(63 days)
No
The summary describes a standard cardiac event recorder that stores and transmits ECG data. There is no mention of AI, ML, or any form of automated analysis or interpretation using these technologies. The device appears to be a data acquisition and transmission tool.
No
The device is described as a "diagnostic evaluation" tool and a "cardiac event recorder" for transmitting ECG recordings, indicating its purpose is to detect and monitor, not to treat, a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic evaluation of patients with asymptomatic and symptomatic disturbances of the cardiac rhythm."
No
The device description explicitly states "The Vitaphone 100 BT device is single-channel cardiac event recorder" and "It is battery driven and utilizes a Flash memory to store ECG data," indicating it is a hardware device with embedded software, not a standalone software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis.
- The Vitaphone 100 BT is a cardiac event recorder that records electrical activity of the heart in vivo (within the body) through electrodes placed on the skin. It's a diagnostic tool, but it's not performing a test on a biological sample outside the body.
The device's function is to capture and transmit ECG data, which is a physiological measurement taken directly from the patient. This falls under the category of a diagnostic device, but not specifically an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
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 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.
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.
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
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: +49 371 40081 0 Fax: +49 371 40081 22
Contact Person: Tilo Borchardt, CTO Phone: +49 371 40081 122 Fax: +49 371 40081 22 Email: tb@vitasystems-gmbh.com
| 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 |
| (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.
1
Image /page/1/Picture/0 description: The image shows a simple line drawing of a rectangular object, possibly a box or a building. The lines are somewhat dashed or broken, giving the image a sketch-like quality. The object is depicted in a way that suggests a three-dimensional perspective, with lines indicating edges and surfaces.
Vitasystems GmbH 510(K) Submission 100 BT Sec. 5, 510(k) Summary
Image /page/1/Picture/2 description: The image shows the word "vitasystems" in a bold, sans-serif font. Above the "ta" in "vitasystems" are three curved lines, resembling sound waves or a stylized representation of connectivity. The word is slightly distressed, with some areas appearing faded or pixelated, giving it a textured look.
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: ....................................................................................
2
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.
3
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 (800) 638-2041 or (301) 796-7100 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
4
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