SPEACELABS MULTIGAS MODULE

K112173 · Spacelabs Healthcare · CBR · Oct 5, 2011 · Anesthesiology

Device Facts

• Record ID: K112173
• Device Name: SPEACELABS MULTIGAS MODULE
• Applicant: Spacelabs Healthcare
• Product Code: CBR · Anesthesiology
• Decision Date: Oct 5, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.1700
• Device Class: Class 2

Intended Use

The Spacelabs Multigas Module, Model 92518 (Model 92518) is intended to provide a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agent(s), oxygen, carbon dioxide or nitrous oxide moves outside of user-defined limits. The multigas module is capable of automatically identifying which anesthetic agent(s) is being administered. The 92518 Multigas Module is intended to be used with and controlled by a Spacelabs Healthcare Ultraview-family monitor. The 92518 Multigas Module is intended to be used for monitoring all hospitalized patients, under the direction of qualified medical personnel. Although the 92518 Multigas Module alarms when the duration between breaths exceeds user defined limits, it is not intended to be a primary diagnostic apnea monitor and/or recording device.

Device Story

The Spacelabs Multigas Module, Model 92518 is a sidestream gas analyzer designed for integration into Spacelabs Ultraview-family monitors. It continuously samples respiratory gases to measure CO2, O2, N2O, and anesthetic agents (Desflurane, Enflurane, Halothane, Isoflurane, Sevoflurane). The module automatically identifies anesthetic agents and calculates MAC and age-dependent MAC values. Used primarily in operating room environments, it is operated by qualified medical personnel. The host Ultraview monitor provides the user interface, displaying numeric concentrations, respiratory rate, and capnograph waveforms. The device triggers alarms when gas concentrations exceed user-defined limits or when breath duration exceeds thresholds. By providing real-time gas monitoring and agent identification, the device assists clinicians in managing patient ventilation and anesthesia delivery, aiming to improve patient safety during procedures.

Clinical Evidence

Bench testing only. Performance verified against IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-1-8 (alarm systems), and ISO 21647 (respiratory gas monitors). Software verified and validated per FDA guidance and IEC 60601-1-4.

Technological Characteristics

Sidestream gas analyzer; infrared sensing for CO2 and anesthetic agents; paramagnetic sensing for O2. Modular form factor for integration into Ultraview-family monitors. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, and ISO 21647.

Indications for Use

Indicated for monitoring gas concentrations (CO2, O2, N2O, anesthetic agents) and respiratory rate in all hospitalized patients under the direction of qualified medical personnel. Not intended as a primary diagnostic apnea monitor.

Regulatory Classification

Identification

A nitrous oxide gas analyzer is a device intended to measure the concentration of nitrous oxide anesthetic in a gas mixture. The device may use techniques such as infrared absorption or mass spectrometry.

Predicate Devices

• Multigas Analyzer Module 91518 and Accessories (K053599)

Submission Summary (Full Text)

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K112173

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| Submission Date: | 29 September 2011<br>OCT - 5 2011 |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Spacelabs Healthcare<br>5150 220th Avenue SE<br>Issaquah, WA 98029 |
| Submitter Contact: | Spacelabs Healthcare<br>5150 220th Avenue SE<br>Issaquah, WA 98029<br>Mr. David J. Geraghty<br>Spacelabs Healthcare<br>Phone: [phone], ext 5889<br>Fax: [phone]<br>Email: [e-mail] |
| Official Contact: | Thomas Kroenke<br>Principal Consultant<br>Speed To Market, Inc.<br>PO Box 3018<br>Nederland, CO 80466 USA<br>[e-mail]<br>303 956 4232 |
| Manufacturing Site: | Spacelabs Healthcare<br>5150 220th Avenue SE<br>Issaquah, WA 98029 |
| Trade Name: | Spacelabs Multigas Module, Model 92518 |
| Common Name: | Multigas analyzer |
| Classification Name: | Carbon dioxide gas analyzer, Enflurane gas analyzer, Desflurane gas<br>analyzer, Sevoflurane gas analyzer, Isoflurane gas analyzer, Halothane<br>gas analyzer, Nitrous oxide gas analyzer, Oxygen gas analyzer |
| Classification<br>Regulation: | 21 CFR §868.1700 |
| Primary Product<br>Code: | CBR |
| Secondary Product<br>Codes: | CCK, CBQ, NHO, NHP, NHQ, CBS, CCL |

