The Siemens SC9000/SC9015 Series Surgical Display Controller is indicated for use in an environment where patient care is provided by healthcare professionals (e.g. surgeons and other operating room personnel). It will be used whenever the professional determines that parameters and functions generated by the SC 9000/9015 Bedside Monitor should be displayed on a remote terminal.

Device Description

The SC900/9015 Series Surgical Display Controller enables SC9000/9015 monitoring to be displayed on a Siemens 15 inch Remote Display or on a standard video display.

AI/ML Overview

The provided text is a 510(k) summary for the Siemens SC9000/SC9015 Series Surgical Display Controller. This document aims to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a study.

Therefore, the input does not contain the information required to answer the questions about acceptance criteria and a study proving those criteria are met. The device is a "Medical Cathode-Ray Tube Display," and its submission to the FDA is based on substantial equivalence to an existing device (Siemens SC9000/9015 Series SC9015 Display), meaning extensive performance studies as requested are typically not required, especially for a display unit.

Here's a breakdown of why the requested information is not available in the provided text:

Acceptance Criteria and Reported Device Performance: This device is a display controller. The primary performance criterion would be its ability to accurately display information from the bedside monitor. This is handled by a claim of "substantial equivalence" rather than a detailed performance study with specific metrics.
Sample Size, Ground Truth, Adjudication, MRMC studies, Standalone performance, Training set details: These are all elements typically involved in performance studies for diagnostic or analytical devices (e.g., AI algorithms, new sensors). A display controller's evaluation focuses on its technical specifications (e.g., resolution, refresh rate, compatibility) and safety, which are generally demonstrated through engineering and compatibility testing, not clinical studies with patients/experts/ground truth as described in your questions.
The document explicitly states: "Assessment of clinical performance data for equivalence: Not applicable; device is substantially equivalent to predicate device."

In summary, the provided 510(k) summary is not designed to present a performance study with the types of details requested. It relies on demonstrating that the new device is essentially the same as a previously cleared device.

Summary

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510(k) SUMMARY

as required per 807.92(c)

K970348

2; Submitter's Name, Address:

Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Tel: (508) 750-7500 Fax: (508) 777-3398 Official Correspondent: David Simard, Director of Quality Assurance and Regulatory Affairs Contact person for this submission: Jacqueline E. M. Emery Date submission was prepared: December 10. 1996

3: Trade Name, Common Name and Classification Name: Medical Cathode-Ray Tube Display

A. Trade Name: Siemens SC9000/ SC9015 Series Surgical Display Controller

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

Common Name	Classification Number	Class	Regulation Number
Cardiac monitor	74DRT	II	21 CFR 870.2300
Arrhythmia detector& Alarm System	74DSI	III	21 CFR 870.1025
Breathing frequencymonitor	73BZQ	II	21 CFR 868.2375
Pulse rate monitor	74BWS	II	21 CFR 870.2300
Non-indwelling bloodpressure monitor	74DXN	II	21 CFR 870.1130
Clinical electronic thermometer	80BWX	II	21 CFR 880.2910
Pulse Oximeter	74DQA	II	21 CFR 870.2700
Cardiac Output Monitor	74KFN	II	21 CFR 870.1435
end-tidal Carbon-Dioxide Monitor	73CCK	II	21 CFR 868.1400
Indwelling Blood Pressure Monitor	74CAA	II	21 CFR 870.1110
Indwelling bloodpressure 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
Medical cathode-ray tube display	74DXJ	II	21 CFR 870.2450

Siemens Medical Systems, Inc.

Electronedical Group

16 Electronics Avenue Danvers, MA 01923 ાડત

Tel: (508) 750-7500 Fax: (508) 777-3398 Telex: 511958 (Siemensm SD)

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4: Predicate Device Identification:

The Siemens SC900/9015 Series Surgical Display Controller is substantially equivalent to the Siemens SC90009015 Series SC9015 Display.

5. Device Description

The SC900/9015 Series Surgical Display Controller enables SC9000/9015 monitoring to be displayed on a Siemens 15 inch Remote Display or on a standard video display.

6. Intended Use:

The intended use of the Siemens SC9000/9015 Series Surgical Display Controller is to display SC9000/9015 Bedside Monitor functions on a Siemens Remote Display or on a standard video display.

7. Table of device similarities and differences to predicate device

	Substantial Equivalent Device:Siemens Medical SystemsSC 9000/9015 SeriesSC9015 Display	Applicant:Siemens Medical SystemsSC 9000/9015 Series SurgicalDisplay Controller
Manufacturer	Siemens Medical Systems Electromedical Group	Siemens Medical SystemsElectromedical Group
510K Number	K946306	K970348
Intended Population	Same as Siemens Component Monitoring System	Same
Displayed Parameters	Same as bedside monitor	Same
Measuring Methods	None: Information and data generated in bedsidemonitor	Same
Waveform Display	Dependent on the bedside monitor's primarydisplay	Same

8. Assesment of non-clinical performance data for equivalence:

The Siemens 90009015 Series Surgical Display Controller is substantially equivalent to the predicate device: Siemens 9000/9015 Series SC9015 display.

9. Assessment of clinical performance data for equivalence:

Not applicable; device is substantially equivalent to predicate device.

1. Biocompatability: Not applicable
1. Sterilization: Not applicable

Siemens Medical Systems, Inc. ... ...

Electromedical Group

16 Electronics Avenue Danvers, MA 01923 usa

Tel: (508) 750-7500 Fax (508) 777 3333 Telex: 511958 (Siemensm SD)

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

AUG 1 5 1997

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

Re: K970348 Siemens SC9000/SC9015 Series Surgical Display Controller Regulatory Class: III (three) Product Code: 74 DSI Dated: May 16, 1997 Received: May 19, 1997

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 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, Druq, 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 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 (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 Requlation (QS) for Medical Devices: General requlation (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 regulatory 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 begin 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 regulation (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/dsmamain.html".

Sincerely yours,

Thomas J. Cillechon

Thomas J. Callahan, 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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Indicated Use Statement

MRI Compatibility Statement:

The Siemens SC9000/9015 Series Surgical Display Controller is not intended for use in an MRI environment.

Prescription Use ✓

Christy Foreman for AAC
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
K970348

Company Confidential

510(k) Number

Siemens Medical Systems, Inc.

Electromedical Group

16 Electronics Avenue Danvers, MA 01923 USA

Tel: (508) 750-7500 Fax: (508) 777-3398 Telex: 511958 (Siemensm SD)

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.