This device uses two anesthetic vapor adsorbent canisters connected to an anesthesia delivery system to prevent unwanted anesthetic vapors emanating from within an anesthesia gas machine from reaching a patient.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Vapor-Clear device, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Anesthetic adsorption rate	Vapor-Clear scavenges >99.95% of isoflurane at a high flow rate.
Scavenging residual vapor from modern anesthesia gas machines to <5 ppm	Inspired isoflurane concentration stays below 1 ppm for the duration of the test (following termination of vapor delivery) in both Draeger Apollo and Ohmeda Aestiva anesthesia gas machines. (Residual vapor exceeded 5 ppm for 78 minutes in Apollo and 58 minutes in Aestiva without the device).
Anesthetic removal capacity	A single Vapor-Clear canister removes 1300 ml of isoflurane before a removal rate of less than 99% is observed.
Anesthetic removal with various vapors	Greater than 99% of anesthetic is removed regardless of which of the three agents (isoflurane, sevoflurane or desflurane) is used.
Product life testing (aged charcoal)	Initial adsorption of >99% was observed. No degradation of anesthetic gas removal capacity was observed when using aged product (71 months).
Environmental testing	No change in device performance was observed following mechanical and environmental stresses (shock, vibration, high/low temperature, humidity) for anesthetic removal, leakage, and increased back pressure.
Internal volume	The internal volume of the device is 92 ml.
Internal compliance	The internal compliance is 14 ml/kPa.
Burst pressure	The Vapor-Clear burst at a pressure of 70 pounds per square inch.
Back-pressure	Added back pressure of 0.5 cm H₂O at 30 L/min was observed.
Leak rate	No leak (0.0 ml/min) was detectable.

Study Details

The provided document describes non-clinical bench testing to demonstrate the substantial equivalence of the Vapor-Clear device to its predicate.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a "sample size" in terms of patient data. The testing involved multiple units of the Vapor-Clear device and utilized two modern anesthesia gas machines (Draeger Apollo and Ohmeda Aestiva) for the residual vapor scavenging test. "A single Vapor-Clear canister" was used for the removal capacity test. "Product containing activated charcoal that has been aged for 71 months" was tested for product life testing.
- Data Provenance: The data is from non-clinical bench testing. The country of origin is not specified but is implied to be related to the manufacturer (Axon Medical Inc., Park City, Utah, USA) and the FDA submission process. This is retrospective in the sense that the studies were completed before the 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The ground truth for this non-clinical testing was established through direct measurement using analytical instruments (e.g., anesthetic gas analyzer capable of detection <0.5 ppm) and standardized test methods (e.g., ASTM F 1205).
- Qualifications of Experts: Not applicable for establishing ground truth as it was based on instrument measurements and direct observation of physical properties.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: None. This was non-clinical bench testing using objective measurements rather than subjective assessments requiring adjudication.
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:
- MRMC Study: No. This device is a physical medical device (gas scavenging apparatus), not an AI-powered diagnostic or decision support tool that would involve human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Yes, in essence. The described non-clinical tests assess the performance of the Vapor-Clear device itself (the "algorithm" or functional mechanism) in a standalone capacity. There is no human intervention in its function of removing anesthetic gases; its performance is measured purely on its physical and chemical properties.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Instrumental measurement and direct physical property assessment.
  - Anesthetic concentrations were measured with an analyzer.
  - Volumes, pressures, flow rates, and physical integrity (burst) were directly measured or observed.
  - "Ground truth" for efficiency (e.g., >99% removal) was determined by comparing measured input and output concentrations.
The sample size for the training set:
- Training Set Sample Size: Not applicable. This device is a physical medical device and does not involve AI or machine learning models that require a training set.
How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. As above, no training set was used.

Summary

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Appendix B, Revised 510K Summary

APR 1 8 2010

510(k) Summary K092031

Page 1 of 6 April 7, 2010

Axon Medical Inc. Tel - (801) 484-3820 2645 Sackett Drive Fax - (801) 581-4367 Park City, Utah 84098

Official Contact: Proprietary or Trade Name: Common/Usual Name: Primary Classification Name Primary Classification Code: Regulation:

Joseph Orr - President Vapor-Clear Breathing circuit anesthetic gas scavenger Gas Scavenging Apparatus CBN 868.5430

Predicate Device: K033028 Gas Scavenging Device (product code: CBN) AneFin 100, Anefin-100 Volatile anesthesia emergence device Manufacturer: Axon Medical Inc

(Note that the product code for this device in the clearance letter dated July 22, 2005 is CBN)

Device Description: This device uses two anesthetic vapor adsorbent canisters connected to an anesthesia delivery system to prevent unwanted anesthetic vapors emanating from within an anesthesia gas machine from reaching a patient.

Intended Use: To remove unwanted anesthetic gases from the patient breathing circuit

Environment of Use: Operating room, surgical suite, anywhere inhaled volatile anesthetics are administered.

