(77 days)
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No
The document does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms. The description focuses on standard gas monitoring and pulse oximetry technology.
No
This device is a monitor, measuring and monitoring gas concentrations and pulse oximetry. It does not actively treat or alleviate a disease or condition.
Yes.
The device measures and monitors physiological parameters (CO2, SpO2, pulse rate) and anesthetic gas concentrations, which provides information used to assess a patient's condition.
No
The device description explicitly states it is an "integrated monitoring system" used for gas analysis and pulse oximetry, implying the presence of hardware components for measurement and analysis. The performance studies also mention "sample gas passing through the Vamos," further indicating a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Vamos Anesthetic Gas monitor measures and monitors gases within the breathing circuit of a patient during anesthesia. It's analyzing gases that are being inhaled and exhaled, not specimens taken from the body.
- Intended Use: The intended use clearly states it measures and monitors gas concentrations and physiological parameters (SpO2, pulse rate) directly from the patient's breathing circuit.
Therefore, the device's function and intended use fall outside the scope of an In Vitro Diagnostic. It's a device used for real-time monitoring of physiological and anesthetic parameters during a medical procedure.
N/A
Intended Use / Indications for 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.
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, Enflurane, Isoflurane and Desflurane. Federal law restricts this device to sale by or on the order of a physician.
Product codes (comma separated list FDA assigned to the subject device)
73 CCK, CBR, CBQ, CBS, NHO, NHP, NHQ, and 74 DQA
73 CCK, CBR, CBQ, CBS, NHO, NHP, NHQ, and DQA
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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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
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510(k) Number: K040847