CARDIOVIT CS-200 by SCHILLER AMERICA, INC.

The Cardiovit CS-200 device maybe used to record and store standard 12 lead Electrocardiograms (ECG) at patients resting or exercising. Resting ECG's are automatically measured and interpreted by the optionally available Schiller ECG interpretation program.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for a device called "Cardiovit CS-200". It states that the device can record and store standard 12-lead Electrocardiograms (ECG) at rest or during exercise. It also mentions that "Resting ECG's are automatically measured and interpreted by the optionally available Schiller ECG interpretation program."

However, the document does not include the detailed information required to fill out a table of acceptance criteria and a study that proves the device meets those criteria. Specifically, the document is a regulatory clearance letter, not a study report or a detailed technical specification.

Therefore, I cannot provide the requested information from the given text.

Here's a breakdown of why this information is missing:

Acceptance Criteria and Reported Device Performance: While the document states the device's function (ECG recording, storage, and interpretation), it does not specify any performance metrics (e.g., sensitivity, specificity, accuracy for specific ECG interpretations) or the quantifiable acceptance criteria for these metrics.
Sample size and data provenance: No details about a test set, its size, or origin are provided.
Number and qualifications of experts for ground truth: This information is not present.
Adjudication method: Not mentioned.
MRMC comparative effectiveness study: There's no indication of any study comparing human readers with and without AI assistance.
Standalone performance: While it mentions "automatically measured and interpreted," it doesn't provide performance data for this standalone function.
Type of ground truth: Not specified.
Sample size for training set: Not mentioned.
How ground truth for training set was established: Not mentioned.

To answer your request, a more detailed technical submission, clinical study report, or a publication describing the validation of the Schiller ECG interpretation program would be needed.

Summary

{0}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized design featuring a symbol that resembles a person embracing or supporting another, representing the department's mission of protecting and promoting the health and well-being of Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Markus Maritz Schiller America, Inc. 3002 Dow Avenue JUN 25 1997 Building 138 Tustin, California 92780

Re: K970879 · Cardiovit CS-200 Regulatory Class: III (three) Product Code: 74 LOS Dated: June 5, 1997 Received: June 9, 1997

Dear Mr. Maritz:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 aqainst misbrandinq and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP requlation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{1}------------------------------------------------

Page 2 - Mr. Markus Maritz

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

ﻤﺴﻴﺴﻴﺔ

Page l of l

5 1 O(k) Number (if known): K970879

Cardiovit CS-200 Davice Nama:

Indications For Use:

דרDL/CਹੈTi------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ	9អញ្ជJใ	్లో ప్ర一黄中山 ←ت ہے۔ مزید دیکھیے بھائی رویدﻟﻠﺘﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻌﺮﻳﻘﺎ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻌﺮﻳﻘﺎ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﺄﺗﻴ
/ਾi		:・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・.ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤ
tri/ഷവ	23	ﺗﺄ ﻴﺴﺎ ﻓﻲ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﺘﻮﻗﻒ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﺘﻮﻗﻒ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﺘﻮﻗﻒ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﺘﻮﻗﻒ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﺘﻮﻗﻒ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ-!
C	2	--------------------------------------------------------------------------------------------tr 211

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
--------------------------------------------------------

Signature

(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number	K970879

Prescription Use V (Per 21 CFR 801.109)

ರಸ

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

N/A