INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II

K012016 · Siemens Medical Solutions USA, Inc. · MHX · Jul 20, 2001 · Cardiovascular

Device Facts

• Record ID: K012016
• Device Name: INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Jul 20, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The INFINITY SC 8000 monitor is intended for multi-parameter patient monitoring. The device will monitor physiological parameters and if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced. This device will connect to a Siemens R50 Bedside recorder, either directly or via the INFINITY Network. 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.

Device Story

INFINITY SC 8000 is a multi-parameter patient monitor for clinical environments; operated by physicians, nurses, and technicians. Inputs include physiological signals (ECG, pressure, temperature, EEG, pulse oximetry, gas concentrations via modules). Device processes inputs to display real-time waveforms, numerical values, and alarm conditions. Modification adds RJ45 interface for MIB II Protocol Converter, supporting IEEE 1073.3.2-2000 standard for medical communication transport. Output allows clinicians to assess patient status, trigger alarms, and generate recordings via bedside recorders or network. Benefits include continuous patient surveillance and timely clinical intervention based on monitored physiological trends.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Multi-parameter patient monitor. Connectivity: RJ45 interface for MIB II Protocol Converter supporting IEEE 1073.3.2-2000 standard. Interfaces with external modules (MultiGas, etCO2, Respiratory Mechanics Pod).

Indications for Use

Indicated for multi-parameter monitoring of adult, pediatric, and neonatal patients. Parameters include heart rate, respiration, invasive/non-invasive pressure, temperature, cardiac output (adult/pediatric), arterial oxygen saturation, pulse rate, apnea, ST segment analysis (adult/pediatric), tcpO2/tcpCO2 (neonatal only, non-anesthesia), EEG, FiO2, and gas concentrations (CO2, O2, anesthetic agents). Arrhythmia detection is not for neonatal mode. Contraindicated for use in MRI magnetic fields.

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 8000 (K983632)
• SC 8000 w/Advanced Communication Option (K990563)
• Siemens INFINITY MIB II Protocol Converter (K010640)

Reference Devices

• MultiGas and MultiGas+ modules (K965062)
• Surgical Display Controller (K970348)
• Medical Information BUS Protocol Converter (MIB and MIB II) (K970368, K973222, K99166, K003248)

Submission Summary (Full Text)

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# 510(k) SUMMARY

as required per 807.92(c)

Submitters Name, Address:

JUL 2 0 2001

P. 1/2

Siemens Medical Systems, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: [phone] Fax: [phone] Official Correspondent: Connie Hertel, Director, QA/RA Contact person for this submission: Penelope H. Greco Date submission was prepared: June 26, 2001

Trade Name, Common Name and Classification Name:

A. Trade Name:

i

Siemens Medical Information Bus (MIB II) Protocol Converter Common Name, Classification Name, Class and Regulation Number:

| Common Name | Product Code | Class | Regulation Number |
|-----------------------------------------------------------------------|--------------|-------|-------------------|
| Monitor, Physiological, Patient (with arrhythmia detection or alarms) | MHX | III | 21 CFR 870.1025 |
| Arrhythmia detector & Alarm | 74DSI | III | 21 CFR 870.1025 |

Legally Marketed Device Identification:

Siemens SC 8000 K983632 SC 8000 w/Advanced Communication Option, K990563 Siemens INFINITY MIB II Protocol Converter, K010640

### Description of Modification:

The SC 8000 Advanced Communication Option II is equivalent to that submitted in K990563 in that it The SC 6000 Authuned Communication of can process and display, from external devices:

MultiGas and MultiGas+ modules (K965062) Surgical Display Controller (K970348) Medical Information BUS Protocol Converter (MIB and MIB II) (K970368, K973222, K99166, K003248, and K010640)

A modification has been implemented in the SC 8000 Advanced Communication Option II to accommodate RJ45 connectors for interfacing to the MIB II Protocol Converter (K010640). The MIB II Protocol Converter supports the new IEEE 1073.3.2-2000, Standard for Medical Communications -Transport Profile - irDA Based - Cable Connected.

