BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005

K990956 · Biosensor Corp. · DQK · Jun 14, 1999 · Cardiovascular

Device Facts

• Record ID: K990956
• Device Name: BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005
• Applicant: Biosensor Corp.
• Product Code: DQK · Cardiovascular
• Decision Date: Jun 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Biosensor CMS Holter Analysis system is intended for patients requiring ambulatory monitoring is most frequently used for the indications below. 1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia. 2. Evaluation of symptoms suggesting arrhythmia in various types or groups of patients. 3. Evaluation of patients for ST segment changes. 4. Evaluation of a patient's response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery.) 5. Clinical and epidemiological research studies. 6. Evaluation of patients with pacemakers 7. Reporting of time and frequency domain heart rate variability 8. Reporting of QT Interval.

Device Story

Biosensor CMS Holter Analysis System processes ambulatory ECG data; inputs include continuous ECG signals from patient recorders. System utilizes signal processing algorithms to perform QRS detection, VE detection, and ST segment measurement. To mitigate noise from myopotentials, baseline wander, and line interference, system employs beat averaging and optional high/low pass filters; users receive on-screen notifications when filters are active. Output consists of heart rate trends, arrhythmia reports, ST values, and other ECG parameters for physician review. Used in clinical settings by healthcare professionals to aid in diagnosis and management of cardiac conditions. System provides diagnostic information to support clinical decision-making regarding patient cardiac health.

Clinical Evidence

No clinical data provided. Evidence relies on adherence to established standards for Holter systems (ANSI/AAMI EC11-1982) and the requirement for diagnostic accuracy testing of QRS/VE detectors and ST measurement algorithms.

Technological Characteristics

Holter analysis system software; utilizes 05-40 Hz bandpass filters for line interference reduction; optional high-pass filters for baseline wander and low-pass filters for EMG interference; employs beat averaging for noise reduction; provides on-screen status notifications for active filters.

Indications for Use

Indicated for patients requiring ambulatory ECG monitoring for evaluation of symptoms suggesting arrhythmia or myocardial ischemia, ST segment changes, post-activity response (e.g., post-MI or cardiac surgery), pacemaker evaluation, heart rate variability, and QT interval assessment.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Submission Summary (Full Text)

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JUN 1 4 1999

## Section 2 - Safety and Effectiveness Summary and Certifications

## Safety

For safe use of Holter systems, labeling and documentation must be complete. Standards for these are also covered in ANSI/AAMI EC11-1982.

## Effectiveness

Holter analysis systems contain software, which must perform effectively, accurately, and reliably. Recommended standards and test methods for the performance of these systems are also compiled in detail in the Association for the Advancement of Medical Instrumentation draft standard for Holter systems.

In addition to these, because of lack of proper user training, problems may arise regarding the following:

(a) Lead placement (Correct positions for electrodes are explained in ECG textbooks such as "Harrison's Principles of Internal Medicine", Eds. R.G. Petersdorf, R.D. Adams, E. Braunwald, K.J. Isselbacher, J.B. Martin and J.D. Wilson, 10th edition, pp: 1320-21. McGraw Hill, 1983).

(b) Line Interference (A comprehensive reference list for causes and reduction methods for line interference is given in "A new technique for line interference monitoring and reduction in biopotential amplifiers", Y.Z. Ider and H. Koymen, IEEE Trans. Biomedical Engineering, Vol. 37, pp. 624-31, 1990.) Patient recorder hardware with 05-40 Hz bandpass filters can reduce partially or substantially an problems with line interference.

(c) EMG (myopotential) interference (A low pass filter may be provided as an option as too much muscle interference may be encountered during an Holter recording. Users should be notified continuously when this filter is in use, since low pass filters may affect the diagnostic value of the ECG recording information. The CMS Holter Analysis System provides such notification on screen.)

(d) Baseline wander (High pass correction filters may be provided as an option as baseline wander may occur during Holter recording. Users should be notified continuously when this filter is used, since baseline wander filters may affect the diagnostic value of the recording. The CMS Holter Analysis System provides such notification on screen.)

(e) Averaging (In Holter systems, ST level changes must be accurately measured for each lead). Due to myopotential, baseline wander and other noise interference, such measurements cannot be reliably made using a single beat. Therefore, beats are averaged and measurements are made from average beats to minimize errors.

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(f) Diagnostic Accuracy (In Holter systems that measure heart rate, arrhythmia content, ST values and other ECG parameters, the algorithms used to make such measurements and report trends to the physician influence the quality of information provided to the physician. Testing of the diagnostic accuracy of the ST measurements, QRS detector and VE detector are necessary to evaluate the value of the measurements and trends supplied to the physician for review.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 4 1999

Mr. Steve Springrose Vice President Biosensor Corporation 11481 Rupp Drive Burnsville, MN 55337

Re: K990956 Biosensor Holter Monitor System Software, Model 1005 Requlatory Class: II (two) Product Code: DQK Dated: March 17, 1999 Received: March 22, 1999

Dear Mr. Springrose:

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 Requlation (QS) for Medical Devices: General requlation (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 regulatory action. In addition, FDA may publish further announcements

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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.

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, ² Misbranding by reference to premarket notification? (21CFR 807.97). Other qeneral 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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Page 1 of 1

| 510(k) Number (if known): | K990956 |
|---------------------------|-------------------------|
| Device Name: | Ambulatory (Holter) ECG |

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Indications For Use:

Ambulatory (Holter) ECG intended use:

The Biosensor CMS Holter Analysis system is intended for patients requiring anbulatory The Biosensor Citis Hotel Analysis 35 oven 10 monitoring is most frequently used for the indications below.

1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.

1. Evaluation of Symptoms suggesting army announce of the works or groups of patients.

3. Evaluation of patients for ST segment changes.

4. Evaluation of a patient's response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery.)

5. Clinical and epidemiological research studies.

6. Evaluation of patients with pacemakers

7. Reporting of time and frequency domain heart rate variability

8. Reporting of QT Interval.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEBDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devic 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

. OR

Over-The-Counter Use

(Optional Format 1-2-96)