(329 days)
Not Found
No
The summary describes a standard ECG Holter recording device and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is a recording device used for diagnostics, not for treatment.
Yes
The device is described as "used to record long term Electrocardiographs for the diagnostics of symptomatic and asymptomatic arrhythmias." This statement directly indicates its use for diagnostic purposes.
No
The device description explicitly states it is a "recording device," implying hardware is involved in capturing the ECG data. The performance studies also mention "Electrical Safety and Reliability," "Environmental Testing," and "Electro Magnetic Compatibility (EMC)," which are typical tests for hardware components.
Based on the provided information, the MICROVIT MT-100 ECG Holter device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is performed outside of the living body ("in vitro").
- Device Function: The MICROVIT MT-100 is a recording device that captures electrical signals from the heart directly from the patient's body ("in vivo"). It records these signals for later analysis.
- Intended Use: The intended use describes the device as a "recording device used to record long term Electrocardiographs for the diagnostics of symptomatic and asymptomatic arrhythmias." This diagnostic process involves analyzing the recorded electrical activity of the heart, not testing bodily specimens.
Therefore, the function and intended use of the MICROVIT MT-100 clearly place it outside the scope of In Vitro Diagnostics. It is a device used for in vivo physiological monitoring.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
74 DSH
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.
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
human beings without restrictions of age, sex or race,
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/3 description: The image shows a date, "AUG 25 1998". The month is August, the day is the 25th, and the year is 1998. The text is in a bold, sans-serif font and is black in color. The background is white.
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.
-
- Patlent Population: human beings without restrictions of age, sex or race,
-
- 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,
1
Image /page/1/Picture/3 description: The image shows the word "SCHILLER" in large, bold, black letters. Below the word is a horizontal line, and below that is the word "SWITZERLAND" in smaller, black letters. The text appears to be a logo or brand name.
A6 Table of Comparison
Predicate device: Braemar DL 700 Holter Monitor (K9451 30)
| Dimensions
| Weight | 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 AA | |
| 2 or 3 | SAME | |
| 2 | ||
| Environmental Conditions | ||
| Operating temperature | ||
| Storage temperature | ||
| Relative humidity | 0 to 70 degree Celsius | |
| -40 to +50 degree Celsius | ||
| 10% to 90% | ||
| (non condensing) | +10 to +40 °C | |
| -10 to +50 °C | ||
| 25% to 95% | ||
| (non condensing) | ||
| ECG Amplifier | ||
| Input Impedance | ||
| DC Offset | ||
| Common Mode rejection | ||
| Recording Bandwidth | > 5 MOhm | |
| ± 300mVDC max. | ||
| 60dB | ||
| 0.05 Hz to 50 Hz | > 10 MOhm | |
| SAME |
80dB
0.05Hz to 40 Hz |
| Recording Time | 24 hours | SAME |
| Electro Static Discharge /
Electro Magnetic
Compatibility
ESD | Fully functional below 4 kV
(Open Air)
No damage below 8kV
(Open Air) | SAME
SAME |
| Radiated Emissions
Radiated Immunity | Less than 30 dB Microvolts
Less than 3 Volts per meter | SAME
SAME |
Discussion of differences
- 1 . Environmental conditions claimed are In accordance with MIL-STD-81D. No concern related to safety and effectiveness of the device.
-
- Input Impedance cialmed are In accordance with AAMI EC38-1994. No concern related to safety and effectiveness of the device.
-
- Common Mode Rejection claimed are In accordance with AAMI EC38-1994. No concern related to safety and effectiveness of the device.
-
- Recording Bandwidth claimed are in accordance with AAMI EC38-1994. No concern related to safety and effectiveness of the device.
2
Image /page/2/Picture/3 description: The image shows the word "SCHILLER" in large, bold, black letters. Below the word "SCHILLER" is a horizontal line. Under the line, the word "SWITZERLAND" is written in smaller, black letters. The text appears to be a logo or brand name.
Non-Clinical Tests B1
-
- 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.
-
- 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
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles below three horizontal bars.
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.
4
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
5
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:
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.
(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)