CARDIOSEN'C

K080047 · Shl Telemedicine International , Ltd. · DXH · Jul 11, 2008 · Cardiovascular

Device Facts

• Record ID: K080047
• Device Name: CARDIOSEN'C
• Applicant: Shl Telemedicine International , Ltd.
• Product Code: DXH · Cardiovascular
• Decision Date: Jul 11, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

Intended Use

The CardioSen'C device is intended to condition an electrocardiographic signal so that it can be transmitted acoustically via telephone and/or digitally over cellular network to a remote location. The CardioSen'C device is designed to be used by a patient to transmit a 12 lead ECG and rhythm strip in real-time to a physician's office, hospital or other medical receiving center.

Device Story

CardioSen'C is a battery-powered, hand-held personal ECG transmitter. Patient operates device to capture 12-lead ECG and rhythm strip. Device conditions signal for transmission via two methods: frequency-modulated acoustical tone for standard/cellular telephones or digital transmission via cellular network. Data sent to physician's office, hospital, or monitoring center. Medical professional receives and interprets transmitted ECG data to inform clinical decision-making. Enables remote cardiac monitoring, facilitating timely medical intervention.

Clinical Evidence

Bench testing only. Device tested against ANSI/AAMI EC11-1991 (Diagnostic Electrocardiographic Devices) and IEC 60601-2-25 (1993) +A1:1999. System meets design specifications.

Technological Characteristics

Battery-powered, hand-held ECG transmitter. Features frequency modulation for acoustic transmission and digital cellular transmission capability. Complies with ANSI/AAMI EC11-1991 and IEC 60601-2-25 standards.

Indications for Use

Indicated for patients requiring remote transmission of 12-lead ECG and rhythm strips to medical professionals for interpretation. Designed for patient self-use to transmit data in real-time via telephone or cellular network.

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

• CardioBeeper CB 12/12 (K002310)
• River 1 (K063609)

Submission Summary (Full Text)

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JUL 11 2008

Image /page/0/Picture/1 description: The image shows the logo for SHL TeleMedicine International Ltd. The logo features the letters "SHL" in a bold, sans-serif font, with a heart symbol incorporated into the design. Below the letters, the words "TeleMedicine International Ltd" are written in a smaller, sans-serif font.

# 510(K) SUMMARY

CardioSen'C

# 510(k) Number K 080047

| Applicant's Name: | SHL Telemedicine International Ltd.<br>90 Igal Alon St.<br>Tel Aviv 67891<br>ISRAEL<br>Tel [phone]<br>Fax [phone] |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------|
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- Contact Person: Yoram Levy, Qsite 31 Haavoda St. Binyamina, Israel 30500 Tel [phone]; Fax [phone] [e-mail]
- Trade Name: CardioSen'C
- Classification: Name: Telephone electrocardiograph transmitter and receiver Product Code: DXH Regulation No: 21 CFR 870.2920 Class: II Panel: Cardiovascular

Device Description: The CardioSen'C is a personal, battery powered, hand-held personal ECG transmitter, enabling an individual to immediately transmit a 12-lead ECG and a rhythm strip from a remote location, to a physician's office, hospital or monitoring center.

> The ECG data can be transmitted in real time via two communication methods. The CardioSen'C produces an ECG frequency modulated acoustical tone that can be coupled with and transmitted by a standard or a cellular telephone. The ECG data can also be transmitted digitally through the cellular network. Either one of these two transmissions methods permits the transfer of a 12-lead ECG and rhythm strip to the medical professional capable of interpreting the data.

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Image /page/1/Picture/0 description: The image shows a logo for SHL TeleMedicine International Ltd. The logo is black and features the letters "SHL" in a large, bold font. Below the letters, the words "TeleMedicine International Ltd." are written in a smaller font. The background of the image is white.

#### Intended Use Statement:

The CardioSen'C device is intended to condition an electrocardiographic signal so that it can be transmitted acoustically via telephone and/or digitally over cellular network to a remote location. The CardioSen'C device is designed to be used by a patient to transmit a 12 lead ECG and rhythm strip in real-time to a physician's office, hospital or other medical receiving center.

### Predicate Devices:

The CardioSen'C is substantially equivalent to the following predicate devices:

- CardioBeeper ® CB 12/12, 12 Lead Personal ECG Transmitter, . cleared under K002310;
- River 1, ECG Event Recorder and Transmitter, cleared under . K063609.

### Performance Data:

The CardioSen'C device has been tested according to various standards and guidance documents, such as ANSI/AAMI EC11-1991 (Diagnostic Electrocardiographic Devices), IEC 60601-2-25 (1993) +A1:1999 requirements for the safety of electrocardiographs, etc. Further IVD study has shown that the system meets its design specifications and is safe and effective for its intended use.

### Conclusions:

The CardioSen'C device has the same intended use and is capable of transmitting the electrocardiographic signal acoustically via customary telephones as the CardioBeeper® CB 12/12. Further, the CardioSen'C can transmit digitally over cellular network to a remote location as the River -1 device. The results of tests studies and analyses performed with the CardioSen'C device demonstrate that the CardioSen'C device is as safe and effective as its predicate devices without raising any new safety and\or effectiveness concerns.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 11 2008

SHL TeleMedicine International LTD c/o Qsite Mr. Yoram Levy 31 Haavoda St. Binyamina, 30500 ISRAEL

Re: K080047

CardioSens'C Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DXH Dated: June 22, 2008 Received: June 27, 2008

Dear Mr. Levy:

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. Yoram Levy

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); labcling (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,
Qamde

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):

K080047

Device Name:

CardioSen'C

Indications for Use:

The CardioSen'C device intended to is condition an electrocardiographic signal so that it can be transmitted acoustically via telephone and/or digitally over cellular network to a remote location. The CardioSen'C device is designed to be used by a patient to transmit a 12 lead ECG and rhythm strip in real-time to a physician's office, hospital or other medical receiving center.

X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-off) Division of Cardiovascular, Respiratory and Neurological Devices 510(k) Number

ces

(Division Sign-Off)
Division of Cardiovascular Devices

Section 1 - Page 2 CardioSen'C - 510k Notifica