K Number
K050686
Device Name
CARDIOVIT AT-10PLUS
Manufacturer
Date Cleared
2005-05-04

(49 days)

Product Code
Regulation Number
870.2340
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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.
Device Description
The AT-10Plus is a 12-channel, ECG device used for the recording, analysis and evaluation of ECG recordings. It has dimensions of 348x288x87mm and weighs 4.2 Kg. It operates in temperatures from +10° - 40° C and storage temperatures from -10° - +50° C, with relative humidity between 25% - 95% (non condensing). It supports Standard / Cabrera leads and has a battery capacity of 2 hrs of normal use. The frequency range of the digital recorder is 0 to 150Hz. It has an Alphanumerics, LCD Display 800x600dots. The Myogram Filter is 25Hz or 35Hz programmable. Paper speeds are 5/10/12.5/25/50 mm/s. The printing process uses a High resolution thermal printhead 8dots per mm 200dots per inch(amplitude axes) 40dots per mm / 1000 dots per inch time axes, 25mm/s. It uses Thermoreactive, Z-folded, 210mm chart paper and has 6 recording tracks, positioned at optimal with on 80 mm / 3.2 inch automatic baseline adjustement. It has 6 channel representation of 12 simultaneously acquired standard leads automatic lead programs. It also provides an optional interface to the SP-250 for spirometry.
More Information

AT-102 (K031557)

Not Found

No
The summary describes a standard ECG device with analysis capabilities, but there is no mention of AI, ML, or related concepts in the provided text. The analysis and evaluation mentioned are likely based on traditional signal processing and algorithms.

No

The device is described as an "ECG Device used for the recording, analysis and evaluation of ECG recordings" and a "diagnostic aid for heart function and heart conditions." It is used for diagnosis, not treatment.

Yes

Recordings made with the AT-10Plus can be used as a diagnostic aid for heart function and heart conditions.

No

The device description clearly outlines physical dimensions, weight, operating temperatures, battery capacity, display type, printing mechanism, and paper type, indicating it is a hardware device with integrated software.

Based on the provided information, the AT-10Plus is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use: The intended use clearly states it's an "ECG Device used for the recording, analysis and evaluation of ECG recordings." ECGs are recordings of electrical activity of the heart, obtained from the body surface. This is a physiological measurement, not an in vitro test.
  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The AT-10Plus does not perform tests on such samples.
  • Device Description: The description focuses on the technical specifications of an ECG machine (leads, filters, paper speed, display, etc.), which are consistent with a device that measures electrical signals from the body.
  • Anatomical Site: The anatomical site is the "Heart," which is where the electrical activity is being measured from, not a sample being analyzed.

Therefore, the AT-10Plus is a physiological monitoring and diagnostic aid device, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for 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 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.

Product codes (comma separated list FDA assigned to the subject device)

DPS

Device Description

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Heart

Indicated Patient Age Range

Not Found

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)

Non-Clinical Tests:

  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.
  1. 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: n.a.

Conclusions from Tests: 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.

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.

AT-102 (K031557)

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

§ 870.2340 Electrocardiograph.

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

0

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.

Page 114

1

A5 Table of Comparison

Predicate device:

CARDIOVIT AT-102 (K031557)

AT-102 K031557CARDIOVIT AT-10Plus
Dimensions:380x328x100mm348x288x87mm 1)
Weight:5.0 kg4.2 Kg
Environmental Conditions:
Operating temperature+10° - 40° Csame
Storage temperature-10° - +50° Csame
Relative humidity25% - 95% (non condensing)same
Leads:Standard / Cabrerasame
Battery capacity:2 hrs of normal usesame
Frequency range of digital recorder:0 to 150Hzsame
Control panelAlphanumerics, LCD DisplayAlphanumerics, LCD Display 800x600dots 2)
Myogram Filter25Hz or 35Hz programmablesame
Paper speed5/10/25/50mm/s direct5/10/12.5/25/50 3)
Printing processHigh resolution thermal printhead 8dots per mm 200dots per inch(amplitude axes)
40dots per mm / 1000 dots per inch time axes, 25mm/ssame
Chart paperThermoreactive, Z-folded, 210mmsame
Recording tracks6 channels, positioned at optimal with on 80 mm / 3.2 inch automatic baseline adjustementsame
Automatic lead programs6 channel representation of 12 simultaneously acquired standard leadssame
SpirometrySP-250 (K984031)same

2

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
Page 3/4

3

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.

    1. 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.

20 4
Page 4/4

4

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.

5

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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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

6

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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