The ECG Holter device, MICROVIT MT-100, is a recording device used to record long term Electrocardiographs for the diagnostics of symptomatic and asymptomatic arrhythmias, i.e. bradycardia, tachycardia, diagnostic of arrhythmias in patients with coronary artery disease, in patients after reanimation, in patients with different diseases such as cardiomyopathy, high blood pressure, long QT syndrome. A Holter ECG recording is also used for clarifying palpitations or syncopes and attacks of dizziness or for controlling medical therapies, or after operative treatments such as bypass operations or PTCA. The ST segment analysis of a Holter ECG is used for the detection of symptomatic or asymptomatic ischemias.

Device Description

The ECG Holter device, MICROVIT MT-100, is a recording device used to record long term Electrocardlographs for 24 hours, on two channels.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what's available:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Braemar DL 700 Holter Monitor K945130) by meeting recognized standards. The "acceptance criteria" are implied by adherence to these standards and the comparison table.

Acceptance Criteria (Implied by Standards/Comparison)	Reported Device Performance (MICROVIT MT-100)
Electrical Safety and Reliability:
Conformity to ANSI/AAMI EC 38-1994 (Ambulatory Electrocardiographs Type 1 Devices)	All tests passed
Conformity to IEC 601-1:1988 (General Safety of Medical Electrical Equipment)	All tests passed
Conformity to IEC 801-1:1984, 801-2:1991, 801-3:1984 (EMC Test, ESD, RF Electromagnetic Field)	All tests passed
Input Impedance (> 5 MOhm for predicate)	> 10 MOhm (conforms to AAMI EC38-1994, superior to predicate)
DC Offset (± 300mVDC max for predicate)	SAME (± 300mVDC max)
Common Mode Rejection (60dB for predicate)	> 80dB (conforms to AAMI EC38-1994, superior to predicate)
Recording Bandwidth (0.05 Hz to 50 Hz for predicate)	0.05Hz to 40 Hz (conforms to AAMI EC38-1994)
Environmental Testing:
Conformity to MIL-STD-81D (Environmental Conditions, Mechanical, Climate)	All tests passed
Operating Temperature (0 to 70 °C for predicate)	+10 to +40 °C (conforms to MIL-STD-81D)
Storage Temperature (-40 to +50 °C for predicate)	-10 to +50 °C (conforms to MIL-STD-81D)
Relative Humidity (10% to 90% non-condensing for predicate)	25% to 95% non-condensing (conforms to MIL-STD-81D)
Electromagnetic Compatibility (EMC):
Conformity to EN 55011 class B (Electromagnetic radiation)	All tests passed
Conformity to IEC 801-1 (Electromagnetic susceptibility)	All tests passed
Conformity to IEC 801-2 (Electrostatic Discharge)	All tests passed
Conformity to IEC 801-3 (Radio Frequency Electromagnetic Field)	All tests passed
Electro Static Discharge (Fully functional below 4 kV, no damage below 8kV for predicate)	SAME
Radiated Emissions (Less than 30 dB Microvolts for predicate)	SAME
Radiated Immunity (Less than 3 Volts per meter for predicate)	SAME
Software Quality:
Reviewed against "reviewer guidance for computer controlled medical devices undergoing 510(k) review"	Software requirements, structure, development, revision, identification, verification, validation, and testing described.
Data Transmission Accuracy:
Maximum deviation between original and transmitted/restored ECG signal	Less than 20 microvolts

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify a "test set" in terms of patient data for clinical evaluation. The testing described is primarily non-clinical, involving the device itself against engineering standards.
Data Provenance: Not applicable for patient data. The "tests" were conducted in a lab setting to verify device compliance with standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This was a non-clinical, engineering-centric evaluation against established standards, not a clinical study involving ground truth established by medical experts on patient data.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication process on patient data is described. The tests were objective measurements against predefined standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

No, an MRMC comparative effectiveness study was not done. The device is a Holter recorder, not an AI-assisted diagnostic tool for human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

The device is a recording device. Its performance is evaluated based on its ability to accurately record and transmit ECG signals, not as an algorithm performing a diagnostic task. The "standalone" performance is implied by the successful completion of the electrical, environmental, and EMC tests against established medical device standards.

7. The Type of Ground Truth Used

The "ground truth" for this submission are the established engineering and medical device standards (e.g., ANSI/AAMI EC 38-1994, IEC 601-1, MIL-STD-81D, IEC 801 series, EN 55011). The device's performance was compared against the requirements specified in these standards and the performance characteristics of the predicate device.

8. The Sample Size for the Training Set

Not applicable. The device is a physical recorder and does not utilize a "training set" in the context of machine learning or AI algorithms.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set was used.

Summary

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K973735

510 K Summary

according to 21 CFR 807.92

A1 Address

SCHILLER America, Inc. 3002 Dow Avenue, #138 Tustin, CA 92780 Mr. Markus Maritz Contact Name: 1619) 635 6023 Tel: 26th September 1997 Date:

Device Name A2

ﺮ

1. Trade Name:	Microvit MT-100
2. Common Name:	Solid State Holter Recorder
3. Classification Name:	Medical Magnetic Tape Recorder (Class II)

Classification Class: 74 DSH

A3 Legally Marketed Device

Legally Marketed Device to which this submitted device is compared: Braemar DL 700 Holter Monitor (K945130)

A4 Description of Submitted Device

The ECG Holter device, MICROVIT MT-100, is a recording device used to record long term Electrocardlographs for 24 hours, on two channels.

