VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY

K111180 · Vasomedical, Inc. · DSH · Jun 28, 2011 · Cardiovascular

Device Facts

• Record ID: K111180
• Device Name: VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY
• Applicant: Vasomedical, Inc.
• Product Code: DSH · Cardiovascular
• Decision Date: Jun 28, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2800
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Vasomedical-Biox 12 - Channel Ambulatory ECG Holter Recorder, Model 1304, is a Non-Invasive device intended to acquire ambulatory 12 - Channel ECG signals from the upper body surfaces. Cardiac rhythm is acquired via ECG signals. Vasomedical-Biox 3 - Channel Miniature Ambulatory ECG Holter Recorder, Model 1303, is also a Non-Invasive device but intended to acquire ambulatory 3 - Channel ECG signals from the upper body surfaces. Cardiac rhythm is also acquired via ECG signals. The Holter Recorders are intended for adults and children who are over the age of six years. The Models 1304 and 1303 work with the CB Series ECG Analysis Software which has been previously cleared under (k)083820. The system is only for measurement, recording and display. It makes no diagnosis.

Device Story

Portable, microprocessor-based Holter recorders (Models 1304, 1303) acquire ambulatory ECG signals from upper body surfaces via electrodes (10 electrodes for 12-channel; 5 for 3-channel). Devices are worn by patients using a carrying case and strap. Data is stored on SD memory cards. Recorders interface with previously cleared CB Series ECG Analysis Software for data processing. Healthcare providers use the software to review recorded ECG rhythms. Devices provide measurement, recording, and display functions only; they do not provide automated diagnosis. Intended for clinical use to assist in cardiac rhythm screening.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Portable, microprocessor-based; 12-channel (Model 1304) or 3-channel (Model 1303) ECG acquisition; SD memory card storage; 256 Hz/channel sample rate; 10-bit resolution; LED (1304) or LCD (1303) display; battery-powered (AA or AAA alkaline); infrared data transfer; works with CB Series ECG Analysis Software.

Indications for Use

Indicated for adults and children >6 years old requiring ambulatory ECG monitoring for up to 72 hours. Used for measurement, recording, and display of cardiac rhythm. No diagnosis provided.

Regulatory Classification

Identification

A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.

Predicate Devices

• Vasomedical - Biox, 3 - Channel Ambulatory ECG Holter Recorder, Model 1305 (K083820)

Submission Summary (Full Text)

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JUN 2 8 2011

## 510(k) Summary

Vasomedical-Biox 12 - Channel Ambulatory ECG Holter Recorder. Model 1304 Vasomedical-Biox 3 - Channel Miniature Ambulatory ECG Holter Recorder, Model 1303

- April 25, 2011 1. Date Prepared:
- 2. Submitter's Name: Vasomedical, Inc. and Address 180 Linden Ave. Westbury, NY 11590
- 3. Contact Person: Richard Gordon Manager, Regulatory and Quality Affairs Vasomedical, Inc. Telephone: [phone] Facsimile: [phone] E-mail: [e-mail]
- 4. Device Names: a) 12 - Channel Ambulatory ECG Holter Recorder, Model 1304 b) 3 - Channel Miniature Ambulatory ECG Holter Recorder, Model 1303
- Proprietary Names: a) Vasomedical-Biox 12 Channel Ambulatory ECG Holter Recorder. Model 1304
- b) Vasomedical-Biox 3 Channel Miniature Ambulatory ECG Holter Recorder, Model 1303
- Common Name: a) 12 - Channel Ambulatory ECG Holter Recorder, Model 1304 b) 3 - Channel Miniature Ambulatory, ECG Holter Recorder, Model 1303

Classification Name: 870.2800 Magnetic Tape Recorder, Medical

- 5. Predicate Device: Vasomedical - Biox, 3 - Channel Ambulatory ECG Holter Recorder, Model 1305 was granted FDA 510(k) clearance on April 1, 2009 (k083820).
- 6. Device Description: Vasomedical-Biox 12 - Channel Ambulatory ECG Holter Recorder and Vasomedical-Biox 3 - Channel Miniature Ambulatory ECG Holter Recorders are intended to be used as a Holter Ambulatory Electrocardiograph device for the purpose of screening ECG rhythms for periods up to 72 hours. Cardiac rhythm is acquired by 12 Channel or 3 Channel ECG signals.

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The Recorders are intended for adults and children over the age of six years old.

The Models 1304 and 1303 are modified versions of Model 1305 which FDA granted clearance on April 1, 2009 (k083820). Model 1304 increases the number of channels and ECG signals to 12 from 3 as in the Predicate device Model 1305.

Model 1303 is a miniaturized version of Model 1305

The Recorders are portable, microprocessor based devices that are worn by a patient with the use of a supplied Carrying Case and Strap.

