(665 days)
The AneFin 100 is intended to speed emergence from the effects of volatile inhaled anesthetics by removing unwanted anesthetic gas and generating through partial rebreathing. It is intended for use with only Isoflurane, Sevoflurane and Desflurane.
The AneFin combines an anesthetic gas absorber to remove anesthetic gas from the breathing circuit and an anesthetic gas CO₂-sensor which allows increased patient ventilation while preventing hypocapnia during emergence from volatile inhaled anesthesia.
The provided document, K033028 for the Axon Medical AneFin 100, is a 510(k) premarket notification. This type of submission by the FDA focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing new safety and effectiveness through clinical trials with defined acceptance criteria and human performance studies common for novel AI/ML medical devices.
Therefore, the requested information regarding acceptance criteria, device performance against those criteria, study specifics (sample size, ground truth, expert involvement, MRMC studies, standalone performance), and training set details is not present in this document.
The document mainly demonstrates equivalence through a comparison table of attributes between the AneFin 100 and predicate devices, as well as descriptive information about the device and its intended use. Here's a breakdown of what is available:
1. A table of acceptance criteria and the reported device performance
- Not applicable / Not provided. This document does not establish specific performance acceptance criteria for the AneFin 100 against which its performance is then measured. The evaluation is based on demonstrating substantial equivalence to predicate devices, which implies meeting similar safety and performance profiles. The comparison table (labeled "Comparison to Predicate Devices to demonstrate substantial equivalence") highlights physical and functional attributes but not quantitative performance metrics against acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. No test set or associated sample sizes are mentioned. The substantial equivalence pathway typically relies on bench testing, engineering analysis, and literature review of predicate devices, rather than new clinical testing on a specific "test set" for performance evaluation in the same way an AI device would be assessed.
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 provided. Since no specific test set is described, there's no mention of experts establishing ground truth. The "ground truth" for substantial equivalence is primarily defined by the established safety and effectiveness of the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided. No adjudication method is described as no test set requiring such expert review is mentioned.
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 / Not provided. The AneFin 100 is a physical medical device (anesthetic gas absorber/rebreathing device), not an Artificial Intelligence (AI) or Machine Learning (ML) driven product. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is entirely irrelevant to this device and its regulatory submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. As the AneFin 100 is a physical device and not an algorithm, the concept of "standalone performance" in the context of AI without human interaction does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. As noted, the "ground truth" in this context is the established safety and effectiveness of predicate devices, which would have been determined through their own regulatory pathways (e.g., historical use, clinical studies at their time of clearance). There's no new "ground truth" derivation described for this specific submission.
8. The sample size for the training set
- Not applicable / Not provided. As this is not an AI/ML device, there is no "training set."
9. How the ground truth for the training set was established
- Not applicable / Not provided. As this is not an AI/ML device, there is no "training set" or ground truth for it.
Summary of the K033028 Submission:
The K033028 submission for the Axon Medical AneFin 100 is a 510(k) premarket notification to demonstrate substantial equivalence to legally marketed predicate devices. The device is an anesthetic gas absorber with rebreathing capabilities intended to speed emergence from volatile inhaled anesthetics.
The method used to "prove" the device meets the regulatory requirements for clearance is through comparison to predicate devices already cleared by the FDA. The application argues that the AneFin 100 shares the same intended use, technological characteristics, and safety profile as the identified predicates, or that any differences do not raise new questions of safety and effectiveness.
- Predicate Devices:
- RFS Vacuum gauge scavenging circuit, K033503
- "Protect-OR" filter, Charcoal based scavenging device, Pre-Amendment (Foregger)
- Model A100 CO2 absorber with bypass valve (Penlon), 510(k) exempt
- Non invasive cardiac output monitor, NICO (Novametrix), K030886 - This appears to be used as a predicate just for the mechanism of increasing CO2 via dead space tubing and rebreathing volume.
The document explicitly states: "There are no significant differences between the intended device and the identified predicates." This statement is the core of the substantial equivalence argument.
