CARDIOVIT AT-10PLUS

K050686 · Schiller AG · DPS · May 4, 2005 · Cardiovascular

Device Facts

• Record ID: K050686
• Device Name: CARDIOVIT AT-10PLUS
• Applicant: Schiller AG
• Product Code: DPS · Cardiovascular
• Decision Date: May 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2

Intended Use

The AT-10Plus is a 12-channel, ECG device used for the recording, analysis and evaluation of ECG recordings. Recordings made with the AT-10Plus can be used as a diagnostic aid for the heart function and heart conditions. The AT-10Plus is designed for indoor use. The device provide an optional interface to the SP-250 pulmonary function data.

Device Story

The CARDIOVIT AT-10Plus is a 12-channel electrocardiograph used in indoor clinical settings to record, analyze, and evaluate ECG signals. It features a high-resolution thermal printhead and an LCD display for viewing waveforms and alphanumeric data. The device captures ECG data, which is processed to provide diagnostic information regarding heart function and conditions. It includes an optional interface for integration with the SP-250 pulmonary function device. The system is operated by healthcare professionals to assist in clinical decision-making by providing objective cardiac data. The device is intended to benefit patients by facilitating the assessment of cardiac health.

Clinical Evidence

No clinical data. Safety and effectiveness were established through bench testing, including electrical safety and reliability testing in accordance with EN60601-1 and IEC 601-2-25 standards.

Technological Characteristics

12-channel ECG device; thermal printhead (8 dots/mm); LCD display (800x600 dots); frequency range 0-150Hz; battery-powered (2-hour capacity); Z-folded thermoreactive chart paper. Standards: EN60601-1, IEC 601-2-25. Connectivity: optional interface for SP-250 spirometry.

Indications for Use

Indicated for use as a diagnostic aid for heart function and heart conditions in patients requiring 12-channel ECG recording, analysis, and evaluation. Designed for indoor clinical use.

Regulatory Classification

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.

Predicate Devices

• CARDIOVIT AT-102 (K031557)

Reference Devices

• SP-250 (K984031)

Submission Summary (Full Text)

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# 510 K Summary

MAY - 4 2005

according to 21 CFR 807.92

- Address A1
SCHILLER AG Altgasse 68 CH-6341 Baar Switzerland

Contact Name: Tel: Date:

Mr. Markus Buetler 001 41 41 766 4252 15.March 2005

#### A2 Device Name

| 1. Trade Name: | CARDIOVIT AT-10Plus |
|-----------------|-----------------------------|
| 2. Common Name: | Electrocardiographie Device |

#### A3 Legally Marketed Device

Legally Marketed Device to which this submitted device is compared: AT-102 (K031557)

#### A4 Intended Use

The AT-10Plus is a 12-channel, ECG device used for the recording, analysis and evaluation of ECG recordings. Recordings made with the AT-10Plus can be used as a diagnostic aid for the heart function and heart conditions. The AT-10Plus is designed for indoor use. The device provide an optional interface to the SP-250 pulmonary function data.

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#### A5 Table of Comparison

Predicate device:

## CARDIOVIT AT-102 (K031557)

| | AT-102 K031557 | CARDIOVIT AT-10Plus |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Dimensions: | 380x328x100mm | 348x288x87mm 1) |
| Weight: | 5.0 kg | 4.2 Kg |
| Environmental Conditions: | | |
| Operating temperature | +10° - 40° C | same |
| Storage temperature | -10° - +50° C | same |
| Relative humidity | 25% - 95% (non condensing) | same |
| Leads: | Standard / Cabrera | same |
| Battery capacity: | 2 hrs of normal use | same |
| Frequency range of digital recorder: | 0 to 150Hz | same |
| Control panel | Alphanumerics, LCD Display | Alphanumerics, LCD Display 800x600dots 2) |
| Myogram Filter | 25Hz or 35Hz programmable | same |
| Paper speed | 5/10/25/50mm/s direct | 5/10/12.5/25/50 3) |
| Printing process | High resolution thermal printhead 8dots per mm 200dots per inch(amplitude axes)<br>40dots per mm / 1000 dots per inch time axes, 25mm/s | same |
| Chart paper | Thermoreactive, Z-folded, 210mm | same |
| Recording tracks | 6 channels, positioned at optimal with on 80 mm / 3.2 inch automatic baseline adjustement | same |
| Automatic lead programs | 6 channel representation of 12 simultaneously acquired standard leads | same |
| Spirometry | SP-250 (K984031) | same |

