(37 days)
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No
The summary describes a software for displaying and monitoring ventilator data, with no mention of AI or ML capabilities.
No
The device provides secondary display, remote monitoring, and alarm surveillance of ventilator data. It supplements existing monitoring procedures and does not directly treat a medical condition.
No
The Bernoulli VMS software provides a secondary display of existing ventilator and respiratory gas monitor data for remote monitoring and alarm surveillance. It is intended to supplement, not replace, current device monitoring procedures, indicating it is for monitoring and not for diagnosing a condition.
Yes
The summary explicitly states "The Bernoulli VMS software" and describes its function as providing a secondary display and remote monitoring of data from other devices. There is no mention of any hardware component being part of the Bernoulli VMS itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the software is used to display and monitor data from ventilators and respiratory gas monitors on mechanically ventilated patients. This involves monitoring physiological parameters and device data, not analyzing biological samples (like blood, urine, or tissue) outside the body to diagnose or monitor a medical condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening based on biological sample analysis.
The Bernoulli VMS software functions as a medical device for monitoring and surveillance of patients and their connected medical equipment. It falls under the category of devices that display and manage patient data, which is distinct from 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 and respiratory gas monitor 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
MOD, MSX
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, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 3 2005
Mr. Jordan Schreck Quality Manager Cardiopulmonary Corporation 200 Cascade Boulevard Milford, Connecticut 06460
Re: K051283
.
Trade/Device Name: Bernoulli™ Ventilator Management System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: II Product Code: MOD, MSX Dated: June 13, 2005 Received: June 16, 2005 :
Dear Mr. Schreck:
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 intersule conmisers prices 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 approvisions 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 (1 111 ), it noy obe are your 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.
1
Page 2 - Mr. Schreck
Please be advised that FDA's issuance of a substantial equivalence determination does not Frease be auvrsod that I Dr. o termination that your device complies with other requirements Incall that I D7 mas made statutes and regulations administered by other Federal agencies. of the Act of ally I outhal the Act's requirements, including, but not limited to: registration 1 ou must continery with and 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 OF RT Fact 807), labality systems (QS) regulation (21 CFR Part 820); and if requirences as set for in are quardion 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) This letter will anow you to began finding of substantial equivalence of your device to a premarket notification - I - I - 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), If you desire specific at no compliance at (240) 276-0120. 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 may other butter generalional 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/industry/support/index.html.
Sincerely yours,
Senette y. Michui Om-D
Chiu Lin, Ph.D. 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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APPENDIX B:
Indications for Use Statement
| 510(k) Number | (K051283) |
|---|---|
| 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 and respiratory gas monitor 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)
Am
Sign Off
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology General Hospital,
Division of Anesthesiology, General Devices Division of Anesthesion of Anesther 83
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:
:
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Prescription Use
(Per 21 CFR 801.109)
OR
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1998年10月
- Participant
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Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________