INFINITY EXPLORER

K013515 · Siemens Medical Solutions USA, Inc. · DXJ · Jan 10, 2002 · Cardiovascular

Device Facts

• Record ID: K013515
• Device Name: INFINITY EXPLORER
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: DXJ · Cardiovascular
• Decision Date: Jan 10, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2450
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The INFINITY EXPLORER is a critical care workstation intended to display physiological parameters received from INFINITY Modular Monitors (SC 7000/SC 9000XL / SC 8000) and to visually display 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 the 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.

Device Story

INFINITY EXPLORER is a critical care workstation; functions as a remote display for physiological parameters and alarm data from connected INFINITY patient monitors (SC 7000, SC 8000, SC 9000XL). Device also displays DICOM images retrieved via hospital information system. Operates within clinical environments; used by trained healthcare professionals (physicians, nurses, technicians) to monitor patient status. Utilizes syngo software platform for user interface and image management. Provides visual alarm indications; does not provide audible alarms. Healthcare providers use the workstation to view real-time patient data and diagnostic images to support clinical decision-making. Benefits include centralized monitoring and improved access to patient information at the point of care.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including verification and validation of software and display performance.

Technological Characteristics

Critical care workstation; syngo software platform; DICOM-compatible; networked connectivity for physiological data and image retrieval. Not MRI compatible. No patient-contacting materials.

Indications for Use

Indicated for adult, pediatric, and neonatal patients in clinical environments. Used by trained healthcare professionals (physicians, nurses, technicians) to display physiological parameters and alarm data from INFINITY monitors and to view DICOM images. Not MRI compatible.

Regulatory Classification

Identification

A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.

Predicate Devices

• SC 9000 / SC 9015 Series Surgical Display Controller (K970348)
• SC3000 MULTIVIEW WorkStation and Remote Display (K955059)

Reference Devices

• SC 7000 / SC 9000XL (K980882)
• SC 8000 (K983632)
• INFINITY Modular Monitors Modifications (K003243)
• syngo Multimodality Workstation (K010938)

Submission Summary (Full Text)

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# JAN 1 0 2002

#### 510(k) SUMMARY

as required per 807.92(c)

K013515

Submitters Name, Address:

Siemens Medical Systems, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: [phone] Fax: [phone] Official Correspondent: Connie Hertel, Director Quality Assurance & Regulatory Affairs Contact person for this submission: Penelope H. Greco October 18, 2001 Date submission was prepared:

Trade Name, Common Name and Classification Name:

- A. Trade Name: Siemens INFINITY EXPLORER
# B. Common Name, Classification Name, Class and Regulation Number:

| Common Name | Classification<br>Number | Class | Regulation Number |
|--------------------------------------------------------------|--------------------------|-------|-------------------|
| Display, Cathode-ray tube, Medical | DXJ | II | 21 CFR 870.2450 |
| System, Network and Communication, Physiological<br>Monitors | MSX | | |
| Computers and Software, Medical | LNX | | |
| System, Digital Image Communications,<br>Radiological | LMD | 1 | 21 CFR 892.2020 |

Predicate Device Identification:

| K970348 | SC 9000 / SC 9015 Series Surgical Display Controller |
|---------|------------------------------------------------------|
| K955059 | SC3000 MULTIVIEW WorkStation and Remote Display |

#### Other relevant submissions

| K980882 | SC 7000 / SC 9000XL |
|---------|-----------------------------------------|
| K983632 | SC 8000 |
| K003243 | INFINITY Modular Monitors Modifications |
| K010938 | syngo Multimodality Workstation |

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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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### Device Description:

Device Doseriping.
The INFINITY EXPLORER is a critical care workstation that acts as a display for physiological parameters received from an INFINITY patient monitor (SC 7000/SC 8000/ physionered. Parameter Froom RER provides the user with a visual indication of alarms SC 900712). Intrass displayed (audio alarming and flashing visual indications are provided on the INFINITY patient monitor screen).

INFINITY EXPLORER utilizes the syngo (510k K010938) software platform and user interface common to other Siemens Medical modalities. INFINITY EXPLORER with syngo meeraeo common to edisplaying DICOM images retrieved from a syngo compatible SOITWate Is capacite of alleges Task Card provides access to DICOM images.

