(51 days)
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No
The summary describes a device that detects a heart waveform and produces a synchronized pulse, which is a standard signal processing function, not indicative of AI/ML. There are no mentions of AI, ML, training data, or performance metrics typically associated with AI/ML devices.
No
The device synchronizes with heart waveforms to trigger other devices for imaging studies, but it does not directly treat a medical condition or disease.
No
The device is described as detecting the heart waveform and producing a synchronized pulse to trigger other imaging devices, which is a functional role for timing, not a diagnostic one. It facilitates diagnostic imaging but does not perform diagnosis itself.
No
The description explicitly states the device is a "Cardiac Trigger Module model CTM-300" and is responsible for "detecting the patient's heart waveform and producing a synchronized pulse". This strongly implies a hardware component is involved in the detection and pulse generation, not just software processing.
Based on the provided information, the Cardiac Trigger Module model CTM-300 is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens obtained from the human body. The CTM-300's intended use and device description clearly state it detects the patient's heart waveform directly from the patient to produce a synchronized pulse for triggering imaging devices. It does not analyze blood, tissue, or other bodily fluids or substances.
- The device's function is related to timing and synchronization for imaging procedures. While it uses the heart's electrical activity, its purpose is to facilitate the acquisition of images at specific points in the cardiac cycle, not to diagnose a condition based on the analysis of a biological sample.
Therefore, the CTM-300 falls under the category of a medical device used for patient monitoring and triggering of imaging equipment, not an IVD.
N/A
Intended Use / Indications for Use
The Cardiac Trigger Module model CTM-300 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 CTM-300 is responsible for detecting the patient's heart waveform and producing a synchronized pulse that is used to trigger a device.
Product codes
DRT
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
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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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 2009
Ivy Biomedical Systems, Inc. c/o Mr. Dick Listro Director of Regulatory Affairs 11 Business Park Drive -Branford, CT 06405
-Re: K083854
Trade/Device Name: Cardiac Trigger, Model CTM300 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II Product Code: DRT Dated: December 22, 2008 Received: January 26, 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 reclassion 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. 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 regilation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Sram D. Zuckerman, M.D. Director Division of Canliovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Cardiac Trigger Module model CTM-300 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 CTM-300 is responsible for detecting the patient's heart waveform and producing a synchronized pulse that is used to trigger a device. I wi
Prescription Use X (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)
Z. A. W. B. Zucklevorn
Page 1 of 1
,
2/09/09 (Division Sign-Off) Division of Cardiovascular Devices K083854 510(k) Number_