K Number

Device Name

SIEMENS SC/9000/SC9015 SERIES SURGICAL DISPLAY CONTROLLER

Manufacturer

SIEMENS MEDICAL SOLUTIONS USA, INC.

Date Cleared

1997-08-15

(198 days)

Product Code

DSI

Regulation Number

870.1025

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K946306

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a display controller for a bedside monitor and does not mention any AI or ML capabilities.

Therapeutic

No
The device is a display controller for patient vital signs, not a device that provides treatment or therapy.

Diagnostic

No.
The device is a display controller for a bedside monitor, which enables the monitor's parameters and functions to be displayed on a remote terminal. It does not perform any diagnostic function itself; it merely outputs information from a separate monitoring device.

SaMD (Software as a Medical Device)

The device description explicitly states it enables display on a "Siemens 15 inch Remote Display or on a standard video display," indicating it includes or interfaces with hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Siemens SC9000/SC9015 Series Surgical Display Controller is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is used to display parameters and functions generated by a bedside monitor. This involves displaying physiological data from a patient, not analyzing samples taken from the patient (which is the core of IVD).
Device Description: The description confirms its function is to enable monitoring display on a remote terminal.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other typical components of an IVD device.
Predicate Device: The predicate device is a display, which aligns with the function of displaying information, not performing in vitro diagnostics.

Therefore, the Siemens SC9000/SC9015 Series Surgical Display Controller is a device for displaying patient monitoring data, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

74DRT, 74DSI, 73BZQ, 74BWS, 74DXN, 80BWX, 74DQA, 74KFN, 73CCK, 74CAA, 74FLO, 73FLS, 74FLP, 74DXJ

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare professionals (e.g. surgeons and other operating room personnel).

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K946306

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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 frequency
monitor	73BZQ	II	21 CFR 868.2375
Pulse rate monitor	74BWS	II	21 CFR 870.2300
Non-indwelling blood
pressure 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 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
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)

ーに、・・

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 Systems
SC 9000/9015 Series
SC9015 Display | Applicant:
Siemens Medical Systems
SC 9000/9015 Series Surgical
Display Controller |
|----------------------|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Manufacturer | Siemens Medical Systems Electromedical Group | Siemens Medical Systems
Electromedical 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 bedside
monitor | Same |
| Waveform Display | Dependent on the bedside monitor's primary
display | 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)

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.

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

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)