VITAPHONE. MODEL 100 BT

K100383 · Vitasystems GmbH · DXH · Apr 20, 2010 · Cardiovascular

Device Facts

• Record ID: K100383
• Device Name: VITAPHONE. MODEL 100 BT
• Applicant: Vitasystems GmbH
• Product Code: DXH · Cardiovascular
• Decision Date: Apr 20, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

Intended Use

The Vitaphone 100 BT device is single-channel cardiac event recorder for transmitting multiple ECG recordings via land-line or GSM telephony networks to a compatible ECG receiving system, such as REMOS ECG Receiving Software (510(k) K050670) or compatible ECG receivers. The Vitaphone 100 BT device is intended for patient activated event recordings. It is battery driven and utilizes a Flash memory to store ECG data with an adjustable event time.

Device Story

Single-channel cardiac event recorder; battery-powered; utilizes Flash memory for ECG data storage. Patient-activated; captures ECG signals during symptomatic or asymptomatic cardiac events. Transmits stored ECG data via land-line or GSM telephony networks to compatible receiving systems (e.g., REMOS ECG software). Used by patients in home or ambulatory settings; physician reviews transmitted ECG data at receiving station to evaluate cardiac rhythm disturbances. Facilitates remote monitoring and diagnostic assessment of transient arrhythmias; aids clinical decision-making regarding cardiac health.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and adherence to recognized safety and performance standards, including EN 60601-1, EN 60601-1-2, and E DIN IEC 60601-2-47.

Technological Characteristics

Single-channel ECG recorder; battery-powered; Flash memory storage. Connectivity via land-line or GSM telephony. Complies with EN 60601-1 (safety), EN 60601-1-2 (EMC), and E DIN IEC 60601-2-47 (ambulatory ECG). Quality management per ISO 13485; biological evaluation per ISO 10993-1; risk management per ISO 14971.

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.

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

• Vitaphone 3100 BT (K053378)
• PMP4 SelfCheck ECG (K042254)

Reference Devices

• REMOS ECG Receiving Software (K050670)

Submission Summary (Full Text)

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Vitasystems GmbH 510(K) Submission 100 BT Sec. 5, 510(k) Summary

# vitasvstem

APR 2 0 2010

## 510(k) Summary

#### Post-Event Recorder vitaphone 100 BT

Submitter:

Vitasystems GmbH Stadlerstraße 14 D-09126 Chemnitz, Germany Phone: [phone] Fax: [phone]

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

| Establishment Registration Number: | 3005191294 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Trade Name: | Vitaphone 100 BT |
| Common Name: | Tele ECG System, Cardiac Event Recorder, Post-Event Recorder |
| Classification Name: | Telephone electrocardiograph transmitter and receiver<br>(per 21 CFR Section 870.2920, Product Code: DXH) |

#### 1. Predicate Devices

| Device Type | Vitaphone 3100 BT | PMP4 SelfCheck ECG |
|---------------|-------------------|--------------------|
| Manufacturer | Vitasystems GmbH | Card Guard Ltd. |
| 510(K) Number | K053378 | K042254 |

Table 5-1

#### 2. Intended Use

The Vitaphone 100 BT device is single-channel cardiac event recorder for transmitting multiple ECG recordings via land-line or GSM telephony networks to a compatible ECG receiving system, such as REMOS ECG Receiving Software (510(k) K050670) or compatible ECG receivers.

The Vitaphone 100 BT device is intended for patient activated event recordings. It is battery driven and utilizes a Flash memory to store ECG data with an adjustable event time.

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Vitasystems GmbH 510(K) Submission 100 BT Sec. 5, 510(k) Summary

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#### 3. Device Classification

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

#### 4. Applicable Standards

- EN 60601-1:2006, "Medical Electrical Equipment, General Requirements for Safety"
- EN 60601-1-2:2007, "Medical Electrical Equipment, Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic compatibility - Requirements and tests"
- E DIN IEC 60601-2-47:2008, "Medical Electrical Equipment, Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems"
- ISO 10993-1:2003, "Biological Evaluation of Medical Devices, Evaluation and Testing"
- ISO 14971:2007, "Medical devices Application of risk management to medical devices"
- ISO 13485:2007, "Medical Devices Quality management systems Requirements for regulatory purposes"

#### 5. Substantial Equivalence

Through the data and information presented, Vitasystems GmbH considers the Vitaphone 100 BT as substantially equivalent to the previously mentioned predicate devices. The operation of the Vitaphone 100 BT shows a safe and reliable means for recording and transmission of patient ECG parameters and no adverse health effect or safety risk to patients when used as intended.

Vitasystems GmbH Tilo Borchardt сто

Signature: ...

Date: ....................................................................................

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Vitasystems GmbH c/o Mr. Tilo Borchardt Chief Technical Officer (CTO) Stadlerstrasse 14 Chemnitz GERMANY 09126

APR 2 0 2010

Re: K100383

> Trade/Device Name: Post-Event Recorder Vitaphone 100 BT Regulatory Number: 21 CFR 870.2920 Regulation Name: Transmitter and Receiver, Electrocardiograph, Telephone Regulatory Class: II (two) Product Code: 74 DXH Dated: February 14, 2010 Received: February 16, 2010

Dear Mr. Borchardt:

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 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. Tilo Borchardt

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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: Post-Event Recorder Vitaphone 100 BT

#### 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 _____________________________________________________________________________________________________________________________________________________________ (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)

***_***_, and I'm here to help.

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K100393