Use of the INFINITY MultiView WorkStation Telemetry System is indicated for adult and pediatric patient populations in an environment where patient care is provided by Healthcare Professionals (Physicians, Nurses, Technicians) when the professional determines that a device is required to measure and produce visual and audible alarms for any one or more of the following parameters:

. Heart rate
ECG Arrhythmia Analysis ●
Arterial oxygen saturation ●
Pulse rate
ST segment analysis .

The INFINITY MultiView WorkStation (MVWS) Telemetry System with TruST is indicated for use when 12-Lead ECG monitoring with a reduced set of electrodes is desired. Reconstructed leads are intended for real-time assessment of ST segment changes.

Device Description

Siemens' INFINITY MultiView WorkStation Telemetry with TruST enables continuous 12-lead ECG monitoring with a reduced number of electrodes. With TruST only 6 lead wires are required to acquire 12 leads of ECG. TruST relies on conventional lead placement and the INFINITY TruST telemetry transmitters. The TruST matrix uses general reconstruction coefficients to compute 4 precordial leads.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Siemens Infinity MultiView WorkStation Telemetry System with TruST, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state numerical performance acceptance criteria (e.g., specific sensitivity, specificity, accuracy thresholds) or precise reported device performance metrics for the TruST feature. Instead, it relies on substantial equivalence to predicate devices and describes the intended functionality. However, we can infer the acceptance criteria are met if the device demonstrates equivalent performance to the predicate devices in terms of its ability to monitor 12-lead ECG with a reduced set of electrodes and reconstruct leads for real-time ST segment assessment.

Feature / Performance Aspect	Acceptance Criteria (Inferred from Substantial Equivalence)	Reported Device Performance (as described in the document)
ST Segment Analysis (12-Lead ECG with reduced electrodes)	The device should effectively reconstruct 12-lead ECG from a reduced set of electrodes and provide real-time assessment of ST segment changes, similar to the predicate devices. This implies accurate ST segment measurement and trending.	"The INFINITY MultiView WorkStation Telemetry with TruST enables continuous 12-lead ECG monitoring with a reduced number of electrodes. With TruST only 6 lead wires are required to acquire 12 leads of ECG. TruST relies on conventional lead placement and the INFINITY TruST telemetry transmitters. The TruST matrix uses general reconstruction coefficients to compute 4 precordial leads." "Reconstructed leads are intended for real-time assessment of ST segment changes."
Intended Use compatibility with reduced electrode set	The device should be usable for its stated intended use (12-lead ECG monitoring and ST segment assessment) with the reduced electrode configuration.	"The INFINITY MultiView WorkStation (MVWS) Telemetry System with TruST is intended for 12-Lead ECG monitoring with a reduced set of electrodes."
Physiological Parameter Monitoring (general)	The system should accurately measure and produce visual/audible alarms for specified physiological parameters, in line with predicate devices.	"...intended to measure and produce visual and audible alarms for one or more physiological parameters" (Heart rate, ECG Arrhythmia Analysis, Arterial oxygen saturation, Pulse rate, ST segment analysis).

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

The document does not explicitly state the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions "Assessment of clinical performance data for equivalence: Section J," implying that clinical data was submitted in that section, but the summary document itself does not contain those details.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it provide an effect size for human readers with vs. without AI assistance. The focus of this 510(k) is on the device's technical capability to reconstruct leads and monitor ST segments, implying a standalone performance assessment or equivalence claim rather than a human-in-the-loop improvement study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The description of the TruST system, specifically that "The TruST matrix uses general reconstruction coefficients to compute 4 precordial leads" and that "Reconstructed leads are intended for real-time assessment of ST segment changes," strongly suggests that a standalone (algorithm-only) performance assessment would have been done to validate the accuracy of these reconstructed leads against a conventionally acquired 12-lead ECG. However, the summary document does not explicitly describe this study or its results in detail. The focus is on establishing substantial equivalence.

7. Type of Ground Truth Used (Test Set)

The document does not explicitly state the type of ground truth used for the test set. Given the nature of ECG monitoring and ST segment analysis, it's highly probable that the ground truth would have been established by:

Comparison to conventionally acquired 12-lead ECGs (e.g., a full 12-lead ECG from the same patient at the same time, reviewed by experts).
Expert consensus based on interpretation of conventional 12-lead ECGs.
Potentially, correlation with clinical outcomes or pathology if the clinical study was designed to assess diagnostic accuracy for specific conditions (though this is less likely for a 510(k) summary focused on technical equivalence for monitoring).

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set.

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

The document does not describe how the ground truth for any potential training set was established. Since the TruST system involves "general reconstruction coefficients," it implies a model or algorithm was developed. For such a model, a training set would typically have ground truth established by:

Conventionally acquired 12-lead ECGs that are considered the gold standard for full 12-lead information.
Expert cardiologists or electrophysiologists who interpret these full 12-lead ECGs and potentially correlate them with patient data or outcomes to develop the "ground truth" for ST segment morphology and deviation.

