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 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.

AI/ML Overview

The provided text refers to a 510(k) premarket notification for the "Infant Flow Nasal CPAP Masks." This is a medical device submission seeking clearance based on substantial equivalence to predicate devices, rather than a de novo submission requiring extensive clinical trials to prove efficacy. Therefore, much of the requested information (like acceptance criteria, specific device performance metrics, large-scale clinical study details, MRMC studies, ground truth establishment for training, etc.) is not present in the provided document.

Here's an analysis based on the available information:

Key Takeaway: The submission leverages the existing clearances of similar CPAP systems and states that no additional clinical tests were performed because the mask's function is the same as the already cleared prongs in the Infant Flow System, with only differences in facial mounting and labeling. The core argument for equivalency relies on non-clinical testing demonstrating no differences in safety or effectiveness when using the mask compared to the prongs.

1. Table of Acceptance Criteria and Reported Device Performance

Criterion	Acceptance Metric	Device Performance	Notes
Safety	No significant differences in safety compared to predicate and existing components of the Infant Flow System.	"Non-clinical testing of the Infant Flow System using the mask as compared to the prongs demonstrated no differences in safety..."	The document highlights that the mask provides the "same function" as the nasal prongs from the previously cleared Infant Flow System.
Effectiveness	No significant differences in effectiveness compared to predicate and existing components of the Infant Flow System in providing CPAP.	"...or effectiveness."	The document indicates that the mask is "similar in purpose" to other CPAP masks and provides the "same function" as the nasal CPAP prongs already part of the Infant Flow System.
Performance (Functional Equivalence)	Ability to provide CPAP with a nasal mask for use in hospitals to treat newborns and infants with RDS or recovering from RDS.	This is the stated intended use and functionality, asserted to be equivalent to the existing prongs.	The mask is described as a "silicone mask that fits into the generator of the Infant Flow System in place of the standard nasal prongs."

No specific quantitative acceptance criteria or detailed performance metrics are provided in the document. The basis for clearance is substantial equivalence, primarily supported by the argument that the mask functions identically to already cleared components within the same system.

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

Sample Size: Not applicable in the context of a clinical test set as described in the prompt. The document explicitly states: "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."
Data Provenance: The "non-clinical testing" mentioned is not detailed, so its provenance (country of origin, retrospective/prospective) is unknown. It's likely internal lab testing.

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

Not applicable. No clinical test set with ground truth established by experts is described for this specific device (the mask). The determination of safety and effectiveness relied on "non-clinical testing" and a claim of functional equivalence to previously cleared devices/components.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring expert adjudication is described for this device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance?

Not applicable. This device is a nasal CPAP mask, not an AI diagnostic or assistive technology for human readers. No MRMC study was conducted or is relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical medical device (mask), not an algorithm or AI system.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Not applicable for this specific device's clearance. The "ground truth" for the clearance of the mask was the established safety and effectiveness of the predicate devices and the existing prongs within the Infant Flow System, as determined by previous FDA clearances (K962848, K974303, K960359, K945740). The current submission relies on non-clinical testing to demonstrate the mask's equivalence to those established components.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI system that requires a training set.

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

Not applicable. As above, no training set for an AI system is involved.

Summary

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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: (714) 283-2228 (714) 283-8411 Fax:

Contact:

Paul L. Kittinger Director, Regulatory Affairs

Proprietary Name:

Infant Flow Nasal CPAP Masks

Common Name:

Nasal CPAP Masks

Intended Use:

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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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, with three lines representing the feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The text is in all caps and is written in a simple, sans-serif font.

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 (301) 594-4648. 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" (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 (800) 638-2041 or (301) 443-6597, 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

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)
	Mark Kramer
	(Division Sign-Off)
	Division of Cardiovascular, Respiratory, and Neurological Devices
Prescription Use(Per 21 CFR 801.109)	510(k) Number
	K984254Over-The-Counter-Use[Optional Format (1-2-96)]

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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).