(105 days)
The Ivy Biomedical Model 7600 Cardiac Trigger Monitor is a simple to use instrument for monitoring the ECG and Heart Rate. It is designed for use in the ICU, CCU and operating room conditions. It can sound an alarm when the HR falls outside of preset limits. It provides an output pulse, synchronized to the R-wave for use in applications requiring precision R-wave synchronization. The Model 7600 is limited to use by trained and qualified medical professionals. This product is not intended for home care monitoring.
The Ivy Biomedical Model 7600 Cardiac Trigger Monitor is a simple to use instrument for monitoring the ECG and Heart Rate. It is designed for use in the ICU, CCU and operating room conditions. It can sound an alarm when the HR falls outside of preset limits. It provides an output pulse, synchronized to the R-wave for use in applications requiring precision R-wave synchronization.
Based on the provided text, the document is a 510(k) clearance letter for the Ivy Biomedical Model 7600 Cardiac Trigger Monitor. It confirms the device's substantial equivalence to a predicate device but does not contain information regarding detailed acceptance criteria, performance studies, or technical specifications of the device's performance.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. The document focuses on regulatory clearance, not the technical validation of the device's performance against specific metrics.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ivy Biomedical Systems, Inc. c/o Mr. Dick Listro Director of Regulatory 11 Business Park Drive Branford, CT 06405
JUL 2 2 2011
Re: K110987
Trade/Device Names: Cardiac Trigger Monitor Model 7600 Regulatory Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including Cardiotachometer and Rate Alarm) Regulatory Class: Class II (Two) Product Code: DRT Dated: June 22, 2011 Received: June 23, 2011
Dear Mr. Listro:
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 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. Dick Listro
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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
210(k) Number (K110987)
Device Name Ivy Biomedical Model 7600
Indications for Use
The Ivy Biomedical Model 7600 Cardiac Trigger Monitor is a simple to use instrument for monitoring the ECG and Heart Rate. It is designed for use in the ICU, CCU and operating room conditions. It can sound an alarm when the HR falls outside of preset limits. It provides an output pulse, synchronized to the R-wave for use in applications requiring precision R-wave synchronization. The Model 7600 is limited to use by trained and qualified medical professionals. This product is not intended for home care monitoring.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use: X
vision Sign-Off) Division of Cardiovascular Devices
510(k) Number K110987
§ 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).