Models 1304 and 1303 specifications are listed in Table 1 below:

| | Model 1504 | Model 1505 |
|-------------------------|-------------------------------------------------------|-----------------------------------------------|
| Lead | 12 | 3 |
| Electrode | 10 | 5 |
| Lead wire type | 10F/10G | 7E/5E |
| Display | LED | LCD |
| Batteries | 1 x "AA" Alkaline | 1 x "AAA" Alkaline |
| Carrying Case/<br>Strap | Supplied | Supplied |
| Card Reader | Supplied | Supplied |
| Dimensions | 3.3 x 2.3 x 0.88" | 2.6 x 2.1 x 0.7" |
| Weight | 2.45 oz | 1.76 oz |
| Storage | SD Memory Card | SD Memory Card |
| Memory<br>Capacity | 1 GB or more | 1 GB or more |
| Sample Rate | 256 Hz/Channel<br>10,000 Hz<br>Pacemaker<br>Detection | 256 Hz/Channel<br>1,000Hz for SAECG<br>option |
| Resolution | 10 Bit | 10 Bit; 12 Bit for<br>SAECG option |
| Infrared<br>Adaptor | Supplied | Supplied |

Model 1304

Model 1303

Table 1: Model 1304 and 1303 Specifications

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## 7. Intended Use:

Vasomedical-Biox 12 - Channel Ambulatory ECG Holter Recorder, Model 1304, is a Non-Invasive device intended to acquire ambulatory 12 - Channel ECG signals from the upper body surfaces. Cardiac rhythm is acquired via ECG signals.

Vasomedical-Biox 3 - Channel Miniature Ambulatory ECG Holter Recorder, Model 1303, is also a Non-Invasive device but intended to acquire ambulatory 3 - Channel ECG signals from the upper body surfaces. Cardiac rhythm is also acquired via ECG signals.

The Holter Recorders are intended for adults and children who are over the age of six years.

The Models 1304 and 1303 work with the CB Series ECG Analysis Software which has been previously cleared under (k)083820

The system is only for measurement, recording and display. It makes no diagnosis.

Refer to Attachment I and II, Vasomedical-Biox Model 1305/1304 AECG Instruction Manual for Users and Model 1303 AECG Instruction Manual for Users, Sections 2.2, Indications for Use, 2.2.1 Intended Use and 2.2.2 for Contraindications.

## 8. Comparison of Technological Characteristics:

Technological and functional characteristics of the devices listed in this Special 510(k) Notification for Modification are essentially the same as those of the Predicate device. The devices listed in this 510(k) Premarket Notification is therefore substantially equivalent to the predicate device.

"The Intended Use of the modified devices as described in its labeling, has not changed as a result of the modifications".

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be an abstract caduceus, a symbol often associated with healthcare.

Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Vasomedical, Inc. c/o Mr. Richard E. Gordon Manager, Regulatory and Quality Affairs 180 Linden Avenue Westbury, NY 11590

JUN 2 8 2011

Re: K11180

Trade/Device Name: Vasomedical-Biox 12-Channel Ambulatory ECG Holter Recorder (Model 1304) and Vasomedical-Biox 3-Channel Miniature Ambulatory ECG Holter Recorder (Model 1303) Regulatory Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: II (two) Product Code: DSH Dated: June 2, 2011

Received: June 3, 2011

Dear Mr. Gordon:

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.

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Page 2 - Mr. Richard E. Gordon

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/CDRHOffices/ucm11.5809.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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours

C. Bram D. Zuckerman, M.D.

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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April 25, 2011 '

K111180

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## Indications for Use

| 510(k) Number: | k | |
|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Device Names: | a) Vasomedical-Biox 12 - Channel Ambulatory ECG Holter Recorder,<br>Model 1304 | |
| | b) Vasomedical-Biox 3 - Channel Miniature Ambulatory ECG Holter<br>Recorder, Model 1303 | |
| Indications for Use: | Vasomedical-Biox 12 - Channel Ambulatory ECG Holter Recorder,<br>Model 1304, is a Non-Invasive device intended to acquire ambulatory<br>12 - Channel ECG signals from the upper body surfaces. Cardiac Rhythm is<br>acquired via ECG signals. | |
| | Vasomedical-Biox 3 - Channel Miniature Ambulatory ECG Holter Recorder,<br>Model 1303, is also a Non-Invasive device intended to acquire ambulatory<br>3 - Channel ECG signals from the upper body surfaces. Cardiac rhythm is<br>also acquired via ECG signals. | |
| | The Holter Recorders are intended for adults and children who are over the<br>age of six years. | |
| | The Models 1304 and 1303 work with the CB Series ECG Analysis Software<br>which has been previously cleared under (k083820) | |
| | "The Intended Use of the modified devices as described in its labeling,<br>has not changed as a result of the modifications".<br>The system is only for measurement, recording and display. It makes no<br>diagnosis. | |
| | | |
| Prescription Use: YES<br>(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use: NO<br>(21 CFR 801 Subpart C) |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF<br>NEEDED) | | |
| | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
| (Division Sign-Off)<br>Division of Cardiovascular Devices | | |

510(k) Number_K 111,80

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