The Boussignac® C.P.A.P. Device is a sterile, single-use, respiratory aid device intended for use with a facemask and gas-supplying device to elevate pressure in a patient's lung. Alternatively, the device may be used in conjunction with an endotracheal tube (via a specific Vygon adapter) to generate and maintain constant positive airway pressure during standard intubation procedures.

The upper, or proximal, port of the device may be connected to a gas-supplying source via an attached connecting tube, while the lower, or distal port may provide for C.P.A.P. pressure monitoring, O2 monitoring, or an additional source of oxygen in the event that the gas administered to the patient via the proximal connection is air not enriched with oxygen.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Boussignac® C.P.A.P. Device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Description	Reported Device Performance (Summary of Non-Clinical Tests / Conclusions)
Pressure decrease with inhalation is not excessive.	Data demonstrated that pressure decrease with inhalation is not excessive.
Pressure increase with exhalation is not excessive.	Data demonstrated that pressure increase with exhalation is not excessive.
Pressure decrease with inhalation is not excessive when an adult bronchoscope is introduced into the device's free-air end.	Data demonstrated that pressure decrease with inhalation is not excessive when an adult bronchoscope is introduced into the device's free-air end.
Pressure increase with exhalation is not excessive when an adult bronchoscope is introduced into the device's free-air end.	Data demonstrated that pressure increase with exhalation is not excessive when an adult bronchoscope is introduced into the device's free-air end.

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

The document describes "non-clinical tests" and explicitly states "Summary of Clinical Tests (Not Applicable)." This indicates that the performance evaluation was based on bench testing/laboratory experiments, not on a test set of patient data. Therefore, questions regarding patient sample size, country of origin, or retrospective/prospective nature are not directly applicable to this submission.

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

Not applicable. As the study was non-clinical (bench testing), there were no patient "cases" or ground truth established by medical experts in the traditional sense. The "ground truth" for these tests would likely be established metrics or engineering specifications for pressure changes.

4. Adjudication Method for the Test Set

Not applicable. Since there were no expert assessments of patient data, there was no need for an adjudication method.

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

No. The document explicitly states "Summary of Clinical Tests (Not Applicable)," meaning no clinical studies, including MRMC studies, were performed. This device is not an AI-powered diagnostic tool, so the concept of human readers improving with AI assistance is not relevant.

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

Yes, in a sense. The "non-clinical tests" represent the standalone performance of the device itself (not an algorithm in this context). The device was tested in a controlled environment to ensure it met specific physical performance criteria related to pressure regulation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests, the "ground truth" would be engineering specifications or established physical parameters for acceptable pressure variations in CPAP devices, likely derived from industry standards or a comparison to predicate devices. The document implies these tests demonstrate equivalence to predicate devices, suggesting the predicate device's performance characteristics served as a reference.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical respiratory aid, not an algorithm-based device that requires a training set of data.

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

Not applicable, as there is no training set for this type of device.

Summary

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JAN 2 1 2003

VII. 510(k) Summary

In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular $807.92, the following summary of safety and effectiveness information is provided:

A. Submitted by

Laetitia Bernard Excaelia™M 45900 Parsippany Court Temecula, CA 92592 Telephone: (909) 695-5474

Authorized Regulatory Agent for: Vygon, S.A. 5-11, Rue Adeline 95440 Ecouen France Telephone: (33) 1 39 92 63 63 Contact: Michel Hanania, Regulatory Affairs/Quality Assurance Manager Date Prepared: November 21, 2001.

B. Device Name

Trade or Proprietary Name: Boussignac® C.P.A.P Device

Flow Generator/ PEEP Valve Common or Usual Name:

Classification Name: Positive end expiratory pressure breathing attachment

C. Predicate Devices

The subject device is substantially equivalent to the Vital Signs® Down Adjustable Flow Generator and PEEP valves (K904874, K831503), and to the Caradyne™ Whisperflow™ Flow Generator and PEEP Valves (K982283).

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D. Device Description

E. Intended Use

The Boussignac® C.P.A.P. Device is intended to provide CPAP to spontaneously breathing patients in the hospital and pre-hospital environment.

F. Comparison to Predicate Devices

Information provided in this submission has demonstrated that the subject device is substantially equivalent to its predicate devices in terms of design, materials of composition, indications for use, performance, and function.

G. Summary of Non-Clinical Tests

A number of tests were completed to provide data supportive of the device's equivalence to other currently marketed CPAP devices in providing effective CPAP, and data supportive of the specifications identified in the device's labeling. These tests included the following:

Data demonstrating that pressure decrease with inhalation and the pressure increase with exhalation are not excessive;
Data demonstrating that pressure decrease with inhalation and the pressure increase with exhalation are not excessive. when an adult bronchoscope is introduced into the device's free-air end.

H. Summary of Clinical Tests

(Not Applicable).

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I. Conclusions of Non-Clinical and Clinical Tests

Pressure decrease with inhalation and the pressure increase with exhalation are not excessive;
Pressure decrease with inhalation and the pressure increase with exhalation are not excessive, when an adult bronchoscope is introduced into the device's free-air end.

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Image /page/3/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 three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top and left side of the eagle in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 1 2003

Vygon S A C/O Ms. Laetitia Bernard Excaelia 45900 Parsippany Court Temecula, California 92592

Re: K013884

Trade/Device Name: Boussignac® C.P.A.P. Device Regulation Number: 868.5965 Regulation Name: Positive End Expiratory Pressure Breathing Attachment Regulatory Class: II Product Code: BYE Dated: December 11, 2002 Received: December 12, 2002

Dear Mr. Bernard:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Bernard

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,

Susan Penney

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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V. Draft Labeling

A. Indications for Use

510(k) Number (if known):	K013884
Device Name:	Boussignac® C.P.A.P. Device

Indications for Use:

The Boussignac® C.P.A.P. Device is intended to provide CPAP to spontaneously breathing patients in the hospital and pre-hospital environment.

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use	✓	OR	Over-The-Counter Use _____
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number	K013884

Regulation Number and Section

§ 868.5965 Positive end expiratory pressure breathing attachment.

(a)
Identification. A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.(b)
Classification. Class II (performance standards).