(69 days)
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.
The Spacelabs Multigas Module, Model 92518 (Model 92518) is an easy-to-use modular unit in the Spacelabs Healthcare Ultraview-family of monitors (Ultraview). The Module 92518 is inserted into a bay within an Ultraview monitor. The Ultraview monitor is then used to control the Model 92518, and provide the user interface for the Model 92518. The Module 92518 is a sidestream analyzer intended to provide a measurement of the following parameters: Carbon Dioxide (CO2); Oxygen (O2) and Nitrous Oxide (N2O); Anesthetic agents including Desflurane; Enflurane; Halothane; Isoflurane; and Sevorflurane; Respiratory rate; and Calculated MAC and age-dependent MAC values. The Spacelabs Ultraview monitors display information from the Module 92518 and are the user interface for the Model 92518. Ultraview monitors provide a number display for the anesthetic agent concentrations and respiratory rate, and a capnograph waveform display for O2 and CO2. The Module 92518 automatically identifies which anesthetic agent or mixture of anesthetic agents is present, and measures the concentration of the identified agent(s). An alarm is issued if a mixture of more than two anesthetic agents is detected. The Module 92518 is intended to be used primarily in the operating room environment
The Spacelabs Multigas Module, Model 92518, is a sidestream analyzer that measures various gas concentrations (CO2, O2, N2O, and anesthetic agents like Desflurane, Enflurane, Halothane, Isoflurane, Sevoflurane) and respiratory rate. It automatically identifies anesthetic agents and calculates MAC values. The module integrates with Spacelabs Ultraview monitors for control and display of information, including numerical values for gas concentrations and respiratory rate, and capnograph waveforms for O2 and CO2. It is primarily intended for use in the operating room to monitor hospitalized patients and alert clinical personnel to gas concentration deviations.
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Acceptance Criteria and Reported Device Performance:
The provided document does not list specific numerical acceptance criteria for gas measurement accuracy, such as +/- X% of reading or a certain Root Mean Square Error (RMSE). Instead, the performance testing section focuses on compliance with general medical device standards. The "Summary of Performance Testing" indicates that the device "complies with its predetermined specification and with the applicable Standards" for various categories.
Acceptance Criteria Category Reported Device Performance Electrical Safety Compliance with IEC 60601-1: 2005 and UL 60601-1: 2003. Electromagnetic Compatibility (EMC) Compliance with IEC 60601-1-2: 2007. Software Testing Software designed and developed according to a robust software development process, rigorously verified and validated. Compliance with FDA guidance documents on software in medical devices (May 05, Sep 99, Jan 02) and IEC 60601-1-4: 2000. Performance Testing (General) Compliance with internal documentation, IEC 60601-1-8: 2006 (alarm systems), and ISO 21647: 2004 (respiratory gas monitors). The device complies with its predetermined specification and with the applicable Standards. -
Sample Size Used for the Test Set and Data Provenance:
The document does not provide details on the sample size (e.g., number of gas samples, duration of testing) used for the performance tests, nor does it specify the provenance of any data (e.g., country of origin, retrospective/prospective). The testing focused on compliance with specified standards rather than analysis of a distinct patient-derived test set. -
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. The described testing involves technical compliance with standards and physical measurements of gas concentrations, not subjective interpretation requiring human expert ground truth. -
Adjudication Method for the Test Set:
Not applicable, as no human expert judgments or interpretations requiring adjudication were involved in the listed performance testing. -
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was conducted or mentioned in the document. The device is a measurement and monitoring tool, not an AI-assisted diagnostic imaging or interpretative system that would typically undergo such a study. -
Standalone (Algorithm-Only) Performance:
The device's performance, as described, is inherently "standalone" in terms of its gas measurement functions. It continuously analyzes gas samples. However, there's no distinction made between an "algorithm-only" performance and the overall device performance, as the device's function is to directly measure and report, not to provide an interpretation that could be assisted by or compared to a human. -
Type of Ground Truth Used:
The "ground truth" for this type of device typically refers to a reference standard against which its measurements are compared. While not explicitly detailed, performance testing for gas analyzers generally involves:- Reference gas mixtures: Using precisely calibrated gas cylinders with known concentrations of CO2, O2, N2O, and anesthetic agents as the "ground truth" to verify the device's accuracy.
- Calibrated flow and pressure sensors: For verifying respiratory rate and flow measurements.
The document states the device complies with "predetermined specification" and "applicable Standards" like ISO 21647, which would inherently require such reference standards.
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Sample Size for the Training Set:
Not applicable. The Spacelabs Multigas Module is a sensor-based device that measures gas concentrations, not a machine learning or AI-driven system that requires a "training set" in the conventional sense. Its underlying technology (infrared for CO2/anesthetics, paramagnetic for O2) is based on established physical principles. -
How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" for this type of device.
