(156 days)
Not Found
No
The summary describes a device that records and transmits ECG data for human interpretation, with no mention of automated analysis or algorithms that would typically involve AI/ML.
No.
The device is indicated for monitoring and recording ECG data to identify cardiac rhythm disorders, and it is not intended to provide treatment.
Yes.
The device is used to monitor adults with abnormal heart rhythms and other symptoms of cardiac disease, and records and transmits ECG data for interpretation by specialists or physicians to identify cardiac rhythm disorders. This process of identifying disorders is diagnostic in nature.
No
The device description explicitly states it is a "wearable device" and mentions hardware components like a cellular modem and input channels for ECG, indicating it is not software-only.
Based on the provided information, the Biowatch Medical VST3 is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to analyze these samples outside of the body.
- VST3 Function: The VST3 is an ambulatory ECG monitor. It directly measures electrical activity of the heart on the body (wearable device) and transmits this data. It does not analyze samples taken from the body.
The device's function is to monitor physiological signals (ECG) directly from the patient, which falls under the category of a medical device but not specifically an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Biowatch Medical VST3 is indicated for use to monitor adults with abnormal heart rhythms and other symptoms of cardiac disease, such as:
- Arrhythmia or dysrhythmia .
- Skipped beats or pauses ●
- Rapid, slow, or irregular heart rate .
- Lightheadedness or faintness ●
- Palpitations .
The VST records and transmits ECG data to a remote central receiving station for interpretation by certified critical care specialists and/or a licensed over-read physician to identify cardiac rhythm disorders. The device is not intended to sound any alarms.
For Over-the-Counter Use.
Product codes (comma separated list FDA assigned to the subject device)
DXH
Device Description
The VST3 is an ambulatory ECG monitor. It is a wearable device capable of monitoring two channels of electrocardiogram. The device monitors each of the input channels and stores the information for later transmission via its cellular modem to a trained critical care specialist located at a remote clinical monitoring center. It provides real-time, continuous, interventional monitoring over extended periods of time. Additionally, upon receipt of appropriate commands, the device is capable of opening a cellular voice channel and/or transmitting its location information.
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
adults
Intended User / Care Setting
trained critical care specialist located at a remote clinical monitoring center; licensed over-read physician.
Over-the-Counter Use
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.
Not Found
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
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SEP 1 5 2004
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. . .
Personal Health Monitoring Services
| 510(k) Summary
| (As Required by 21 C.F.R. §807.92) | ||
|---|---|---|
| Submitted by: | Ursula E. Wilson | |
| QA Manager | ||
| Biowatch Medical, Inc. | ||
| 1233 Washington Street, Suite 400 | ||
| Columbia, SC 29201-3221 | ||
| Tel: 803-233-0244 | ||
| Fax: 803-233-0240 | ||
| Date of summary: | December 19, 2003 | |
| Device name: | VST3 | |
| Common name: | Vital Signs Recorder and Transmitter | |
| Classification names: | Regulation No. | |
| and Class | Description | |
| 870.2920, II | Telephone ECG Transmitter and Receiver | |
| (Telephone) | ||
| 870.2800, II | Medical Magnetic Tape Recorder | |
| 870.2300, II | Ambulatory ECG (without analysis) | |
| User Physiological Monitor (without arrhythmia | ||
| detection or alarms) | ||
| Predicate Devices | The VST3 is substantially equivalent to the following cleared | |
| predicate devices: | ||
| K012223 | ||
| Device Description | The VST3 is an ambulatory ECG monitor. It is a wearable device | |
| capable of monitoring two channels of electrocardiogram. The | ||
| device monitors each of the input channels and stores the | ||
| information for later transmission via its cellular modem to a | ||
| trained critical care specialist located at a remote clinical | ||
| monitoring center. It provides real-time, continuous, | ||
| interventional monitoring over extended periods of time. | ||
| Additionally, upon receipt of appropriate commands, the device is | ||
| capable of opening a cellular voice channel and/or transmitting its | ||
| location information. |
.
:
1
Image /page/1/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 5 2004
Biowatch Medical, Inc. c/o Mr. Ned Devine Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548
Re: K040942
Trade Name: VST3 Vital Signs Recorder and Transmitter Regulation Number: 21 CFR 870.2920 Regulation Name: Electrocardiograph Telephone Transmitters and Receivers Regulatory Class: Class II (two) Product Code: DXH Dated: August 27, 2004 Received: August 30, 2004
Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device w & nate roved your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass surver in the encrease of 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 I va mayy ators 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 may or subject to been as a succeral Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Mr. Ned Devine
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally prested predicate 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 contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the O iniv go.net Small Manufacturers, 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/dsma/dsmamain.html
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: Biowatch Medical VST3
Indications for Use:
The Biowatch Medical VST3 is indicated for use to monitor adults with abnormal heart rhythms and other symptoms of cardiac disease, such as:
- Arrhythmia or dysrhythmia .
- Skipped beats or pauses ●
- Rapid, slow, or irregular heart rate .
- Lightheadedness or faintness ●
- Palpitations .
The VST records and transmits ECG data to a remote central receiving station for interpretation by certified critical care specialists and/or a licensed over-read physician to identify cardiac rhythm disorders. The device is not intended to sound any alarms
For Over-the-Counter Use.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
X Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division/Sign-Off) Division of Cardiovascular Devices | Page ___ of ___ |
|---|---|
| 510(k) Number | K040942 |