INFANT FLOW SYSTEM

K974303 · Sensor Medics Corp. · BZD · Jan 30, 1998 · Anesthesiology

Device Facts

• Record ID: K974303
• Device Name: INFANT FLOW SYSTEM
• Applicant: Sensor Medics Corp.
• Product Code: BZD · Anesthesiology
• Decision Date: Jan 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The SensorMedics Infant Flow System, consisting of a Driver and NCPAP Prongs, is intended to provide CPAP for use in hospitals to treat newboms and infants with RDS or who are recovering from RDS.

Device Story

SensorMedics Infant Flow System provides continuous positive airway pressure (CPAP) to newborns and infants. System comprises a Driver unit and NCPAP prongs. Used in hospital settings by clinicians to treat RDS or support recovery from RDS. Device delivers respiratory support to stabilize infant breathing; assists in managing respiratory distress. Clinicians monitor patient response to CPAP therapy to guide clinical decisions regarding respiratory support levels.

Clinical Evidence

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

Technological Characteristics

System consists of a Driver and NCPAP prongs for CPAP delivery. Class II device (Product Code BZD).

Indications for Use

Indicated for newborns and infants with Respiratory Distress Syndrome (RDS) or recovering from RDS requiring CPAP therapy in a hospital setting.

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

JAN 30 1998

Mr. Paul L. Kittinger Director, Requlatory Affairs SensorMedics 22705 Savi Ranch Parkway Yorba Linda, CA 92887-4645

Re: K974303 SensorMedics Infant Flow System Regulatory Class: II (two) Product Code: BZD Dated: November 11, 1997 Received: November 17, 1997

Dear Mr. Kittinger:

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 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, qood 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 Reqister. 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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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.qov/cdrh/dsmamain.html".

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): K974303

DEVICE NAME:

Infant Flow System

INDICATIONS FOR USE:

The SensorMedics Infant Flow System, consisting of a Driver and NCPAP Prongs, is intended to provide CPAP for use in hospitals to treat newboms and infants with RDS or who are recovering from RDS.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

*John Westenshausen*

| Prescription Use | <span> ✓ </span> |
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| (Per 21 CFR 801.109) | |

(Division Sign-Off)

Division of Cardiovascular, Respiratory, Over-The-Counter-Use __________

and Neurological Devices (Optional Format (1-2-96)

| 510(k) Number | __________ |
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