(148 days)
Not Found
No
The description focuses on the mechanical and cryosurgical aspects of the device, with no mention of AI, ML, or related concepts like image processing or data analysis for decision making.
Yes.
The device is used as a cryosurgical tool for the destruction of unwanted tissue, specifically for treating chronic rhinitis in adults, which is a therapeutic purpose.
No
The device is described as a cryosurgical tool used for the destruction of unwanted tissue during surgical procedures. It is a handheld, single patient-use device that performs cryosurgery by cooling a cryoprobe to destroy tissue, not diagnose conditions.
No
The device description clearly outlines a physical, handheld cryosurgical device with hardware components (Handle, Cannula, Cryoprobe, Canister Cap, mechanical valve). It is not solely software.
Based on the provided information, the ClariFix Device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is "as a cryosurgical tool for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis." This describes a surgical intervention performed directly on the patient's tissue, not a test performed on a sample taken from the patient.
- Device Description: The device description details a handheld cryosurgical tool that delivers cold to tissue for destruction. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ClariFix Device directly treats tissue within the body.
N/A
Intended Use / Indications for Use
The ClariFix Device is intended to be used as a cryosurgical tool for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.
Product codes
GEH
Device Description
The ClariFix Device is a handheld, single patient-use, disposable cryosurgical device used for the destruction of tissue during surgical procedures. The device consists of a Handle attached to a Cannula with a Cryoprobe at the distal end. The ClariFix Device is provided sterile to the user. The user can select from two nitrous oxide Canister (cryogen Canister) sizes.
To perform cryosurgery, the ClariFix Device is removed from the sterile packaging and the desired cryogen Canister is inserted into the Handle. A Canister Cap is then tightened onto the Handle, which pierces the Canister. The cryogen is held in the Handle until the user opens a mechanical valve that allows cryogen to flow down the Cannula into the Cryoprobe.
The Cryoprobe is placed into contact with the target tissue via direct visualization. The Cannula can be rotated to ensure proper positioning. Once the Cryoprobe is in the desired position, cryosurgery can start.
The Cryoprobe is held in contact with the target location during cryosurgery. As cryogen flows into the Cryoprobe, the liquid partially evaporates and the inside of the Cryoprobe cools to
§ 878.4350 Cryosurgical unit and accessories.
(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.
0
Image /page/0/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" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, with flowing lines above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 14, 2017
Arrinex, Inc. Vahid Saadat CEO 1755 East Bayshore RD., Suite 26 Redwood City, California 94063
Re: K162608
Trade/Device Name: ClariFix Device Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II Product Code: GEH Dated: January 11, 2017 Received: January 12, 2017
Dear Vahid Saadat:
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.
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
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Image /page/1/Picture/8 description: The image shows the text "Jennifer R. Stevenson -S" in a large, sans-serif font. The text is black, and the background is white. The letters are well-defined and easy to read. The text appears to be a name, possibly of a person or organization.
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162608
Device Name ClariFix Device
Indications for Use (Describe)
The ClariFix Device is intended to be used as a cryosurgical tool for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for "Arrinex, Inc.". The logo features a stylized letter "A" with a red accent on the left side. The text "rrinex, Inc." is written in a cursive font to the right of the "A".
510(k) Summary (K162608)
| I. Submitter Information | |
|---|---|
| Submitter name: | Arrinex, Inc |
| 1755 Bayshore Rd, Suite 26 | |
| Redwood City, CA 94063 | |
| Contact person: | Vahid Saadat |
| CEO | |
| 408.802.2052 | |
| Date Prepared: | 13 February 2017 |
| II. Product Classification | |
| Device Name: | ClariFix Device |
| Common Name: | Cryosurgical Unit and accessories |
| CFR Classification: | 21 CRF 878.4350 |
| Device Class: | II |
III. Predicate Device Arrinex, Inc., ClariFix Device (K160669) Predicate: This predicate has not been subject to any recalls.
GEH
IV. Device Description
Product Code:
The ClariFix Device is a handheld, single patient-use, disposable cryosurgical device used for the destruction of tissue during surgical procedures. The device consists of a Handle attached to a Cannula with a Cryoprobe at the distal end. The ClariFix Device is provided sterile to the user. The user can select from two nitrous oxide Canister (cryogen Canister) sizes.
To perform cryosurgery, the ClariFix Device is removed from the sterile packaging and the desired cryogen Canister is inserted into the Handle. A Canister Cap is then tightened onto the Handle, which pierces the Canister. The cryogen is held in the Handle until the user opens a mechanical valve that allows cryogen to flow down the Cannula into the Cryoprobe.
The Cryoprobe is placed into contact with the target tissue via direct visualization. The Cannula can be rotated to ensure proper positioning. Once the Cryoprobe is in the desired position, cryosurgery can start.
The Cryoprobe is held in contact with the target location during cryosurgery. As cryogen flows into the Cryoprobe, the liquid partially evaporates and the inside of the Cryoprobe cools to