BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1

K991831 · Boston Medical Technologies, Inc. · DPS · Jun 11, 1999 · Cardiovascular

Device Facts

• Record ID: K991831
• Device Name: BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1
• Applicant: Boston Medical Technologies, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Jun 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The ANScore™ System is intended for use in heart rate variability measurements in response to paced respiration and controlled exercises. It is not intended for any specific clinical diagnosis. Assessment is indicated for patients in the physician office or hospital environment.

Device Story

ANScore™ System is a cart-based device for heart rate variability (HRV) assessment; inputs include 3-lead ECG signals, optional blood pressure, and breathing apparatus data. System features computer-based user interface for data acquisition, testing, and transmission for remote processing. Operated by clinicians in physician offices or hospitals. Device transforms physiological inputs into HRV metrics; output used by healthcare providers to assess patient response to paced respiration and controlled exercise. Not intended for specific clinical diagnosis; provides physiological data to support clinical assessment.

Clinical Evidence

Bench testing only. Performance confirmed via safety and functional testing using calibrated instrumentation to simulate physiological inputs across various test subjects and states. A usability study was conducted by clinicians to validate ease of use.

Technological Characteristics

Cart-based system; 3-lead ECG, optional blood pressure monitor, and breathing apparatus. Computer-based user interface; data acquisition and transmission for remote processing. Operates using standard ECG monitoring technology.

Indications for Use

Indicated for patients in physician office or hospital settings requiring heart rate variability measurements during paced respiration and controlled exercise. No specific disease state or age/gender restrictions specified.

Regulatory Classification

Identification

An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

Predicate Devices

• qmed monitor one nDx (K972991)
• D.E. Hokanson, Inc. ANS2000 (K973426)

Submission Summary (Full Text)

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## 13,39 JUN 11

## 510(k) Summary 10.0

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92.

- 1. The submitter of this premarket notification is: Donald Brooks Director of Operations Boston Medical Technologies, Inc. 591 North Avenue, Suite 5 Wakefield, MA Tel: [phone], Fax: [phone]
This summary was prepared on June 10, 1999.

- The name of this device is the ANScore™ System. The common name is 2. ECG monitor and Respiration Pacer. Classification names are as follows:

| Regulation Number | CALLERS AN HORE CHARLES COLLEGE AND A FRIEND A BRICAL CONTRACTORS CONTRACTOR COLLEGIAL CONTRACTOR COLLEGIAL CONTRACTOR COLLEGIAL CONTRACTOR COLLECTION CONTRACTOR COLLECTION C |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| LA COLORIO COLLECTION LA COLLECTION LA BOLLER AND | Classification Name |
| 870.2340 74 DPS.IT | 1<br>Electrocardiograph |

- 3. The ANScore™ System is substantially equivalent to the following predicate devices: The qmed monitor one nDx (K972991), and the D.E. Hokanson, Inc. ANS2000 (K973426),
- 4. The ANScore™ System is a cart-based system with a computer-based user interface and data acquisition system for testing, data collection and data transmission for remote processing. The device features a 3 lead ECG, an optional blood pressure monitor, and a breathing apparatus.
- The ANScore™ System has the same intended use as the legally marketed S. predicate Devices. The ANScore™ System is intended for use in heart rate variability measurements in response to paced respiration and controlled exercises. It is not intended for any specific clinical diagnosis. Assessment is indicated for patients in the physician office or hospital environment.

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- ఈ. The ANScore™ System operates using the same monitoring technology employed in the predicates. The measurement technology and the transmission of ECG signals are similar and therefore the technological characteristics are essentially the same as those of the legally marketed predicate devices.
- 7. The ANScore™ System was subjected to safety and performance tests against applicable recognized standards. Final testing for the system included various performance tests to confirm compliance with functional requirements and performance specifications. Psysiological input was simulated using calibrated instrumentation representative of a range of test subjects and physiological states. A usability study of the ANScore™ System was performed by clinicians to validate ease of use.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol resembling an eagle or bird with stylized wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 11 1999

Mr. Donald James Sherratt Boston Medical Technologies, Inc. Intertek Testing Services 70 Codman Hill Road Boxborough, MA 01719

K991831 Re: ANScore™ Health Management System Requlatory Class: II (two) Product Code: 74 DPS Dated: May 26, 1999 Received: May 28, 1999

Dear Mr. Sherratt:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Donald James Sherratt

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

| 510(k) Number | K991831 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | The ANScore™ System |
| Indications for Use | Indications: The ANScore™ System is intended<br>for use in heart rate variability measurements<br>in response to paced respiration and controlled<br>exercises. It is not intended for any specific<br>clinical diagnosis. Assessment is indicated for<br>patients in the physician office or hospital<br>environment |

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

A. H. Ciavol.

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

Prescription Use (Per 21 CFR 801.109)

510(k) Number Over-The-Counter Use