SENSOR MOBILE SM 100 VITAPHONE 1001R REMOS

K050670 · Tms Telemedizinische Systeme GmbH · DXH · Mar 30, 2005 · Cardiovascular

Device Facts

• Record ID: K050670
• Device Name: SENSOR MOBILE SM 100 VITAPHONE 1001R REMOS
• Applicant: Tms Telemedizinische Systeme GmbH
• Product Code: DXH · Cardiovascular
• Decision Date: Mar 30, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The telemedical system "sensor mobile" comprises the patient activated Tele-ECG device SM100 / vitaphone 100IR and the REMOS Receiving Software. The SM100 / vitaphone 100IR records and stores one-channel ECG episodes and transmits these data by means of a telephone or a mobile phone to a receiving station equipped with the REMOS Receiving Software for further processing.

Device Story

Patient-activated, one-channel ECG event recorder; records 30-second ECG episodes via chest-placed metal contacts. Device stores up to three episodes; transmits data via telephone (FSK) or infrared (IrDA) to a central station. Operated by patients at home; used by clinicians at receiving stations. REMOS software at receiving station processes, stores, and converts ECG data into PDF reports. Provides clinicians with diagnostic data for rhythm assessment (sinus rhythm, atrial fibrillation, flutter, tachycardia) and pacemaker function monitoring. Benefits patients by enabling remote cardiac event capture and transmission for clinical evaluation.

Clinical Evidence

Clinical testing performed on 80 patients with suspected or known cardiac dysrhythmia. 100 ECG examples were transmitted and interpreted. 98% of received ECGs were interpretable. Study demonstrated capability to detect basic rhythms (sinus, AFib, flutter, SVT, nodal) and identify pacemaker spikes and bundle-branch block patterns.

Technological Characteristics

One-channel ECG recorder; bipolar recording. Materials: Makrolon 2458 (cover), 316L 1.4404 steel (electrodes). Power: 3V CR2032 battery. Connectivity: Telephone (FSK) and IrDA. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-47, ISO 10993-1, ISO 14971, ISO 13485.

Indications for Use

Indicated for patients experiencing symptomatic cardiac rhythm disturbances including palpitations, fatigue, heart racing, fluttering, chest discomfort, or pain.

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

• PHD™ Heart Alert, Inc. (K963904)

Submission Summary (Full Text)

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<050670
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| 510(K) Submission „sensor mobile" SM100/100IR<br>Document:<br>Date: | Sec. 5, Summary of Safety and Effectiveness<br>2005-02-14<br><br>Image: TELEMEDIZINISCHE<br>SYSTEME logo |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Section 5 | |
| 510(K) Summary of Safety and Effectiveness<br>Telemedical System "sensor mobile" | |
| Submitter: | TMS Telemedizinische Systeme GmbH<br>Stadlerstraße 14<br>D-09126 Chemnitz<br>Phone: [phone]<br>Fax: [phone]<br>Contact Person:<br>Joachim Schlund, Managing Director |
| Trade Name: | Telemedical System „sensor mobile" SM100, vitaphone<br>100IR, REMOS |
| Common Name: | Tele ECG System, Event Recorder, ECG Recording Card |
| Classification Name: | Telephone electrocardiograph transmitter and receiver<br>(per 21 CFR Section 870.2920) |

#### 1. Intended Use

The telemedical system "sensor mobile" comprises the patient activated Tele-ECG device SM100 / vitaphone 100IR and the REMOS Receiving Software. The SM100 / vitaphone 100IR records and stores one-channel ECG episodes and transmits these data by means of a telephone or a mobile phone to a receiving station equipped with the REMOS Receiving Software for further processing.

#### 2. Indications for Use

Symptomatic disturbances of cardiac rhythm such as palpitations, fatigue, heart racing, fluttering, chest discomfort or pain.

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| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br> 510(K) Submission "sensor mobile" SM100/100IR |
|-----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Document: | Sec. 5, Summary of Safety and Effectiveness |
| Date: | 2005-02-14 |

# 3. Contra-indications

The system is not for use as a critical care monitoring system. The device is not to be used with

- simultaneous defibrillation
- treatment using electrosurgical units or electrocoagulation
- too strong electromagnetic interference fields (aerials, high-voltage transformers, generators, NMR tomographs)
- external pacemakers

## 4. Device Class

The system is classified as Class II medical device (21 CFR 870.2920).

