(145 days)
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Not Found
No
The summary does not mention AI, ML, or related terms, and the described function is data display and alarm surveillance, which does not inherently require AI/ML.
No
The device provides a secondary display of ventilator data and remote monitoring/alarm surveillance; it supplements existing procedures rather than directly treating a condition.
No
The Bernoulli VMS software is described as providing a secondary display of ventilator data for remote monitoring and alarm surveillance. It is intended to supplement existing monitoring procedures, not to diagnose conditions or make clinical decisions.
Yes
The device is described as "Bernoulli VMS software" and its intended use is to provide a secondary display and remote monitoring/alarm surveillance of ventilator data on a central monitoring station. The description focuses solely on the software's function and does not mention any associated hardware components that are part of the device itself.
Based on the provided information, the Bernoulli VMS software is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Bernoulli VMS function: The description clearly states that the Bernoulli VMS software is used to display and monitor data from mechanically ventilated patients. This data is coming directly from the ventilator, which is a medical device supporting a patient's breathing. It's not analyzing samples taken from the patient.
- Lack of mention of biological samples: There is no mention of analyzing blood, urine, tissue, or any other biological sample.
The Bernoulli VMS is a software intended for monitoring and displaying real-time physiological data from a medical device (ventilator) on a central station. This falls under the category of medical device software, but not specifically in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Bernoulli™ VMS software is intended to be used on a central monitoring station on mechanically ventilated patients in a hospital or hospital type environment. It is used to provide a secondary display of the ventilator data to the central station, and to provide remote monitoring and alarm surveillance. The Bernoulli™ VMS is intended to supplement and not replace any part of the current device monitoring procedures.
Product codes
73 MOD
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
central monitoring station on mechanically ventilated patients in a hospital or hospital type environment.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the upper portion of the circular border.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 6 2001
Mr. John Laviola Cardiopulmonary Corp. 200 Cascade Boulevard Milford, CT 06460
Re: K011861
Bernoulli™ Ventilator Management System Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II (two) Product Code: 73 MOD Dated: October 9, 2001 Received: October 9, 2001
Dear Mr. Laviola:
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.
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
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Page 2 - Mr. John Laviola
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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
K. Dea Telle
Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K011861
CONFIDENTIAL
. .. . .
NOV 0 6 2001
APPENDIX B:
| Indications for Use Statement | |
|---|---|
| 510(k) Number | K011861 |
| Device Name | Bernoulli™ Ventilator Management System |
| Indications for Use | The Bernoulli VMS software is intended to be used on a central monitoring station on mechanically ventilated patients in a hospital or hospital type environment. It is used to provide a secondary display of the ventilator data to the central station, and to provide remote monitoring and alarm surveillance. The Bernoulli VMS is intended to supplement and not replace any part of the current device monitoring procedures. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K011861
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________