UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE

K091985 · Ivy Biomedical Systems, Inc. · DRT · Jul 24, 2009 · Cardiovascular

Device Facts

• Record ID: K091985
• Device Name: UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE
• Applicant: Ivy Biomedical Systems, Inc.
• Product Code: DRT · Cardiovascular
• Decision Date: Jul 24, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Intended 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.

Device Story

UPMM detects patient heart waveforms to generate synchronized pulses for triggering medical imaging equipment; used in clinical settings for applications including gamma cameras, TMR/PMR, multislice CT, PET/CT, and SPECT/CT. Device processes ECG signals to identify R-waves; outputs trigger signal to imaging system to ensure temporal alignment of image acquisition with cardiac cycle. Facilitates gated imaging studies; improves diagnostic image quality by reducing motion artifacts related to cardiac activity.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and technological comparison to legally marketed predicate devices.

Technological Characteristics

Physiological signal acquisition module; processes ECG waveforms for R-wave detection; provides synchronized trigger output for imaging systems. Operates as a component within a larger imaging workflow. Specific materials and standards not detailed in provided text.

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)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

## 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.

{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 regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

{2}------------------------------------------------

## 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