LOOP RECORDER VITAPHONE, 3100 SERIES

K053378 · Tms Telemedizinische Systeme GmbH · DXH · Feb 23, 2006 · Cardiovascular

Device Facts

• Record ID: K053378
• Device Name: LOOP RECORDER VITAPHONE, 3100 SERIES
• Applicant: Tms Telemedizinische Systeme GmbH
• Product Code: DXH · Cardiovascular
• Decision Date: Feb 23, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for Use

The 3100 Series device is single-channel looping cardiac event recorder for transmitting multiple ECG recordings via land-line or GSM telephony networks to a compatible ECG receiving system, such as "sensor mobile" REMOS ECG Receiving Software (510(k) K050670) or compatible standard acoustic ECG receivers. The 3100 series device is intended for auto-triggered and patient activated event recordings (Bradycardia, Tachycardia and Atrial Fibrillation). It is battery driven and utilizes a loop-memory to capture ECG data with an adjustable pre- and post-event time.

Device Story

Single-channel loop-recorder captures ECG data via patient-activated or auto-triggered mechanisms; detects bradycardia, tachycardia, and atrial fibrillation. Device utilizes loop-memory with adjustable pre- and post-event timing. Data transmitted via land-line or GSM telephony networks to compatible receiving systems (e.g., REMOS ECG Receiving Software). Used by patients to record cardiac events; healthcare providers review transmitted ECGs to evaluate rhythm disturbances. Facilitates diagnosis of symptomatic/asymptomatic cardiac conditions; aids clinical decision-making regarding rhythm management.

Clinical Evidence

No clinical data provided; substantial equivalence based on technical specification comparison and shared operating characteristics with predicate devices.

Technological Characteristics

Single-channel ECG loop-recorder; battery-powered; loop-memory storage; connectivity via land-line or GSM telephony; transmits to compatible acoustic ECG receivers or software systems.

Indications for Use

Indicated for diagnostic evaluation of patients with asymptomatic and symptomatic cardiac rhythm disturbances, including dizziness, heart race, palpitations, and syncopes of unknown cause. Prescription use only.

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

• ER800 (K042469)
• King of Hearts Express AF (K020825)
• SM100 (K050670)
• PMP4 SelfCheck ECG (K042254)

Submission Summary (Full Text)

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FEB 2 3 2006

K053378

TMS Telemedizinische Systeme GmbH 510(K) Submission 3100 Series Document: Sec. 5, 510(k) Summary

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# 510(k) Summary Loop-Recorder vitaphone 3100 Series

| Submitter: | TMS Telemedizinische Systeme GmbH<br>Stadlerstraße 14<br>D-09126 Chemnitz |
|------------|---------------------------------------------------------------------------|
| | Phone: [phone] |
| | Fax: [phone] |

Contact Person: Tilo Borchardt, Director Engineering Phone: [phone] Fax: [phone] Email: [e-mail]

| Establishment<br>Registration Number: | 3005191294 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Trade Name: | Vitaphone 3100 Series |
| Common Name: | Tele ECG System, Cardiac Event Recorder, Loop-Recorder |
| Classification Name: | Telephone electrocardiograph transmitter and receiver<br>(per 21 CFR Section 870.2920, Product Code: DXH) |

### 1. Predicate Devices

| Device Type | ER800 | King of Hearts<br>Express AF | SM100 | PMP4 SelfCheck<br>ECG |
|---------------|--------------|------------------------------|-------------------------------------------|-----------------------|
| Manufacturer | Braemar Inc. | Instromedix | TMS Tele-<br>medizinische<br>Systeme GmbH | Card Guard Ltd. |
| 510(K) Number | K042469 | K020825 | K050670 | K042254 |

The subject device shares operating characteristics and features with the predicate devices.

The technical specification comparison reveals no substantial differerence between the 3100 Series device and the predicate devices and no differences which affect safety or efficacy.

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Image /page/1/Picture/1 description: The image shows a logo with the words "TELEMEDIZINISCHE SYSTEME" written in bold, sans-serif font. Above the text is a circular graphic that appears to depict a human figure or a stylized representation of a person. The logo is simple and likely represents a company or organization involved in telemedicine systems.

## 2.Intended Use

The 3100 Series device is single-channel looping cardiac event recorder for transmitting multiple ECG recordings via land-line or GSM telephony networks to a compatible ECG receiving system, such as "sensor mobile" REMOS ECG Receiving Software (510(k) K050670) or compatible standard acoustic ECG receivers.

The 3100 series device is intended for auto-triggered and patient activated event recordings (Bradycardia, Tachycardia and Atrial Fibrillation). It is battery driven and utilizes a loop-memory to capture ECG data with an adjustable pre- and post-event time.

### 3. Device Classification

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

#### 4. Substantial Equivalence

Through the data and information presented in this 510(k) submission TMS Telemedizinische System GmbH considers the 3100 Series device as substantially equivalent to the previously discussed predicate devices.

TMS Telemedizinische Systeme GmbH Tilo Borchardt Director Engineering

Signature: B_de

Date: 2005-10-14

File: sec 5.sxw Date: 2005-10-14 Copyright © 2005

K053378
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 3 2006

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

Re: K053378 Trade Name: TMS Loop Recorder Vitaphone 3100 Series Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter And Receiver Regulatory Class: Class II (two) Product Code: DXH Dated: February 8, 2006 Received: February 10, 2006

Dear Mr. Rongero:

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 - Ms. Rebecca Kitchens

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r has be advised that i Dri onstan that your device complies with other requirements of the Act that I Dri has made a associations administered by other Federal agencies. You must or any I each statutes and regairements, including, but not limited to: registration and listing (21 comply with an the Not 8 requirements, while and manufacturing practice requirements as set CI It Far 807); adomig (21 OFF CFR Raveton (21 CFR Part 820); and if applicable, the electronic forth in the quant) bystems (Sections 531-542 of the Act); 21 CFR 1000-1050. product taxiation control pro here as a seting your device as described in your Section 510(k) This letter will and w you to cognifinding of substantial equivalence of your device to a legally prematicate 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 if you don't office of Compliance at [phone]. Also, please note the regulation entitled, Contact the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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,

Brimmer 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 (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Loop Recorder vitaphone 3100 series

#### Indications for Use:

Diagnostic evaluation of patients with asymptomatic and symptomatic disturbances of the cardiac rhythm such as:

- Dizziness
- Heart race
- Palpitations
- Syncopes of unknown cause

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)

Blumimon

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