ANEFIN, MODEL 100

K033028 · Axon Medical · CBN · Jul 22, 2005 · Anesthesiology

Device Facts

• Record ID: K033028
• Device Name: ANEFIN, MODEL 100
• Applicant: Axon Medical
• Product Code: CBN · Anesthesiology
• Decision Date: Jul 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5430
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The AneFin 100 is intended to speed emergence from the effects of volatile inhaled anesthetics by removing unwanted anesthetic gases and generating CO2 through partial rebreathing. It is intended for use with only Isoflurane, Sevoflurane and Desflurane.

Device Story

AneFin 100 is a gas scavenging and rebreathing device used in the operating room. It consists of dead space tubing placed between the endotracheal tube and the Y-piece of the breathing circuit, combined with an activated charcoal-based anesthetic gas absorber. The device functions by allowing partial rebreathing of expired gases, which increases CO2 levels to prevent hypocapnia during emergence from volatile anesthesia, while simultaneously scavenging waste anesthetic gases via charcoal adsorption. It is operated by clinicians in surgical settings. By managing CO2 levels and removing anesthetic agents, the device facilitates a faster recovery from anesthesia for the patient.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Activated charcoal, polypropylene housing, rebreathing hose. Form factor: Dead space tubing placed between endotracheal tube and Y-piece. Scavenging principle: Charcoal adsorption. CO2 management: Partial rebreathing via dead space. Connectivity: Standalone. Sterilization: Not specified.

Indications for Use

Indicated for surgical patients receiving volatile inhaled anesthetics (Isoflurane, Sevoflurane, Desflurane) to speed emergence from anesthesia.

Regulatory Classification

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.

Predicate Devices

• RFS Vacuum gauge scavenging circuit (K033503)
• Protect-OR filter, Charcoal based scavenging device (Pre-Amendment)
• Model A100 CO2 absorber with bypass valve (Penlon, 510(k) exempt)
• Non invasive cardiac output monitor, NICO (K030886)

Submission Summary (Full Text)

{0}------------------------------------------------

### 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.<br>2355 South 1070 West, Suite D<br>Salt Lake City, Utah 84119 | Tel - [phone]<br>Fax - [phone] | | | |
| 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,<br>Accutron - K033503<br>"Protect-OR" filter, Charcoal based scavenging device,<br>Foregger - Pre-Amendment | | | |
| Secondary Predicate: | Model A100 CO2 absorber with bypass valve<br>Penlon, 510(k) exempt<br>Non invasive cardiac output monitor, NICO<br>(Product code: CCK)<br>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.

{1}------------------------------------------------

## 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 | Proposed<br>Device | RFS Vacuum<br>scavenging<br>K033503 | Protect-OR<br>scavenging<br>device<br>Pre-amendment | Model A100 CO₂<br>absorber bypass<br>valve,<br>exempt | Non-invasive<br>cardiac output<br>monitor, NICO<br>K030886 |
|--------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------|------------------------------------------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------|
| Intended Use | Speed<br>emergence from<br>inhaled volatile<br>anesthetics | Remove<br>anesthetic agent<br>from operating<br>room | Remove<br>anesthetic agent<br>from operating<br>room | Remove CO₂ and<br>allow rapid build-<br>up of CO₂ by<br>rebreathing | Measure cardiac<br>output by partial<br>CO₂ rebreathing |
| Scavenging<br>method | Charcoal<br>adsorption | Vacuum system<br>conveys waste gas<br>out of operating<br>room | Charcoal<br>adsorption | Not applicable | Not applicable |
| Method of<br>increasing<br>CO₂ | Dead space<br>tubing placed<br>between patient<br>and Y-Piece. | Not applicable | Not applicable | Valve on absorber<br>allows expired<br>gas containing<br>CO₂ to bypass<br>absorber | Dead space tubing<br>placed between<br>patient and Y-Piece |
| Rebreathing<br>Volume | 431 ml max. | Not applicable | Not applicable | Depends on the<br>volume of the<br>breathing circuit | > 400 ml |
| Intended<br>Population | Surgical Patients<br>receiving inhaled<br>anesthetics | Dental patients<br>receiving inhaled<br>anesthetics | Surgical Patients<br>receiving inhaled<br>anesthetics Same | Surgical Patients<br>receiving inhaled<br>anesthetics | Surgical Patients<br>receiving inhaled<br>anesthetics |
| Environment<br>of Use | Operating Room | Operating Room,<br>Dental Suite | Operating Room | Operating Room | Operating Room,<br>ICU |
| Placement in<br>circuit | Between<br>endotracheal<br>tube and Y-Piece | Gas evacuation<br>port | Gas evacuation<br>port | Between inspired<br>and expired one-<br>way valves | Between<br>endotracheal tube<br>and Y-piece |
| Materials | Activated<br>charcoal,<br>polypropylene<br>housing and<br>rebreathing hose | Not applicable | Activated<br>Charcoal | Not applicable | Polypropylene<br>housing and<br>rebreathing hose |

# Differences between Other Legally Marketed Predicate Devices

There are no significant differences between the intended device and the identified predicates.

{2}------------------------------------------------

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.

{3}------------------------------------------------

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 [phone] or [phone] 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

{4}------------------------------------------------

### 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