(77 days)
The Vamos Anesthetic Gas monitor is indicated for measuring and monitoring CO2 concentration, functional oxygen saturation (SPO2), pulse rate and the concentrations of N2O, Halothane, Isoflurane, Enflurane and Desflurane.
The modified Vamos is an integrated monitoring system used for the multiple gas analysis (CO2), N2O), and anesthetic agent concentrations). Pulse Oximetry may also be included as an option.
This document is a 510(k) premarket notification for the Vamos Anesthetic Gas Monitor, which is a modified version of an existing device. The notification primarily focuses on demonstrating substantial equivalence to predicate devices, particularly regarding the ability to return sample gas to the breathing circuit. It is not a study report that describes acceptance criteria, device performance results, or a detailed study design.
Therefore, many of the requested elements for describing acceptance criteria and a study that proves the device meets them cannot be found in the provided text. The document is a regulatory submission for market clearance, not a scientific publication detailing a performance study against specific acceptance criteria.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify quantitative acceptance criteria or report device performance against such criteria. It states that "Testing was performed to assure that there would be no adverse effects to the patient as a result of the sample gas passing through the Vamos and back to the breathing circuit instead of being routed to the scavenger." This is a qualitative statement about the purpose of testing, not a report of the test results themselves or the criteria used to deem them acceptable.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not detail any specific test set, its sample size, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided. No information about ground truth establishment or experts is included.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No test set or adjudication method is described.
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
- Cannot be provided. This device is an anesthetic gas monitor, not an AI-assisted diagnostic tool for human readers. No MRMC study or AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This question is not applicable as the device is a monitor, not an algorithm, and the concept of "standalone performance" in the AI sense does not apply here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No specific ground truth methodology is mentioned. The "testing" referred to appears to be engineering or bench testing related to the gas return mechanism, not a clinical study requiring ground truth for diagnostic accuracy.
8. The sample size for the training set
- Cannot be provided. This document describes a modification to an existing device, which doesn't typically involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Cannot be provided. See point 8.
In summary: The provided text is a regulatory submission for premarket clearance based on substantial equivalence, not a scientific or clinical study report. It focuses on the device's description, intended use, and its similarities to previously cleared devices, particularly highlighting a modification and confirming testing was done without adverse effects. It does not contain the detailed performance data, acceptance criteria, or study methodologies requested.
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JUN 1 7 2004
Summary of Safety and Effectiveness Data Relating to Substantial Equivalence
Proprietary Name: Vamos Anesthetic Gas Monitor
Common Name: Analyzer, Gas
Classification Name: Analyzer Gas, Carbon-Dioxide, Gaseous Phase Analyzer, Gas, Nitrous-Oxide, Gaseous Phase Analyzer, Gas, Enflurane, Gaseous Analyzer, Gas, Halothane, Gaseous Oximeter
73 CCK, CBR, CBQ, CBS, NHO, NHP, NHQ, and 74 DQA Product Codes:
Device Class:Class II
Manufacturer: Draeger Medical AG & Co KGaA 53/55 Moislinger Allee Luebeck, Germany
Establishment Registration Number: 9611500
Devices to which substantial equivalence is claimed: Vamos Anesthetic Gas Monitor K012139 As/3 Anesthesia Delivery Unit (As/3Adu) K973985 Capnomac Ultima Anesthesia Monitor K932098
Device Description:
The modified Vamos is an integrated monitoring system used for the multiple gas analysis (CO2), N2O), and anesthetic agent concentrations). Pulse Oximetry may also be included as an option.
Intended Use:
The Vamos, is intended to be used for measuring and monitoring the functional oxygen saturation (SPO2), pulse rate and the concentrations of CO2, N2O), Enflurane, Desflurane, Isoflurane, Halothane, and Sevoflurane.
Substantial Equivalence:
Like the AS/3 ADU with the integrated Capnomac Ultima Anesthesia Monitor, the Vamos (K012139) is being modified to include the ability to use return sample gas to the breathing circuit as an option during gas analysis. Testing was performed to assure that there would be no adverse effects to the patient as a result of the sample gas passing through the Vamos and back to the breathing circuit instead of being routed to the scavenger.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 7 2004
Ms. Gale E. Winarsky, RAC Regulatory Affairs Project Manager Draeger Medical, Incorporated 3135 Quarry Road Telford, Pennsylvania 18969
Re: K040847
Trade/Device Name: Vamos Anesthesia Gas Monitor Regulation Number: 868.1400, 868.1700, 868.1500, 868.1620, 870.2700 Regulation Name: Carbon Dioxide Gas Analyzer, Nitrous Oxide Gas Analyzer, Enflurane Gas Analyzer, Halothane Gas Analyzer, Oximeter Regulatory Class: II Product Code: 73 CCK, CBR, CBQ, CBS, NHO, NHP, NHQ, and DQA Dated: May 28, 2004 Received: June 1, 2004
Dear Ms. Winarsky:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have to rowed your and have determined the device is substantially equivalent (for the referenced a o the national in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate comments, 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 the Federal F od; Drag, and Coou may, therefore, market the device, subject to the general approval upportions of the Act. The general controls provisions of the Act include controls provisions of a 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 III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Wry, it may of subject to tax 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 - Ms. Winarsky
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that 1 DA s issualled of that your device complies with other requirements Incall that IDA has made a actession regulations administered by other Federal agencies. of the Act of ally rederal statues and regarates. Including, but not limited to: registration You must comply with an the Piece brog (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 067), labeling (21 CFR Part 820); and if requirents as set form in the quality sjochly (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 letter will anow you to begin made ... ... ... ... ... ... ... ... ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . premarket notification. The PDF maing or 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), If you desire specific advice for your de at (301) 594-4646. 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 may obtain other generational 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,
Ous
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
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _ Vamos Anesthesia Gas Monitor_____
Indications for Use:
The Vamos Anesthetic Gas monitor is indicated for measuring and monitoring CO2 The Vallios Aliestifications oxygen saturation (SPO2), pulse rate and the concentrations of concentration, functional oxygen staturane and Desflurane and Desflurane. Federal law NEO, Italoniane, Broosale by or on the order of a physician.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Stan-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
Page 1 of 1
510(k) Number: K040847
§ 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).