BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1

• K Number: K991831
• Device Name: BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1
• Manufacturer: BOSTON MEDICAL TECHNOLOGIES, INC.
• Date Cleared: 1999-06-11 ( 14 days)
• Product Code: DPS
• Regulation Number: 870.2340

Intended Use

Indications: 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 Description

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.

Predicate Devices

K972991, K973426

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a system for physiological data acquisition and remote processing, but there is no mention of AI, ML, or related terms, nor any description of training or test sets typically associated with AI/ML development.

Therapeutic

No
The device is used for measuring heart rate variability in response to paced respiration and controlled exercises, and it explicitly states it is "not intended for any specific clinical diagnosis." This indicates it is for assessment rather than treatment, which is characteristic of a diagnostic or monitoring device, not a therapeutic one.

Diagnostic

No

The "Intended Use / Indications for Use" section explicitly states, "It is not intended for any specific clinical diagnosis." This indicates it is not a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "cart-based system" with hardware components including a "3 lead ECG, an optional blood pressure monitor, and a breathing apparatus." This indicates it is a hardware system with integrated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, the ANScore™ System is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• ANScore™ System Function: The ANScore™ System measures heart rate variability in response to paced respiration and controlled exercises. This is a physiological measurement taken directly from the patient's body (via ECG leads and potentially a blood pressure monitor), not a test performed on a sample taken from the body.
• Intended Use: The intended use explicitly states it's for "heart rate variability measurements" and "not intended for any specific clinical diagnosis." While the measurements might be used by a physician in the context of a diagnosis, the device itself is providing physiological data, not performing a diagnostic test on a sample.

Therefore, the ANScore™ System falls under the category of a physiological monitoring or measurement device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

74 DPS

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

physician office or hospital environment

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K972991, K973426

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

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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
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.

2

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

4

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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
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

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