## 5. Predicate Device

Predicate 510(K): Predicate Device: Manufacturer: PHD™ K963904 Heart Alert, Inc.

# 6. Applicable Standards

- IEC 60601-1:1988, "Medical Electrical Equipment, General Requirements for Safety"
- IEC 60601-1-2:2001, "Medical Electrical Equipment Part 1-2: General Requirements for Safety, Collateral Standard: Electromagnetic Compatibility"
- IEC 60601-1-4:1999, "Medical Electrical Equipment Part 1-4: General Requirements for Safety, Collateral Standard: Programmable Electrical Medical Systems"
- IEC 60601-2-47:2001, "Medical Electrical Equipment Part 2-47: Particular requirements for safety, including essential performance, for ambulatory electrocardiographic systems "
- ISO 10993-1:2003, "Biological Evaluation of Medical Devices, Evaluation and Testing"
- ISO 14971:2001. "Medical devices Application of risk management to medical devices"
- ISO 13485:2003, "Medical Devices Quality management systems Requirements for regulatory purposes"
- "Off-The-Shelf Software Use in Medical Device", FDA, September 1999
- "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", FDA, May 1998
- "General Principles of Software Validation; Final Guidance for Industry and Staff" FDA, June 1997

Project No .: 3015 File: 510k summary.sxw TMS Telemedizinische Systeme GmbH Coovright Copy prohibited without prior written permission of TMS Telemedizinische Systeme GmbH

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| 510(K) Submission „sensor mobile“ SM100/100IR | |
|-----------------------------------------------|---------------------------------------------|
| Document: | Sec. 5, Summary of Safety and Effectiveness |
| Date: | 2005-02-14 |

Image /page/2/Picture/2 description: The image shows a logo with a figure standing in the center of a circular design. Below the logo, the text "TELEMEDIZINISCHE SYSTEME" is printed in bold, sans-serif font. The text appears to be German, suggesting the logo is associated with telemedicine systems in a German-speaking region.

# 7. Operational Characteristics

The Tele ECG device "sensor mobile" SM 100 / vitaphone 100IR, manufactured by TMS, is capable of recording, storing and transmitting up to three ECG episodes of 3C seconds each. The "sensor mobile" SM 100 is placed on the chest for post-event recording. The device is patient activated by pressing the record button. The 30-second ECG is stored in the device memory for later acoustic transmission via telephone or mobile phone in form of digital data (FSK) or via infrared (IrDA) and IrDA-enabled mobile phone to a telemedical central station equipped with the "sensor mobile" Receiving Software REMOS. The transmission is activated by pressing the send button. The device does not impair internal pacemakers and implantable cardioverters / defibrillators.

| Comparison (Feature /<br>Spec) | „sensor mobile" | PHD™ | Explanation of<br>Differences |
|--------------------------------|-------------------------|-------------------------------|--------------------------------------------------------|
| Length | 90 mm | 84 mm | |
| Width | 53 mm | 54 mm | |
| Thickness | 8 mm | 7 mm | |
| Weight | 37 g | 30 g | |
| Cover material * | Makrolon 2458<br>550115 | Unknown Plastic | |
| Electrode material * | Steel, 316L 1.4404 | Steel with unknown<br>plating | |
| Batterie(s) | 3 V, CR2032 | 3 V, CR2430 | |
| Battery lasts approx. | 5 Years | 1 Year | Provides greater<br>operational patient<br>convenience |
| Backup-Battery | Not necessary | CR1220 | |
| Operating Temperature | 5 - 45 °C | 10 - 40 °C | |
| Storage Temperature | -20 - +60 °C | -10 - +60 °C | |
| Relative Humidity | 10 - 95 % | 10 - 95 % | |
| Input Impedance | 100 MOhm | 100 MOhm | |
| CMRR | 80 dB | 60 dB | 80 dB gives improved<br>signal fidelity |
| Differential Range AC | 6 mV | 4 mV | |
| Differential Range DC | 300mV | 250 mV | |

