(69 days)
Not Found
Not Found
No
The provided text describes a central monitoring station software that displays data from other medical devices and provides remote monitoring and alarm surveillance. There is no mention of AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms.
No
The device is a software for displaying and monitoring patient data, intended to supplement current monitoring procedures, not to treat or directly interact with the patient's body for therapeutic purposes.
No
The device provides a secondary display of patient data and remote monitoring/alarm surveillance. It supplements, rather than replaces, current monitoring procedures and does not perform any diagnostic interpretation of the data itself.
Unknown
The provided text describes the intended use and care setting of the Bernoulli MS software, which functions as a secondary display and remote monitoring/alarm surveillance system for data from various medical devices. However, the "Device Description" section is "Not Found," which is crucial for determining if the device is purely software or includes hardware components. Without a description of the device itself, it's impossible to definitively classify it as software-only.
Based on the provided information, the Bernoulli MS 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Bernoulli MS Function: The Bernoulli MS software is described as a central monitoring station software that displays data from medical devices (ventilators, monitors) connected to patients. It provides a secondary display and remote monitoring/alarm surveillance.
- Lack of Sample Analysis: The description does not mention the software analyzing any biological samples from the patient. It is processing data from medical devices that are monitoring the patient's physiological parameters.
Therefore, the Bernoulli MS software falls under the category of medical device software that monitors and displays patient data, rather than performing in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Bernoulli MS software is intended to be used on a central monitoring station on patients using supported devices in a hospital or hospital type environment. It is used to provide a secondary display of ventilator, respiratory monitor, and/or multi parameter monitor data (ECG, respiratory rate, pulse oximetry, ETCO2, blood pressure, cardiac output, temperature and associated derived outputs) to the central station, and to provide remote monitoring and alarm surveillance. The Bernoulli MS is intended to supplement and not replace any part of the current device monitoring. procedures.
Product codes
MSX, MOD
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
central monitoring station on patients using supported devices in a hospital or hospital type 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
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).
Not Found
§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EP 1 4 2006
Mr. Jordan Schreck Ouality Manager Cardiopulmonary Corporation 200 Cascade Boulevard Milford, Connecticut 06460
Re: K061932
Trade/Device Name: Bernoulli™ Management System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: II Product Code: MSX, MOD Dated: June 22, 2006 Received: July 17, 2006
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 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 - Mr. Schreck
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 (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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sulte y. Mohue Dmd.
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
2
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APPENDIX B:
Indications for Use Statement
| 510(k) Number | K061932 |
|---|---|
| Device Name | Bernoulli TM Management System |
| Indications for Use | The Bernoulli MS software is intended to be used on a central monitoring station on patients using supported devices in a hospital or hospital type environment. It is used to provide a secondary display of ventilator, respiratory monitor, and/or multi parameter monitor data (ECG, respiratory rate, pulse oximetry, ETCO2, blood pressure, cardiac output, temperature and associated derived outputs) to the central station, and to provide remote monitoring and alarm surveillance. The Bernoulli MS is intended to supplement and not replace any part of the current device monitoring. procedures. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
8
Prescription Use _ × (Per 21 CFR 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ live William
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