#### Intended Use:

The INFINITY SC 8000 monitor is intended for multi-parameter patient monitoring. The device will r no INT I 1 1 50 0000 months if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced. This device will connect to a Siemens R50 Bedside recorder, either directly or via the INFINITY Network.

| COMPANY CONFIDENTIAL | | |
|--------------------------------------------------------------------|--------------------------------------------|--------------------------------------------|
| Siemens Medical Systems, Inc.<br>Electromedical Systems Group. PCS | 16 Electronics Avenue<br>Danvers, MA 01923 | Tel: [phone]<br>Fax: [phone] |

{1}------------------------------------------------

Assessment of non-clinical performance data for equivalence:_Section J

Assessment of clinical performance data for equivalence: Not applicable

Biocompatability: Not applicable

Sterilization: Not applicable

Standards and Guidances:

1073.3.2 - 2000 IEEE Standard for Medical Communications Transport Profile - IrDA Based - Cable Connected

# 2

## COMPANY CONFIDENTIAL

Siemens Medical Systems, Inc.

Electromedical Systems Group, PCS

16 Electronics Avenue Danvers. MA 01923

Tel: [phone] Fax: [phone]

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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 features a stylized image of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the left and top of the emblem in a circular fashion. The logo is presented in black and white.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 2 0 2001

Ms. Penelone H. Greco Regulatory Submissions Manager Siemens Medical Systems, Inc. Electromedical Systems Group, PCS 16 Electronics Avenue Danvers, MA 01923

Re: K012016

Trade Name: INFINITY SC 8000 with Advanced Communications Option II Regulation Number: 21 CFR 870.1025 Regulatory Class: III (three) Product Code: 74 MHX Dated: June 26, 2001 Received: June 28, 2001

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 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 control provisions of the Act. The general control 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

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Page 2 - Ms. Penelope H. Greco

Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will anow you to ovegn mansoning your device of your device to a legally marketed notification. The PDA midning of substantal vour 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 If you desire specific as no room in devices), please contact the Office of Compliance at additionally 807.10 for m This allestions on the promotion and advertising of your device, [phone]. Truuntonally, 10. quice at [phone]. Also, please note the regulation 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 . Information on your responsionnities and research or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Ken Miller

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_KO120 كا 20120)

Device Name: INFINITY SC 8000 Monitor_ Indications for Use:

The INFINITY SC 8000 Monitor is capable of monitoring:

- Heart rate ●
- Respiration rate .
- Invasive pressure ●
- Non-invasive pressure .
- Arrhythmia ◆
- . Temperature
- Cardiac output .
- Arterial oxygen saturation .
- Pulse rate .
- Apnea .
- ST Segment Analysis .
- 12-Lead ST Segment Analysis .
- tcp02/tcpC02 .
- EEG signals .
- FiO2 ●

With the MultiGas and MultiGas+ modules the monitor is capable of measuring respiration rate, Inspired and expired Carbon Dioxide (CO2), inspired and expired Oxygen (MultiGas+ only), average inspired Oxygen (MultiGas only), inspired and expired gas concentrations of Enflurane, Halothane, Isoflurane, Desflurane, Sevoflurane, and Nitrous Oxide.

With etCO2 the monitor can measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode

With the INFINITY etCO2 + Respiratory Mechanics Pod the monitor can provide spirometric and carbon dioxide monitoring.

The monitor can interface with specific third party devices via an MIB protocol converter.

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 parameler Cardiac Output and ST Segment Analysis which are intended for use in the adult and pediarric populations only; Arrhylhmia which is not intended for use in neonatal mode; and tcpO2 which is to be used in the neonatal population only when the patient is not under gas anesthesia.

#### MRI Compatibility Statement:

The INFINITY SC 8000 Monitor is not compatible for use in a MRI magnetic field.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | <div>OR</div> | Over-The-Counter Use |
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Division of Cardiovascular & Respiratory Devices (Optional Format 1-2-96)

| 510(k) Number | 12012016 |
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