## 8. Predicate Device Comparison

Copyright TMS Telemedizinische Systeme GmbH

Copy prohibited without prior written permission of TMS Telemedizinische Systeme GmbH

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| 510(K) Submission „sensor mobile" SM100/100IR<br>Document:<br>Date:<br>2005-02-14 | Sec. 5, Summary of Safety and Effectiveness | | |
|-----------------------------------------------------------------------------------|---------------------------------------------|-----------------------------------------------|------------------------------------------------------------------|
| Comparison (Feature /<br>Spec) | „sensor mobile" | PHD™ | Explanation of<br>Differences |
| Bandwidth | 0,5 - 40 Hz | 0,5 - 30 Hz | 40 Hz gives improved<br>signal fidelity |
| Resolution | 6 mV | 15,6 mV | Improved resolution |
| Recording Period | 3x30s | 3x30s | |
| Memory hold time | 5 Years | 128 days | Safety improvement |
| ECG lead | 1 | 1 | |
| ECG Recording | bipolar | bipolar | |
| Timer accuracy | max. 30 s / month | 10s / month | No risk for patient safety,<br>refer to risk analysis |
| AD accuracy | 12 Bit | 8 Bit | 12 Bit gives improved ECG<br>output quality |
| Pacemaker Spike<br>Recognition | Yes | No | Provides better diagnostic<br>capabilities |
| Defibrillator Protection | No | No | |
| Acoustic transmission | FSK | FSK, FM modulation | |
| Digital transmission | IrDA | none | Provides greater<br>operational patient<br>convenience |
| ECG output | PDF file format,<br>5mm grid | Unknown format | Extended capabilities for<br>archiving and further<br>processing |
| ECG Receiver | PC based Software | Hardware Receiver<br>and PC based<br>software | No use of proprietary<br>hardware for „sensor<br>mobile" system |
| Operating System for<br>Receiving Software | Linux | Windows | |

Tab. 8.1

* Materials with contact to the skin of the user / patient.

#### 9. Substantial Equivalence

The technical specification comparison reveals no substantial differerence between the "sensor mobile" system and the predicate device and no differences which affect safety or efficacy.

These devices are patient activated Cardiac Event Recorders that sense ECG signals from the skin surface. The method of placing the device on the skin has been used successfully by Heart Alerts's PHD™ The use of FSK encoding for transtelephonic transmission of

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| 510(K) Submission „sensor mobile“ SM100/100IR | | |
|-----------------------------------------------|---------------------------------------------|-----------------------------|
| Document: | Sec. 5, Summary of Safety and Effectiveness | |
| Date: | 2005-02-14 | TI LEMEDIZINISCH<br>SYSTEME |

digital data is also used in the predicate device PHD™. The method of obtaining the ECG signal via metal contacts is identical.

The usage of the SM100 / vitaphone 100IR is also identical to the predicate device. The operational details are identical with the exception of the possibility of infrared / IrDA data transmission of the SM100 / vitaphone 100IR.

The "sensor mobile" Receiving Software REMOS receives the digital ECG data via telephone line and stores it into a database. The receiving software is designed for automatic operation 24 hours a day. The ECG data will be converted to a human readable output in PDF file format with anonymized patient / user information.

In the whole sending and receiving procedure is no substantial differerence between the telemedical system "sensor mobile" and the predicate device. Both systems are designed for transtelephonic transmission and uses software on the receiving side for further processing of the ECG data.

## 10. Summary of Non-Clinical Testing

The system "sensor mobile" meets or exceeds the applicable requirements of international standards for ambulatory electrocardiographs and the safety requirements of IEC 60601-1 and its applicable follow-up standards.

Biocompatibility assessment was performed for any materials in contact with the skin of the user / patient.

# 11. Summary of Clinical Testing

TMS has performed clinical testing on the "sensor mobile" system. The system was tested with 80 patients suffering from different cardiac dysrhythmia or patients that are suspected of having cardiac dysrhythmia (patients subjectively feel palpitations or pauses). One hundred ECG examples of the eighty patients have been transmitted and interpreted.

