VST3

K040942 · Biowatch Medical, Inc. · DXH · Sep 15, 2004 · Cardiovascular

Device Facts

• Record ID: K040942
• Device Name: VST3
• Applicant: Biowatch Medical, Inc.
• Product Code: DXH · Cardiovascular
• Decision Date: Sep 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended 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

Device Story

VST3 is a wearable ambulatory ECG monitor; captures two channels of ECG data. Device stores data and transmits via cellular modem to remote clinical monitoring center. Operated by patient; data interpreted by trained critical care specialists or licensed physicians. Device also supports cellular voice channel and location transmission upon command. Provides continuous, interventional monitoring for cardiac rhythm disorders. Benefits patient through remote access to cardiac rhythm analysis without requiring immediate in-clinic presence.

Technological Characteristics

Wearable ambulatory ECG monitor; two-channel sensing; cellular modem for data transmission; supports cellular voice and location tracking. No specific materials or software architecture details provided.

Indications for Use

Indicated for adults with abnormal heart rhythms and cardiac symptoms including arrhythmia, dysrhythmia, skipped beats, pauses, irregular heart rates, lightheadedness, faintness, or palpitations.

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

• K012223

Submission Summary (Full Text)

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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<br>(As Required by 21 C.F.R. §807.92) | | |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Submitted by: | Ursula E. Wilson<br>QA Manager<br>Biowatch Medical, Inc.<br>1233 Washington Street, Suite 400<br>Columbia, SC 29201-3221<br>Tel: [phone]<br>Fax: [phone] | |
| Date of summary: | December 19, 2003 | |
| Device name: | VST3 | |
| Common name: | Vital Signs Recorder and Transmitter | |
| Classification names: | Regulation No.<br>and Class | Description |
| | 870.2920, II | Telephone ECG Transmitter and Receiver<br>(Telephone) |
| | 870.2800, II | Medical Magnetic Tape Recorder |
| | 870.2300, II | Ambulatory ECG (without analysis)<br>User Physiological Monitor (without arrhythmia<br>detection or alarms) |
| Predicate Devices | The VST3 is substantially equivalent to the following cleared<br>predicate devices: | |
| | K012223 | |
| Device Description | The VST3 is an ambulatory ECG monitor. It is a wearable device<br>capable of monitoring two channels of electrocardiogram. The<br>device monitors each of the input channels and stores the<br>information for later transmission via its cellular modem to a<br>trained critical care specialist located at a remote clinical<br>monitoring center. It provides real-time, continuous,<br>interventional monitoring over extended periods of time.<br>Additionally, upon receipt of appropriate commands, the device is<br>capable of opening a cellular voice channel and/or transmitting its<br>location 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 [phone]. 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 [phone] or [phone] 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 ___ |
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| 510(k) Number | K040942 |