(69 days)
Not Found
No
The document describes a gas analysis module that automatically identifies anesthetic agents and measures concentrations, but there is no mention of AI or ML in the description, intended use, or performance studies. The technology appears to be based on standard gas analysis techniques.
No
The device is described as a "Multigas Module" intended for "monitoring a variety of gas concentrations" and "alert[ing] clinical personnel" when levels are outside of user-defined limits. Its function is to measure and display parameters, not to treat a condition. While it aids in patient management, it does not directly apply therapy.
No
The device is intended to monitor gas concentrations and alert clinical personnel, and explicitly states it is "not intended to be a primary diagnostic apnea monitor and/or recording device."
No
The device description clearly states it is a "modular unit" that is "inserted into a bay within an Ultraview monitor" and is a "sidestream analyzer," indicating it is a hardware component that performs physical measurements of gas concentrations.
Based on the provided information, the Spacelabs Multigas Module, Model 92518, is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are intended for use in the examination of specimens derived from the human body. The intended use and device description clearly state that this module is used for monitoring gas concentrations in the breathing circuit of a patient. It analyzes gases being inhaled and exhaled, not biological samples taken from the patient's body (like blood, urine, tissue, etc.).
- The purpose is monitoring and alerting, not diagnosing conditions based on biological samples. The device monitors gas levels and alerts clinical personnel to deviations from user-defined limits. While this information is used in patient care, it's not a diagnostic test performed on a biological specimen.
Therefore, the Spacelabs Multigas Module, Model 92518, falls under the category of a patient monitoring device, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
CBR, CCK, CBQ, NHO, NHP, NHQ, CBS, CCL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
all hospitalized patients
Intended User / Care Setting
qualified medical personnel, primarily in the operating room environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Electrical Safety: The Model 92518 was tested for performance in accordance with 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.
Electromagnetic Compatibility (EMC) Testing: The Model 92518 was tested for performance in accordance with IEC 60601-1-2: 2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests. Test results indicated that the Model 92518 complies with the Standards.
Software Testing: Software device modifications made to the Model 92518 were designed and developed according to a robust software development process, and were rigorously verified and validated. Software information is provided in accordance with internal documentation and the following Standards and guidance documents: FDA guidance: The content of premarket submissions for software contained in medical devices, 11 May 05; FDA guidance: Off-the-shelf software use in medical devices, 09 Sep 99; FDA guidance: General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02; IEC 60601-1-4: 2000, Medical electrical equipment Medical electrical equipment – Part 1-4: General requirements for safety – Collateral Standard: Programmable electrical medical systems. Test results indicate that the Model 92518 complies with its predetermined specification and the Standards and guidance documents.
Performance Testing: The Model 92518 was tested for performance in accordance with internal 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 for alarm systems in medical electrical equipment and medical electrical systems; and ISO 21647: 2004, Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors. Test results indicated that the Model 92518 complies with its predetermined specification and with the applicable Standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
(1
| Submission Date: | 29 September 2011
OCT - 5 2011 |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Spacelabs Healthcare
5150 220th Avenue SE
Issaquah, WA 98029 |
| Submitter Contact: | Spacelabs Healthcare
5150 220th Avenue SE
Issaquah, WA 98029
Mr. David J. Geraghty
Spacelabs Healthcare
Phone: +1 (425) 657-7200, ext 5889
Fax: +1 (425) 657-7210
Email: david.geraghty@spacelabs.com |
| Official Contact: | Thomas Kroenke
Principal Consultant
Speed To Market, Inc.
PO Box 3018
Nederland, CO 80466 USA
tkroenke@speedtomarket.net
303 956 4232 |
| Manufacturing Site: | Spacelabs Healthcare
5150 220th Avenue SE
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
analyzer, Sevoflurane gas analyzer, Isoflurane gas analyzer, Halothane
gas analyzer, Nitrous oxide gas analyzer, Oxygen gas analyzer |
| Classification
Regulation: | 21 CFR §868.1700 |
| Primary Product
Code: | CBR |
| Secondary Product
Codes: | CCK, CBQ, NHO, NHP, NHQ, CBS, CCL |
1
| Substantially
Equivalent Devices: | New Spacelabs Model | Predicate 510(k)
Number | Predicate
Manufacturer / Model |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|--------------------------------------------------------------------------------------|
| | Spacelabs Multigas
Module, Model 92518 | K053599 | Spacelabs Medical,
Inc. / Multigas
Analyzer Module
91518 and
Accessories |
| Device Description: | 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 | | |
| 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: | | |
2
- . 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.
3
.
| Electromagnetic
Compatibility (EMC)
Testing | The Model 92518 was tested for performance in accordance with the
following Standard:
IEC 60601-1-2: 2007, Medical electrical equipment - Part 1-2:
General requirements for basic safety and essential performance –
Collateral standard: Electromagnetic compatibility – Requirements
and tests. Test results indicated that the Model 92518 complies with the
Standards. |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Software Testing | Software device modifications made to the Model 92518 were designed
and developed according to a robust software development process, and
were rigorously verified and validated.
Software information is provided in accordance with internal
documentation and the following Standards and guidance documents:
FDA guidance: The content of premarket submissions for software
contained in medical devices, 11 May 05; FDA guidance: Off-the-shelf software use in medical devices, 09
Sep 99; FDA guidance: General principles of software validation; Final
guidance for industry and FDA staff, 11 Jan 02; IEC 60601-1-4: 2000, Medical electrical equipment Medical
electrical equipment – Part 1-4: General requirements for safety –
Collateral Standard: Programmable electrical medical systems. Test results indicate that the Model 92518 complies with its
predetermined specification and the Standards and guidance documents. |
| Performance Testing | The Model 92518 was tested for performance in accordance with
internal 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 for
alarm systems in medical electrical equipment and medical
electrical systems; and ISO 21647: 2004, Medical electrical equipment - Particular
requirements for the basic safety and essential performance of
respiratory gas monitors. Test results indicated that the Model 92518 complies with its
predetermined specification and with the applicable Standards. |
4
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.
5
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.
6
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
7
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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