SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR

K982730 · Siemens Medical Solutions USA, Inc. · DSI · Aug 24, 1998 · Cardiovascular

Device Facts

• Record ID: K982730
• Device Name: SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: DSI · Cardiovascular
• Decision Date: Aug 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The intended use of the SC 7000 and SC 9000XL Bedside Monitoring Series is to monitor heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, arterial oxygen saturation and pulse rate, cardiac output, central apnea, end-tidal carbon dioxide, ST segment analysis, 12-Lead ST Segment Analysis, and transcutaneous oxygen & 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

Modular bedside monitors (SC7000/SC9000XL) for continuous physiological monitoring; inputs include ECG, invasive/non-invasive pressure, temperature, SpO2, CO2, cardiac output, and gas concentrations (via MultiGas modules). System processes signals to display waveforms/numerics, perform arrhythmia/ST segment analysis, and trigger visual/audible alarms for out-of-limit conditions. Used in clinical environments by physicians, nurses, and technicians. Integrates with Siemens R50 recorders and Infinity networks. Provides real-time patient status to support clinical decision-making and patient safety.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing and comparison of technological characteristics to the predicate device.

Technological Characteristics

Modular bedside monitor; 10.4" color TFT display; supports up to 8 waveforms. Parameters: ECG, IBP, NBP (oscillometric), SpO2, CO2, temperature, cardiac output, gas analysis. Connectivity: Infinity network, MIB compatible. Software-based arrhythmia and ST segment analysis. Not MRI compatible.

Indications for Use

Indicated for adult, pediatric, and neonatal patients in healthcare settings by professionals. Cardiac output and ST segment analysis limited to adult/pediatric. Arrhythmia detection limited to adults. Transcutaneous oxygen limited to neonates not under gas anesthesia. 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 SC9000/SC9015 Patient Monitoring System (K946306)

Submission Summary (Full Text)

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# 510(k) NOTIFICATION SIEMENS SC7000 and SC9000XL INFINITY Modular BedsideMonitors

# AUG 24 1998

# 510(k) SUMMARY

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: Jacqueline Emerv Date submission was prepared: August 13, 1998

Trade Name, Common Name and Classification Name:

- A. Trade Name:
Siemens SC7000 & SC9000 XL INFINITY Modular Bedside Monitor Series

- 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 |
| End-tidal Carbon-Dioxide Monitor | 73CCK | II | 21 CFR 868.1400 |
| Monitor, Carbon-Dioxide, Cutaneous | 73LKD | II | 21 CFR 868.2480 |
| Monitor, Oxygen, Cutaneous, for infants not under gas<br>anesthesia | 73KLK | II | 21 CFR 868.2500 |

Predicate Device Identification:

Siemens SC9000/SC9015 Patient Monitoring System, original 510(k) submission K946306.

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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# 510(k) NOTIFICATION SIEMENS SC7000 and SC9000XL INFINITY Modular BedsideMonitors

#### Device Description:

The SC 7000 and SC 9000XL modular bedside monitors are enhanced versions of the SC 9000 (predicate device - original submission K946306) and use the same front panel display and user interface as the SC 9000. In addition, the SC 9000 docking station is compatible with the SC 7000 and SC 9000XL for power and communication capabilities.

The SC 7000 (mid-level monitor) and the SC 9000XL (high-end monitor) are additions to the Siemens INFINITY Modular Portable Bedside Monitoring Series. Both the SC7000 and SC 9000 XL utilize the same electronics and software, but with different base configurations and available options.

### Intended Use:

The intended use of the SC 7000 and SC 9000XL Bedside Monitoring Series is to monitor heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, arterial oxygen saturation and pulse rate, cardiac output, central apnea, end-tidal carbon dioxide, ST segment analysis, 12-Lead ST Segment Analysis, and transcutaneous oxygen & 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.

