Use of the MultiView WorkStation Infinity 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 device is intended to be used in the 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.

Device Description

The MultiView WorkStation Infinity Telemetry System, 510(k) K972714, has been modified to enable the Pause, Bradycardia, and Tachycardia Arrhythmia calls.

AI/ML Overview

The provided document is incomplete and only describes a 510(k) submission for a device modification, but it does not contain the actual study or acceptance criteria. The information provided here focuses on the administrative aspects of a 510(k) application, such as the device's trade name, common name, classification, and intended use. It also mentions that the modification enables "Pause, Bradycardia, and Tachycardia Arrhythmia calls."

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them from the given text.

To answer your request, I would need a document specifically detailing the verification and validation (V&V) testing performed for the device modification, which would include:

Acceptance Criteria: Specific thresholds or performance metrics that the device must meet.
Study Design: How the test was conducted.
Device Performance: The results observed during the study.
Sample Size and Data Provenance: Details about the dataset used.
Ground Truth: How the reference standard was established.
Expert Details: Qualifications and number of experts involved.
Adjudication Method: If applicable.
MRMC or Standalone Studies: If such studies were performed.
Training Set Details: If applicable for an AI/algorithm.

Without this information, I cannot complete the table or answer the specific questions about the study.

Summary

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K983980

Special 510(k): Device Modification Siemens MultiView WorkStation Infinity Telemetry System

510(k) SUMMARY

as required per 807.92(c)

Submitters Name, Address:

Siemens Medical Systems, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879 Official Correspondent: David Simard, Director Quality Assurance & Regulatory Affairs Contact person for this submission: Penelope H. Greco Date submission was prepared: November 5, 1998

Trade Name, Common Name and Classification Name:

A. Trade Name:

Siemens MultiView WorkStation Infinity Telemetry System

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

Common Name	ClassificationNumber	Class	Regulation Number
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
Radiofrequency physiological signal transmitter andreceiver	74DRG	II	21 CFR 870.2910
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

Legally Marketed Device Identification:

Siemens MultiView WorkStation Infinity Telemetry System

Description of Modification:

The MultiView WorkStation Infinity Telemetry System, 510(k) K972714, has been modified to enable the Pause, Bradycardia, and Tachycardia Arrhythmia calls.

Intended Use: (Same as K972714)

Biocompatability: Not applicable Sterilization: Not applicable Standards and Guidances: (Same as K972714)

COMPANY CONFIDENTIAL

Siemens Medical Systems, Inc.

Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923 USA

Tel: (978) 907-7500 Fax: (978) 750-6879 Telex: 511958 (Siemensm SD)

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 1998

Mr. David Simard Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923

K983980 Re: Siemens MultiView Workstation Infinity Telemetry System Regulatory Class: III (three) Product Code: 74 DSI Dated: November 5, 1998 Received: November 9, 1998

Dear Mr. Simard:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. David Simard

This letter will allow you to beqin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Thomas J. Callahan

Thomas J. Čallahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_K983980

Device Name: __ Siemens MultiView WorkStation Infinity Telemetry System

Indications for Use: (Same as K972714)

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

MRI Compatibility Statement:

The MultiView WorkStation Infinity 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)

Krave

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number _

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.