INFINITY MEGACARE

K031970 · Siemens Medical Solutions USA, Inc. · DQK · Sep 9, 2003 · Cardiovascular

Device Facts

• Record ID: K031970
• Device Name: INFINITY MEGACARE
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Sep 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

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. 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.

Device Story

INFINITY MegaCare is a software application for managing digitized ECG records from various sources (Rest, Exercise, Ambulance, Holter, Monitoring System). It functions as a diagnostic computer system; it ingests ECG data to provide automated analysis and serial comparison of Rest ECGs. The software facilitates manual editing, printing, and archiving of records. Used in clinical environments by trained healthcare professionals (physicians, nurses, technicians), the system integrates into hospital networks via HL7 protocols. The output provides preliminary diagnostic data for physician review and confirmation, supporting clinical decision-making by enabling longitudinal review of patient ECG history. The device is not MRI compatible.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and the use of a previously cleared ECG analysis algorithm.

Technological Characteristics

Software-based diagnostic computer system. Operates on user-provided IBM-compatible servers. Utilizes the Glasgow ECG analysis algorithm. Connectivity via HL7 protocols for hospital information system integration. Not MRI compatible.

Indications for Use

Indicated for all patient populations requiring analysis, viewing, editing, printing, or archiving of digitized ECG records (Rest, Exercise, Ambulance, Holter, or Monitoring System). Intended for use by trained healthcare professionals (physicians, nurses, technicians) to provide preliminary data for physician confirmation.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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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: [phone] Fax: [phone] 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 with<br>Diagnostic Statements (Rest ECG) |
|---------|----------------------------------------------------------------------------------|
| K992637 | Muse Cardiovascular Information System |
| K974420 | TraceMaster ECG Management System |
| K946281 | Burdick Eclipse 4 Electrocardiograph |

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.

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#### COMPANY CONFIDENTIAL

Siemens Medical Solutuions Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

Tel: [phone] Fax: [phone]

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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).

### Intended Use:

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.

# 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: [phone] Fax: [phone]

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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 [phone]. 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 [phone] or [phone] 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

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510(k) Number (if known):

Siemens INFINITY MegaCare Device Name:

Indications for Use:

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.

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)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

rdiovascular Devices

**510(k) Number** K031170