MEDILOGAR4, MEDILOGAR12

K070818 · Tom Medical Entwicklungs GmbH · DSH · Apr 6, 2007 · Cardiovascular

Device Facts

• Record ID: K070818
• Device Name: MEDILOGAR4, MEDILOGAR12
• Applicant: Tom Medical Entwicklungs GmbH
• Product Code: DSH · Cardiovascular
• Decision Date: Apr 6, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The MedilogAR4 and MedilogAR12 Digital Holter Recorders are used to record a 3 channel ECG and to measure the time intervals between consecutive R peaks in the ECG. The system is designed for a measuring duration of more than 24h and is therefore worn by the patient throughout the whole day. The preparation for the recording (attaching electrodes, etc.) is undertaken by the technician or doctor. During the recording, the instrument is carried in a special protective pouch which can be attached to a belt. The instrument is not designed for emergency monitoring purposes (intensive medical monitor); the instrument is only designed to record the ECG and/or information derived from ECG. The recorder is not protected against the effects of defibrillation as outlined in EN60601-2-25. The instruments also record other information: HF component of the ECG, time point of the P-wave, time point of the T-wave, and time point of the pacemaker pulse. In addition the MedilogAR12 records the ECG amplitude.

Device Story

Ambulatory Holter recorder (AR4/AR12) captures 3-channel ECG via body surface electrodes; worn by patient in protective pouch for 24+ hours. Technician/doctor performs electrode attachment. Device digitizes analog signals via 16-bit A/D converter; microprocessor performs signal processing including pacemaker spike detection, R-peak detection, PT-wave detection, and R-S amplitude measurement (EDR). Data stored on removable CompactFlash card. Output transferred via infrared interface to PC/PDA for clinician review. Facilitates diagnosis of arrhythmias, ischemia, and pacemaker function; aids in assessing patient recovery and heart rate variability. Benefits include long-term cardiac rhythm monitoring in ambulatory settings.

Clinical Evidence

Bench testing only. R-peak detection validated against MIT, AHA, and NST databases (sensitivity/positive predictivity >99%). Pacemaker detection validated using phantom artificial ECG signal generator (100% detection). PT-wave detection validated against QT database (sensitivity/positive predictivity >80%). R-S amplitude measurement validated against recordings with airflow channel (mean deviation <1 c/min).

Technological Characteristics

3-channel digital Holter recorder. 16-bit A/D conversion. CompactFlash storage. Infrared interface for data transfer. Microprocessor-based signal processing. Powered by batteries. Not defibrillation-protected per EN60601-2-25. Software performs digital signal processing including R-peak, PT-wave, and pacemaker spike detection.

Indications for Use

Indicated for patients requiring 24+ hour 3-channel ECG monitoring. Used for evaluation of symptoms suggesting arrhythmia or myocardial ischemia, documenting therapeutic interventions, ST segment changes, patient response after resuming activities (e.g., post-MI or cardiac surgery), clinical/epidemiological research, pacemaker evaluation, heart rate variability, and QT interval reporting. Not for emergency/intensive monitoring. Not suitable for infants <10 kg.

Regulatory Classification

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.

Predicate Devices

• Medilog FD4 (K970902)
• DXP1000 (K993618) (marketed as Medilog FD5)

Submission Summary (Full Text)

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sstrengrubergas A-8010 Graz, AUSTRIA al: + 43 (316) 261609

# MK3A 510(k) Summary

Version: 1
Status: RELEASE

K070818
p1/3

| Proprietary name: | MK3A | APR - 6 2007 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Trade name: | medilogAR4, medilogAR12 | |
| Common name: | Ambulatory ECG Monitor, Holter Recorder | |
| Classification name: | Ambulatory ECG Monitor (21 CFR 870.2800, Product Code DSH) | |
| 510(k) submitter: | TOM Medical Entwicklungs GmbH<br>Anzengrubergasse 8, A-8010 Graz, Austria<br>Tel. + 43 (316) 261609-0<br>Fax. + 43 (316) 261609-10 | |
| Contact person: | Thomas Hasiba, General Manager Graz,<br>Tel. + 43 (316) 261609-14 | |
| Manufacturer: | Huntleight Healthcare Cardiology Products Division<br>35 Portmanmoor Road, Cardiff, Wales CF24 5HN, UK | |
| Predicate devices: | Medilog FD4 [510 (k) Number K970902]<br>DXP1000 [510 (k) Number K993618] (marketed as Medilog FD5) | |

### 1 Concise description of the device

#### 1.1 General

The recorder (type reference AR4 or AR12) is used to record a 3 channel ECG and to measure the time intervals between consecutive R peaks in the ECG. The system is designed for a measuring duration of more than 24h and is therefore worn by the patient throughout the whole day. The preparation for the recording (attaching electrodes, etc.) is undertaken by the technician or doctor. During the recording, the instrument is carried in a special protective pouch which can be attached to a belt. After inserting a memory card and batteries, the instrument can be switched on by pressing and holding the button on the top of the instrument. The recording is stopped by pressing and holding the same button on the top of the instrument or the recorder stops the recording automatically after a pre-set time. The instrument is not designed for emergency monitoring purposes (intensive medical monitor); the instrument is only designed to record the ECG and/or information derived from ECG. The recorder is not protected against the effects of defibrillation as outlined in EN60601-2-25.

