SIEMENS SC/9000/SC9015 SERIES SURGICAL DISPLAY CONTROLLER

K970348 · Siemens Medical Solutions USA, Inc. · DSI · Aug 15, 1997 · Cardiovascular

Device Facts

• Record ID: K970348
• Device Name: SIEMENS SC/9000/SC9015 SERIES SURGICAL DISPLAY CONTROLLER
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: DSI · Cardiovascular
• Decision Date: Aug 15, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

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.

Device Story

The Siemens SC9000/SC9015 Series Surgical Display Controller acts as a remote interface for the SC9000/9015 Bedside Monitor. It receives physiological data and monitoring parameters generated by the bedside monitor and transmits them for display on a Siemens Remote Display or a standard video monitor. Used in clinical settings like the operating room, it allows surgeons and other healthcare personnel to view patient monitoring information at a distance from the primary bedside unit. The device does not perform independent measurements or data processing; it functions solely as a display controller to facilitate clinical visualization of patient status, aiding in real-time clinical decision-making during procedures.

Clinical Evidence

No clinical data; device is substantially equivalent to the predicate device.

Technological Characteristics

The device is a display controller for medical monitoring systems. It functions as a signal interface to route data from a bedside monitor to a remote or standard video display. It does not perform physiological sensing or measurement. It is not MRI compatible.

Indications for Use

Indicated for use in environments where patient care is provided by healthcare professionals, such as surgeons and operating room personnel, whenever the professional determines that parameters and functions generated by the SC 9000/9015 Bedside Monitor should be displayed on a remote terminal. Not intended for use in an MRI environment.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Siemens SC9000/9015 Series SC9015 Display (K946306)

Submission Summary (Full Text)

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510 (K) Notification
Siemens SC9000 / SC9015 Series Surgical Display Controller
AUG 15 1997

# 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: [phone]
Fax: [phone]
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 | 21CFR870.2450 |

Siemens Medical Systems, Inc.
Electromedical Group
16 Electronics Avenue
Danvers, MA 01923
USA
Tel: [phone]
Fax: [phone]
Telex: 511958 (Siemensm SD)

200·39Hd
020010015 01

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10 (1) NtHcA

Siemens SC9000 / SC9015 Series Surgical Display Controller

4: Predicate Device Identification:

The Siemens SC9000/9015 Series Surgical Display Controller is substantially equivalent to the Siemens SC9000/9015 Series SC9015 Display.

5. Device Description

The SC9000/9015 Series Surgical Display Controller enables SC9000/9015 monitoring functions 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 SC9000/9015 Series SC9015 Display | Applicant: Siemens Medical Systems SC9000/9015 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. Assessment of non-clinical performance data for equivalence:

The Siemens 9000/9015 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.

10. Biocompatibility: Not applicable

11. Sterilization: Not applicable

Siemens Medical Systems, Inc.

Electromedical Group

16 Electronics Avenue

Danvers, MA 01923

USA

Tel: [phone]

Fax: [phone]

Telex: 511958 (Siemensm SD)

000.396d

0200810516 01

SINIH7dW0C SRENNN WORH 16. 26. 97

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20856

AUG 15 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, 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 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 regulations 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 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


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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510 (K) Notification
Siemens SC9000/ SC9015 Series Surgical Display Controller

## Indicated Use Statement

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.

## MRI Compatibility Statement:

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

*Prescription Use √*

*Chouety-Soumen for AAC*
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number **K970348**

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## Company Confidential

**Siemens Medical Systems, Inc.**
Electromedical Group
16 Electronics Avenue
Danvers, MA 01923
USA
Tel: [phone]
Fax: [phone]
Telex: 511958 (Siemensm SD)