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Discussion of Differences:

Discussion of Differences (1, 2 or 3) can be considered as safety relevant differences.

differences.
We consider the submitted device to be as safe and effective as the Predicate (AT-102) device.

003
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#### Non-Clinical Tests B1

- 1. Electrical Safety and Reliability
The CARDIOVIT AT-AT-10Plus device has been tested to be in accordance with the following standards:

- Medical Electrical Equipment: essential requirements for safety EN60601-1 i (Document no .: 052-077403-000)
- Medical Electrical Equipment: requirements for the safety of IEC 601-2-25 electrocardiographs (Document no .: 052-077403-000)

All tests are passed.

- 4) Data related to software quality
SCHILLER has reviewed its software development process following the guideline " reviewer quidance for 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.

#### Clinical Tests B2

n.a.

#### Conclusions from Tests B3

The fulfilling 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 (AT-102 K031557) Device.

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Image /page/4/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The seal is simple and monochromatic.

MAY - 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SCHILLER AG c/o Mr. Markus Buetler Quality Assurance and Regulatory Affairs Manager Altgasse 68 CH-6341 Baar SWITZERLAND

Re: K050686

Trade Name: CARDIOVIT AT-10Plus ECG Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: March 15, 2005 Received: March 17, 2005

Dear Mr. Buetler:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encroours) is regardy to regarders.
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to Connieres proc to May 20, 1976, the enaordance with the provisions of the Federal Food, Drug, de necs that have been recident require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Tou may, utcrerore, market the act include requirements for annual registration, listing of general connols provisions of ractice, 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 If your device is olasbinou (600 a00 royals. Existing major regulations affecting your device can may oc subject to sable addrensity regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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### Page 2 – Mr. Markus Buetler

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issuance or wouldevice complies with other requirements of the Act that IDA has made a decommancia and regulations administered by other Federal agencies. You must or ally recetal statutes and regarations and admited to: registration and listing (21 comply with an the Act 3 requirements, me, canny, canny, canny, can ice requirements as set CTK Fat 807), labeling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Decions our device as described in your Section 510(k) This letter will anow you to obgen manisang your antial equivalence of your device to a legally premarket notification. The PDF miaing of basification 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 If you desire specific advice for Jour accell [phone]. Also, please note the regulation entitled, Colliati the Office of Compilance w (21CFR Part 807.97) you may obtain. Misolallumg by telefone to premarked no hillers.
Other general information on your responsibilities under the Act may be obtained from the Oiller general information on your respontional 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,

Duma R. Vochner

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

Enclosure

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## Indications for Use

510(k) Number (if known): K050 686 Device Name: Cardiovit AT-10Plus

Indications for Use:

The AT-10Plus is a 12-channel, ECG Device used for the recording, analysis and The AT-10Plus is a 12-channel, ECG Device used with the AT-10Plus can be used as
evaluation of ECG recordings. Recordings made with the AT-10Plus is designed evaluation of ECG recordings. Recordings made with the P. For as a
a diagnostic aid for heart function and heart conditions. The AT-10Plus is designed

for indoor use.
The device provide an optional interface to the SP-250 for pulmonary function data.

SCHULLER AG
Altegg 69
CH-6341 Baar / Switzerland

15/03/05

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

Over-The-Counter 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)

P. Vachner

(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular Devices

510(k) Number طلق 10(k) Number

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