As well as measuring the ECG and the beat to beat heart rate, the instrument also records other information: HF component of the ECG (quantifies muscle artefacts or disturbances), time point of the P-wave, time point of the T-wave, and time point of the pacemaker pulse.

In addition the MedilogAR12 records the ECG amplitude - Due to the heart's mechanical connection to the ribcage, breathing causes the electrical heart vector to turn and therefore changes the ECG amplitude. This reveals information about the breathing frequency and QPA (pulse /breathing quotient).

The data is stored digitally on a memory card. After removing the memory card, the data can be read by an appropriate card reader (e.g. PCMCIA slot and adapter).

The content of this document is intellectual property of TOM Medical Entwicklungs GmbH and has confidential. You are not allowed to print, copy, store, modify, publish or use any material for any purpose at all without the written consent of TOM Medical Entwicklongs GmbH.

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Version: 1
Status: RELEASE

The recorder is not designed for emergency monitoring purposes (intensive medical monitor only designed for recording the ECG and/or heart rate.

The recorder is not protected against the effects of defibrillation as outlined in EN60601-2-25.

The recorder is not suitable for infants weighing less than 10 kg (22 lbs).

### 1.2 Technology

The MedilogAR4 and MedilogAR12 Digital Holter Recorders measure the voltage difference to derive the electrical ECG from body surface electrodes. A ground electrode is used to keep ground potential of the measured patient and of the recorder at the same level. After amplification the analogue signal is digitised using conventional 16 bit A/D converter. A microprocessor gathers the so sampled data. The microprocessor processes the data before it stores them onto a removable flash memory card (CompactFlash technology). Processing includes:

- Pacemaker spike detection .
- R- peak detection .
- . R-S amplitude measurement
- . PT- wave detection
- . Resample to storage sample rate
- Loss-less delta coding (Huffmann) .

The data stored on the flash memory card is organised in one Windows FAT16 file.

### 1.3 Indications for use

The MedilogAR4 and MedilogAR12 Digital Holter Recorders are used to record a 3 channel ECG and to measure the time intervals between consecutive R peaks in the ECG. The system is designed for a measuring duration of more than 24h and is therefore worn by the patient throughout the whole day. The preparation for the recording (attaching electrodes, etc.) is undertaken by the technician or doctor. During the recording, the instrument is carried in a special protective pouch which can be attached to a belt.

The instrument is not designed for emergency monitoring purposes (intensive medical monitor); the instrument is only designed to record the ECG and/or information derived from ECG. The recorder is not protected against the effects of defibrillation as outlined in EN60601-2-25.

The instruments also record other information: HF component of the ECG, time point of the Pwave, time point of the T-wave, and time point of the pacemaker pulse.

In addition the MedilogAR12 records the ECG amplitude.

Such monitoring is most frequent used for the indications below:

- . Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
- Evaluation of ECG documenting therapeutic interventions in individual patients or groups of . patients.
- . Evaluation of patients for ST segment changes (no online ST measurement implemented in recorder)
- Evaluation of a patient's response after resuming occupational or recreational activities (e.g., . after M.I. or cardiac surgery)
- Clinical and epidemiological research studies. .
- . Evaluation of patients with pacemakers
- Reporting of time and frequency domain heart rate variability (no online calculation . implemented in recorder)
- Reporting of QT interval (no online QT interval measurement implemented in recorder) .

The content of this document is intellectual property of TOM Medial Entwicklungs GmbH and has contidential. You are not allowed to print, copy, store, modily, publish or use any material for any purpose at all without the written consent of TOM Medical Entyvicklungs GrtbH

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads facing to the right. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" written around it.

MAY 2 4 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tom Medical Entwicklungs Gmbh c/o Mr. Stefan Preiss TUV America, Inc. 1175 Old Highway 8 NW, Suite 104 New Brighton, MN 55112

Re: K070818

Trade/Device Name: Medilog AR4, MedilogAR12 Regulation Number: 21 CFR 870.2800 Regulation Name: Medical magnetic tape recorder Regulatory Class: Class II Product Code: DSH Dated: March 22, 2007 Received: March 26, 2007

Dear Mr. Preiss:

This letter corrects our substantially equivalent letter of April 6, 2007.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other

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Page 2 - Mr. Preiss

requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]_ Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Version: 1 Status: RELEASE

Image /page/4/Picture/1 description: The image shows the text "K070818" on the top line and "P 3/3" on the second line. The text is written in a handwritten style with a black ink or marker. The numbers and letters are clearly visible, and the image appears to be a close-up shot of the text.

