(191 days)
The Vamos Variable Anesthetic Gas Monitor is indicated for measuring and monitoring the CO2 concentration, functional oxygen saturation SpO2, pulse rate and the concentrations of N20, Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane. Federal law restricts this device to sale by or on the order of a physician.
The Vamos is an integrated monitoring system used for multiple gas analysis (CO2, N2O, and anesthetic agent concentrations). Pulse oximetry may also be included as an option.
The provided document is a 510(k) summary for the Vamos Anesthetic Gas Monitor. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria, a dedicated study proving performance against those criteria, or the methodology of such a study (sample sizes, ground truth establishment, expert qualifications, etc.).
Therefore, I cannot fully complete the requested table and answer all questions based solely on the provided text. The document refers to "Qualification of the Vamos included hazard analysis, functional, communication, environmental, and electromagnetic compatibility testing," which implies testing was done, but the specifics of acceptance criteria and results are not detailed.
Here's an attempt to answer the questions based on the available information, noting where information is absent:
1. Table of acceptance criteria and the reported device performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| General Device Performance | (Not specified in document) | Functionally equivalent to predicate devices (Vitalert 3000 and NPB4000 Pulse Oximeter) in multi-gas analysis (CO2, N2O, anesthetic agents) and pulse oximetry. Uses infrared absorption technology for gas analysis. |
| Specific Performance Metrics (e.g., accuracy, precision) | (Not specified in document) | (Not specified in document) |
| Functional Testing | (Not specified in document) | "Functional... testing" was performed. Specific results not reported. |
| Hazard Analysis | (Not specified in document) | "Hazard analysis" was performed. Specific results not reported. |
| Communication Testing | (Not specified in document) | "Communication... testing" was performed. Specific results not reported. Includes RS-232 serial communication. |
| Environmental Testing | (Not specified in document) | "Environmental... testing" was performed. Specific results not reported. |
| Electromagnetic Compatibility Testing | (Not specified in document) | "Electromagnetic compatibility testing" was performed. Specific results not reported. |
| Battery Backup Performance (Optional Battery) | (Not specified in document, implied to provide at least 1 hour) | Provides a one-hour minimum power reserve time from full charge (for optional battery backup system). |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified in the provided document.
- Data Provenance: Not specified in the provided document. The document refers to "qualification" testing but does not detail the nature, source, or type of data used (e.g., retrospective, prospective, country of origin).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable or not provided. The document describes a medical device's technical qualification and substantial equivalence, not an AI or diagnostic algorithm requiring expert-established ground truth for performance evaluation in the clinical sense.
4. Adjudication method for the test set
- Not applicable or not provided. This typically relates to diagnostic studies with human readers, which is not the primary focus of this 510(k) submission for a monitoring device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or performed, as this device report is for a physiological monitoring device, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, the qualification testing described ("hazard analysis, functional, communication, environmental, and electromagnetic compatibility testing") appears to be a standalone evaluation of the device's performance characteristics. However, the details of these tests and their specific results are not provided in this summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For a gas monitor and pulse oximeter, the ground truth would typically be established using highly accurate reference methods or calibrated instruments for gas concentrations (e.g., mass spectrometry, certified gas mixtures) and oxygen saturation (e.g., co-oximetry, arterial blood gas analysis from a laboratory). The document does not explicitly state the specific ground truth methods used during its qualification testing.
8. The sample size for the training set
- Not applicable. This device is a hardware monitoring system, not an AI/ML algorithm that requires a "training set" in the context of machine learning model development.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set" in the context of this traditional medical device.
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JAN 1 7 2002
K012/39
SUMMARY OF SAFETY AND EFFECTIVENESS DATA RELATING TO SUBSTANTIAL EQUIVALENCE
| Proprietary Name: | Vamos Anesthetic Gas Monitor |
|---|---|
| Classification Name: | Analyzer, Gas, Carbon-Dioxide, Gaseous Phase - 73 CCKAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase - 73 CBRAnalyzer, Gas, Enflurane, Gaseous Phase - 73 CBQAnalyzer, Gas, Halothane, Gaseous Phase - 73 CBSOximeter - 74 DQA |
| Device Class: | Class II |
| Manufacturer: | Dräger Medizintechnik GmbH53/55 Moislinger AlleeLübeck, Germany 23558 |
| Establishment Registration No.: | 9611500 |
| Devices to which substantialequivalence is claimed: | Vitalert 3000 Monitoring System - K913995NPB4000 Pulse Oximeter - K962424 |
Device Description:
The Vamos is an integrated monitoring system used for multiple gas analysis (CO2, N2O, and anesthetic agent concentrations). Pulse oximetry may also be included as an option.
