BMT ANSCORE HEALTH MANAGEMENT SYSTEM

K993875 · Boston Medical Technologies, Inc. · DPS · Aug 11, 2000 · Cardiovascular

Device Facts

• Record ID: K993875
• Device Name: BMT ANSCORE HEALTH MANAGEMENT SYSTEM
• Applicant: Boston Medical Technologies, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Aug 11, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2

Intended Use

The Anscore™ system is intended for use in heart rate variability (HRV) measurements in response to paced respiration and controlled exercises.

Device Story

Anscore™ is a cart-based system for heart rate variability (HRV) testing; utilizes 3-lead ECG and breathing apparatus to collect physiological data; system includes computer-based user interface for data acquisition and transmission for remote processing; used by physicians to assess autonomic function and dysfunction; output provides HRV measurements; clinical benefit includes objective assessment of autonomic nervous system status; device operates via same monitoring technology as predicate.

Clinical Evidence

Bench testing only. Performance testing confirmed compliance with functional requirements and specifications. Physiological input was simulated using calibrated instrumentation representative of a range of test subjects and physiological states.

Technological Characteristics

Cart-based system; 3-lead ECG; breathing apparatus; computer-based user interface; data acquisition and transmission system for remote processing. Operates using same monitoring technology as predicate.

Indications for Use

Indicated for heart rate variability (HRV) measurements in response to paced respiration and controlled exercises for assessment of autonomic function and dysfunction.

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

• Anscore™ Health Management System (K991831)

Submission Summary (Full Text)

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AUG 1 1 2000

K993875

## 510(k) Summary for Boston Medical Technologies, Inc. (BMT) Anscore™ Health Management System ("Anscore™")

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

## Submitter:

Cesidio Tempesta Manager of Regulatory Affairs/Quality Assurance Boston Medical Technologies, Inc. 591 North Avenue, Suite 5 Wakefield, MA Tel: [phone], Fax: [phone]

This summary was prepared on July 26, 2000.

Name of Device: The name of this device is the Anscore™ Health Management System. The common name is ECG monitor and Respiration Pacer. Classification names are as follows:

| Regulation Number | Classification Name |
|-----------------------|---------------------|
| 870.2340 - 74 DPS, II | Electrocardiograph |

Predicate Device: The Anscore™ Health Management System is substantially equivalent to the previously 510(k)-cleared Anscore™ Health Management System (K991831).

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Intended Use: The Anscore™ has the same intended use as the legally marketed predicate devices. The Anscore™ system is intended for use in heart rate variability (HRV) measurements in response to paced respiration and controlled exercises.

Description Device: The Anscore™ 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 and a breathing apparatus, in order to conduct heart rate variability testing. Heart rate variability testing is one of various measurement tools used by physicians in their assessment of autonomic function and dysfunction. 4

Technical Characteristics: 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.

I

See The American Association of Clinical Endocrinologists Medical Guidelines for the Management of Diabetes Mellitus: The AACE System of Intensive Diabetes Self-management -2000 Update, Endocrine Practice 2000; 6(1):43-84; American Heart Association, 1999. AHA Scientific Statement: Diabetes and cardiovascular disease. Circulation 100:1134-1146; Assessment: Clinical autonomic testing report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology, 1996;46:873-880; Consensus Statement: Report and recommendations of the San Antonio Conference on Diabetic Neuropathy, Diabetes 1988:37:1000-1004; Proceedings of a consensus development conference on standardized measures in diabetic neuropathy. Autonomic nervous system testing. Neurology 1992; 42(9):1831-1837; Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Heart rate variability: standards of measurement, physiological interpretation, and clinical use. Circulation 1996; 93(5)1043-1065; R. Freeman. Noninvasive evaluation of heart rate variability: the time domain. In Low, PA (ed.) Clinical Autonomic Disorders, 2nd ed. Lippincott-Raven Publishers, 1997:297-307; Anonymous. The effect of intensive diabetes therapy on measures of autonomic nervous system function in the Diabetes Control and Complications Trial (DCCT). Diabetologia 1998; 41(4):416-423; A.I. Vinik and S. Suwanwalaikorn. Autonomic Neuropathy. In deFronzo. R.M. (ed.) Current Therapy of Diabetes Mellitus. Yearbook Inc. 1997;165-176; D.J. Ewing. Cardiac Autonomic Neuropathy. In Jarret (ed.) Diabetes and Heart Disease. Elsevier, 1984;99-132; D. Ziegler et al. Effects of treatment with antioxidant alpha-lipoic acid on cardiac autonomic neuropathy in NIDDM patients: a 4-month randomized controlled multi-center trial (DEKAN Study). Diabetes Care 1997:369-373: H. Genovely and M.A. Pfeifer, 1988. RR-variation: the autonomic test of choice in diabetes, Diabetes/Metabolism Review 4(3):225-271.

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Performance Data: The Anscore™ system is the same as the previously 510(k)-cleared Anscore™ Health Management System and, thus, the results of the performance testing for that cleared system apply to this device. Final testing for the system included various performance tests to confirm compliance with functional requirements and performance specifications. Physiological input was simulated using calibrated instrumentation representative of a range of test subjects and physiological states.

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Public Health Service

AUG 1 1 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Cesidio Tempesta Boston Medical Technologies, Inc. 591 North Avenue, Suite 5 Wakefield, MA 01880-1641

K993875 Re: R999873 Regulatory Class: II (two) Product Code: DPS Dated: July 14, 2000 Received: July 14, 2000

Dear Mr. Tempesta:

We have reviewed your Section 510(k) notification of intent to market we nave reviewed your boosized we have determined the device is the device referenced above and as addications for use stated in the SubStantially Cquivaters (eted predicate devices marketed in encrosure) to regally may 28, 1976, the enactment date of the Interstate Commerce prior of to devices that have been reclassified Medical Device Americanship, is ons of the Federal Food, Drug, and In accordance with the provisions of the device, subject to the general controls provisions of the Act. The general controls che general controls provisions of the success for annual registration, provisions of the not in manufacturing practice, labeling, and Frochibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special II your device is crabbirou (it may be subject to such controls) of class fri (firsting major regulations affecting your device additional concerner. Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set with the Quality System Regulation (QS) for Medical Devices: _ General regulation (21 CFR Part 820) and that, through periodic QS oencrai regaracion od Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in assumptions. Trailer of Ottion, FDA may publish further announcements rogaroom your device in the Federal Register. Please note: _ this concerning your avremarket notification submission does not affect any response of your got have under sections 531 through 542 of the Act obrigation you might Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Cesidio Tempesta

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,

for Mark N Milkinson

James E. Riddle, III

E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

The ANScore™ Health Management System Device Name The Anscore™ system is intended for use in heart rate variability Indications for Use (HRV) measurements in response to paced respiration and controlled exercises.

K993875

510(k) Number:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

2 Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

for Mark N. Melkerson
Division of Cardiovascular & Respiratory Devices
510(k) Number K993875

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