(22 days)
The Universal Physiological Measurement Module is intended for use on patients requiring Rwave synchronization and timed imaging studies. Applications include: gamma cameras, TMR/PMR, multislice CT, PET/CT, and SPECT/CT.
The UPMM is responsible for detecting the patient's heart waveform and producing a synchronized pulse that is used to trigger a device.
Universal Physiological Measurement Module (UPMM)
This document is a 510(k) clearance letter from the FDA for a device called "Universal Physiological Measurement Module (UPMM)". It is not a study report or clinical trial documentation. Therefore, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.
The document states that the FDA reviewed a "Section 510(k) premarket notification" and determined the device is substantially equivalent to legally marketed predicate devices. This means the device met the regulatory requirements for 510(k) clearance at the time, which typically involves demonstrating that the new device is as safe and effective as an already legally marketed device. However, the clearance letter itself does not provide:
- A table of acceptance criteria or reported device performance.
- Details about sample sizes for test sets, data provenance, number of experts, or adjudication methods for any studies.
- Information on comparative effectiveness studies (MRMC) or standalone performance studies.
- Information on ground truth establishment for test or training sets, nor the sample size of any training sets.
In summary, based on the provided text, it is not possible to answer your questions as the document is an FDA clearance letter, not a scientific study report.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 4 2009
Ivy Biomedical Systems, Inc. c/o Mr. Dick Listro Director of Regulatory 11 Business Park Dr. Branford, CT 06405
Re: K091985
Universal Physiological Measurement Module (UPMM) Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: DRT Dated: July 06, 2009 Received: July 02, 2009
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 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. 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); 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,
7 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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K091985
Indications for Use Statement
510(k) Number (if known):
Device Name: Universal Physiological Measurement Module (UPMM)
Indications for Use:
The Universal Physiological Measurement Module is intended for use on patients requiring Rwave synchronization and timed imaging studies. Applications include: gamma cameras, TMR/PMR, multislice CT, PET/CT, and SPECT/CT.
The UPMM is responsible for detecting the patient's heart waveform and producing a synchronized pulse that is used to trigger a device.
Prescription Use ਮ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
2/23/09
rdiovascular Devices 510fk) Ni
Sec. 10c Page 1 of 1
§ 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).