CARDIAC TRIGGER, MODEL: CTM300

K083854 · Ivy Biomedical Systems, Inc. · DRT · Feb 13, 2009 · Cardiovascular

Device Facts

• Record ID: K083854
• Device Name: CARDIAC TRIGGER, MODEL: CTM300
• Applicant: Ivy Biomedical Systems, Inc.
• Product Code: DRT · Cardiovascular
• Decision Date: Feb 13, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Intended 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.

Device Story

The CTM-300 Cardiac Trigger Module detects patient heart waveforms via ECG leads; processes signals to identify R-waves; generates a synchronized output pulse to trigger external imaging equipment (gamma cameras, CT, PET/CT, SPECT/CT). Used in clinical imaging environments; operated by medical staff. Output pulse enables precise timing of image acquisition relative to cardiac cycle; facilitates gated imaging studies; improves image quality by reducing motion artifacts.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cardiac monitor/trigger; detects ECG waveforms; generates synchronized trigger pulse for imaging systems. Class II device (21 CFR 870.2300, Product Code DRT).

Indications for Use

Indicated for patients requiring R-wave synchronization for timed imaging studies, including gamma cameras, TMR/PMR, multislice CT, PET/CT, and SPECT/CT.

Regulatory Classification

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.

Submission Summary (Full Text)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### 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.

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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 regilation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 [phone] or [phone] 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

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2/09/09 (Division Sign-Off) Division of Cardiovascular Devices K083854 510(k) Number_