TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS +

K061780 · Rozinn Electronics, Inc. · DXH · Sep 15, 2006 · Cardiovascular

Device Facts

• Record ID: K061780
• Device Name: TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS +
• Applicant: Rozinn Electronics, Inc.
• Product Code: DXH · Cardiovascular
• Decision Date: Sep 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

Intended Use

The TTM For Windows + is used for Transtelephonic Cardiac Monitoring. It provides the ability to download, present and store the ECG signal via a phone using commercially available transtelephonic cardiac monitoring devices. It only presents the data such as one, two or twelve lead ECC and pacer spikes. There is no age or other physiological limitations using this device TTM For Windows +. It is intended that TTM For Windows + will be used only by a physician and trained technicians. It also acts as a database for patients with or without pacemakers or implantable cardioverter defibrillators.

Device Story

TTM For Windows + is a PC-based transtelephonic cardiac monitoring station. System components include standard PC, monitor, printer, and proprietary download module. Device receives ECG signals transmitted via telephone from commercially available transtelephonic cardiac monitoring devices. System functions as a data presentation and storage database; it does not contact the patient and performs no diagnostic functions. Operated by physicians and trained technicians in clinical settings. Output consists of visual presentation of 1, 2, or 12-lead ECGs and pacer spikes. Facilitates remote cardiac monitoring and patient data management.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

PC-based system comprising standard computer, monitor, printer, and proprietary download module. Connectivity via telephone line for ECG signal reception. Software-based data presentation and database management. No patient-contacting components. Non-diagnostic.

Indications for Use

Indicated for transtelephonic cardiac monitoring of patients, including those with pacemakers or implantable cardioverter defibrillators, to download, present, and store ECG signals (1, 2, or 12-lead) and pacer spikes. No age or physiological limitations. For use by physicians and trained technicians.

Regulatory Classification

Identification

A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.

Predicate Devices

• TTM For Windows + (K061780)

Submission Summary (Full Text)

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Κα61780

510 (k) Summary

SEP 15 2006

Submitter:

Mark Rosoff, President Rozinn Electronics, Inc. 71-22 Myrtle Avenue Glendale, NY 11385 Telephone: [phone] Fax: [phone] E-mail: [e-mail] Contact: Mark Rosoff Date of Summary: June 20, 2006

Name of Device: TTM For Windows + Common Name: Transtelephonic cardiac monitoring station Product Code: DXH Classification name: Telephone electrocardiograph transmitter and receiver.

Substantial Equivalence claimed to legally marketed device:

TTM For Windows + Transtelephonic cardiac monitoring station

Description of Device:

The TTM For Windows + system is designed and manufactured by Rozinn Electronics Inc. It is a PC based computer that is used for Transtelephonic cardiac monitoring. It consists of a standard PC computer, monitor, printer and proprietary download module. . It provides the ability to download, present and store the ECG signal via a phone using commercially available transtelephonic cardiac monitoring devices. TTM For Windows + does not come in contact with the patient. TTM For Windows + does not perform any diagnostic functions. It only presents the data. There is no age or other physiological limitations using this device TTM For Windows +.

Intended use of Device:

The TTM For Windows + is used for Transtelephonic Cardiac Monitoring. It provides the ability to download, present and store the ECG signal via a phone using commercially available transtelephonic cardiac monitoring devices. It only presents the data such as one, two or twelve lead ECC and pacer spikes. There is no age or other physiological limitations using this device TTM For Windows +. It is intended that TTM For Windows + will be used only by a physician and trained technicians. It also acts as a database for patients with or without pacemakers or implantable cardioverter defibrillators.

Image /page/0/Picture/12 description: The image shows the text "Page 1 of 1". The text is written in a handwritten style. The words are written in black ink on a white background.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the emblem.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 1 5 2006

Rozinn Electronics, Inc. c/o Mr. Mark Rosoff President 71-22 Myrtle Avenue Glendale, NY 11385

Re: K061780

Trade Name: TTM For Windows + Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitters and Receiver Regulatory Class: Class II (two) Product Code: DXH Dated: June 20, 2006 Received: June 26, 2006

Dear Mr. Rosoff:

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. Mark Rosoff

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r reaso be actived 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 or any i 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. product raaaallen. 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 promaticated predicated 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 it you active 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 vours.

B.Jemima 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 Statement

510(k) Number (if known): K 04 / 7 80

Device Name: TTM For Windows +

Indications for Use:

The TTM For Windows + is used for Transtelephonic Cardiac Monitoring. It provides the ability to download, present and store the ECG signal via a phone using commercially available transtelephonic cardiac monitoring devices. It only presents the data such as one, two or twelve lead ECG and pacer spikes. There is no age or other physiological limitations using this device TTM For Windows +. It is intended that TTM For Windows + will be used only by a physician and trained technicians. It also acts as a database for patients with or without pacemakers or implantable cardioverter defibrillators.

B. Hemmingson

ular Devices s Jik) Number

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)