BOUSSIGNAC C.P.A.P. DEVICE

K013884 · Vygon SA · BYE · Jan 21, 2003 · Anesthesiology

Device Facts

• Record ID: K013884
• Device Name: BOUSSIGNAC C.P.A.P. DEVICE
• Applicant: Vygon SA
• Product Code: BYE · Anesthesiology
• Decision Date: Jan 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5965
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Boussignac® C.P.A.P. Device is a sterile, single-use respiratory aid; connects to facemask or endotracheal tube (via adapter) and gas-supplying source. Device generates and maintains constant positive airway pressure in patient's lungs. Proximal port connects to gas source; distal port allows for CPAP pressure monitoring, O2 monitoring, or supplemental oxygen delivery. Used in hospital and pre-hospital environments by clinicians. Provides respiratory support to spontaneously breathing patients; helps maintain airway pressure during intubation procedures.

Clinical Evidence

No clinical data. Bench testing only. Tests confirmed that pressure decrease with inhalation and pressure increase with exhalation are not excessive, including when an adult bronchoscope is introduced into the device's free-air end.

Technological Characteristics

Sterile, single-use respiratory aid. Functions as a flow generator/PEEP valve. Features proximal gas-supply port and distal monitoring/supplemental oxygen port. Mechanical design for pressure regulation.

Indications for Use

Indicated for spontaneously breathing patients in hospital and pre-hospital settings requiring CPAP therapy.

Regulatory Classification

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.

Predicate Devices

• Vital Signs® Down Adjustable Flow Generator and PEEP valves (K904874, K831503)
• Caradyne™ Whisperflow™ Flow Generator and PEEP Valves (K982283)

Submission Summary (Full Text)

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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: [phone]

Authorized Regulatory Agent for: Vygon, S.A. 5-11, Rue Adeline 95440 Ecouen France Telephone: [phone] 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

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.

#### 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 [phone]. 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 [phone] or [phone] 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 | <div style="display:inline-block; vertical-align:top;">✓</div> | 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 | | |