INFINITY MegaCare is a software application for viewing, manual editing, printing, and archiving of digitized electrocardiograph records from Rest ECG devices, Exercise ECG devices, Ambulance ECG devices, Holter ECG devices and the Infinity Monitoring System.

INFINITY MegaCare is intended to provide analysis of Rest ECG's and to provide preliminary data for editing and confirmation by a physician. INFINITY MegaCare can provide a serial comparison of Rest ECG data to facilitate the review of current and previous Rest ECG's.

INFINITY MegaCare is designed for network compatibility to facilitate retrieval of data and to interface with other hospital information systems though HL7 protocols.

Device Description

INFINITY MegaCare is a computer software program that allows viewing, manual editing, printing and archiving of digitized electrocardiograph records from Rest ECG devices, Exercise ECG devices, ambulance ECG devices, Holter ECG devices and the INFINITY Monitoring System.

INFINITY MegaCare uses the Microsoft Windows 2000 server operating system, Microsoft IIS Web server, and Microsoft SOL Server 2000 relational database. The system consists of a software application, which is installed on a user provided IBM compatible server running the Microsoft Windows 2000 Server operation system. MegaCare utilizes the ECG analysis algorithm developed under the direction of Dr. Peter MacFarlane at the University of Glasgow and used for the INFINITY MVWS Rest ECG (K980625) and Burdick's Eclipse 4 Electrocardiograph (K946281).

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria, study details, and ground truth establishment:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific acceptance criteria in a quantitative or pass/fail manner. It claims "substantially equivalent" for both non-clinical and clinical performance.

However, the "Device Description" and "Intended Use" sections imply general performance expectations related to analysis of Rest ECGs, serial comparison, viewing, editing, printing, and archiving. The text also mentions that the device "utilizes the ECG analysis algorithm developed under the direction of Dr. Peter MacFarlane at the University of Glasgow and used for the INFINITY MVWS Rest ECG (K980625) and Burdick's Eclipse 4 Electrocardiograph (K946281)." This suggests that the performance of those predicate devices effectively sets the "acceptance criteria" for the analysis algorithm within INFINITY MegaCare.

Given this, the table would primarily reflect the reliance on the predicate device's performance rather than independently stated criteria for INFINITY MegaCare's analysis algorithm.

Acceptance Criteria (Implied)	Reported Device Performance
ECG Analysis Performance: Equivalent to predicate devices K980625 and K946281, which utilize the same core algorithmdeveloped by Dr. Peter MacFarlane. (Implied for "preliminary data for editing and confirmation by a physician" and "serial comparison")	"substantially equivalent" to predicate devices (K980625 and K946281) for non-clinical and clinical performance, based on the use of the same ECG analysis algorithm. The system provides "preliminary data for editing and confirmation by a physician" and "serial comparison of Rest ECG data."
Functional Capabilities: Viewing, manual editing, printing, and archiving of digitized ECG records.	The device is a "software application for viewing, manual editing, printing, and archiving of digitized electrocardiograph records" from various ECG devices. It can "interface with other hospital information systems though HL7 protocols."
Network Compatibility: Operate within a network environment and interface with hospital information systems.	"designed for network compatibility to facilitate retrieval of data and to interface with other hospital information systems though HL7 protocols."

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not explicitly state a sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The submission relies on demonstrating substantial equivalence to predicate devices for which the ECG analysis algorithm was already validated.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not provide this information. It mentions that the ECG analysis algorithm was "developed under the direction of Dr. Peter MacFarlane at the University of Glasgow," implying expert involvement in the algorithm's initial development and validation for the predicate devices. However, it does not specify how ground truth was established for the INFINITY MegaCare's own assessment.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The focus is on the device's standalone performance and its equivalence to predicate devices, not on human readers' improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study of the algorithm was implicitly done for the predicate devices, and that performance is leveraged for INFINITY MegaCare. The filing states: "MegaCare utilizes the ECG analysis algorithm developed under the direction of Dr. Peter MacFarlane at the University of Glasgow and used for the INFINITY MVWS Rest ECG (K980625) and Burdick's Eclipse 4 Electrocardiograph (K946281)." This indicates that the core analytical capabilities of INFINITY MegaCare are based on an already validated standalone algorithm. The submission itself then claims "Assessment of non-clinical performance data for equivalence: Substantially equivalent (Section S)" and "Assessment of clinical performance data for equivalence: Substantially equivalent (Section T)," further implying that the standalone performance of the algorithm (inherited from the predicate) was deemed sufficient.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the algorithm's original validation or for INFINITY MegaCare's assessment. Given it's an ECG analysis algorithm intended "to provide preliminary data for editing and confirmation by a physician," it is highly probable that the ground truth for an ECG analysis algorithm would involve a consensus of expert cardiologists or electrophysiologists, meticulously reviewing and annotating ECG waveforms and clinical outcomes.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set of the ECG analysis algorithm. This information would typically be tied to the initial development and validation of the algorithm by Dr. MacFarlane.

