SIEMENS INFINITY GATEWAY SUITE

K014213 · Siemens Medical Solutions USA, Inc. · MHX · Jan 17, 2002 · Cardiovascular

Device Facts

• Record ID: K014213
• Device Name: SIEMENS INFINITY GATEWAY SUITE
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Jan 17, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Siemens MultiView WorkStation, INFINITY Network and remote display are intended to act as a central monitoring device, communications network, and remote display for Siemens INFINITY Patient Monitoring Systems and recorders. The INFINITY Gateway Suite is intended to provide clinicians with the capability of viewing patient data remotely via the INFINITY Network and the hospital network infrastructure for the data exchange of select clinical and administrative information. The INFINITY Gateway is not patient connected.

Device Story

Infinity Gateway Suite is server-based software connecting Infinity Network to hospital network infrastructure; facilitates data exchange of clinical/administrative information. Input: patient data from Siemens Patient Monitoring Systems/recorders. Output: remote viewing of patient data for clinicians. Used in clinical settings; operated by healthcare professionals. Not patient-connected; not MRI compatible. Benefits: enables remote access to patient monitoring data and integration with hospital information systems.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Server-based software application; connects to Infinity Network and hospital network infrastructure. Supports data exchange protocols for medical devices, hospital information systems, clinical information systems, and laboratory systems. Not MRI compatible. No patient-contacting materials.

Indications for Use

Indicated for use as a central monitoring device, communications network, and remote display for Siemens Patient Monitoring Systems and recorders, enabling clinicians to view patient data remotely and exchange clinical/administrative information between the Infinity Network and hospital network infrastructure.

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Predicate Devices

• Olympus Communications Network, SC 3000 WorkStation and Remote Display (K955059)

Submission Summary (Full Text)

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# JAN 1 7 2002

### 1. 510(k) SUMMARY as required per 807.92(c)

Submitters Name, Address:

Siemens Medical Solutions, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: [phone] Fax: [phone] Establishment Registration Number: 1220063 Official Correspondent: Connie Hertel, Director, QA/RA Contact person for this submission: Penelope H. Greco Date submission was prepared: December 20, 2001

Trade Name, Common Name and Classification Name:

- A. Trade Name: INFINITY Gateway Suite
- B. Common Name, Classification Name, Class and Regulation Number:

| Common Name | Product Code | Class | Regulation Number |
|--------------------------------------------------------------|--------------|-------|-------------------|
| System, Network and Communication,<br>Physiological Monitors | MSX | | |
| Computers and Software, Medical | LNX | | |

### Legally Marketed Device Identification:

Olympus Communications Network, SC 3000 WorkStation and Remote Display K955059

### Device Description:

The Infinity Gateway Suite is a server-based software application that provides a connection to the Infinity Network (K955059) and the hospital network infrastructure for the data exchange of select clinical and administrative information. The Infinity Gateway complies with healthcare information protocols to support data sets of many different sources, including medical devices, hospital information systems, clinical information systems, and laboratory systems.

Infinity Gateway includes a suite of software products to support the unique needs of hospitals, and provide a complete range of options for information connectivity:

- Server Software 1
- . Interface Software Options
- Developers Tools 내
- Remote View Applications B

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## COMPANY CONFIDENTIAL

Siemens Medical Systems, Inc. Electromedical Systems Group. PCS

16 Electronics Avenue Danvers. MA 01923

Tel: [phone] Fax: [phone]

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### Intended Use:

Siemens MultiView WorkStation, INFINITY Network and remote display are intended to act as a central monitoring device, communications network, and remote display for Siemens INFINITY Patient Monitoring Systems and recorders. The INFINITY Gateway Suite is intended to provide clinicians with the capability of viewing patient data remotely via the INFINITY Network and the hospital network infrastructure for the data exchange of select clinical and administrative information. The INFINITY Gateway is not patient connected.

Assessment of non-clinical performance data for equivalence: Section J

Assessment of clinical performance data for equivalence: Not applicable

Biocompatability: Not applicable

Sterilization: Not applicable

Standards and Guidances: Section E

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## COMPANY CONFIDENTIAL

## Siemens Medical Systems, Inc.

Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

Tel: [phone] Fax: [phone]

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Image /page/2/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HL" is written around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2002

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

Re: K014213

Trade Name: INFINITY Gateway Suite Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: MHX Dated: December 20, 2001 Received: December 21, 2001

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

V. O. Tull

m D. Zuckerman, M.I Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K014213

Page 1 of 1

Device Name: INFINITY Gateway Suite

Indications for Use:

Siemens MultiView WorkStation, INFINITY Network and Remote Display are indicated for use as a central monitoring device, communications network, and remote display for Siemens Patient Monitoring Systems and recorders.

The Infinity Gateway Suite software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.

## MRI Compatibility Statement:

The MultiView WorkStation, Infinity Network and Gateway Suite are 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)

V Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Oak Mth
Division of Cardiovascular & Respiratory Devices
510(k) number K014213