SIEMENS INFINITY GATEWAY SUITE, MODEL VF2

K030657 · Siemens Medical Solutions · MHX · Mar 21, 2003 · Cardiovascular

Device Facts

• Record ID: K030657
• Device Name: SIEMENS INFINITY GATEWAY SUITE, MODEL VF2
• Applicant: Siemens Medical Solutions
• Product Code: MHX · Cardiovascular
• Decision Date: Mar 21, 2003
• 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 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.

Device Story

INFINITY Gateway Suite (VF2) is a server-based software application facilitating data exchange between Siemens INFINITY Network and hospital information systems. Inputs include clinical/administrative data from patient monitors and hospital systems. The VF2 release adds a Pager Interface, which transforms select alphanumeric monitor alarm data into signals compatible with Telocator Alphanumeric (TAP) Protocol 1.7 and European Standard Paging Application (ESPA) Protocol 4.4.4. The system is used in clinical settings by healthcare providers to remotely monitor patient status. Output is provided via remote viewing applications and pager notifications, enabling clinicians to receive timely alarm information, potentially improving response times to patient events.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Server-based software application. Connectivity via hospital network infrastructure and INFINITY Network. Supports TAP Protocol 1.7 and ESPA Protocol 4.4.4 for pager integration. Not patient-connected. Not MRI compatible.

Indications for Use

Indicated for use by clinicians to remotely view patient data and exchange clinical/administrative information between Siemens INFINITY Patient Monitoring Systems and hospital network infrastructure. Not patient-connected. Not compatible with MRI environments.

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

• INFINITY Gateway Suite (K014213)
• Olympus Communications Network, SC 3000 WorkStation and Remote Display (K955059)

Submission Summary (Full Text)

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

# 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: February 27, 2003

Trade Name, Common Name and Classification Name:

## A. Trade Name: INFINITY Gateway Suite, VF2

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

| Common Name | Product<br>Code | Class | Regulation Number |
|--------------------------------------------------------------|-----------------|-------|-------------------|
| System, Network and Communication,<br>Physiological Monitors | MHX | III | 21 CFR 870.1025 |
| Computers and Software, Medical | LNX | | |

Legally Marketed Device Identification:

K014213 INFINITY Gateway Suite

K955059 Olympus Communications Network, SC 3000 WorkStation and Remote Display

### Device Description:

The Infinity Gateway Suite (K014213) 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
- Interface Software Options
- Developers Tools ●
- Remote View Applications
- Pager Interface .

Page 1 of 2

### COMPANY CONFIDENTIAL

#### Siemens Medical Solutions, Inc.

Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

Tel: [phone] Fax: [phone]

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

K030657
page 2 of 2

The primary modification included in the VF2 software release of the INFINITY Gateway Suite is the option for the Infinity Gateway Pager Interface. The pager interface transmits select alphanumeric monitor alarm data to paging service providers that support the Telocator Alphanumeric (TAP) Protocol, Revision 1.7 and European Standard Paging Application (ESPA) Protocol. Revision 4.4.4

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 software applications are intended to provide clinicians with the capability of viewing patient data remotely via the INFINITY Network and the hospital network infrastructure and 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

Page 2 of 2

COMPANY CONFIDENTIAL

Siemens Medical Solutions, Inc. Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

Tel: [phone] Fax: [phone]

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its head turned to the left. The eagle is composed of three curved lines that suggest feathers and the shape of a human profile. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 1 2003

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

Re: K030657

Trade Name: Infinity Gateway Suite, VF2 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm Regulatory Class: Class III (three) Product Code: 74 MHX Dated: February 27, 2003 Received: March 3, 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.

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

{3}------------------------------------------------

## Page 2 - Ms. Penelope H. Greco

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 (OS) 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 vours,

Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

030657

Page 1 of 1

510(k) Number (if known):

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)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K032657