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510(k) Summary Page 2 of 6 April 7, 2010 .

Summary of comparison between device and predicate(s)

Attribute	Vapor-Clear (K092031)	AneFin (K033028)	Comparison
General indications for use	Remove unwantedanesthetic gases	Remove unwantedanesthetic gases	Identical
Specific indications for use	N/A	To speed emergencefrom volatile inhaledanesthetics andincreasing spontaneousbreathing throughpartial rebreathing.	Vapor-Clear is notintended to speedemergence or increasespontaneous breathing.
Patient population	Surgical patients beingventilated by ananesthesia gas machine	Surgical patients beingventilated by ananesthesia gas machine	Identical
Environment of Use	Operating Room	Operating Room	Identical
Rationale for use	To remove unwantedresidual anestheticvapor from thebreathing circuit whenthe vaporizer is turnedoff.	To remove unwantedresidual anestheticvapor from thebreathing circuit whenthe vaporizer is turnedoff.	Identical
Placement in theanesthesia circuit	Near the anesthesia gasmachine ports betweenthe anesthesia gasmachine and thebreathing circuit hoses.	Between the patientand the breathingcircuit wye.	The Vapor-Clear doesnot rely on rebreathingso there is no need toplace the devicebetween the patientand the wye. Vapor-Clear does not includeadded dead volume.
Change in dead space	None as the device isplaced in circuitbetween the anesthesiagas machine and thebreathing circuit hosesPlacement is identicalto the use of a bacterialfilter at the machineend of the circuit	Adds dead spacebetween the wye andthe patient.Placement in thebreathing circuit issimilar to a heat-moisture exchanger	Vapor-Clear does notadd dead space. AneFinrequires addition ofdead space to achievefast emergence andincrease spontaneousbreathing.
Equipment	Used with anesthesiagas machine	Used with anesthesiagas machine	Identical
Attribute	Vapor-Clear (K092031)	AneFin (K033028)	Comparison
Anesthetic removal material	Activated charcoal granules	Activated charcoal granules	Identical
Charcoal capacity	0.6" thick, 3 inch diameter. 4.25 cubic inches of charcoal	0.25" thick, 3inch diameter. 1.76 cubic inches of charcoal	Vapor-Clear contains 2.4 times as much charcoal as the AneFin
Anesthetic Removal	>99% of anesthetic gas removed	>95% of anesthetic gas removed	Similar, Vapor-Clear performance is superior
Rebreathing hose	None	Rebreathing hose placed between charcoal canister and breathing circuit wye	The rebreathing hose is used by the AneFin to achieve the additional (specific) intended use. Vapor-Clear does not include a rebreathing hose.
Back pressure	< 2.0 cm H2O at 60 L/min	<1.8cm H2O at 60 L/min	Similar
Internal compliance	7 ml/kPa	14 ml/kPa	Vapor-Clear has less internal compliance
Internal volume	92 ml	183 ml	Vapor-Clear has less internal volume
Anesthetic removal	1300 ml before less than 99% of vapor removed	400 ml before less than 50% of vapor is removed	Vapor-Clear removes more anesthetic gas
Method and timing of installation in breathing circuit	User must break the breathing circuit to install. Placed in breathing circuit when the anesthesia vaporizer has been turned off	User must break the breathing circuit to install. Placed in breathing circuit when the anesthesia vaporizer has been turned off.	Identical

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510{k) K092031 Summary Page 3 of 6 April 7, 2010

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510(k) K092031 Summary Page 4 of 6 April 7, 2010

