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 Description

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

AI/ML Overview

This document describes a 510(k) submission for the SiPAP Infant Nasal CPAP Circuit. The submission claims substantial equivalence to previously cleared devices.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Equivalency to Predicate Devices	The SiPAP Infant Nasal CPAP Circuit is stated to be equivalent to the Infant Flow distributed by Hamilton Medical ("Aladdin" - K960359 and K945740) and the Infant Flow distributed by SensorMedics (K974303, K984254, K991972). Specifically, the document states: "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…"
Safety and Effectiveness	The device is substantially equivalent to the legally marketed predicate devices, implying it meets the same safety and effectiveness standards, as per the FDA review.
Intended Use	The device is intended to provide CPAP for use in hospitals to treat newborns and infants with RDS or who are recovering from RDS, matching the intended use of the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document explicitly states: "no additional clinical or non-clinical tests were performed or submitted in the premarket notification." This means there was no new test set for this specific 510(k) submission. The evaluation relies on data from the predicate devices.
Data Provenance: The data provenance is from the studies conducted for the predicate devices (K960359, K945740, K974303, K984254, and K991972). The document instructs to "Refer to 510(k) numbers s K960359 and K945740 for this data," implying that the original testing for those devices established the safety and effectiveness. The nature of these original studies (retrospective or prospective, country of origin) is not detailed in this document.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable. Since no new clinical or non-clinical tests were conducted for this submission, there was no new test set requiring new ground truth establishment or expert involvement for this specific 510(k) submission. The original predicate device studies would have had such experts, but their details are not provided here.

4. Adjudication Method for the Test Set

Not Applicable. As no new test set was used, no new adjudication method was employed for this submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A MRMC comparative effectiveness study was not conducted for this 510(k) submission. The basis for clearance is substantial equivalence, not a new comparative effectiveness trial demonstrating improvement with or without AI assistance (which is not relevant for this device type).

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This device is a mechanical CPAP circuit, not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable and was not performed.

7. Type of Ground Truth Used

The implicit "ground truth" for the substantial equivalence claim comes from the established safety and effectiveness of the predicate devices. This would have been based on performance data and potentially clinical outcomes from the studies supporting the original predicate device clearances. The specific type of ground truth (e.g., direct patient outcomes, expert clinical assessment of device function, etc.) from those prior studies is not detailed in this document.

8. Sample Size for the Training Set

Not Applicable. This device is a mechanical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set for this type of device, ground truth establishment for a training set is not relevant.

Summary

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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:

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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Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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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Page 1 of 1

510(k) NUMBER (IF KNOWN): K012034

DEVICE NAME:

SiPAP Infant Nasal CPAP Circuit

INDICATIONS FOR USE:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

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

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

Appendix 6

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
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.(b)
Classification. Class II (performance standards).