SIEMENS SC9000/SC9015 MULTIGAS AND MULTIGAS+ MODULES

K965062 · Siemens Medical Solutions USA, Inc. · DSI · Jun 4, 1997 · Cardiovascular

Device Facts

• Record ID: K965062
• Device Name: SIEMENS SC9000/SC9015 MULTIGAS AND MULTIGAS+ MODULES
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: DSI · Cardiovascular
• Decision Date: Jun 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The intended use of the Siemens SC9000/ SC9015 MULTIGas™ Module and MULTIGas™+ Module is to measure inspiratory and expiratory carbon dioxide, inspiratory and expiratory oxygen, inspiratory and expiratory Nitrous Oxide and anesthetic agents. This device will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce recordings. This device will connect to either the Siemens SIRENET or Infinity (Olympus) network.

Device Story

The Siemens MULTIGas™ and MULTIGas+™ modules are sidestream gas monitoring units designed for integration with SC9000/SC9015 bedside monitors. The modules sample respiratory gases to measure CO2, N2O, anesthetic agents, and O2. The basic MULTIGas module uses a galvanic cell for O2 measurement, while the MULTIGas+ uses a faster-responding paramagnetic sensor. The modules process gas concentration data and transmit it to the bedside monitor for display of waveforms, trends, and numerical values. Healthcare professionals use the device in clinical environments to monitor patient respiratory status; the system provides visual and audible alarms when parameters exceed preset limits, aiding in clinical decision-making during anesthesia or respiratory care. The device benefits patients by providing continuous, real-time monitoring of gas concentrations and respiratory effort.

Clinical Evidence

No clinical data. Substantial equivalence is based on non-clinical performance data and the use of the same OEM gas measurement hardware (Andros Inc Model 4700 MGM) as the predicate device.

Technological Characteristics

Sidestream gas measurement using non-dispersive infrared (NDIR) technology. MULTIGas uses a galvanic cell for O2; MULTIGas+ uses a paramagnetic sensor for O2. Connectivity via Siemens SIRENET or Infinity (Olympus) network. Software version VB1.1. Standalone module form factor.

Indications for Use

Indicated for adult and pediatric patients in clinical settings where care is provided by healthcare professionals (physicians, nurses, technicians) to measure respiration rate, CO2, O2, and anesthetic gas concentrations (Enflurane, Halothane, Isoflurane, Desflurane, Sevoflurane, Nitrous Oxide). Not 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

• Hewlett-Packard model M1026A Anesthesia Gas Module (K951127)

Reference Devices

• SC9000/9015 Bedside Monitor System (K946306)

Submission Summary (Full Text)

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K 965062
JUN - 4 1997

510 (K) Notification
Siemens SC9000/ SC9015 MULTIGas™ and MULTIGas+™ Modules

## 510(k) SUMMARY
as required per 807.92(c)

### 2: Submitters Name, Address:
Siemens Medical Systems, Inc.
16 Electronics Avenue
Danvers, MA 01923
Tel: [phone]
Fax: [phone]
Official Correspondent: David Simard, Director Quality Assurance and Regulatory Affairs
Contact person for this submission: Jacqueline E. M. Emery
Date submission was prepared: December 9, 1996

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

A. Trade Name: Siemens SC9000/ SC9015 Series MULTIGas™ Module
Siemens SC9000/SC9015 Series MULTIGas+™ Module

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 |

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

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510 (K) Notification
Siemens SC9000/ SC9015 MULTIGas™ and MULTIGas+™ Modules

| Multi Gas Monitor | | | |
| --- | --- | --- | --- |
| Analyzer, Gas, Carbon Dioxide, Gaseous | 73CCK | II | 21CFR868.1400 |
| Analyzer, Gas, Enflurane Gaseous | 73CBQ | II | 21CFR868.1500 |
| Analyzer, Gas, Halothane, Gaseous | 73CBS | II | 21CFR868.1620 |
| Analyzer, Gas, Nitrous Oxide, Gaseous | 73CBR | II | 21CFR868.1700 |
| Analyzer, Gas, Oxygen, Gaseous | 73CCL | II | 21CFR868.1720 |

## 4: Predicate Device Identification:

The MULTIGas modules use the same hardware, provided by the same OEM manufacturer, as the Hewlett-Packard model M1026A Anesthesia Gas Module Gas Module, cleared under 510(K) number K951127.

