(424 days)
Not Found
No
The device description and performance studies focus on mechanical pressure generation and monitoring, with no mention of AI or ML algorithms for analysis, prediction, or control.
Yes.
The device is intended to provide CPAP to spontaneously breathing patients, which is a therapeutic intervention to elevate pressure in a patient's lung and maintain constant positive airway pressure.
No
This device is a respiratory aid that provides CPAP. Its function is to deliver therapy (elevating pressure in a patient's lung) rather than to diagnose a condition.
No
The device description explicitly states it is a "sterile, single-use, respiratory aid device" and describes physical ports and connections, indicating it is a hardware device.
Based on the provided information, the Boussignac® C.P.A.P. Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide CPAP to spontaneously breathing patients, which is a therapeutic intervention applied directly to the patient's respiratory system.
- Device Description: The device is described as a respiratory aid device used with a facemask or endotracheal tube to elevate pressure in the patient's lung. This is a medical device used for treatment, not for testing samples from the body.
- No mention of in vitro testing: There is no indication that this device is used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed for testing samples outside of the body. The Boussignac® C.P.A.P. Device is clearly used on the patient to provide respiratory support.
N/A
Intended Use / 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.
Product codes
BYE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital and pre-hospital environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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).
1
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).
2
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.
3
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 |