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.

AI/ML Overview

This 510(k) summary describes a device, the CARDIOVIT AT-10Plus, that is an Electrocardiographie Device. The submission focuses on demonstrating substantial equivalence to a predicate device (CARDIOVIT AT-102, K031557) through non-clinical testing and comparison of technical specifications, rather than clinical performance studies with specific acceptance criteria that are typically seen for novel diagnostic algorithms.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, as they relate to clinical performance, is largely not applicable (N/A) in the context of this 510(k) submission.

Here's a breakdown based on the provided document:

Acceptance Criteria and Device Performance

The core "acceptance criteria" in this 510(k) are related to safety, effectiveness, and technical specifications, demonstrating substantial equivalence to the predicate device.

Acceptance Criteria Category	Reported Device Performance (CARDIOVIT AT-10Plus)
Electrical Safety	Conforms to EN60601-1 and IEC 601-2-25. "All tests are passed."
Software Quality	Software development process reviewed per "reviewer guidance for controlled medical devices undergoing 510(k) review." Requirements, structure, development, revision, identification, verification, validation, and testing are described.
Intended Use	Same as predicate: Recording, analysis, and evaluation of 12-channel ECG recordings for diagnostic aid of heart function and conditions; indoor use; optional interface to SP-250 pulmonary function data.
Technical Specifications (Comparison to AT-102)	Generally "same" or minor differences considered not safety-relevant. - Dimensions: 348x288x87mm (vs 380x328x100mm) - Weight: 4.2 Kg (vs 5.0 kg) - Control panel: Alphanumerics, LCD Display 800x600dots (vs LCD Display) - Paper speed: 5/10/12.5/25/50 (vs 5/10/25/50mm/s direct)

Study Details Based on the Provided Document:

A table of acceptance criteria and the reported device performance: See table above. The primary acceptance criterion here is meeting relevant electrical safety standards and demonstrating equivalent technical specifications and intended use to the predicate device.
Sample size used for the test set and the data provenance: N/A. This 510(k) relies on non-clinical engineering and software testing, and a comparison of technical specifications, not a clinical "test set" of patient data for performance evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth establishment for a patient-data test set is not described as part of this submission. The "experts" involved would be those assessing compliance with electrical safety standards and reviewing software documentation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A. No clinical test set requiring adjudication is described.
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: N/A. This device is an electrocardiograph, not an AI-assisted diagnostic tool that would involve human readers and a comparative effectiveness study of this nature.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. The submission does not describe a standalone algorithm performance study. The device's "analysis" function is intrinsic to its role as an ECG device, and its safety and effectiveness are established through reference to the predicate and compliance with standards.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A for clinical performance. The "ground truth" for the non-clinical tests is regulatory standards (e.g., EN60601-1, IEC 601-2-25) and engineering specifications of the predicate device.
The sample size for the training set: N/A. This is not a machine learning or AI device that would have a "training set" in the typical sense.
How the ground truth for the training set was established: N/A. Not applicable for this device type and submission.

Summary

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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.

Page 114

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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)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
Page 3/4

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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.

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

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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 (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

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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

Page 1 of __

Regulation Number and Section

§ 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).