Intended Use:
The Vamos may be used for measuring and monitoring the functional oxygen saturation (SpO2), pulse rate and the concentrations of CO2, N2O and the following anesthestic agents; Halothane, Enflurane, Isoflurane, Sevoflurane, and Desflurane.
Substantial Equivalence:
Like the Vitalert 3000 (VA3000), the Vamos is an integrated monitoring system used for multiple gas analysis (CO2, N2O, and anesthetic agent concentrations) and Pulse oximetry. The VA3000 offers Non-Invasive Blood Pressure (NIBP) monitoring as an option while the Vamos does not.
The Vamos and VA3000 integrate the function of the electronic monitors. Measurement data, a real time CO2 waveform, and alarms are displayed. Both use an electro- luminescent display.
The Vamos and VA3000 use a combination of a keypad and incremental encoder to control screen formats and settings.
The Vamos offers an optional battery backup system, which is automatically enabled in the event of power failure and provides a one hour minimum power reserve time from full charge. The VA3000 does not have a battery backup system.
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The Vamos uses the same pulse oximetry module as the NPB4000 Pulse Oximeter (K962424).
The gas analyzer used in the Vamos is similar to that used in the VA3000 in that both utilize infrared absorption technology.
The Vamos and the VA3000 incorporate an RS-232 serial communication port.
Qualification of the Vamos included hazard analysis, functional, communication, environmental, and electromagnetic compatibility testing.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with a single snake winding around a staff.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 7 2002
Mr. Michael A. Kelhart Draeger Medical Inc. 3135 Quarry Road Telford, PA 18969
K012139 Re:
Vamos Anesthetic Gas Monitor Vallos Anesthere Gas Monton
Regulation Number: 868.1400, 868.1700, 868.1500, 868.1620, and 870.2700 Regulation Name: 6001-000, 00017700, 00017700, 00011900, Oxide Gas Analyzer, Enflurane Gas Analyzer, Halothane Gas Analyzer, and Oximeter Regulatory Class: II (two) Regulatory Class: 11 (1.10)
Product Code: 73 CCK, CBR, CBQ, CBS, NHO, NHP, NHQ, and 74 DQA Dated: October 23, 2001 Received: October 24, 2001
Dear Mr. Kelhart:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications felerenced above and have actions. In the enclicate devices marketed in interstate for use stated in the encreations) it regard) and entirent date of the Medical Device Amendments, or to connineres prior to May 20, 1978, as excordance with the provisions of the Federal Food, Drug, devices that have been received in assee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, therefore, market the Act include requirements for annual registration, listing of general controls provisions of the rice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is olassined (600 as 100 strols. Existing major regulations affecting your device can may or subject to such additions, 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. Michael A. Kelhart
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc advised that I Dris issualites vour device complies with other requirements of the Act that I DA has made a acterimiations administered by other Federal agencies. You must of any irederal statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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) This iciticition. The FDA finding of substantial equivalence of your device to a legally premarket notincation: "The PPA miams of casification 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 If you desire specific ad 100 for in vitro diagnostic devices), please contact the Office of additionally 21 CHC Far 807.10 For questions on the promotion and advertising of Compliance at (301) 597-1810. I first of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Tegulation Chitica, "Misoranang of responsibilities under the Act may be obtained from the Outcl general information on your versational 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/dsma/dsmamain.html
Sincerely yours,
Qada Till
ram D. Zuckerman, M.D Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| Page | 1ot | ||
|---|---|---|---|
| A Market Pro and Collection Company of Concession | - |
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _ Vamos Anesthetic Gas Monitor
Indications for Use:
STAKI NUmbe
The Vamos Variable Anesthetic Gas Monitor is indicated for measuring and monitoring the CO2 concentration, functional oxygen saturation SpO2, pulse rate and the concentrations of N20, Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane. Federal law restricts this device to sale by or on the order of a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | ✓ |
|---|---|
| --------------------------------------- | -------------- |
OR
| Over-The-Counter-Use | |
|---|---|
| ---------------------- | -- |
(Optional Format 1-2-96)
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).