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| Substantially<br>Equivalent Devices: | New Spacelabs Model | Predicate 510(k)<br>Number | Predicate<br>Manufacturer / Model |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|--------------------------------------------------------------------------------------|
| | Spacelabs Multigas<br>Module, Model 92518 | K053599 | Spacelabs Medical,<br>Inc. / Multigas<br>Analyzer Module<br>91518 and<br>Accessories |
| Device Description: | The Spacelabs Multigas Module, Model 92518 (Model 92518) is an<br>easy-to-use modular unit in the Spacelabs Healthcare Ultraview-family<br>of monitors (Ultraview). The Module 92518 is inserted into a bay<br>within an Ultraview monitor. The Ultraview monitor is then used to<br>control the Model 92518, and provide the user interface for the Model<br>92518.<br><br>The Module 92518 is a sidestream analyzer intended to provide a<br>measurement of the following parameters: Carbon Dioxide (CO2);<br>Oxygen (O2) and Nitrous Oxide (N2O); Anesthetic agents including<br>Desflurane; Enflurane; Halothane; Isoflurane; and Sevorflurane;<br>Respiratory rate; and Calculated MAC and age-dependent MAC values.<br><br>The Spacelabs Ultraview monitors display information from the<br>Module 92518 and are the user interface for the Model 92518.<br>Ultraview monitors provide a number display for the anesthetic agent<br>concentrations and respiratory rate, and a capnograph waveform display<br>for O2 and CO2. The Module 92518 automatically identifies which<br>anesthetic agent or mixture of anesthetic agents is present, and<br>measures the concentration of the identified agent(s). An alarm is<br>issued if a mixture of more than two anesthetic agents is detected.<br><br>The Module 92518 is intended to be used primarily in the operating<br>room environment | | |
| Intended Use: | The Spacelabs Multigas Module, Model 92518 (Model 92518) is intended to provide a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agent(s), oxygen, carbon dioxide or nitrous oxide moves outside of user-defined limits. The multigas module is capable of automatically identifying which anesthetic agent(s) is being administered. | | |
| | The 92518 Multigas Module is intended to be used with and controlled by a Spacelabs Healthcare Ultraview-family monitor. The 92518 Multigas Module is intended to be used for monitoring all hospitalized patients, under the direction of qualified medical personnel. | | |
| | Although the 92518 Multigas Module alarms when the duration between breaths exceeds user defined limits, it is not intended to be a primary diagnostic apnea monitor and/or recording device. | | |
| Technology Comparison: | The Model 92518 employs the same technological characteristics as the predicate device. | | |
| | Characteristic | Predicate Device | Proposed Device |
| | Sampling Technique | Sidestream | Same |
| | Carbon-Dioxide (CO2) Measurement | Infrared | Same |
| | Oxygen (O2) Measurement | Paramagnetic | Same |
| | Anesthetic Agent Measurement | Infrared | Same |
| Summary of Performance Testing: | | | |
| Electrical Safety | The Model 92518 was tested for performance in accordance with the following Standards: | | |

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- . IEC 60601-1: 2005, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance; and
- UL 60601-1: 2003, Medical electrical equipment Part 1: General . requirements for basic safety and essential performance.

Test results indicated that the Model 92518 complies with the Standards.

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| Electromagnetic<br>Compatibility (EMC)<br>Testing | The Model 92518 was tested for performance in accordance with the<br>following Standard:<br>IEC 60601-1-2: 2007, Medical electrical equipment - Part 1-2:<br>General requirements for basic safety and essential performance –<br>Collateral standard: Electromagnetic compatibility – Requirements<br>and tests. Test results indicated that the Model 92518 complies with the<br>Standards. |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Software Testing | Software device modifications made to the Model 92518 were designed<br>and developed according to a robust software development process, and<br>were rigorously verified and validated.<br>Software information is provided in accordance with internal<br>documentation and the following Standards and guidance documents:<br>FDA guidance: The content of premarket submissions for software<br>contained in medical devices, 11 May 05; FDA guidance: Off-the-shelf software use in medical devices, 09<br>Sep 99; FDA guidance: General principles of software validation; Final<br>guidance for industry and FDA staff, 11 Jan 02; IEC 60601-1-4: 2000, Medical electrical equipment Medical<br>electrical equipment – Part 1-4: General requirements for safety –<br>Collateral Standard: Programmable electrical medical systems. Test results indicate that the Model 92518 complies with its<br>predetermined specification and the Standards and guidance documents. |
| Performance Testing | The Model 92518 was tested for performance in accordance with<br>internal documentation and the following Standards:<br>IEC 60601-1-8: 2006, Medical electrical equipment - Part 1-8:<br>General requirements for basic safety and essential performance –<br>Collateral Standard: General requirements, tests and guidance for<br>alarm systems in medical electrical equipment and medical<br>electrical systems; and ISO 21647: 2004, Medical electrical equipment - Particular<br>requirements for the basic safety and essential performance of<br>respiratory gas monitors. Test results indicated that the Model 92518 complies with its<br>predetermined specification and with the applicable Standards. |

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#### Conclusion

Verification and validation activities were conducted to establish the performance and safety characteristics of the software device modifications made to the Model 92518. The results of these activities demonstrate that the Model 92518 is safe and effective when used in accordance with its intended use and labeling.

Therefore, the Model 92518 is considered substantially equivalent to the predicate device.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Spacelabs Healthcare C/O Mr. Thomas Kroenke Principal Consultant Speed To Market, Incorporated P.O. Box 3018 Nederland, Colorado 80466

OCT - 5 2011

Re: K112173

Trade/Device Name: Spacelabs Multigas Module, Model 92518 Regulation Number: 21 CFR 868.1700 Regulation Name: Nitrous Oxide Gas Analyzer Regulatory Class: II Product Code: CBR, CCK, CBQ, NHO, NHP. NHQ, CBS, CCL Dated: September 6, 2011 Received: September 8, 2011

Dear Mr. Kroenke:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your 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 – Mr. Kroenke

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

K112173 510(k) Number (if known): Spacelabs Multigas Module, Model 92518 Device Name: The Spacelabs Multigas Module, Model 92518 (Model 92518) is Indications for Use: intended to provide a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agent(s), oxygen, carbon dioxide or nitrous oxide moves outside of user-defined limits. The multigas module is capable of automatically identifying which anesthetic agent(s) is being administered. The 92518 Multigas Module is intended to be used with and controlled by a Spacelabs Healthcare Ultraview-family monitor. The 92518 Multigas Module is intended to be used for monitoring all hospitalized patients, under the direction of qualified medical personnel. Although the 92518 Multigas Module alarms when the duration between breaths exceeds user defined limits, it is not intended to be a primary diagnostic apnea monitor and/or recording device.

Prescription Use X (Part 21 CFR 801 Subpart D)

... ..........................................................................................................................................................................

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schultheis
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K112173

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