9. How the Ground Truth for the Training Set Was Established

The document does not detail how the ground truth for the training set was established. As inferred in point 7, it's highly likely that it involved expert review and consensus of ECGs, possibly correlated with patient outcomes, for the development of Dr. MacFarlane's algorithm.

Summary

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510(k) SUMMARY

as required per 807.92(c)

Submitters Name, Address:

Siemens Medical Solutuions Electromedical Systems Group, PCS 16 Electronics Avenue Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879 Official Correspondent: Connie Hertel, Director Ouality Assurance & Regulatory Affairs Contact person for this submission: Penelope H. Greco Date submission was prepared: June 20, 2003

Trade Name, Common Name and Classification Name:

A. Trade Name: INFINITY MegaCare

B. Common Name, Classification Name, Class and Regulation Number:

Common Name	Product Code	Class	Regulation Number
System, ECG Analysis	LOS
Computer, diagnostic, programmable	DQK	II	21CFR 870.1425

Predicate Device Identification:

K980625	Infinity MultiView WorkStation Enhanced withDiagnostic Statements (Rest ECG)
K992637	Muse Cardiovascular Information System
K974420	TraceMaster ECG Management System
K946281	Burdick Eclipse 4 Electrocardiograph

Device Description:

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COMPANY CONFIDENTIAL

Siemens Medical Solutuions Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

Tel: (978) 907-7500 Fax: (978) 750-6879

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Intended Use:

INFINITY MegaCare is intended to provide analysis of Rest ECG's and to provide preliminary data for editing and confirmation by a physician. Infinity MegaCare can provide a serial comparison of Rest ECG data to facilitate the review of current and previous Rest ECG's.

INFINITY MegaCare is designed for network compatibility to facilitate retrieval of data and to interface with other hospital information systems though HL7 protocols.

Assessment of non-clinical performance data for equivalence: Substantially equivalent (Section S)

Assessment of clinical performance data for equivalence: Substantially equivalent (Section T)

Biocompatability: Not applicable

Sterilization: Not applicable

Standards and Guidance: Section R

COMPANY CONFIDENTIAL

Siemens Medical Solutions Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

Tel: (978) 907-7500 Fax: (978) 750-6879

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Public Health Service

Image /page/2/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles three overlapping human profiles or figures. The symbol is abstract and appears to be in motion or flowing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 9 2003

Siemens Medical Solutions USA, Inc. Electromedical Systems Group, PCS c/o Ms. Penelope H. Greco Regulatory Submissions Manager 16 Electronics Avenue Danvers, MA 01923

Re: K031970

Trade Name: Siemens INFINITY MegaCare Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II (two) Product Code: DQK Dated: June 20, 2003 Received: June 26, 2003

Dear Ms. Greco:

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 - Ms. Penelope H. Greco

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. 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

A. E. Zeller, M.D.

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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K031970

Page 1 of 1

510(k) Number (if known):

Siemens INFINITY MegaCare Device Name:

Indications for Use:

INFINITY MegaCare is designed for network compatibility to facilitate retrieval of data and to interface with other hospital information systems though HL7 protocols.

The device is intended for use in an environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

The device is intended for use with all patient populations.

MRI Compatibility Statement:

The INFINITY MegaCare is not compatible for use in a MRI magnetic field.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

rdiovascular Devices

510(k) Number K031170

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).