 PAGE 4/4

Center for Devices and Radiological Health Page 1 of 1

510(k) Number (if known): K974453

Device Name: Nasal Interface

Indications for Use:

The Nasal Interface is intended for use with nasal CPAP and bilevel devices for the treatment of adult patients with Obstructive Sleep Apnea. The Nasal Interface may be used in the home, hospital, nursing home, sub-acute care center or other location where nasal CPAP or bilevel therapy is applied. The Nasal Interface will facilitate nasal CPAP or bilevel therapy via a silicone seal which makes contact solely with the patient's nose on the external aspects of the nares. This device is further supported by padded protuberances, which rest on the patient's cheeks below the zygomatic processes. The device is held in place with headgear, which extends back from the nasal interface around the back and top of the patient's head.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

[Handwritten: Male Frame]

FOR PRESCRIPTION USE

(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number