(69 days)
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.
Not Found
This appears to be a 510(k) clearance letter from the FDA for the Bernoulli™ Management System. This document does not contain the specific acceptance criteria and detailed study results that you are asking for.
FDA 510(k) clearance letters primarily state that the device has been found substantially equivalent to a predicate device, meaning it's as safe and effective as a device already on the market. They typically do not include the detailed performance study results or acceptance criteria used by the manufacturer during their development and validation process. Those details would normally be found in the 510(k) submission itself, which is a confidential document submitted to the FDA by the manufacturer.
Therefore, I cannot provide the information you requested based on the provided text.
To answer your questions, I would need to analyze the actual 510(k) summary, often referred to as the "510(k) Premarket Notification." Sometimes, manufacturers publish these summaries publicly.
If you can provide the 510(k) Summary document for K061932, I could potentially extract the requested information.
{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.
{1}------------------------------------------------
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}------------------------------------------------
.
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
. വാന Siyn-Off ion of Anesthesiology, General Hospital, t John Control, Dental Devices
; Rumber
§ 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).