INFINITY EXPLORER

K030615 · Siemens Medical Solutions USA, Inc. · MSX · Mar 21, 2003 · Cardiovascular

Device Facts

• Record ID: K030615
• Device Name: INFINITY EXPLORER
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: MSX · Cardiovascular
• Decision Date: Mar 21, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

The INFINITY EXPLORER is a critical care workstation intended to display physiological parameters received from INFINITY Modular Monitors and to visually display alarm data for those parameters. The device is capable of displaying DICOM images received over a hospital information system.

Device Story

Infinity Explorer is a software-driven critical care workstation; displays real-time physiological parameters and alarm data from Infinity modular monitors (SC 7000, 8000, 9000XL); integrates DICOM images from hospital information systems. Originally designed for Siemens Medside Data Station (MDS); modification enables operation on commercially available patient vicinity computers (MDS II). Used by clinicians in hospital settings to centralize patient data; provides control back to bedside monitors. Facilitates clinical decision-making by consolidating patient information on a single display.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Software-driven application; runs on patient vicinity computer hardware (MDS II). Connectivity via hospital information system for DICOM image retrieval and network integration with Infinity modular monitors. Not MRI compatible.

Indications for Use

Indicated for adult, pediatric, and neonatal patient populations in clinical environments where care is provided by trained healthcare professionals (physicians, nurses, technicians) who determine use based on professional assessment of the patient's medical condition.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Predicate Devices

• Siemens Infinity Explorer (K013515)

Submission Summary (Full Text)

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K030615
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## 510(k) SUMMARY

as required per 807.92(c)

MAR 2 1 2003

Submitters Name, Address:

Siemens Medical Solutions, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: [phone] Fax: [phone] Official Correspondent: Connie Hertel, Director, QA/RA Contact person for this submission: Penelope H. Greco Date submission was prepared: February 24, 2003

Trade Name, Common Name and Classification Name:

A. Trade Name:

Siemens INFINITY Explorer

Common Name, Classification Name, Class and Regulation Number:

| Common Name | Product Code | Class | Regulation Number |
|--------------------------------------------------------------|--------------|-------|-------------------|
| System, Network and Communication,<br>Physiological Monitors | MSX | II | 870.2300 |

Legally Marketed Device Identification:

Siemens Infinity Explorer, 510(k) K013515

## Description of Modification:

The INFINITY EXPLORER is a software-driven application that allows the user to extend the viewing capability of the Infinity modular monitors (SC 7000, 8000 9000XL) and integrate additional patient information on a single display. INFINITY EXPLORER is capable of displaying real-time patient data, providing control back to the bedside and integrating other applications with patient data on the PC. In the initial release of the Infinity EXPLORER, the software was run on Siemens' own dedicated Medside Data Station (MDS), a patient vicinity computer based on Low Power Intel Pentium-III embedded processor.

The subject of this submission is a modification implemented that enables the INFINITY EXPLORER to run on a commercially available patient vicinity computer. With the release of software version VF2.1 the INFINITY EXPLORER has been tested for use with the Medside Data Station II (MDS II).

### Intended Use:

The INFINITY EXPLORER is a critical care workstation intended to display physiological parameters received from INFINITY Modular Monitors and to visually display alarm data for those parameters. The device is capable of displaying DICOM images received over a hospital information system.

## 1

## COMPANY CONFIDENTIAL

Siemens Medical Solutions, Inc. Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

Tel: [phone] Fax: [phone]

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K030615
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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 J

2

# COMPANY CONFIDENTIAL

Siemens Medical Solutions, 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. 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 21 2003

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

Re: K030615

Trade Name: Infinity Explorer Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: 74 MSX Dated: February 24, 2003 Received: February 26, 2003

Dear Ms. Greco:

We have reviewed your Section 510(k) premarket notification of intent to market the device feferenced 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

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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 (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,

J. Dela Tull

uckerman, M.D. ram D. Director Division of Cardiovascular Devices Office of Device Evaluation ' Center for Devices and Radiological Health

Enclosure

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K030615

Page_1_of_1

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Siemens INFINITY EXPLORER

Indications for Use:

This device is capable of displaying physiological parameters received from INFINITY monitors (SC 7000, SC 8000, SC 9000XL) and visually displaying alarm data for those parameters. The device is capable of displaying DICOM images received over a hospital information system.

The device is intended to be used 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 the adult, pediatric and neonatal populations.

### MRI Compatibility Statement:

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

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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)

X Delatta

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K10308 15