(156 days)
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
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.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the VST3 Vital Signs Recorder and Transmitter as an ambulatory ECG monitor. However, it does not specify quantitative acceptance criteria or provide a study detailing the device’s performance against such criteria. The document is a 510(k) summary and clearance letter, primarily establishing substantial equivalence to predicate devices, not reporting on a detailed performance study with specific metrics.
Therefore, I cannot populate a table of acceptance criteria and reported device performance from this document.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific test set with a sample size or data provenance (country of origin, retrospective/prospective). The 510(k) process focuses on demonstrating substantial equivalence, which often relies on comparison to existing legally marketed devices rather than extensive de novo clinical trials for performance metrics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention a specific test set with established ground truth, nor does it specify the number or qualifications of experts involved in such a process. It states that ECG data is transmitted for "interpretation by certified critical care specialists and/or a licensed over-read physician," but this refers to the intended use of the device in clinical practice, not the establishment of ground truth for a performance study.
4. Adjudication Method for the Test Set
As no specific test set is described, no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
The document does not indicate that an MRMC comparative effectiveness study was performed. The focus is on the device itself as an ambulatory ECG monitor, not on an AI-assisted interpretation system or the improvement of human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The VST3 is described as a "Vital Signs Recorder and Transmitter" that records and transmits ECG data for human interpretation. It does not appear to incorporate an internal algorithm for automated interpretation without human intervention. Therefore, a standalone algorithm performance study is not applicable to this device as described.
7. The Type of Ground Truth Used
The document does not describe any specific ground truth used for performance evaluation, as it doesn't detail such a study. The stated intended use involves interpretation by "certified critical care specialists and/or a licensed over-read physician," implying clinical interpretation as the ultimate reference for the data it collects.
8. The Sample Size for the Training Set
The document does not mention a training set size. As the device is described as an ECG recorder and transmitter rather than an AI-driven interpretive algorithm, the concept of a "training set" in the context of machine learning is not directly relevant to this description.
9. How the Ground Truth for the Training Set Was Established
Since no training set is discussed or implied for an AI algorithm (as this is an ECG recorder), this information is not applicable.
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Image /page/0/Picture/0 description: The image shows the logo for BiOWATCH MEDICAL. The word "BiOWATCH" is in large, bold letters, with the letters "TM" in superscript next to it. Below the word "BiOWATCH" is a curved line, and below that is the word "MEDICAL" in smaller letters. The logo is simple and clean, and it is likely used to identify the company and its products.
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. WilsonQA ManagerBiowatch Medical, Inc.1233 Washington Street, Suite 400Columbia, SC 29201-3221Tel: 803-233-0244Fax: 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 arrhythmiadetection or alarms) | |
| Predicate Devices | The VST3 is substantially equivalent to the following clearedpredicate devices: | |
| K012223 | ||
| Device Description | The VST3 is an ambulatory ECG monitor. It is a wearable devicecapable of monitoring two channels of electrocardiogram. Thedevice monitors each of the input channels and stores theinformation for later transmission via its cellular modem to atrained critical care specialist located at a remote clinicalmonitoring center. It provides real-time, continuous,interventional monitoring over extended periods of time.Additionally, upon receipt of appropriate commands, the device iscapable of opening a cellular voice channel and/or transmitting itslocation information. |
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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.
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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
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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 |
§ 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).