The TM2000 FetalTrace Transtelephonic Receiving Center is a software system designed and intended for supporting a remote (transtelephonic) monitoring of patient Fetal/Maternal parameters. The System enables receiving, storing, displaying, updating, printing and retransmitting of patient Fetal/Maternal parameters and other patient related data. (such as demographics, doctors, medical history and status, diagnoses, etc.).

The TM2000 FetalTrace Telemedicine Receiving Center is intended for supporting transtelephonic monitoring of the Fetal/Maternal parameters of patients.

Device Description

Operational Characteristics, Features and Functions:

Runs on any MS Windows operating system
Maximum database file size of 2 GB. Storage of up to 10 - 40 thousand transmissions (depending on transmitter type)
Accessing and updating the receiving center DB. Manual entry of patient and physician detail
Receiving and processing patients' transmitted signals and medical data
Graphic representation of FM signals
Intuitive, user friendly HMI
Capability for signal/data transmission over Web (Planned for implementation in future)
Localization
Reports generation
Reports previewing and printing
Manageable security, fail-safe protection against unauthorized access. Discretionary access control, restrictions based on privileges (Not yet implemented)

AI/ML Overview

The provided text describes the TM2000 FetalTrace Transtelephonic Receiving Center, a software system for remote monitoring of fetal/maternal parameters. However, it does not contain a detailed study demonstrating device performance against specific acceptance criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device (TM2000 K013879 Receiving Center) and addressing regulatory requirements for a 510(k) Premarket Notification.

Here's an analysis based on the information provided, highlighting what's present and absent regarding acceptance criteria and a detailed study:

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

Acceptance Criteria: Not explicitly stated as a table with specific performance metrics (e.g., accuracy, sensitivity, specificity, or response times for data processing). The document mentions "testing was conducted to verify the system compliance with all its design specifications" (page 4), but these specifications themselves are not detailed.
Reported Device Performance: No quantitative performance metrics are provided. The "Conclusion" states: "The system constitutes a safe and reliable means for receiving, storing, displaying, analyzing, updating, printing and re-transmitting of patient Fetal/Maternal parameters and other patient related data. Its operation present no adverse health effect or safety risks to patients when used as intended." (page 4). This is a qualitative statement of intended function and safety, not a quantified performance report.

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. The document does not mention any test dataset, its size, or its provenance.

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 applicable / Not provided. Since there's no mention of a test set or specific performance evaluation, there's no information about experts establishing ground truth for such a set.

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

Not applicable / Not provided. No test set or ground truth establishment process is described.

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

Not applicable / Not provided. The device is a "Receiving Center" software for processing and displaying fetal/maternal parameters, not an AI-assisted diagnostic tool for human readers in the typical MRMC study context. There's no mention of AI assistance or comparative effectiveness studies with human readers.

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

Not provided. While the device is software that performs tasks like receiving, storing, and displaying data automatically, the document doesn't detail a "standalone" performance study in the sense of evaluating an algorithm's diagnostic accuracy or automated interpretation without human intervention. The focus is on the functionality and safety of the system as a whole.

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

Not applicable / Not provided. As no specific performance study with a test set is detailed, the type of ground truth is not mentioned. The device deals with "Fetal/Maternal parameters," which implies objective physiological data, but how the correctness of the processing or display of this data was validated isn't specified in terms of ground truth.

8. The sample size for the training set

Not applicable / Not provided. The document does not describe any machine learning or AI components that would require a "training set." The system's purpose outlined is data handling (receiving, storing, displaying, etc.).

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

Not applicable / Not provided. No training set is mentioned.

Summary of what is present and relevant to "study" information:

The document describes the TM2000 FetalTrace Transtelephonic Receiving Center as a software system designed to handle remote fetal/maternal monitoring data. It states that "testing was conducted to verify the system compliance with all its design specifications" within the framework of "Design Controls and Hazard Analysis." The system was determined to be a "moderate level of concern system." The overall conclusion is that it is a "safe and reliable means" and "present no adverse health effect or safety risks."

However, this is presented at a high level and acts as a declaration of compliance rather than a detailed report of a performance study with specific acceptance criteria, methodologies, or quantitative results. The provided information is typical for a 510(k) submission seeking substantial equivalence, emphasizing functional characteristics and safety over a detailed, quantitative performance validation study against defined acceptance metrics.

Summary

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Image /page/0/Figure/0 description: This document is a Special 510(k) Premarket Notification for the TM2000 FetalTrace Transtelephonic Receiving Center. The document is dated August 12, 2002, and includes a summary of safety and effectiveness for the TM2000 FetalTrace Receiving Center Software. The document also includes a restriction on use, duplication, or disclosure of proprietary information.

	Name	Title	Date
Written by	A. Gonorovsky	Deputy Chief Engineer	March 26, 2002
Approved by	Amnon Shur	Project Manager	March 26, 2002

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	Special 510(k) Premarket NotificationTM2000 FetalTrace Transtelephonic Receiving Center	K021574 page 2/4
Submitter:	Card Guard Scientific Survival Ltd.,2 Pekeris St. P.O.B. 527Rehovot 76100, IsraelTel: 972-8-9484600Fax: 972-8-9484605
Contact Person:	Alex Gonorovsky,Deputy Chief Engineer, Regulatory AffairsTel: 972-8-9484624E-mail: alexanderg@cardguard.com

Date Prepared: 18 April 2002

1.	Definition and Intended Use	3
2.	Device Class	3
3.	Applicable Regulatory Documents and Card Guard Procedures	3
4.	Operational Characteristics, Features and Functions	3
5.	User Interface	4
6.	Substantial Equivalence	4
7.	Design Controls and Hazard Analysis	4
8.	Conclusions	4

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KCZ1574 pi34

1. Definition and Intended Use

2. Device Class

The TM2000 FetalTrace Transtelephonic Receiving Center system is class II medical device (21 C.F.R. Par. 870.2920 (1992)).

