PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 112

K063735 · Presym, Inc. · DRT · Sep 19, 2007 · Cardiovascular

Device Facts

• Record ID: K063735
• Device Name: PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 112
• Applicant: Presym, Inc.
• Product Code: DRT · Cardiovascular
• Decision Date: Sep 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Indications for Use

The Presym TrCG (Tracheocardiogram) is a non-invasive device intended to measure acceleration (displacement over time2) of the trachea. The trachea is mechanically linked to the heart and therefore its movement is directly related to that of the heart. The TrCG displays are shown with the patient's ECG (electrocardiograph) and presented for the physician's consideration. There are no set alarms or preset force limits.

Device Story

Presym TrCG measures tracheal acceleration via neck-worn motion sensor; sensor connects to belt pack unit. System utilizes Nasiff Associates Cardio-Card Management System II for signal acquisition/display. Device displays TrCG waveform alongside ECG for physician review. No automated alarms or force limits. Used in clinical settings to provide cardiac-related motion data to assist physician decision-making. Non-sterile device.

Clinical Evidence

Bench testing only. Device complies with IEC 60601-1 and IEC 60601-1-2 standards. Internal performance testing conducted per company procedures.

Technological Characteristics

Non-invasive tracheal motion sensor (neck collar); belt pack unit; PC-based signal acquisition/display. Connectivity via integration with Nasiff Cardio-Card Management System II. Non-sterile. Complies with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC).

Indications for Use

Indicated for non-invasive measurement of tracheal acceleration to monitor cardiac-related movement in patients. Used in conjunction with ECG for physician review. No specific patient population, age, or gender restrictions stated. No contraindications listed.

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.

Predicate Devices

• Vital Science Quantascope Model 103
• Respironics Actiheart
• VivoMetrics Lifeshirt
• Nasiff Cardio-Card Management System II (K972795)

Submission Summary (Full Text)

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### 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92©

The assigned 510(k) number is: K063735 Name and Address of Applicant: Presym, Inc. 15 Twelve Oaks Drive Pleasanton, CA 94588-8210 Primary Contact: Tamim Hamid 510-714-0525 Preparation Date: July 17, 2007 Trade Name: Presym Tracheocardiogram System (TrCG) Common Name: Cardiac Monitor Product Code: DRT Predicate Devices: Vital Science Quantascope Model 103 Respironics Actiheart VivoMetrics Lifeshirt Nasiff Cardio-Card Management Stystem II Description of new device:

The Presym TrCG is a non-invasive device intended to measure acceleration (displacement over time2) of the trachea.

A tracheal motion sensor is implemented as a neck collar worn by the patient, connected electronically to a TrCG/ECG belt pack unit. The belt pack and associated PC software for signal acquisition and display utilizes the Nasiff Associates Cardio-Card Management System II (K972795). The monitor displays the TrCG waveform alongside the patient's ECG.

The TrCG system is provided non-sterile.

21/2

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## Intended Use / Indications for Use:

The Presym TrCG (Tracheocardiogram) is a non-invasive device intended to measure acceleration (displacement over time") of the trachea.

The trachea is mechanically linked to the heart and therefore its movement is directly related to that of the heart.

The TrCG displays are shown with the patient's ECG (electrocardiograph) and presented for the physician's consideration.

There are no set alarms or preset force limits.

## Technological characteristics and comparison to predicate devices:

The Presym TrCG device has the same technological features and characteristics as the predicate devices. The intended use of the predicate devices and the TrCG device is similar.

Each of the technological characteristics features found in the Presym TrCG device is similar or identical to the specified predicate devices. Therefore, Presym, Inc. believes the claim of substantial equivalence to the commercially available predicate devices and the Presym TrCG device to be consistent with the 510(k) regulatory paradigm.

#### Performance / test data:

The Presym device complies with IEC 60601-1 and IEC 60601-1-2 as verified by independent test facilities. The TrCG device passed internal performance testing per internal company procedures.

## Conclusions:

The Presym TrCG device has the same intended use as the predicate devices. The TrCG device also includes similar or identical technical features and characteristics as the predicate devices. Performance testing and validation exercises have produced results consistent with design input requirements. Therefore, the Presym TrCG device does not raise new questions of safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three heads, representing health, human services, and security. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 9 2007

Presym, Inc. c/o Mr. Tamim Hamid President and CEO 15 Twelve Oaks Drive Pleasanton, CA 94588-8210

Re: K063735

> Trade/Device Name: Presym TrCG (Tracheocardiogram) Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II Product Code: DRT Dated: September 2, 2007 Received: September 5, 2007

Dear Mr. Hamid:

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.

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

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Page 2 - Mr. Tamim Hamid

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, permitts 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliation 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 Biometric's (OSB's) Division of Postmarlee, Surveillance at 240-276-3474. For questions regarding the reporting of devices 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 tollo free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Arlene B. Boam

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

510(k) Number: K063735

Device Name: Presym TrCG

Indications for Use:

The Presym TrCG (Tracheocardiogram) is a non-invasive device intended to measure acceleration (displacement over time2) of the trachea.

The trachea is mechanically linked to the heart and therefore its movement is directly related to that of the heart.

The TrCG displays are shown with the patient's ECG (electrocardiograph) and presented for the physician's consideration.

There are no set alarms or preset force limits.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arlule Soane fa 6DZ

(Division Sign Off)
Division of Cardiovascular Devices

510(k) Number ks63735