The Schwarzer cardis heart catheter measuring systems with hemodynamical evaluation software are indicated for the registration, display, real-time recording, printout and storage of biophysiological data. Hemodynamic signals as intracardiac pressure and ECG signals are recorded and displayed and a number of hemodynamic calculations are performed based on the measured values of the input signals.

The Schwarzer cardis systems are intended for use in catheterization labs.

The Schwarzer cardis systems are indicated for use with patients of all ages under direct supervision of a physician or other trained health care professionals.

Device Description

AI/ML Overview

This document is a 510(k) summary for the Schwarzer cardis heart catheter measuring system. It does not contain a detailed study and acceptance criteria proving the device's performance. Instead, it states that the device is substantially equivalent to a predicate device (CATHCOR Desktop 510(k) Number K0021137) based on identical or comparable physical characteristics, design, safety, efficacy, and intended use.

Therefore, many of the requested details about acceptance criteria, study specifics, and ground truth establishment are not present in this document.

Here's a breakdown of the information that can be extracted and a clear indication of what is not available:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not provided as specific numerical criteria. The acceptance is based on substantial equivalence to a predicate device.	Not provided as specific numerical performance metrics. The device is stated to be "equivalent to the predicate device" and that "Physical characteristics including design, safety and efficacy characteristics and intended use of the cardis systems and the predicate device are either identical or comparable."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. This document is a 510(k) summary, which often summarizes findings rather than detailing the full study methodology. It claims substantial equivalence rather than presenting an independent performance study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not provided. As there's no independent performance study detailed with a test set requiring ground truth, this information is not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not provided. Not applicable due to the absence of a detailed performance study with a test set.

5. 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

No. This document does not mention an MRMC comparative effectiveness study. The device is a "programmable diagnostic computer" for physiological data acquisition and hemodynamic calculations, not an AI-assisted diagnostic tool in the sense of image interpretation where MRMC studies are common.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not explicitly stated as a standalone study in this summary. The document focuses on the system's (hardware and software) equivalence to a predicate device for its defined functions (registration, display, recording, printout, storage, and calculation of biophysiological data). The "stand-alone" performance is implicitly covered by the claim of equivalence to the predicate device for these functionalities.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not provided. Ground truth methodology for performance evaluation is not detailed as the submission relies on substantial equivalence.

8. The sample size for the training set

Not provided. As the device is for collecting and calculating biophysiological data based on measured values, rather than an AI/machine learning model whose performance depends on a training set, this information is not relevant or provided.

9. How the ground truth for the training set was established

Not provided. Not applicable for the reasons mentioned in point 8.

Summary

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SEP 2 5 2002

510(k) Summary

Date

Manufacturer

Contact Person Telephone Fax

30.04.2002

cardis

Schwarzer GmbH Medical Equipment for Diagnosis Baermannstr 38 D-81245 Munich Germany Juergen Neubert, President +49 89-83942-1 +49 89-83942-186

Device Trade Name
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Classification

Device Classification Name Classification / Panel Product Code Requlation Number

Computer, diagnostic, programmable Class II / Cardiovascular DOK 870.1425

Predicate Device

Legally marketed device to which equivalence is being claimed: CATHCOR Desktop 510(k) Number K0021137

Applied Guidances

Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement); -
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; -
Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Used in ー Medical Devices.

Indications for Use

The Schwarzer cardis systems are intended for use in catheterization labs.

The Schwarzer cardis systems are indicated for use with patients of all ages under direct supervision of a physician or other trained health care professionals.

Comparison to Predicate Device

cardis systems are equivalent to the predicate device. Physical characteristics including design, safety and efficacy characteristics and intended use of the cardis systems and the predicate device are either identical or comparable.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 5 2002

Schwarzer GmbH c/o Mr. Mark Job TPR Program Manager TÜV Product Service 1775 Old Highway 8 New Brighton, MN 55112-1891

Re: K023015

Trade Name: Cardis Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DOK Dated: August 19, 2002 Received: September 10, 2002

Dear Mr. Job:

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 application (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 such 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.

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Page 2 - Mr. Mark Job

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 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 (OS) 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 begin 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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,

Elvis Malles

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 Statement

KD23015 510(k) Number:

cardis

Device Name

Indications for Use:

The Schwarzer cardis heart catheter measuring systems with hemodynamical evaluation software are indicated for the registration, display, real-time recording, printout and storage of biophysiological data. Hemodynamic signals as intracardiac pressure, and ECG signals are recorded and displayed and a number of hemodynamic calculations are performed based on the measured values of the input signals.

The Schwarzer cardis systems are intended for use in catheterization labs.

The Schwarzer cardis systems are indicated for use with patients of all ages under direct supervision of a physician or other trained health care professionals.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number	Elias Mallis

Image /page/3/Picture/12 description: The image shows the words "Prescription Use" followed by a symbol that looks like an X. Below that, the text "(Per 21 CFR 801.109)" is printed. The text and symbol are all in black and white. The image appears to be a label or a marking indicating that the product is for prescription use only.

Over-The Counter Use

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).