98 percent of the received ECGs could be interpreted which can be rated as a very good achievement. Especially due to the technical recording, the basic rhythm (sinus rhythm, atrial fibrillation, atrial flutter, supraventricular (heart atrium) tachycardia, or nodal

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510(K) Submission "sensor mobile" SM100/100IR Sec. 5, Summary of Safety and Effectiveness Document: Date: 2005-02-14

rhythm) could be detected with all the ECGs.

Furthermore, the function of pacemakers could be checked. The pacemaker spikes imaging and the reply of these spikes in the atrium or in the ventricle is good. Another possibility was the determination of wide QRS complexes (in the sense of a bundle-branch block pattern) in ECG examples.

The device sensor mobile SM100 and the service meet clinical demands.

# 12. Conclusion

Through the data and information presented TMS Telemedizinische System GmbH considers the "sensor mobile" system as substantially equivalent to the previously discussed predicate device.

The operation of the "sensor mobile" system shows a safe and reliable means for recording, transmission, storing, forwarding and presentation of patient ECG parameters and no adverse health effect or safety risk to patients when used as intended.

TMS Telemedizinische Systeme GmbH loachim Schlund Managing Director

Signature: .

Date: 21.02.05

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/6/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's emblem in the center. The emblem is a stylized representation of a bird or eagle with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

MAR 3 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

TMS Telemedizinische Systeme GmbH c/o Mr. Williams Sammons Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive P.O. Box 13995 Research Triangle Park, NC 27709-3995

Re: K050670

K0.0070
Trade Name: Telemedical System "Sensor Mobile" SM100 / Vitaphone 100IR, REMOS Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: II (two) Product Code: DXH Dated: February 28, 2004 Received: March 15, 2005

Dear Mr. Sammons:

We have reviewed your Section 510(k) premarket notification of intent to market the device indication we nave reviewed your section 310(x) premium is substantially equivalent (for the indications felerenced above and nave determined the acresed predicate devices marketed in interstate for use stated in the encrosure) to regally management date of the Medical Device American Frank For J. Dava commence prior to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been reclassified in accessaries who f a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approvial controls provisions of the Act. The You may, merciole, market the device, belyer in the more
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the rist 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 If your device is classified (500 a0070) into Existing major regulations affecting your device can may be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Outs acements concerning your device in the Federal Register.

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Page 2 -- Mr. Williams Sammons

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualic of a substitute of the requirements of the Act
that FDA has made a determination that your device of a complies. You must that FDA has made a determination that your crees by other Federal agencies. You must or any Federal statules and regulations administered of registration and listing (21 l
comply with all the Act's requirements, including, but not its research as set comply with all the Act s requirements, menames our open ice requirements as set
CFR Part 807); labeling (21 CFR Part 81) ; gDD = 820); englicable, the electronic CFR Part 807); labeling (21 CFR Part 800); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Patt 820); and if applicable, 11 CFP 1000-10 forth in the quality systems (QS) regulation (21-51-542 of the Act); 21 CFF 100-1050.
product radiation control provisions (Sections 531-542 of the Action Section S product radiation control provisions (Sections 991 - 12 - 2 decribed in your Section 5 10(k)
This letter will allow you to begin marketing your device of your device to legal This letter will allow you to begin nakemig your avince of your device of your device to a legally premarket notification. The PDA inding of substanced by 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
r the regulation of the 100 m on 100 m the regulation antitled If you desire specific advice for your act [phone]. Also, please note the regulation entitled, contact the Office of Complance at (217) =16 ° =1 ° =1 807.97). You may obtain "Misbranding by reference to premarket notifications of Set from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its to the new in html Manufacturers, International and Combailer Proved.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bhimmarfor

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 (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Telemedical System "sensor mobile" SM100 / vitaphone 100IR, REMOS

Indications for Use:

Symptomatic disturbances of cardiac rhythm such as palpitations, fatigue, heart racing, fluttering, chest discomfort or pain.

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

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)

Bhemmmon
Division Sign-Off

Avision of Cardlovascular Devices : 1 O(k) Number