3. Applicable Regulatory Documents and Card Guard Procedures

No performance standards have been developed under Section 514 of the Federal Food, Drug and Cosmetic Act for telephone ECG and Spirometric transmitter devices.

The complete list of the Applicable Documents referenced and/or incorporated in this project is provided in the FDA submission package: Chapter 18, Applicable Normative Documents: Standards, Regulations, Guidances, Procedures; Publications

Chapter 18 includes the following sections:

Applicable FDA Documents ●
. American National Standards Institute (ANSI), Association for the Advancement of Medical Instrumentation (AAMI)
. International Electrotechnical Commission (IEC/CEI), International Organization for Standardization (ISO), European Norm (EN)
. Code of Federal Regulations
International Special Committee On Radio Interference (CISPR) .
Institute of Electrical and Electronics Engineers (IEEE) .
Card Guard Ltd: Applicable Procedures .
Card Guard Ltd: Product Definitive Reference .
. Articles, Publications
1. Operational Characteristics, Features and Functions
1. Runs on any MS Windows operating system
1. Maximum database file size of 2 GB. Storage of up to 10 - 40 thousand transmissions (depending on transmitter type)
1. Accessing and updating the receiving center DB. Manual entry of patient and physician detail
1. Receiving and processing patients' transmitted signals and medical data
1. Graphic representation of FM signals
1. Intuitive, user friendly HMI
1. Capability for signal/data transmission over Web (Planned for implementation in future)
1. Localization
1. Reports generation

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Image /page/3/Figure/0 description: The image contains the logo for Card Guard Scientific Survival LTD on the left. On the right, the text reads "Special 510(k) Premarket Notification TM2000 FetalTrace Transtelephonic Receiving Center". The text appears to be the title or heading of a document or presentation. The logo includes a stylized graphic resembling a heartbeat.

1. Reports previewing and printing
KOZ1574 page 4/4 11. Manageable security, fail-safe protection against unauthorized access. Discretionary access control, restrictions based on privileges (Not yet implemented)

5. User Interface

The TM2000 Graphic User Interface (GUI) features pull down menus and dialog boxes for representation and updating of data. Generation of GUI and implementation of the related DB connectivity mechanism utilizes the C/C++ native methods in conjunction with the Windows API functions.

6. Substantial Equivalence

The TM2000 FetalTrace is substantially equivalent to its predicate TM2000 K013879 Receiving Center, cleared on Nov 23, 2001.

The TM2000 FetalTrace has the Fetal/Maternal service, with the user interface forms totally identical to those of TM2000 K013879.

The TM2000 FetalTrace differs from the TM2000 K013879 in two aspects:

1. Unlike the TM2000 K013879, the TM2000 FetalTrace has no ECG and Spiro services.
1. The TM2000 FetalTrace uses the Access DB engine while the TM2000 K013879 uses the Oracle DB engine. This aspect will be discussed in further detail Substantial Equivalence 2 TM2000 FetalTrace vs. TM2000 EasyTrace since the latter also uses Access.

The proof of substantial equivalence in all that concerns the intended use, principles of operation, features and technological characteristics is provided in Chapter 7. Substantial Equivalence to Cleared Devices.

7. Design Controls and Hazard Analysis

The Card Guard's product design procedure, and QA and QC policy, formalize the design and production process and assure that all the respective requirements are met. In the framework of the Design Controls the testing was conducted to verify the system compliance with all its design specifications.

The device Level of Concern criteria were evaluated and the system was determined to be a moderate level of concern system.

The rigorous design evaluation and the System Safety and Risk analysis expose potential failures or possible system flaws which could directly or indirectly effect the patient.

8. Conclusions

The system constitutes a safe and reliable means for receiving, storing, displaying, analyzing, updating, printing and re-transmitting of patient Fetal/Maternal parameters and other patient related data.

Its operation present no adverse health effect or safety risks to patients when used as intended.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal for the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus features a staff with two snakes coiled around it, topped with a pair of wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2 2002

Mr. Alex Gonorovsky Deputy Chief Engineer, Regulatory Affairs Card Guard Scientific Survival, Ltd. 2 Pekeris St. P.O.B. 527 Rehovot 76100 ISRAEL

Re: K021574

Trade/Device Name: TM2000 Fetal Trace Transtelephonic Receiving Center Software Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring system and accessories

Regulatory Class: II Product Code: 85 HGM Dated: May 8, 2002 Received: May 14, 2002

Dear Mr. Gonorovsky :

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 (sec above) into either class II (Special Controls) or class III (PMA). it may be subject to 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.

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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 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,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/6/Picture/0 description: The image shows the logo for Card Guard Scientific Survival LTD. The logo is in black and white and features the words "CARD GUARD" in bold letters, with the words "Scientific Survival LTD." underneath in a smaller font. To the right of the text is a graphic that resembles an EKG readout.

Indications For Use TM2000 Fetal Trace Receiving Center Software

The TM2000 FetalTrace Telemedicine Receiving Center is intended for supporting transtelephonic monitoring of the Fetal/Maternal parameters of patients.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

V Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use

(Optional Format 1-2-96)

David A. Ingram

(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number

Regulation Number and Section

§ 884.2740 Perinatal monitoring system and accessories.

(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).

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