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.

Device Description

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/SC 9000XL). Parameters are 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 software is capable of displaying DICOM images retrieved from a syngo compatible image archive. A Task Card provides access to DICOM images.

AI/ML Overview

The Siemens INFINITY EXPLORER is a critical care workstation intended to display physiological parameters from INFINITY patient monitors and visually display alarm data. It is also capable of displaying DICOM images.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format of a table. Instead, it relies on a comparison to predicate devices and general statements about safety and effectiveness.

Acceptance Criteria (Implied)	Reported Device Performance
Display physiological parameters and alarm data accurately from INFINITY patient monitors.	"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." (Page 2)
Capable of displaying DICOM images received over a hospital information system.	"The device is capable of displaying DICOM images received over a hospital information system." (Page 2)
Be as safe and effective as identified predicate devices.	"Verification and validations tests have been performed which indicate that the INFINITY EXPLORER is as safe and effective as the predicate devices." (Page 3)
Intended Population: Adult, Pediatric, and Neonatal.	"The INFINITY EXPLORER is intended to be used with the same patient populations as the INFINITY Modular Monitors, Adult, Pediatric, and Neonatal." (Page 3)
Intended Environment: Healthcare environment where patient care is provided by healthcare professionals.	"In a healthcare environment where patient care is provided by healthcare professionals." (Page 3)
Visual Alarm functionality.	"Yes" (Page 3, comparison table)
No Audible Alarm functionality.	"No" (Page 3, comparison table)
Not connected to patients directly.	"Not connected to patients" (Page 3, comparison table)

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for a "test set" in the context of clinical performance data for the INFINITY EXPLORER. It mentions "Verification and validations tests have been performed," but details about these tests, including sample sizes and data provenance (e.g., country of origin, retrospective/prospective), are not provided in this summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the 510(k) summary. The document focuses on technical equivalence and intended use rather than studies requiring expert-established ground truth for a diagnostic AI.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. As no specific clinical test set is detailed, an adjudication method is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study is mentioned for the INFINITY EXPLORER. This device is a display and workstation, not an AI diagnostic tool, so such a study would not be applicable in this context.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable as the INFINITY EXPLORER is a display and workstation, not an algorithm or AI product requiring standalone performance evaluation in the usual sense. Its performance is tied to its ability to accurately display data from other devices.

7. The Type of Ground Truth Used

Given the nature of the device (a display and workstation for physiological parameters and DICOM images), the concept of "ground truth" as typically applied to diagnostic algorithms (e.g., pathology, outcomes data) does not directly apply. The performance evaluation would likely focus on the accuracy and fidelity of data display and system functionality when compared against the source data (e.g., patient monitor outputs, DICOM image files).

8. The Sample Size for the Training Set

This information is not applicable. The INFINITY EXPLORER is a workstation/display device and does not inherently involve machine learning models that require a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no mention of a "training set" for this device.

Summary

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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: (978) 907-7500 Fax: (978) 750-6879 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	ClassificationNumber	Class	Regulation Number
Display, Cathode-ray tube, Medical	DXJ	II	21 CFR 870.2450
System, Network and Communication, PhysiologicalMonitors	MSX
Computers and Software, Medical	LNX
System, Digital Image Communications,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

1/4

COMPANY CONFIDENTIAL

Siemens Medical Systems, Inc.

Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

Tel: (978) 907-7500 Fax: (978) 750-6879

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

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

2/4

COMPANY CONFIDENTIAL

Siemens Medical Systems, Inc. Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

Tel: (978) 907-7500 Fax: (978) 750-6879

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ble of Device Similarities and differences to legally marketed dev

Manufacturer	Legally Marketed DeviceOlympus Communications Network, SC 3000Workstation and Remote Display (MultiViewWorkStation and INFINITY Network)Siemens Medical Systems	Legally Marketed DeviceSC 9000/9015 Bedside Monitoring SystemSurgical Display Controller	New DeviceINFINITY EXPLORER	Explanation of Differences
510(k)Intended Use	K955059To act as a communications network, central monitoring device, and remote display for Siemens Patient Monitoring Systems and recorders	K970348The Surgical Display Controller is to display SC 9000/9015 Bedside Monitor functions on a Siemens 15" Remote Display or on a standard video display	SameTo be determinedThe 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
IntendedEnvironment	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 DeviceOlympus CommunicationsNetwork, SC 3000Workstation and RemoteDisplay (MultiViewWorkStation andINFINITY Network)Siemens Medical Systems	Legally Marketed DeviceSC 9000 / 9015 Bedside MonitoringSystemSurgical Display Controller	New DeviceINFINITY EXPLORER	Explanation of Differences
510(k)	K955059	K970348	Same
Intended Population	Not connected to patients	Same	To be determinedSame	Although not connecteddirectly to patients, theINFINITY EXPLORER isintended to be used with thesame patient populations asthe INFINITY ModularMonitors, Adult, Pediatric,and Neonatal.
Display	Displays data received from thepatient monitor and theINFINITY Telemetry Systemvia the INFINITY Network	User selectable. Independent frombedside 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

3/4

16 Electronics Avenue
Danvers, MA 01923

Siemens Medical Systems,
Electromedical Systems Group, PCS

Tel: (978) 907-7500
Fax: (978) 750-6879

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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: (978) 907-7500
Fax: (978) 750-6879

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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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

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)

Over-The-Counter Use_

(Optional Format 1-2-96)

LG Th

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

Regulation Number and Section

§ 870.2450 Medical cathode-ray tube display.

(a)
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.(b)
Classification. Class II (performance standards).