# 2 Device comparison table

Tel: + 43 (316) 261GOS

The candidate devices Medilog AR4 and Medilog AR12, subject of this 510(k), have been compared to the following predicate devices: Medilog FD4 [510 (k) Number K970902], DXP1000 [510 (k) Number K993618] (marketed as Medilog FD5).

The significant differences to the Medilog FD4 are found as:

- Infrared interface Medilog AR4 and Medilog AR12 recorders provide a infrared interface . instead of a fibre optical cable. This improves the usability, as fibre optic interfaces to PCs became obsolete resently
- Enhanced input voltage range more contemporary electronic provides better ECG quality for . the sake of better ECG quality
- Digital pacemaker detection The Medilog AR4 and Medilog AR12 are equipped with an . internal spike detection algorithm offering a method for pacemaker functional analysis in Holter recordings
- Digital R peak detection The R- peak detection feature is a preprocessing tool for off line . beat detection algorithms to realign off line detected beats at a higher resolution, and, hence, provide a higher accuracy for e.g. HRV (heart rate variability) analysis.
- R-S amplitude measurement -- The Medilog AR12 also records the R-S amplitude, which . represents, according to several publications, an indicator for the heart position and movement in the chest, which is mainly induced by breathing and body position.

The significant differences to the Medilog FD5 (DXP 1000) are found as:

- No display Instead of showing ECG traces directly on the recording device, the Medilog AR4 and Medilog AR12 recorders provide an infrared interface, compatible with PDAs and PCs. The ECG traces can then reviewed on a remote PDA or PC.
- Enhanced input voltage range see discussion above .
- . Digital R peak detection - see discussion above
- R-S amplitude measurement see discussion above .

## 3 Summary for performance testing

Only bench tests were required to prove the device's performance.

The following tests have been performed:

| Test | Benchmark | Criteria | Result |
|--------------------------------------|-----------------------------------------------------|-----------------------------------------------------------------------------|--------|
| R peak detection | against MIT, AHA, and NST<br>database | sensitivity and positive<br>predictivity higher than 99%<br>for MIT and AHA | PASSED |
| Pacemaker<br>detection | Phantom artificial ECG signal<br>generator | 100% detection of<br>pacemaker spikes in all<br>programms | PASSED |
| PT wave<br>detection | against QT database | sensitivity and positive<br>predictivity higher than 80%<br>for QT database | PASSED |
| RS amplitude<br>measurement<br>(EDR) | against a set of recordings<br>with airflow channel | differences of mean<br>deviation lower than 1 c/min | PASSED |

#### Conclusion ব

The AR4/AR12 were found to meet all requirements. The devices are save and at least as effective, and perform at least as well as the predicate devices.

The content of this document is intellectual property of TOM Medial Entwickungs GmbH and has contidential. You are not allowed to prin, copy, store, modily, publish or use any material from this document for any purpose at all without the written consent of TOM Medical Entyvishings GmbH.

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'5818

### Indications for Use

510(k) Number (if known):

not assigned yet

Device Name:

MedilogAR4, MedilogAR12

Indications for Use:

The MedilogAR4 and MedilogAR12 Digital Holter Recorders are used to record a 3 channel ECG and to measure the time intervals between consecutive R peaks in the ECG. The system is designed for a measuring duration of more than 24h and is therefore worn by the patient throughout the whole day. The preparation for the recording (artaching electrodes, etc.) is undertaken by the technician or doctor. During the instrument is carried in a special protective pouch which can be attached to a belt.

The instrument is not designed for emergency monitoring purposes lintensive medical monitor); the instrument is only designed to record the ECG and/or information derived from ECG, The recorder is not protected against the effects of defibrillation as outlined in ENRO601-2-25.

The instruments also record other information: HF component of the ECG, time point of the Pwave, time point of the T-wave, and time point of the pacemaker pulse.

In addition the MedilogAR12 records the ECG amplitude.

Such monitoring is most frequent used for the indications below:

- Evaluation of symptoms suggesting archythmia or myocardial ischomia.
- Evaluation of ECG documenting therapeutic in individual patients or groups of patients.
- Evaluation of patients for ST segment changes ino online ST measurement in promotive in recorder! 3.
- Evaluation of a patiant's responsa after resuming occupational activities in recentional actually of র্ব cardiac surgary)
- 5 Clinical and epidemiological revearch studies.
- 6. Evaluation of pationts with pacemakers
- Reporting of time and frequency the variebility the online calculation implemented in racorded) 7 য়ে
- Reporting of OT interval (no online, OT interval messurement implemented in recorder)

Prescription Use yES (Part 21 GFR 801 Subpart D) AND/OR

Over-The Gounter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K07818

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