A5 Intended Use

The ECG Holter device. MICROVIT MI-100. Is a recording device used to record long term Electrocardlographs for the diagnostics of symptomatic and asymptomatic arrhythmlas.

1. Patlent Population: human beings without restrictions of age, sex or race,
1. Difference to the Predicate Device: mode of data transmission to the analysis station. Predicate Device: PCMCIA Card Submitted Device: Serial Optical Transmission. The maximum deviation between the original ECG signal and the transmitted and restored ECG signal Is less than 20 microvotts. This difference In fransmission rises no concern regarding the safety and effectiveness of the device,

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A6 Table of Comparison

Predicate device: Braemar DL 700 Holter Monitor (K9451 30)

DimensionsWeight	DL 700	MT - 100
	6.0"x3.5"x0.95"10 ounces incl. batteries	4.3" x 2.7" x 0.7"140g, 5 ounces incl.batteries
Battery:Channels	1.5V Alkaline AA2 or 3	SAME2
Environmental ConditionsOperating temperatureStorage temperatureRelative humidity	0 to 70 degree Celsius-40 to +50 degree Celsius10% to 90%(non condensing)	+10 to +40 °C-10 to +50 °C25% to 95%(non condensing)
ECG AmplifierInput ImpedanceDC OffsetCommon Mode rejectionRecording Bandwidth	> 5 MOhm± 300mVDC max.60dB0.05 Hz to 50 Hz	> 10 MOhmSAME> 80dB0.05Hz to 40 Hz
Recording Time	24 hours	SAME
Electro Static Discharge /Electro MagneticCompatibilityESD	Fully functional below 4 kV(Open Air)No damage below 8kV(Open Air)	SAMESAME
Radiated EmissionsRadiated Immunity	Less than 30 dB MicrovoltsLess than 3 Volts per meter	SAMESAME

Discussion of differences

1 . Environmental conditions claimed are In accordance with MIL-STD-81D. No concern related to safety and effectiveness of the device.
1. Input Impedance cialmed are In accordance with AAMI EC38-1994. No concern related to safety and effectiveness of the device.
1. Common Mode Rejection claimed are In accordance with AAMI EC38-1994. No concern related to safety and effectiveness of the device.
1. Recording Bandwidth claimed are in accordance with AAMI EC38-1994. No concern related to safety and effectiveness of the device.

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Non-Clinical Tests B1

1. Electrical Safety and Reliability The Microvit MT-100 device has been tested to be in accordance with the following standards:
- ANSI / AAMI, EC 38-1994: Ambulatory Electrocardlographs Type 1 Devloes -
- IEC 601-1:1988: Safety of Medical Electrical Equipment part 1, General : requirements
- IEC 801-1:1984, IEC 801-2:1991, IEC 801-3:1984, Electromagnetic Compatibility Test, Electrostatio Discharge, Radlo Frequency Electromagnetic Fleld.

All tests are passed.

1. Environmental Testing
- The following environmental tests have been conducted:
- mechanical tests (vibration, shock, fall, toppling) (IEC 601 1 , MIL-STD-81D)
- climate tests (storage/operation temperatures) (MIL-STD-81D)

All tests are passed.

3. Electro Magnetic Compatibility (EMC)

The following electromagnetic magnetic compatibility tests have been conducted:

EN 55011 class B Electromagnetic radiation .
IEC 801-1 Electromagnetic susceptibility
IEC 801-2 Electrostatic Discharge
IEC 801-3 Radlo Frequency Electromagnetic Field

All tests are passed. The test reports are enclosed.

4) Data related to software quality

Schiller has reviewed its software development process following the guideline * reviewer guidance for computer controlled medical devices undergoing 510 (k) review". Device software requirements, software structure chart, software development, software revision/ modification, software Identification, software verification, validation and testing are described in the data attached.

B2 Cilnical Tests

n.a.

B3 Conclusions from Tests

The fulfilment of the above standards ensures the safety and effectiveness of the submitted device. We consider the submitted device to be as safe and effective as the Predicate (Braemer) Device.

LD/510 K Summary.doc

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 25 1998

Mr. Markus Maritz Schiller America, Inc. 3002 Dow Avenue, Suite 138 Tustin, CA 92780

Re: K973735 Microvit MT-100 Requlatory Class: II (two) Product Code: 74 DSH Dated: May 29, 1998 Received: June 2, 1998

Dear Mr. Maritz:

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, Druq, 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 regulatory 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. Markus Maritz

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation 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 (800) 638-2041 or (301) 443-6597, 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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WELCH ALLYN 07/31/88 11:28 . 07/31/88 13:04 FAI

ID:619-621-6610 2201 143 9101

AUG 04'98 FD4-0ST : DECS

Page 1 of _1

810(k) Number (if known): 973735

Holter MICROVIT MT-100 Device Name:_

Indications For Use:

A Holter ECG recording is also used for clarifying palpitations or syncopes and attacks of dizziness or for controlling medical therapies, or after operative treatments such as bypass operations or PTCA. The ST segment analysis of a Holter ECG is used for the detection of symptomatic or asymptomatic ischemias.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
for (Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number	K973735

Prescription Use_V (Per 21 CFR 801.109) OR

Over-The-Counter Use_

(Optional Pormat 1-2-90)

Regulation Number and Section

§ 870.2800 Medical magnetic tape recorder.

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