(665 days)
K033503, Pre-Amendment
No
The document describes a device that uses gas absorption and CO2 sensing for anesthetic gas removal and ventilation control. There is no mention of AI, ML, or related concepts.
Yes.
The device is intended to speed emergence from the effects of volatile inhaled anesthetics, indicating a direct therapeutic effect on the patient's physiological state.
No
The device is designed to remove anesthetic gas and regulate CO₂ during emergence from anesthesia. While it has a CO₂-sensor, its primary function is therapeutic (removing gas and generating partial rebreathing) rather than diagnosing a disease or condition. The monitoring of CO₂ is for managing the patient's ventilation during this process, not for diagnostic purposes.
No
The device description explicitly mentions hardware components: an "anesthetic gas absorber" and an "anesthetic gas CO₂-sensor."
Based on the provided information, the AneFin 100 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to speed emergence from inhaled anesthetics by removing gas and generating CO₂ through partial rebreathing. This is a therapeutic intervention directly applied to the patient's breathing circuit, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device description focuses on the mechanism of action within the breathing circuit (gas absorption and CO₂ sensing for ventilation control), not on analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
The AneFin 100 is a device used in the administration and management of anesthesia, which falls under the category of therapeutic or life support devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The AneFin 100 is intended to speed emergence from volatile inhaled anesthetics by removing unwanted anesthetic gas from the breathing circuit and by generating increased carbon dioxide through partial rebreathing.
The AneFin 100 is intended to speed emergence from the effects of volatile inhaled an(e)sthetics by removing unwanted inhaled anesthetic agents from the patient’s breathing circuit and by generating increased CO2 through partial rebreathing. It is intended for use with only Isoflurane, Sevoflurane and Desflurane.
Product codes (comma separated list FDA assigned to the subject device)
CBN, BYW
Device Description
The AneFin combines an anesthetic gas absorber to remove anesthetic gas from the breathing circuit and an improved method of increasing and maintaining end tidal CO2, which allows increased patient ventilation while preventing hypocapnia during emergence from volatile inhaled anesthesia.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating room, surgical suite, anywhere inhaled volatile anesthetics are administered.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K033503, Pre-Amendment
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.
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).
Not Found
§ 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).
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. | ||||
| 2355 South 1070 West, Suite D | ||||
| Salt Lake City, Utah 84119 | Tel - (801) 484-3820 | |||
| Fax - (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 valve | |||
| Penlon, 510(k) exempt | ||||
| Non 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.
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
Device | RFS Vacuum
scavenging
K033503 | Protect-OR
scavenging
device
Pre-amendment | Model A100 CO₂
absorber bypass
valve,
exempt | Non-invasive
cardiac output
monitor, NICO
K030886 |
|--------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------|------------------------------------------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------|
| Intended Use | Speed
emergence from
inhaled volatile
anesthetics | Remove
anesthetic agent
from operating
room | Remove
anesthetic agent
from operating
room | Remove CO₂ and
allow rapid build-
up of CO₂ by
rebreathing | Measure cardiac
output by partial
CO₂ rebreathing |
| Scavenging
method | Charcoal
adsorption | Vacuum system
conveys waste gas
out of operating
room | Charcoal
adsorption | Not applicable | Not applicable |
| Method of
increasing
CO₂ | Dead space
tubing placed
between patient
and Y-Piece. | Not applicable | Not applicable | Valve on absorber
allows expired
gas containing
CO₂ to bypass
absorber | Dead space tubing
placed between
patient and Y-Piece |
| Rebreathing
Volume | 431 ml max. | Not applicable | Not applicable | Depends on the
volume of the
breathing circuit | > 400 ml |
| Intended
Population | Surgical Patients
receiving inhaled
anesthetics | Dental patients
receiving inhaled
anesthetics | Surgical Patients
receiving inhaled
anesthetics Same | Surgical Patients
receiving inhaled
anesthetics | Surgical Patients
receiving inhaled
anesthetics |
| Environment
of Use | Operating Room | Operating Room,
Dental Suite | Operating Room | Operating Room | Operating Room,
ICU |
| Placement in
circuit | Between
endotracheal
tube and Y-Piece | Gas evacuation
port | Gas evacuation
port | Between inspired
and expired one-
way valves | Between
endotracheal tube
and Y-piece |
| Materials | Activated
charcoal,
polypropylene
housing and
rebreathing hose | Not applicable | Activated
Charcoal | Not applicable | Polypropylene
housing and
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 (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
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