(80 days)
No
The summary describes a standard cardiac event recorder with auto-triggering based on predefined conditions (Bradycardia, Tachycardia, Atrial Fibrillation). There is no mention of AI, ML, training data, or performance metrics typically associated with AI/ML algorithms.
No
The device is described as a "diagnostic evaluation" device for cardiac rhythm disturbances, and its function involves recording and transmitting ECG data for analysis, not for providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic evaluation of patients with asymptomatic and symptomatic disturbances of the cardiac rhythm." Additionally, the "Device Description" states it is a "cardiac event recorder for transmitting multiple ECG recordings" for "auto-triggered and patient activated event recordings," which are then received by a "ECG Receiving Software" for further analysis related to conditions like "Bradycardia, Tachycardia and Atrial Fibrillation." These functions are inherently diagnostic.
No
The device description explicitly states it is a "single-channel looping cardiac event recorder" which is a hardware device that captures and transmits ECG data. It is battery-driven and utilizes a loop-memory, further indicating it is a physical device, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "Diagnostic evaluation of patients with asymptomatic and symptomatic disturbances of the cardiac rhythm". This indicates the device is used to aid in the diagnosis of a medical condition.
- Device Description: The device records and transmits ECG data, which is a physiological measurement used in the diagnostic process.
- Predicate Devices: The listed predicate devices (cardiac event recorders and ECG receiving systems) are also IVDs used for diagnostic purposes.
While the device doesn't process images or use AI/ML, its function of collecting and transmitting physiological data for diagnostic evaluation firmly places it within the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Diagnostic evaluation of patients with asymptomatic and symptomatic disturbances of the cardiac rhythm such as:
- Dizziness
- Heart race
- Palpitations
- Syncopes of unknown cause
Product codes (comma separated list FDA assigned to the subject device)
DXH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K042469, K020825, K050670, K042254
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
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.(b)
Classification. Class II (performance standards).
0
FEB 2 3 2006
TMS Telemedizinische Systeme GmbH 510(K) Submission 3100 Series Document: Sec. 5, 510(k) Summary
Image /page/0/Picture/3 description: The image shows a logo with the words "TELEMEDIZINISCHE SYSTEME" stacked on top of each other. Above the text is a graphic of a person standing inside of a circle. The image is black and white and appears to be of low resolution.
510(k) Summary Loop-Recorder vitaphone 3100 Series
| Submitter: | TMS Telemedizinische Systeme GmbH
Stadlerstraße 14
D-09126 Chemnitz |
|------------|---------------------------------------------------------------------------|
| | Phone: +49 371 40081 0 |
| | Fax: +49 371 40081 22 |
Contact Person: Tilo Borchardt, Director Engineering Phone: +49 371 40081 122 Fax: +49 371 40081 22 Email: tb@telemedsys.de
| Establishment
| 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 |
| (per 21 CFR Section 870.2920, Product Code: DXH) |
1. Predicate Devices
| Device Type | ER800 | King of Hearts
Express AF | SM100 | PMP4 SelfCheck
ECG |
|---------------|--------------|------------------------------|-------------------------------------------|-----------------------|
| Manufacturer | Braemar Inc. | Instromedix | TMS Tele-
medizinische
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.
1
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.
3
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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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
4
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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