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| Submission Date: | 29 September 2011OCT - 5 2011 |
|---|---|
| Submitter: | Spacelabs Healthcare5150 220th Avenue SEIssaquah, WA 98029 |
| Submitter Contact: | Spacelabs Healthcare5150 220th Avenue SEIssaquah, WA 98029Mr. David J. GeraghtySpacelabs HealthcarePhone: +1 (425) 657-7200, ext 5889Fax: +1 (425) 657-7210Email: david.geraghty@spacelabs.com |
| Official Contact: | Thomas KroenkePrincipal ConsultantSpeed To Market, Inc.PO Box 3018Nederland, CO 80466 USAtkroenke@speedtomarket.net303 956 4232 |
| Manufacturing Site: | Spacelabs Healthcare5150 220th Avenue SEIssaquah, WA 98029 |
| Trade Name: | Spacelabs Multigas Module, Model 92518 |
| Common Name: | Multigas analyzer |
| Classification Name: | Carbon dioxide gas analyzer, Enflurane gas analyzer, Desflurane gasanalyzer, Sevoflurane gas analyzer, Isoflurane gas analyzer, Halothanegas analyzer, Nitrous oxide gas analyzer, Oxygen gas analyzer |
| ClassificationRegulation: | 21 CFR §868.1700 |
| Primary ProductCode: | CBR |
| Secondary ProductCodes: | CCK, CBQ, NHO, NHP, NHQ, CBS, CCL |
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| SubstantiallyEquivalent Devices: | New Spacelabs Model | Predicate 510(k)Number | PredicateManufacturer / Model |
|---|---|---|---|
| Spacelabs MultigasModule, Model 92518 | K053599 | Spacelabs Medical,Inc. / MultigasAnalyzer Module91518 andAccessories | |
| Device Description: | The Spacelabs Multigas Module, Model 92518 (Model 92518) is aneasy-to-use modular unit in the Spacelabs Healthcare Ultraview-familyof monitors (Ultraview). The Module 92518 is inserted into a baywithin an Ultraview monitor. The Ultraview monitor is then used tocontrol the Model 92518, and provide the user interface for the Model92518.The Module 92518 is a sidestream analyzer intended to provide ameasurement of the following parameters: Carbon Dioxide (CO2);Oxygen (O2) and Nitrous Oxide (N2O); Anesthetic agents includingDesflurane; Enflurane; Halothane; Isoflurane; and Sevorflurane;Respiratory rate; and Calculated MAC and age-dependent MAC values.The Spacelabs Ultraview monitors display information from theModule 92518 and are the user interface for the Model 92518.Ultraview monitors provide a number display for the anesthetic agentconcentrations and respiratory rate, and a capnograph waveform displayfor O2 and CO2. The Module 92518 automatically identifies whichanesthetic agent or mixture of anesthetic agents is present, andmeasures the concentration of the identified agent(s). An alarm isissued if a mixture of more than two anesthetic agents is detected.The Module 92518 is intended to be used primarily in the operatingroom 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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.
| ElectromagneticCompatibility (EMC)Testing | The Model 92518 was tested for performance in accordance with thefollowing Standard:IEC 60601-1-2: 2007, Medical electrical equipment - Part 1-2:General requirements for basic safety and essential performance –Collateral standard: Electromagnetic compatibility – Requirementsand tests. Test results indicated that the Model 92518 complies with theStandards. |
|---|---|
| Software Testing | Software device modifications made to the Model 92518 were designedand developed according to a robust software development process, andwere rigorously verified and validated.Software information is provided in accordance with internaldocumentation and the following Standards and guidance documents:FDA guidance: The content of premarket submissions for softwarecontained in medical devices, 11 May 05; FDA guidance: Off-the-shelf software use in medical devices, 09Sep 99; FDA guidance: General principles of software validation; Finalguidance for industry and FDA staff, 11 Jan 02; IEC 60601-1-4: 2000, Medical electrical equipment Medicalelectrical equipment – Part 1-4: General requirements for safety –Collateral Standard: Programmable electrical medical systems. Test results indicate that the Model 92518 complies with itspredetermined specification and the Standards and guidance documents. |
| Performance Testing | The Model 92518 was tested for performance in accordance withinternal documentation and the following Standards:IEC 60601-1-8: 2006, Medical electrical equipment - Part 1-8:General requirements for basic safety and essential performance –Collateral Standard: General requirements, tests and guidance foralarm systems in medical electrical equipment and medicalelectrical systems; and ISO 21647: 2004, Medical electrical equipment - Particularrequirements for the basic safety and essential performance ofrespiratory gas monitors. Test results indicated that the Model 92518 complies with itspredetermined 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 (800) 638-2041 or (301) 796-7100 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
Page 1 of 1
§ 868.1700 Nitrous oxide gas analyzer.
(a)
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.(b)
Classification. Class II (performance standards).