(155 days)
V60 Anesthetic Vaporizer is an unheated, calibrated anesthetic vaporizer used for evaporating liquid anesthetic agents and delivering mixed gas of controlled concentration to an anesthetic delivery system.
The V60 Anesthetic Vaporizer is available in models specific for use with Isoflurane and models available specific for use with Sevoflurane.
The V60 Anesthetic Vaporizer is an unheated, calibrated anesthetic vaporizer. Fresh gas enters the vaporizer and is divided into two pathways: carrier gas (through pressure compensation and liquid vaporizing systems) and diluted gas (through bypass and temperature compensation systems). These two pathways mix to form mixed anesthetic gas with a controlled concentration before the outlet. It includes a filling system, can be installed on an anesthetic delivery system, evaporates liquid anesthetic agents to deliver mixed gas of controlled concentration, and provides a mechanism to adjust output concentration.
The provided documentation does not describe a study involving a medical device that uses AI or requires expert adjudication for establishing ground truth, nor does it discuss clinical performance metrics like sensitivity, specificity, or AUC. The submission is for an anesthetic vaporizer, which is a physical device, not a software algorithm.
Therefore, many of the requested categories are not applicable to this document. I will fill in the relevant information based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Predicate Device K971923) | Reported Device Performance (Mindray V60 Anesthetic Vaporizer) | Conclusion regarding Substantial Equivalence |
|---|---|---|---|
| Output Concentration Accuracy: | |||
| Operating Environment (Range 1) | 15 to 35°C or 0.2 to 10 L/min | 15 to 35°C or 0.25 to 10 L/min | Similar |
| Operating Environment (Range 2) | 10 to 15°C or 35 to 40°C or 10 to 15 L/min | 10 to 15°C or 35 to 40°C or 10 to 15 L/min | Similar |
| Set concentration 6% | ±0.25 vol.% or ±20% rel., whichever is greater | +0.35/-0.25 vol.% or +30/-20% rel., whichever is greater | Similar |
| Flow Range | 0.25 to 15 L/min; 0.25 to 10 L/min for concentrations >5 Vol.% | 0.2 to 15 L/min; 0.2 to 10 L/min for concentrations >5 Vol.% | Similar |
| Environmental Conditions | |||
| Temperature | 10 to 40°C | 10 to 40°C | Identical |
| Humidity | 0 to 95%, non-condensing | 15 to 95%, non-condensing | Similar |
| Atmospheric Pressure | 70 to 110 kPa | 70 to 106 kPa | Similar |
| Other Technical Characteristics | |||
| Filling System | Vapor of filling spout, Keyed filling, Quik Fil | Pour Fill, Key Filler, Quik-Fil | Identical (functionally) |
| Volume | 360 ml (dry wick), 300 ml (moist wick), 260 ml (between min & max marks) | 360 ml (dry wick), 300 ml (moist wick), 260 ml (between min & max marks) | Identical |
| Connection to anesthesia gas machine | Selectatec-compatible plug-in connectors | Selectatec-compatible plug-in connectors | Identical |
| Maximum angle of tilt (fixed on machine) | 30° | 30° | Identical |
| Difference between pressure range & ambient pressure on vaporizer outlet | -10 kPa~20 kPa | -10 kPa~20 kPa | Identical |
| Resistance | 70 cmH2O@10L/min | 70 cmH2O@10L/min | Identical |
| Dial/calibration markings (Isoflurane) | 0, 0.2, 0.4, 0.6, 0.8, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0 | 0, 0.2, 0.4, 0.6, 0.8, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0 | Identical |
| Dial/calibration markings (Sevoflurane) | 0, 0.2, 0.4, 0.6, 0.8, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0 | 0, 0.2, 0.4, 0.6, 0.8, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0 | Identical |
| Other Tests | |||
| Biological Evaluation (ISO 10993) | Compliance with ISO 10993 standards and biocompatibility requirements | Compliance with ISO 10993 for gas contacting components; Particulates Matter (PM2.5/PM10) and Volatile Organic Compounds (VOCs) testing performed. | Compliant |
| Electrical Safety (ANSI/AAMI ES60601-1) | Compliance with ANSI/AAMI ES60601-1:2005 | Compliance with ANSI/AAMI ES60601-1:2005 and A1:2012, C1:2009, A2:2010 | Compliant |
| Risk Management (ISO 14971) | Application of risk management to medical devices | Compliance with ISO 14971:2007 | Compliant |
| Usability Engineering (IEC 62366 and IEC 60601-1-6) | Application of usability engineering | Compliance with IEC 62366:2014 and IEC 60601-1-6:2010 | Compliant |
| Anaesthetic Vaporizers (ISO 5360, 8835-4) | Specific requirements for anaesthetic vaporizers and vapor delivery devices | Compliance with ISO 5360:2012 and ISO 8835-4:2004 | Compliant |
Studies that prove the device meets acceptance criteria are documented under "7. Performance Data" and "6. Substantial Equivalence Considerations" in the provided text. Functional and system-level tests were conducted to evaluate the performance of each model of the V60 Anesthetic Vaporizer. These tests included measurements for filling rate, filling leakage, volume, output concentration accuracy, flow rates, maximum angles of tilt, temperature range, humidity, maximum atmospheric pressure, pressure difference at outlet, resistance, dial mark calibration, and compatibility. The results of these tests are presented in Appendix H4, H10, G1, and G3 (though the appendices themselves are not included in this document). The document states that all performance of the V60 vaporizer was verified through the successful completion of all tests, demonstrating that the device meets its predetermined specifications and FDA recognized consensus standards, and is equivalent to the predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "sample size" for a test set in terms of patients or independent data points for a diagnostic algorithm. This is a submission for a physical medical device. The "test set" would refer to the anesthetic vaporizers themselves that underwent functional and system-level testing. The document states that "functional and system level testing on the subject devices" was conducted, implying at least one, and likely several, units of the V60 Anesthetic Vaporizer were tested. The provenance of the data is implicitly from Shenzhen Mindray Bio-medical Electronics Co., Ltd, in China, based on the manufacturer's location. The tests are described as non-clinical, indicating lab-based, prospective testing rather than retrospective data analysis.
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)
Not applicable. This is for a physical medical device (anesthetic vaporizer), not a diagnostic device requiring expert interpretation or ground truth establishment in a clinical sense. The "ground truth" for the performance tests would be the established scientific and engineering principles and the specifications of the predicate device, against which the V60's physical performance was measured.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is for a physical medical device, not a diagnostic device requiring adjudication of interpretations.
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
Not applicable. This is for a physical anesthetic vaporizer, not an AI-powered diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for a physical anesthetic vaporizer, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is established by the functional specifications and international standards (e.g., ISO, IEC, ANSI/AAMI) that define the expected output concentration accuracy, flow rates, resistance, and other physical properties of an anesthetic vaporizer. The predicate device's performance also serves as a benchmark for substantial equivalence.
8. The sample size for the training set
Not applicable. This is a submission for a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As this is not a machine learning algorithm, there is no "training set" or establishment of ground truth for it in that context.
§ 868.5880 Anesthetic vaporizer.
(a)
Identification. An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.(b)
Classification. Class II (performance standards).