(117 days)
Not Found
No
The summary describes automated identification of anesthetic agents and calculation of MAC values, but does not mention AI or ML technologies. The validation focuses on compliance with standards and software development processes, not performance metrics typically associated with AI/ML models.
No
The device is described as a multigas analyzer intended for monitoring gas concentrations and respiratory rate, and for alerting clinical personnel. It does not exert any direct therapeutic action on the patient.
No
The "Intended Use / Indications for Use" section explicitly states, "Although the Module 91518 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." This indicates its purpose is monitoring, not diagnosing.
No
The device is described as a "modular unit" and a "multigas sidestream analyzer," which are physical hardware components. It also interfaces with and is controlled by Spacelabs Medical monitors, further indicating it is not solely software.
Based on the provided text, the Spacelabs Medical Multigas Analyzer Module 91518 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Module 91518 analyzes gases inhaled and exhaled by the patient directly, not specimens taken from the patient. It monitors gas concentrations in the patient's airway during respiration.
- Intended Use: The intended use is for monitoring gas concentrations and alerting clinical personnel, not for diagnosing a disease or condition based on analysis of a biological sample.
Therefore, the device falls under the category of a patient monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The Spacelabs Medical Multigas Analyzer Module 91518 (Module 91518) is intended to provide a means of monitoring a variety of gas concentrations and to alert clinical personnel when the concentration of anesthetic agent, oxygen, carbon dioxide or nitrous oxide falls outside of user defined limits. The Module 91518 is capable of automatically identifying which anesthetic agent(s) is being administered.
The Module 91518 is intended to be used with, and is controlled by, any Spacelabs Medical monitor, except the SLP100.
The Module 91518 is intended for use monitoring all hospitalized patients under the direction of qualified medical personnel.
Although the Module 91518 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
Device Description
The Spacelabs Medical Multigas Analyzer Module 91518 (Module 91518) is an easy-to-use modular unit in the Spacelabs Medical product family. The Module 91518 is a multigas sidestream analyzer intended to provide a measurement of the following parameters;
- CO2 produced by the patient;
- . O2 and N2O administered to the patient;
- Anesthetic agents administered to the patient which includes: .
- Desflurane;
- O Enflurane:
- Halothane; O
- lsoflurane; and O
- Sevorflur-ane.
- . Respiratory rate of the patient; and
- Calculated MAC and age-dependent MAC values. .
The Module 91518 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 91518 interfaces with all Spacelabs Medical monitors, except the SLP100. The monitor provides a numeric display for the gas concentrations and respiratory rate, and a waveform display for O2 and CO2. The Module 91518 is intended to be used for monitoring all hospitalized patients under the direction of qualified medical personnel.
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
Not Found
Intended User / Care Setting
qualified medical personnel / hospitalized patients
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)
The Module 91518 was validated through rigorous testing that, in part, support the compliance of the Module 91518 to the Standards mentioned in Section 6.1 of this submission. Additionally, the software for the Module 91518 was developed following a robust software development process and was fully specified and validated.
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
510(k) Premarket Notification Spacelabs Medical, Inc. APR 1 9 2006 Multigas Analyzer Module 91518 and Accessories Summary of Safety and Effectiveness
The Spacelabs Medical Multigas Analyzer Module 91518 (Module 91518) is Device Description: an easy-to-use modular unit in the Spacelabs Medical product family. The Module 91518 is a multigas sidestream analyzer intended to provide a measurement of the following parameters;
- CO2 produced by the patient;
- . O2 and N2O administered to the patient;
- Anesthetic agents administered to the patient which includes: .
- Desflurane; ಂ
- O Enflurane:
- Halothane; O
- lsoflurane; and O
- Sevorflur-ane. ਼
- . Respiratory rate of the patient; and
- Calculated MAC and age-dependent MAC values. .
The Module 91518 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 dctected.
The Module 91518 interfaces with all Spacelabs Medical monitors, except the SLP100. The monitor provides a numeric display for the gas concentrations and respiratory rate, and a waveform display for O2 and CO2. The Module 91518 is intended to be used for monitoring all hospitalized patients under the direction of qualified medical personnel.
- Intended Use: The Spacelabs Medical Multigas Analyzer Module 91518 (Module 91518) is intended to provide a means of monitoring a variety of gas concentrations and to alert clinical personnel when the concentration of anesthetic agent, oxygen, carbon dioxide or nitrous oxide falls outside of user defined limits. The Module 91518 is capable of automatically identifying which anesthetic agent(s) is being administered.
The Module 91518 is intended to be used with, and is controlled by, all Spacelabs Medical monitors, except the SLP100,
The Module 91518 is intended for use monitoring all hospitalized patients under the direction of qualified medical personnel.
Although the Module 91518 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.
1
510(k) Premarket Notification Spacelabs Medical, Inc. Multigas Analyzer Module 91518 and Accessories Summary of Safety and Effectiveness
| Test
Discussion: | The Module 91518 is substantially equivalent in design concepts, technologies
and materials to the combination of the Spacelabs Medical Module 90518
(K954962) and the Date-Ohmeda Compact Airway Module E-CAIOVX
(K051092). The Module 91518 was validated through rigorous testing that, in
part, support the compliance of the Module 91518 to the Standards mentioned
in Section 6.1 of this submission. Additionally, the software for the Module
91518 was developed following a robust software development process and
was fully specified and validated. |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Module 91518 is the next generation in the Spacelabs Medical Integrated
Multiparameter Module family of products for the Spacelabs line of patient
monitors. |
| Test | The Module 91518 is substantially equivalent to its predicate devices in design |
Conclusion: concepts, technologics and materials.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is composed of four curved lines that resemble human figures. The logo is surrounded by the words "U.S. Department of Health and Human Services" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 9 2006
Mr. Al Van Houdt Director, Regulatory Affairs and Quality Spacelabs Medical, Incorporated 5150 220th Avenue SF P.O. Box 7018 Issaquah, Washington 98027-7018
Re: K053599
Trade/Device Name: Spacelabs Medical Multigas Analyzer Module 91518 and Accessories Regulation Number: 868.1700 Regulation Name: Nitrous Oxide Gas Analyzer Regulatory Class: II Product Code: CBR Dated: April 4, 2006 Received: April 5, 2006
Dear Mr. Houdt:
We have reviewed vour 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 Hi (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
3
Page 2 -Mr. Houdt
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 (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.
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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sudete Y. Michica Cins
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
| 510(k) Number (if known): | K053599 |
|---|---|
| Device Name: | Spacelabs Medical Multigas Analyzer Module 91518 and Accessories |
| Indications for Use: | The Spacelabs Medical Multigas Analyzer Module 91518 (Module 91518) is intended to provide a means of monitoring a variety of gas concentrations and to alert clinical personnel when the concentration of anesthetic agent, oxygen, carbon dioxide or nitrous oxide falls outside of user defined limits. The Module 91518 is capable of automatically identifying which anesthetic agent(s) is being administered. |
| The Module 91518 is intended to be used with, and is controlled by, any Spacelabs Medical monitor, except the SLP100. | |
| The Module 91518 is intended for use monitoring all hospitalized patients under the direction of qualified medical personnel. | |
| Although the Module 91518 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. |
X Prescription Use (Part 21 CFR 801 Subpart D)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart Cr
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chun Hukum
ry General Hospt
000001