MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT

K012034 · Sensor Medics Corp. · BZD · Jul 24, 2001 · Anesthesiology

Device Facts

• Record ID: K012034
• Device Name: MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT
• Applicant: Sensor Medics Corp.
• Product Code: BZD · Anesthesiology
• Decision Date: Jul 24, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The SensorMedics SiPAP Infant Nasal CPAP Circuit, consisting of a pressure generator, Nasal CPAP Prongs and Masks, is intended to provide CPAP for use in hospitals to treat newborns and infants with RDS or who are recovering from RDS.

Device Story

The SiPAP Infant Nasal CPAP Circuit is a patient interface system used in hospital settings to deliver Continuous Positive Airway Pressure (CPAP) to neonates and infants. The device consists of a pressure generator, nasal prongs, and masks. It functions as a delivery circuit for CPAP therapy, facilitating respiratory support for patients with RDS. The device is operated by clinical staff in a hospital environment. It does not incorporate electronic sensors or active software-based processing; it serves as a mechanical conduit for gas delivery.

Clinical Evidence

No clinical or non-clinical tests were performed or submitted for this notification. The manufacturer relies on data from previously cleared predicate devices (K960359, K945740, K974303, K984254, K991972) to demonstrate substantial equivalence.

Technological Characteristics

The device is a mechanical circuit comprising a pressure generator, nasal prongs, and masks. It is a passive respiratory accessory used for CPAP delivery. No electronic components, software, or energy sources are described. Materials and specifications are consistent with previously cleared predicate circuits.

Indications for Use

Indicated for newborns and infants with Respiratory Distress Syndrome (RDS) or those recovering from RDS, requiring hospital-based CPAP 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.

Predicate Devices

• Infant Flow (Aladdin) (K960359)
• Infant Flow (Aladdin) (K945740)
• Infant Flow (K974303)
• Infant Flow (K984254)
• Infant Flow (K991972)

Submission Summary (Full Text)

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K012034

## Infant Flow System - Summary of Safety and Effectiveness

Company:

SensorMedics Corporation 22705 Savi Ranch Parkway Yorba Linda, CA 92887 714 283-1830

### Contact:

Paul Kittinger

# Proprietary Name:

SiPAP Infant Nasal CPAP Circuit

# Common Name:

Nasal CPAP Circuit

### Intended Use:

The SensorMedics SiPAP Infant Nasal CPAP Circuit, consisting of a pressure generator, Nasal CPAP Prongs and Masks, is intended to provide CPAP for use in hospitals to treat newborns and infants with RDS or who are recovering from RDS.

# Description of the Device:

Detailed description of the device circuit is contained in the SiPAP Infant Nasal CPAP Operator's Instructions.

## Clinical and Non-Clinical Tests of Equivalency:

The SiPAP Infant Nasal CPAP Circuit is the equivalent device circuit as the Infant Flow distributed by Hamilton Medical under the "Aladdin" name (510(k) #"s K960359 and K945740) and the Infant Flow distributed by SensorMedics under 510(k)'s K974303, K984254 and K991972.

Because there are no performance differences between the SensorMedics SiPAP Infant Nasal CPAP Circuit, the SensorMedics Infant Flow Circuit and the Hamilton Medical Aladdin Circuit, no additional clinical or non-clinical tests were performed or submitted in the premarket notification. Refer to 510(k) numbers s K960359 and K945740 for this data.

Appendix 7

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JUL 2 4 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Earl Draper SensorMedics Corporation 22705 Savi Ranch Parkway Yorba Linda, CA 92887-4645

Re: K012034

SiPAP Infant Nasal CPAP Circuit Regulation Number: 868.5905 Regulatory Class: II (two) Product Code: 73 BZD Dated: June 27, 2001 Received: June 29, 2001

Dear Mr. Draper:

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

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Page 2 - Mr. Earl Draper

have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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" (21CFR 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,

Q. Tell

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) NUMBER (IF KNOWN): K012034

DEVICE NAME:

SiPAP Infant Nasal CPAP Circuit

INDICATIONS FOR USE:

The SensorMedics SiPAP Infant Nasal CPAP Circuit, consisting of a pressure generator, Nasal CPAP Prongs and Masks, is intended to provide CPAP for use in hospitals to treat newborns and infants with RDS or who are recovering from RDS.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter-Use (Optional Format (1-2-96)

Oaktell
Division of Cardiovascular & Respiratory Devices
510(k) Number K012034

Appendix 6