Summary of Non-Clinical Testing

Test Condition	Test Method	Test Results
Anesthetic adsorption rate	Anesthetic gas removal using an analyzer capable of detection <0.5 ppm	Vapor-Clear scavenges >99.95% of isoflurane at a high flow rate
Scavenging residual vapor from 2 models of modern anesthesia gas machines	Saturate two modern anesthesia gas machines (Draeger Apollo and the Ohmeda Aestiva) with isoflurane for an extended period. Measure the time after the vaporizer has been turned off before the inspired isoflurane falls below 5 parts per million (ppm). Repeat the procedure with and without the Vapor-Clear in the breathing circuit.	Residual vapor exceeds the 5 ppm limit for 78 minutes in the Apollo and 58 minutes in the Aestiva following termination of vapor delivery without the Vapor-Clear. Using, the Vapor- Clear, inspired isoflurane concentration stays below 1 ppm for the duration of the test following termination of vapor delivery. The Vapor-Clear scavenger decreased the concentration of inspiratory isoflurane to less than 1 ppm throughout the tests in both the Draeger Apollo and the Ohmeda Aestiva anesthesia gas machines
Anesthetic removal capacity test	Pass isoflurane through the Vapor-Clear device at a known concentration (2%) and flow rate (5 L/min). Measure the total volume of isoflurane that passes through the device before less than 99% of isoflurane gas is being removed by the device.	A single Vapor-Clear canister removes 1300 ml of isoflurane before a removal rate of less than 99% is observed.
Test adsorption using various anesthetic vapors	Pass anesthetic gas through the device at a known inspired concentration. Measure the concentration entering and exiting the Vapor-Clear device. Repeat the test for each gas (isoflurane, sevoflurane and desflurane)	Greater than 99% of anesthetic is removed regardless of which of the three agents (isoflurane, sevoflurane or desflurane) is used.
Test Condition	Test Method	Test Results
Product life testing	Product containing activatedcharcoal that has been agedfor 71months was tested forinitial anesthetic removal andanesthetic removal capacity.	Initial adsorption of >99% wasobserved. No degradation ofanesthetic gas removalcapacity was observed whenusing the aged product.
Environmental testing	The Vapor-Clear device wassubjected to mechanical andenvironmental stressesincluding shock, vibration,high and low temperature andhumidity. The stressedproduct was then tested foranesthetic removal, leakageand increased back pressure	No change in deviceperformance was observedfollowing the environmentalstresses.
Internal volume testing	The internal compressiblevolume was measured using adirect volume measure. Theinternal compliance wastested by observing thevolume needed to achieve apressure change in a sealeddevice.	The internal volume of thedevice is 92 ml. The internalcompliance is 14 ml/kPa.
Burst testing	Increasing pressure wasapplied to a sealed device in astepwise fashion until thedevice burst was observed.The pressure at which a burstwas observed was recorded.	The Vapor-Clear burst at apressure of 70 pounds persquare inch.
Back-pressure tests	Added back pressure causedby placing the Vapor-Clear inthe breathing circuit wasmeasured per ASTM F 1205	Added back pressure of 0.5cm H₂O at 30 L/min wasobserved
Leak test	A pressure of 30 cm H₂O wasapplied to a sealed device.The flow rate of air into thesealed device was taken asthe leak rate per ASTM F 1205	No leak (0.0 ml/min) wasdetectable.

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510(k) K092031 Summary Page 5 of 6 April 7, 2010 :

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510(k) K092031 Summary Page 6 of 6 April 7, 2010

Testing Summary Statement

The bench testing of the Vapor-Clear device demonstrates that the device is capable of removing unwanted anesthetic gases from the breathing circuit with greater efficiency and capacity than the predicate device. The testing also shows that the Vapor-Clear is capable of scavenging greater than 99% of the residual anesthetic vapors emitted by an anesthesia gas machine after the vaporizer has been turned off. Multiple gas removal testing demonstrated than 99% of anesthetic agent is removed for each anesthetic agent (desflurane, isoflurane and sevoflurane). Testing demonstrated that the activated charcoal used in the device is capable of capturing a volume of anesthetic gas that is well beyond what is emitted by an anesthesia gas machine after the vaporizer has been turned off. Testing using aged activated charcoal granules demonstrate that the device will perform as specified throughout the product lifetime. Environmental and mechanical testing demonstrates that the leak, back pressure and internal volume of the device are sufficiently small that installation of the device will not interfere with delivery of mechanical ventilation during an anesthetic and that the device is sufficiently rugged to withstand the rigors of shipping and storage.

These tests demonstrate that the subject device (Vapor-Clear) is substantially equivalent to the predicate device.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Dr. Joseph Orr President Axon Medical, Incorporated 2645 Sackett Drive Park City, Utah 84098

APR 1 3 2010

Re: K092031 Trade/Device Name: Vapor-Clear Regulation Number: 21CFR 868.5430 Regulation Name: Gas-Scavenging Apparatus Regulatory Class: II Product Code: CBN Dated: April 5, 2010 Received: April 8, 2010

Dear Dr. Orr:

We have reviewed your 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your 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.

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Page 2- Dr. Orr

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Nh for

Anthony Watson, B.S., M.S., M.B.A. 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 Statement

510(k) Number: K092031

Device Name: Vapor-Clear

Indications for Use: To remove unwanted anesthetic gases from the patient breathing circuit

Intended patient population: Surgical patients being ventilated by an anesthesia gas machine.

Environment of Use: Operating room, surgical suite, anywhere inhaled volatile anesthetics are administered.

Prescription Use: XX

Over-The-Counter Use_

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schultheis

Tivision Sign-Off) ାsion of Anesthesiology, General Hospital ection Control, Dental Devices

3)(k) Number: k-092031

Regulation Number and Section

§ 868.5430 Gas-scavenging apparatus.

(a)
Identification. A gas-scavenging apparatus is a device intended to collect excess anesthetic, analgesic, or trace gases or vapors from a patient's breathing system, ventilator, or extracorporeal pump-oxygenator, and to conduct these gases out of the area by means of an exhaust system.(b)
Classification. Class II (performance standards).