Summary

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

'JUN - 6 2003

510(k) SUMMARY

as required per 807.92(c)

1. Submitters Name, Address:

Siemens Medical Solutions, 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 Greco Date submission was prepared: March 7, 2003

2. Trade Name, Common Name and Classification Name:

A. Trade Name:

SIEMENS INFINITY MultiView WorkStation™ Telemetry System with TruST™

Common Name	ClassificationNumber	Class	Regulation Number
Monitor, Physiological, Patient (with arrhythmiadetection or alarms)	MHX	III	21 CFR 870.1025
Radiofrequency physiological signal transmitterand receiver	74DRG	II	21 CFR 870.2910
Cardiac monitor	74DRT	II	21 CFR 870.2300
Pulse rate monitor	74BWS	II	21 CFR 870.2300
Pulse oximeter	74DQA	II	21 CFR 870.2700
Breathing Frequency Monitor	73BZQ	II	21 CFR 868.2375
Clinical Electronic Thermometer	80BWX	II	21 CFR 880.2910
Indwelling Blood Pressure Monitor	74CAA	II	21 CFR 870.1110
Heart Rate Monitor, Neonatal	74FLO	II	21 CFR 870.2300
Ventilatory Effort Monitor (Apnea Detector)	73FLS	II	21 CFR 868.2375
Monitor Blood Pressure, Neonatal, Invasive	74FLP	II	21 CFR 870.1110
Arrhythmia detector & Alarm	74DSI	III	21 CFR 870.1025
Medical Cathode-Ray Tube Display	74DXJ	II	21 CFR 870.2450
ST Segment Monitor with Alarm	74MLD	III	21 CFR 870.1025
Non-indwelling Blood Pressure Monitor	74DXN	II	21 CFR 870.1130
End-tidal Carbon-Dioxide Monitor	73CCK	II	21 CFR 868.1400

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

Page 1 of 4

COMPANY CONFIDENTIAL

Siemens Medical Solutions, Inc.

Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

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

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

3. Predicate Device Identification:

Philip's (HP) Viridia Component Monitoring System with EASI™ ST Segment- 510(k) K992595

INFINITY MultiView WorkStation Telemetry System Modification - K024108 INFINITY MultiView WorkStation Modifications - K022889 SC 9000 / SC 9015 Enhanced with 12-Lead ST Segment Analysis - 510(k) K974698 MultiView WorkStation Enhanced with Diagnostic Statement (Rest ECG) - 510(k) K980625 SC 7000 / SC 9000XL Infinity Modular Bedside Monitors - 510(k) K982730 SC 8000 w/Advanced Communication Option - 510(k) K990563

Device Description: 4.

5. Intended Use:

The INFINITY MultiView WorkStation (MVWS) Telemetry System is intended to measure and produce visual and audible alarms for one or more physiological parameters

The INFINITY MVWS telemetry System with TruST is intended for 12-Lead ECG monitoring with a reduced set of electrodes. Reconstructed leads are intended for real-time assessment of ST segment changes.

This device is intended for use in an environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

Page 2 of 4

COMPANY CONFIDENTIAL

Siemens Medical Solutions, Inc.

Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

Tel: (978) 907-7500 Fax: (978) 750-6879 050-38

: Of

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

030738 50F )

510(k) Notification
SIEMENS INFINITY MultiView WorkStation™ Telemetry with TruST™

Table of Device Similarities and differences to predicate device
Manufacturer	Substantial Equivalent Device	Substantial Equivalent Device	Applicant	Explanation ofDifferences
(k) Number	HP Viridia ComponentMonitoring System with EASITMST Segment MeasurementPhilips (HP)	SC 9000 / SC 9015 BedsideMonitoring System Enhanced with12-Lead ST Segment AnalysisSiemens Medical Solutions	Siemens Medical Systems InfinityMultiView WorkStation TelemetrySystem with TruSTSiemens Medical Solutions
	K992595	K974698	To be assigned
Intended Use	Assessment of real time STsegment analysis in adultpatients.	To determine the ST Segment of theECG signal and to compute thedeviation of this ST Segment fromthe iso-electric point (baseline).	The INFINITY MultiViewWorkStation (MVWS) TelemetrySystem is intended to measure andproduce visual and audible alarmsfor one or more physiologicalparameters	Similar to Philips' Easiin that the MVWS withTruST monitors 12-leadECG with a reduced setof electrodes.
Intended Population	Adult	Adult/Pediatric	The INFINITY MVWS telemetrySystem with TruST is intendedfor 12-Lead ECG monitoring with areduced set of electrodes.Reconstructed leads are intended forreal-time assessment of ST segmentchanges.
IntendedEnvironment	In the medical clinic or hospitalenvironment for use byphysicians, nurses and ECGtechnicians.	Adult/Pediatric	Same
DiagnosticST Analysis	No	Yes	No
	Up to 12 Derived Complexes	Up to 12 Measured ST Complexes	Up to 8 Measured ST ComplexesUp to 4 Derived ST Complexes	dV1, dV3, dV4, dV6
	5	12	6

Page 3 of 4

COMPANY CONFIDENTIA

16 Electronics Avenue
Danvers, MA 01923

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

Siemens Medical Solutions,
Electromedical Systems Group, PCS

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

1. Assessment of non-clinical performance data for equivalence: Currently there are no FDA standards for this device.
1. Assessment of clinical performance data for equivalence: Section J
1. Biocompatability: Not applicable
1. Sterilization: Not applicable
1. Standards and Guidances: Section P

Page 4 of 4

COMPANY CONFIDENTIAL

Siemens Medical Solutions, Inc. Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

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

K 0 30 7 38 by afy

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

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 6 2003

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

Re: K030738

Trade Name: MultiView WorkStation Telemetry System with TruSTTM Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm Regulatory Class: Class III (three) Product Code: MHX Dated: March 7, 2003 Received: March 10, 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

{5}------------------------------------------------

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 (301) 594-4646. 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 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,

Bram D. Zuckerman, M.D.

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

Enclosure

{6}------------------------------------------------

510(k) Number (if known): K030738

Siemens Infinity MultiView WorkStation Telemetry System Device Name: Enhanced with TruST™

Indications for Use:

. Heart rate
ECG Arrhythmia Analysis ●
Arterial oxygen saturation ●
Pulse rate
ST segment analysis .

MRI Compatibility Statement:

The Infinity MultiView WorkStation Telemetry System 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)

N. Carter

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
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.(b)
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.