## Intended Use:

The INFINITY EXPLORER is a critical care workstation intended to display physiological The INTTT EAT BORDIC To a comy Modular Monitors and to visually display alarm data parameters rocerers. The device is capable of displaying DICOM images received over a hospital information system.

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

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

Biocompatability: Not applicable

Sterilization: Not applicable

Standards and Guidance: Section R

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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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ble of Device Similarities and differences to legally marketed dev

| Manufacturer | Legally Marketed Device<br>Olympus Communications Network, SC 3000<br>Workstation and Remote Display (MultiView<br>WorkStation and INFINITY Network)<br>Siemens Medical Systems | Legally Marketed Device<br>SC 9000/9015 Bedside Monitoring System<br>Surgical Display Controller | New Device<br>INFINITY EXPLORER | Explanation of Differences |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)<br>Intended Use | K955059<br>To act as a communications network, central monitoring device, and remote display for Siemens Patient Monitoring Systems and recorders | K970348<br>The Surgical Display Controller is to display SC 9000/9015 Bedside Monitor functions on a Siemens 15" Remote Display or on a standard video display | Same<br>To be determined<br>The INFINITY EXPLORER is a critical care workstation intended to display physiological parameters received from INFINITY Modular Monitors (SC 7000/SC 9000XL / SC 8000) and to visually display alarm data for those parameters. The device is capable of displaying DICOM images received over a hospital information system. | The SC 7000 / SC 9000XL (K980882) and SC 8000 with Advanced Communication Option, 510(k) K990563 included the Surgical Display Controller |
| Intended<br>Environment | In a healthcare environment where patient care is provided by healthcare professionals. | Wherever the Siemens SC 9000 / 9015 Bedside Monitor is used | Wherever a Siemens INFINITY Monitor (SC 7000 / SC 8000/ SC 9000XL) is used | |
| Manufacturer | Legally Marketed Device<br>Olympus Communications<br>Network, SC 3000<br>Workstation and Remote<br>Display (MultiView<br>WorkStation and<br>INFINITY Network)<br>Siemens Medical Systems | Legally Marketed Device<br>SC 9000 / 9015 Bedside Monitoring<br>System<br>Surgical Display Controller | New Device<br>INFINITY EXPLORER | Explanation of Differences |
| 510(k) | K955059 | K970348 | Same | |
| Intended Population | Not connected to patients | Same | To be determined<br>Same | Although not connected<br>directly to patients, the<br>INFINITY EXPLORER is<br>intended to be used with the<br>same patient populations as<br>the INFINITY Modular<br>Monitors, Adult, Pediatric,<br>and Neonatal. |
| Display | Displays data received from the<br>patient monitor and the<br>INFINITY Telemetry System<br>via the INFINITY Network | User selectable. Independent from<br>bedside monitor's primary display | Same as K970348 | |
| Audible Alarm | Yes | No | No | |
| Visual Alarm | Yes | No | Yes | |
| Testing | | | | Verification and validations tests have been performed which indicate that the INFINITY EXPLORER is as safe and effective as the predicate devices |

OMPANY CONFIDENTIA

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16 Electronics Avenue
Danvers, MA 01923

Siemens Medical Systems,
Electromedical Systems Group, PCS

.

Tel: [phone]
Fax: [phone]

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510(k) Notification
INFINITY EXPLORE

16 Electronics Avenue
Danvers, MA 01923

OMPANY CONFIDENTIA

4/4

Siemens Medical Systems, Inc
Electromedical Systems Group, PCS

Tel: [phone]
Fax: [phone]

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Image /page/4/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health and Human Services. The logo features the department's emblem, which is a stylized caduceus with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 0 2002

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

Re: K013515

Trade Name: Infinity Explorer Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor Regulatory Class: Class II (two) Product Code: MSX Dated: October 18, 2001 Received: October 22, 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,

N. Donnell

am D. Zuckerman, M.D 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):_____________________________________________________________________________________________________________________________________________________

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 the 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.

(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)

LG Th

Division of Cardiovascular & Respiratory Devices
510(k) Number K013515