# 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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| | able of Device Similarities and differences to predicate device | Applicant | |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|-------------------|
| | Substantial Equivalent Device | Siemens Medical Systems | |
| | Siemens SC9000 | Siemens SC 7000 | Siemens SC9000 XL |
| Manufacturer | Siemens | Same | Same |
| 510(k) Number | K946306 (original submission) | To be assigned | |
| Intended Use | The intended use of the SC 7000<br>and SC 9000XL Bedside<br>Monitoring Series is to monitor<br>heart rate, respiration rate,<br>invasive pressure, non-invasive<br>pressure, arrhythmia,<br>temperature, arterial oxygen<br>saturation and pulse rate, cardiac<br>output, central apnea, end-tidal<br>carbon dioxide, ST segment<br>analysis, 12-Lead ST Segment<br>Analysis, and transcutaneous<br>oxygen & transcutaneous carbon<br>dioxide. This device will<br>produce visual and audible<br>alarms if any of these parameters<br>vary beyond preset limits and<br>produce timed or alarm<br>recordings. This device will<br>connect to a Siemens R50<br>Bedside Recorder, either directly<br>or via the Infinity network. | Same | Same |
| Intended Population | Adult/Pediatric/Neonatal | Same | Same |
| Intended Environment | In a healthcare environment<br>where patient care is provided<br>by healthcare professionals. | Same | Same |
| Display type | Color TFT, 10.4" | Same | Same |
| Waveforms | Up to 8 | Same | Same |
| Arrhythmia Detection | Basic<br>Enhanced Optional | Same | Same |
| Modular | Yes | Same | Same |
| Networking | Standard | Same | Same |
| NBP | Oscillometric | Same | Same |
| MIB | Compatible | Same | Same |
| MultiGas | Compatible | Same | Same |
| ST | 3/7/8/12 leads | Same | Same |
| IBP | Up to 8 channels | Same | Same |

#### f Device Similarities and differences to predicate device i Tabl

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

Assessment of clinical performance data for equivalence: See Section V

Biocompatability: Not applicable

Sterilization: Not applicable

Standards and Guidances: See Section W

3

# 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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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a symbol that resembles a stylized human figure in profile, repeated three times. The figures are connected and appear to be facing the same direction.

AUG 2 4 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David Simard, Director Quality Assurance and Regulatory Affairs Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923

Re: K982730 Siemens SC 7000 and SC 9000XL Bedside Monitors Requlatory Class: III (three) Product Code: DSI Dated: July 13, 1998 Received: July 16, 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 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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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 Reqister. 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 requlations.

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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 Also, device, please contact the Office of Compliance at [phone]. please note the requlation entitled, ?Misbranding by reference to premarket notification? (21CFR 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/dsma/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):

Siemens SC 7000 and SC 9000 XL INFINITY Modular Bedside Monitors Device Name:

Indications for Use:

The SC 7000 and SC 9000XL INFINITY Modular Bedside monitors are capable of monitoring:

- Heart rate .
- Respiration rate .
- Invasive pressure .
- Non-invasive pressure .
- Arrhythmia ●
- . Temperature
- Cardiac output .
- Arterial oxygen saturation .
- Pulse rate .
- End-tidal carbon dioxide .
- (central) apnea
- ST Segment Analysis .
- 12-Lead ST Segment Analysis .
- Transcutaneous Oxygen and Transcutaneous Carbon Dioxide (tpO2/CO2) .

With the MultiGas™ and MultiGas+™ modules the SC 7000 and SC 9000XL are capable of measuring:

- Respiration rate
- Inspired and expired Carbon Dioxide (CO2) .
- Inspired and expired Oxygen (MultiGas+TM only) .
- Average inspired Oxygen (MultiGas™ only) .
- Inspired and expired gas concentrations of Enflurane, Halothane, Isoflurane, Desflurane, Sevoflurane, . and Nitrous Oxide.

The SC 7000 and SC 9000XL can interface with third party devices.

The devices are 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 devices are 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 Transcutaneous Oxygen which is intended for use in the neonatal population when the patient is not under gas anesthesia.

#### MRI Compatibility Statement:

The Siemens SC 7000 and SC 9000XL INFINITY Modular Bedside Monitors are 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) | | |
|----------------------|-------------------------------------------------------|--------------------------|---------|
| | | Stuart Portnoy for DBT | 8-18-98 |
| Prescription Use | | | |
| (Per 21 CFR 801.109) | (Division Sign-Off) OR | | |
| | Division of Cardiovascular, Respiratory, | | |
| | and Neurological Devices | | |
| | 510(k) Number | Over-The-Counter Use | |
| | | (Optional Format 1-2-96) | |