SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL, WITH SCIO

K031340 · Siemens Medical Solutions USA, Inc. · MHX · Nov 25, 2003 · Cardiovascular

Device Facts

• Record ID: K031340
• Device Name: SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL, WITH SCIO
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Nov 25, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The INFINITY Modular Monitors are intended for multi-parameter patient monitoring. The devices will produce visual and audible alarms 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.

Device Story

Modular patient monitoring system; inputs include physiological signals (ECG, EEG, pressure, temperature, SpO2) and sampled breathing gases (CO2, N2O, O2, anesthetic agents) via SCIO/MultiGas modules. System processes inputs to provide real-time monitoring, derived gas information, and arrhythmia detection. Used in clinical environments by physicians, nurses, and technicians. Output displayed on monitor; provides visual/audible alarms for out-of-limit parameters. Supports clinical decision-making by providing continuous patient status updates; enables timely intervention for physiological instability.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical performance data and bench testing.

Technological Characteristics

Modular patient monitor with plug-in gas analysis modules (SCIO/MultiGas). Measures physiological parameters via sensors and gas content via sampling. Connectivity via INFINITY Network or direct connection to R50 recorder. Software-based monitoring and alarm system. Not MRI compatible.

Indications for Use

Indicated for adult, pediatric, and neonatal patients for multi-parameter monitoring including heart rate, respiration, pressure (invasive/non-invasive), arrhythmia, temperature, cardiac output, SpO2, pulse, apnea, ST segment, EEG, tcpO2/tcpCO2, FiO2, and anesthetic gases. Cardiac output, ST segment, etCO2 sidestream, and arrhythmia are for adult/pediatric only. tcpO2 is for neonates only (not under gas anesthesia).

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

• INFINITY Modular Monitors (K022889)
• Vamos Anesthetic Gas Monitor (K012139)

Reference Devices

• SC 9000 / SC 9015 Multigas and Multigas+ Modules (K965062)
• SC 8000 with Advanced Communication Option II (K012016)
• SC 7000 / SC 9000XL Modular Monitors (K980882)
• INFINITY Modular Monitors (SC 7K, 8K, 9KXL) (K003243)
• SC 8000 with Advanced Communication Option (K990563)
• SC 8000 Bedside Monitor (K983632)

Submission Summary (Full Text)

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## NOV 2 5 2003

### 510(k) Notification INFINITY Modular Monitors (SC 7000, SC 8000, SC 9000XL) with SCIO

#### 510(k) SUMMARY

as required per 807.92(c)

Submitters Name, Address:

KO31340 Siemens Medical Solutions, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: [phone] Fax: [phone] Official Correspondent: Connie Hertel, Director Quality Assurance & Regulatory Affairs Contact person for this submission: Penelope H. Greco April 23, 2003 Date submission was prepared:

#### Trade Name, Common Name and Classification Name:

#### A. Trade Name:

INFINITY Modular Monitors (SC 7000 / SC 9000XL / SC 8000) with SCIO

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

| Common Name | Product Code | Class | Regulation Number |
|--------------------------------------------------------------------------|--------------|-------|-------------------|
| Monitor, Physiological, Patient (with<br>Arrhythmia Detection or Alarms) | MHX | III | 21 CFR 870.1025 |

#### Legally Marketed Device Identification:

INFINITY SC 8000 Monitor, 510(k) K983632 / K990563 INFINITY SC 7000 / SC 9000XL Modular Monitors, 510(k) K003243/K982730/ K980882

#### Predicate Device Identification:

| K022889 | INFINITY Modular Monitors |
|---------|------------------------------|
| K012139 | Vamos Anesthetic Gas Monitor |

Other relevant submissions

| K965062 | SC 9000 / SC 9015 Multigas and Multigas+ Modules |
|---------|--------------------------------------------------|
| K012016 | SC 8000 with Advanced Communication Option II |
| K980882 | SC 7000 / SC 9000XL Modular Monitors |
| K003243 | INFINITY Modular Monitors (SC 7K, 8K, 9KXL) |
| K990563 | SC 8000 with Advanced Communication Option |
| K983632 | SC 8000 Bedside Monitor |

#### Device Description:

Siemens INFINITY Modular Monitors are intended for multi-parameter patient monitoring. The SCIO module samples breathing gases from adults and pediatrics. SCIO continuously measures the content of CO2, N2O, O2 and one of the anesthetic agents: halothane, isoflurane, enflurane, sevoflurane, and desflurane in any mixture. When SCIO is connected to an INFINITY Modular monitor it communicates real time and derived gas information to the monitor for display.

Page 1 of 2 COMPANY CONFIDENTIAL Siemens Medical Solutions, Inc. Electromedical Systems Group, PCS 16 Electronics Avenue Tel: [phone] Danvers, MA 01923 Fax: [phone]

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Intended Use:

The INFINITY Modular Monitors are intended for multi-parameter patient monitoring. The devices will produce visual and audible alarms 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.

Assessment of non-clinical performance data for equivalence: Substantially equivalent (Section S)

Assessment of clinical performance data for equivalence: Substantially equivalent (Section U)

Biocompatibility: Section M

Sterilization: Not applicable

Standards and Guidance: Section R

Page 2 of 2

#### COMPANY CONFIDENTIAL

Siemens Medical Solutions, 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 is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 25 2003

Ms. Penelope H. Greco Regulatory Submissions Manager Siemens Medical Solutions USA, Incorporated 16 Electronics Avenue Danvers, MA 01923

Re: K031340

Trade/Device Name: INFINITY Monitors (SC 7000/SC 900XL) with SCIO Regulation Number: 21 CFR 870.1025 Regulation Name: Physiological Patient Monitor, (W/ Arrhythmia Detection or Alarms) Regulatory Class: III Product Code: MHX Dated: August 29, 2003 Received: September 2, 2003

Dear Ms. Greco:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2 – Ms. Penelope H. Greco

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Susa Qum
Chiu Lin, Ph.D.

Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Eyaluation Center for Devices and Radiological Health

Enclosure

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# 510(k) Number (if known): KO31340

## Device Name:

Indications for Use:

The INFINITY Modular monitors are 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 ●

The Scio and MultiGas/MultiGas+ modules sample breathing gases from adults and pediatrics. The gas modules continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, halothane, isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the INFINITY monitors.

With etCO2 the monitors can measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode; and with etCO2+Respiratory Mechanics, spirometry and carbon dioxide can be monitored.

The monitors can interface with specific third party devices via a MIB protocol converter.

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 patients, with the exception of the parameter Cardiac Output, ST Segment Analysis, etCO2 sidestream, and arrhythmia which are intended for use in the adult and pediatric populations only; 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 Modular 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) | | |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|-----------------------|
| Prescription Use | <div> <p>✓</p> </div> | OR | Over-The-Counter Use_ |
| (Per 21 CFR 801.109) | | | |
| | <div> <p><u>E. Zintch</u> 11/25/03 (Optional Format 1-2-96)</p> <p>(Division Sign-Off)</p> <p>Division of Anesthesiology, General Hospital,</p> <p>Infection Control, Dental Devices</p> </div> | | |

510(k) Number 109/5