The SC9000/9015 Bedside Monitor System (510 (K) number K946306) provides the display and user interface capabilities for the MULTIGas™ modules.

## 5. Device Description

There are two multi gas modules being submitted as part of this 510(K) Notification: the MULTIGas™ (MGM) and the MULTIGas+™ (MGM+). Both modules are free standing units that perform sidestream measurements of respiratory gases (CO₂, N₂O, and O₂) and anesthetic gases. Both modules automatically identify and report measurement data to the SC9000/SC9015 Bedside Monitor for display.

The MULTIGas™ and MULTIGas+™ modules differ only in the way they measure O₂. The basic MULTIGas Module measures O₂ using a galvanic cell, and calculates average inspiratory values for O₂ (labeled iO₂). The MULTIGas+ incorporates a faster-responding paramagnetic sensor that provides both inspired and expired O₂ measurements (iO₂ and etO₂).

The enhanced software (version VB1.1) is compatible with previously sold versions of the monitor. A retrofit will be offered to the owners of units with previous software versions.

## 6. Intended Use:

The intended use of the Siemens SC9000/ SC9015 MULTIGas™ Module and MULTIGas™+ Module is to measure inspiratory and expiratory carbon dioxide, inspiratory and expiratory oxygen, inspiratory and expiratory Nitrous Oxide and anesthetic agents. This device will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce recordings. This device will connect to either the Siemens SIRENET or Infinity (Olympus) network.

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

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510 (K) Notification

Siemens SC9000/ SC9015 MULTIGas™ and MULTIGas+™ Modules

7. Table of device similarities and differences to predicate device

| | Substantial Equivalence
Hewlett Packard
Model M1026A Anesthesia Gas Module | SC 9000/9015 Series MULTIGAS™
and MULTIGAS+™ Modules |
| --- | --- | --- |
| Manufacturer | Hewlett-Packard | Siemens Medical Systems -
Electromedical Group |
| 510K Number | K951127 | New |
| Intended Population | Not stated in literature | Adult and Pediatric |
| Module/Stand-Alone Monitor | Module: Communicates only
with HP Anesthesia Component
Monitoring System | Module: Communicates only
with Siemens SC9000/9015
Bedside Monitors |
| Displayed Parameters | CO2, N2O, Respiration Rate,
Anesthetic Agents | Same |
| Principle of Operation | Non-dispersive Infra Red | Same |
| Measuring Methods | sidestream | Same |
| Waveform Display | Inspired and expired
concentrations (in %) plus
waveform and trend data | Same |
| Dimensions HxWxD (mm/in) | 80x370x439 / 3.5x14.5x17.3 | 146x183x451 / 5.7x7.2/17.8 |
| Weight kg / lb | 8.2 / 18 | 7.3 / 16.0 |

8. Assessment of non-clinical performance data for equivalence: Both the Siemens MULTIGas™ Modules and the HP M1026A Anesthesia Gas module employ, internally, the Andros Inc Model 4700 MGM Multi Gas Module as the means for measuring the various gases.

9. Assessment of clinical performance data for equivalence: Not applicable

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)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN - 4 1997

Ms. Jacqueline E. M. Emery
Siemens Medical Systems, Inc.
16 Electronics Avenue
Danvers, Massachusetts 01923

Re: K965062
Siemens SC9000/SC9015 MULTIGas™ and MULTIGas+™ Modules Regulatory Class: III (three)
Product Code: 74 DSI
Dated: March 25, 1997
Received: March 27, 1997

Dear Ms. Emery:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 - Ms. Jacqueline E. M. Emery

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 MULTIGas
^{\text{tm}}
and MULTIGas+ tm Modules

# Indicated Use Statement

The Siemens SC9000/SC9015 MULTIGas™ and MULTIGas+™ Modules are indicated for adult and pediatric patient populations in an environment where patient care is provided by healthcare professionals (Physician, Nurse, Technician) when the professional determines that these devices are required to measure any one or more of the following parameters:

- 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

# MRI Compatibility Statement:

The Siemens SC9000/9015 MULTIGas tm and MULTIGas+ tm modules are not intended for use in an MRI magnetic field



(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number Over-the-Counter VSL

# Company Confidential

Siemens Medical Systems, Inc.

Electromedical Group

16 Electronics Avenue

Danvers, MA 01923

USA

Tel: [phone]

Fax: [phone]

Telex: 511958 (Siemensm SD)