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Axon Medical – K033028
Response to AI letter of 18 Jan 05
JUL 2 2 2 2005
Non-Confidential Summary of Salety and Effectiveness
| Page 1 of 2 | ||||
|---|---|---|---|---|
| April 29, 2005 | ||||
| Axon Medical Inc.2355 South 1070 West, Suite DSalt Lake City, Utah 84119 | Tel - (801) 484-3820Fax - (801) 977-0363 | |||
| Official Contact: | Joseph Orr - President | |||
| Proprietary or Trade Name: | AneFin 100 | |||
| Common/Usual Name: | Rebreathing / Absorber | |||
| Primary Classification Name | Gas Scavenging Apparatus | |||
| Primary Classification Code: | CBN | |||
| Secondary Classification Name: | Rebreathing Device | |||
| Secondary Classification Code: | BYW | |||
| Primary Predicate Devices: | RFS Vacuum gauge scavenging circuit,Accutron - K033503"Protect-OR" filter, Charcoal based scavenging device,Foregger - Pre-Amendment | |||
| Secondary Predicate: | Model A100 CO2 absorber with bypass valvePenlon, 510(k) exemptNon invasive cardiac output monitor, NICO(Product code: CCK)Novametrix - K030886 |
Device Description: The AneFin combines an anesthetic gas absorber to remove anesthetic gas from Device Description: "The Anchilding and ansanone gCO-senounts which allows increased patient wentilation while preventing hypocapnia during emergence from volatile inhaled anesthesia.
Intended Use:
The AneFin 100 is intended to specd emergence from volatile inhaled anestheins by removing unwanted The Ancruit Too Is intendou to spood one generating through partial rebreathing.
Environment of Use: Operating room, surgical suite, anywhere inhaled volatile anesthetics are administcred.
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Axon Medical - K033028
Non-Confidential Summary of Safety and Effectiveness
Page 2 of 2 April 29, 2005
Comparison to Predicate Devices to demonstrate substantial equivalence
| Attribute | ProposedDevice | RFS VacuumscavengingK033503 | Protect-ORscavengingdevicePre-amendment | Model A100 CO₂absorber bypassvalve,exempt | Non-invasivecardiac outputmonitor, NICOK030886 |
|---|---|---|---|---|---|
| Intended Use | Speedemergence frominhaled volatileanesthetics | Removeanesthetic agentfrom operatingroom | Removeanesthetic agentfrom operatingroom | Remove CO₂ andallow rapid build-up of CO₂ byrebreathing | Measure cardiacoutput by partialCO₂ rebreathing |
| Scavengingmethod | Charcoaladsorption | Vacuum systemconveys waste gasout of operatingroom | Charcoaladsorption | Not applicable | Not applicable |
| Method ofincreasingCO₂ | Dead spacetubing placedbetween patientand Y-Piece. | Not applicable | Not applicable | Valve on absorberallows expiredgas containingCO₂ to bypassabsorber | Dead space tubingplaced betweenpatient and Y-Piece |
| RebreathingVolume | 431 ml max. | Not applicable | Not applicable | Depends on thevolume of thebreathing circuit | > 400 ml |
| IntendedPopulation | Surgical Patientsreceiving inhaledanesthetics | Dental patientsreceiving inhaledanesthetics | Surgical Patientsreceiving inhaledanesthetics Same | Surgical Patientsreceiving inhaledanesthetics | Surgical Patientsreceiving inhaledanesthetics |
| Environmentof Use | Operating Room | Operating Room,Dental Suite | Operating Room | Operating Room | Operating Room,ICU |
| Placement incircuit | Betweenendotrachealtube and Y-Piece | Gas evacuationport | Gas evacuationport | Between inspiredand expired one-way valves | Betweenendotracheal tubeand Y-piece |
| Materials | Activatedcharcoal,polypropylenehousing andrebreathing hose | Not applicable | ActivatedCharcoal | Not applicable | Polypropylenehousing andrebreathing hose |
Differences between Other Legally Marketed Predicate Devices
There are no significant differences between the intended device and the identified predicates.
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Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures connected in a flowing design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 24, 2013
Mr. Joseph Orr President Axon Medical, Incorporated 2355 South 1070 West, Suite D SALT LAKE CITY UT 84119
Re: K033028
Trade/Device Name: Anefin 100 Regulation Number: 21 CFR 868.5430 Regulation Name: Gas-Scavenging Apparatus Regulatory Class: II Product Code: CBN, BYW Dated: April 29, 2005 Received: May 2, 2005
Dear Mr. Orr:
This letter corrects our substantially equivalent letter of July 22, 2005.
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 - Mr. 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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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.
Antrim Co. Mich.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Axon Medical - K033028
Revision 18 May 05
Indications for Use
Page i of I
K033028 (To be assigned) 510(k) Number:
AneFin 100 Device Namc:
Indications for Use:
The AneFin 100 is intended to specd emergence from the effects of volatile inhaled ansthetics by The AneFin 100 is intended to spect entergence from the orietely of them through partial rebreaking.
It is intended for use with only Isoflurane, Sevoflurane and Desflurane.
or
XX Prescription Use_ (Per CFR 801.109)
Over-the-counter use _
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ann Graham
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Denta
510(k) Number. K033028
§ 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).