SIEMENS SC 8000 BEDSIDE MONITOR

K983632 · Siemens Medical Solutions USA, Inc. · DSI · Nov 6, 1998 · Cardiovascular

Device Facts

• Record ID: K983632
• Device Name: SIEMENS SC 8000 BEDSIDE MONITOR
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: DSI · Cardiovascular
• Decision Date: Nov 6, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The intended use of the SC 8000 Bedside Monitor is to monitor heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, arterial oxygen saturation, pulse rate, (central) apnea, cardiac output, ST Segment Analysis, 12-lead ST Segment Analysis, and transcutaneous partial pressure of oxygen and transcutaneous carbon dioxide. This device will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to a Siemens R50 Bedside recorder, either directly or via the Infinity Network.

Device Story

The Siemens SC 8000 is a modular bedside monitor reengineered from the SC 7000/SC 9000XL (K982730) as a display-less unit, allowing integration with third-party medical-grade displays. It processes physiological inputs including ECG, invasive/non-invasive blood pressure, temperature, pulse oximetry, respiratory effort, and transcutaneous gas levels. The device performs real-time signal processing for arrhythmia detection, ST segment analysis, and apnea monitoring. It provides visual and audible alarms for parameter limit violations and supports data recording via the Infinity Network or direct connection to a Siemens R50 recorder. Operated by physicians, nurses, and technicians in clinical care environments, the device assists in patient assessment and clinical decision-making by providing continuous physiological status updates. It is not MRI compatible.

Clinical Evidence

No clinical data provided; substantial equivalence is based on non-clinical performance data and design similarity to the predicate device.

Technological Characteristics

Modular bedside monitor; display-less hardware configuration for external display integration. Supports standard I/O connections and Infinity Network connectivity. Software-based monitoring for physiological parameters (ECG, pressure, temperature, SpO2, gas levels).

Indications for Use

Indicated for adult, pediatric, and neonatal patient populations for monitoring heart rate, respiration, invasive/non-invasive pressure, temperature, cardiac output, arterial oxygen saturation, pulse rate, apnea, ST segment, and tcpO2/CO2. Arrhythmia monitoring is indicated for adults only. Cardiac output and ST segment analysis are indicated for adult and pediatric populations only. tcpO2/CO2 monitoring is indicated for neonates only. Not MRI compatible.

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 SC 7000/SC9000 XL INFINITY Modular Bedside Monitors (K982730)

Submission Summary (Full Text)

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#### 510(k) SUMMARY

6 1998 NOW

as required per 807.92(c)

Submitters Name, Address:

Siemens Medical Systems, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: [phone] Fax: [phone] Official Correspondent: David Simard, Director Quality Assurance & Regulatory Affairs Contact person for this submission: Penelope H. Greco Date submission was prepared: October 9, 1998

Trade Name, Common Name and Classification Name:

A. Trade Name: Siemens SC 8000 Bedside Monitor

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

| Common Name | Classification<br>Number | 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 |
| 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 |
| Monitor, Carbon-Dioxide, Cutaneous | 73LKD | II | 21 CFR 868.2480 |
| Monitor, Oxygen, Cutaneous, for infant not under gasanesthesia | 73KLK | II | 21 CFR 868.2500 |

Legally Marketed Device Identification:

Siemens SC 7000/SC9000 XL INFINITY Modular Bedside Monitors, 510(k) submission K982730.

l

#### COMPANY CONFIDENTIAL

# Siemens Medical Systems, Inc.

Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923 USA

Tel: [phone] Fax: [phone] Telex: 511958 (Siemensm SD)

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# Description of Modification:

The SC 8000 bedside monitor is a modified version of the SC 7000/SC 9000XL INFINITY Modular Bedside Monitors (K982730). The SC 8000 supports all SC 7000 software based options and offers all of the standard I/O connections of the SC 7000 plus interface plate. The hardware has been reengineered as a unit without a display that allows customers the option of providing their own medical-grade display.

# Intended Use:

The intended use of the SC 8000 Bedside Monitor is to monitor heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, arterial oxygen saturation, pulse rate, (central) apnea, cardiac output, ST Segment Analysis, 12-lead ST Segment Analysis, and transcutaneous partial pressure of oxygen and transcutaneous carbon dioxide. This device will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to a Siemens R50 Bedside recorder, either directly or via the Infinity Network.

Assessment of non-clinical performance data for equivalence: See Section L

Assessment of clinical performance data for equivalence: Not applicable

Biocompatability: Not applicable

Sterilization: Not applicable

Standards and Guidances: See Declaration of Conformity, Section P-1

2

### COMPANY CONFIDENTIAL

### Siemens Medical Systems, Inc.

Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923 USA

Tel: [phone] Fax: [phone] Telex: 511958 (Siemensm SD)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6 1998 NOV

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

K983632 Re : Siemens SC 8000 Bedside Monitor Trade Name: Requlatory Class: III Product Code: 74 DSI Dated: October 14, 1998 Received: October 15, 1998

Dear Ms. Greco:

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, qood 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. 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 - Ms. Penelope H. Greco

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

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) Number (if known):_

Device Name:

Indications for Use:

The SC 8000 Bedside monitor is capable of monitoring:

- . Heart rate
- Respiration rate .
- Invasive pressure .
- Non-invasive pressure .
- Arrhythmia ●
- Temperature .
- Cardiac output .
- Arterial oxygen saturation .
- . Pulse rate
- (central) apnea ●
- ST segment analysis .
- 12-Lead ST Segment Analysis ●
- tcpO2/CO2 .

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.

The device is intended to be used on Adult, Pediatric and Neonatal populations, with the exception of the parameter Cardiac Output and ST Segment Analysis which are intended for use in the adult and pediatric populations only; Arrhythmia which is intended for use in the adult population only; and tcpO2/CO2 which is to be used in the neonatal population only.

### MRI Compatibility Statement:

The Siemens SC 8000 Bedside Monitor 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)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

N. Deelutelli

sion Sion-Off Division of Cardiovascular, Respiratory, and Neurological Devi 510(k) Number