INFANT FLOW NCPAP MASKS

K984254 · Sensor Medics Corp. · BZD · Feb 24, 1999 · Anesthesiology

Device Facts

• Record ID: K984254
• Device Name: INFANT FLOW NCPAP MASKS
• Applicant: Sensor Medics Corp.
• Product Code: BZD · Anesthesiology
• Decision Date: Feb 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The SensorMedics Infant Flow Nasal CPAP Mask is intended for use with the SensorMedics Infant Flow System, consisting of a Driver and NCPAP Generator. It is intended to provide CPAP with a nasal mask for use in hospitals to treat newborns and infants with RDS or who are recovering from RDS.

Device Story

Silicone nasal mask designed as an interface for the SensorMedics Infant Flow System; replaces standard nasal prongs in the NCPAP generator. Used in hospital settings by clinicians to deliver continuous positive airway pressure (CPAP) to newborns and infants with RDS. Device functions as a patient interface to maintain airway pressure; provides an alternative mounting method to nasal prongs. Benefits include providing respiratory support for neonates; clinical decision-making relies on standard CPAP therapy protocols.

Clinical Evidence

No clinical data submitted. Substantial equivalence established via non-clinical bench testing comparing the mask to existing nasal prongs, demonstrating no differences in safety or effectiveness.

Technological Characteristics

Silicone nasal mask; designed for integration with the SensorMedics Infant Flow System (Driver and NCPAP Generator). Replaces standard nasal prongs. Non-powered, passive interface device.

Indications for Use

Indicated for newborns and infants with Respiratory Distress Syndrome (RDS) or recovering from RDS, treated in a hospital setting using the SensorMedics Infant Flow System.

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.

Predicate Devices

• Hans Rudolph CPAP Mask (K962848)
• SensorMedics Infant Flow System (K974303)
• Hamilton Aladdin CPAP System (K960359)
• Hamilton Aladdin CPAP System (K945740)

Submission Summary (Full Text)

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K984254

# Appendix 3: 510(k) Summary

Preparation Date: November 23, 1998

## Company:

SensorMedics Corporation 22705 Save Ranch Parkway Yorba Linda, CA 92887 Telephone: [phone] [phone] Fax:

### Contact:

Paul L. Kittinger Director, Regulatory Affairs

### Proprietary Name:

Infant Flow Nasal CPAP Masks

### Common Name:

Nasal CPAP Masks

## Intended Use:

The SensorMedics Infant Flow Nasal CPAP Mask is intended for use with the SensorMedics Infant Flow System, consisting of a Driver and NCPAP Generator. It is intended to provide CPAP with a nasal mask for use in hospitals to treat newborns and infants with RDS or who are recovering from RDS.

### Description:

The SensorMedics Infant Flow Nasal CPAP Mask is a silicone mask that fits into the generator of the Infant Flow System in place of the standard nasal prongs.

## Clinical and Non-Clinical Tests of Equivalency:

The Infant Flow Mask is similar in purpose to the Hans Rudolph CPAP Mask (K962848) and provides the same function as the nasal CPAP prongs of the SensorMedics Infant Flow System (K974303) and Hamilton Aladdin CPAP System (K960359 and K945740).

Because there are no differences other than facial mounting and labeling between the SensorMedics Infant Flow System prongs and the SensorMedics Infant Flow Mask, no additional clinical tests were performed or submitted in the premarket notification. Refer to 510(k) numbers K960359 and K945740 for these data.

Non-clinical testing of the Infant Flow System using the mask as compared to the prongs demonstrated no differences in safety or effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 4 1999

Mr. Paul L. Kittinger SensorMedics Corporation 22705 Savi Ranch Parkway Yorba Linda, CA 92887

Re : K984254 Infant Flow NCPAP Masks Regulatory Class: II (two) Product Code: 73 BZD Dated: November 23, 1998 Received: November 27, 1998

Dear Mr. Kittinger:

We have reviewed your Section 510(k) notification of intent to market we have referenced above and we have determined the device is ene as tially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in encessare, or logo to May 28, 1976, the enactment date of the Incelstate Commerco press, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and in accordante with o 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, pisting 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 Existing major regulations affecting your device additional controls. 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 Failure to comply with the GMP regulation may result in assumptions. aegulatory 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. Paul L. Kittinger

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

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:

K984254

DEVICE NAME:

Infant Flow NCPAP Masks

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INDICATIONS FOR USE:

The SensorMedics Infant Flow NCPAP Masks are intended for use with the The Gensonnedics Infant Flow System, consisting of a Driver and NCPAP Generator. SensorMedics Infrant Flow Bystoitt, a nasal mask for use in hospitals to treat it is intended to provide of P.P. Maran are recovering from RDS.

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|-------------------------------------------------------------------|
| | <i>Mark Kramer</i> |
| | (Division Sign-Off) |
| | Division of Cardiovascular, Respiratory, and Neurological Devices |
| Prescription Use<br>(Per 21 CFR 801.109) | 510(k) Number |
| | K984254<br>Over-The-Counter-Use<br>[Optional Format (1-2-96)] |

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