(107 days)
No
The description details a mechanical cryosurgical device that uses nitrous oxide for tissue destruction. There is no mention of any computational or data-driven components that would suggest the use of AI or ML. The device operation is entirely user-controlled based on direct visualization.
Yes
The device is described as a "cryosurgical tool for the destruction of unwanted tissue during surgical procedures," indicating its use in treating medical conditions.
No
Explanation: The device is described as a cryosurgical tool for the destruction of unwanted tissue, which is a treatment function, not a diagnostic one.
No
The device description clearly outlines a physical, handheld cryosurgical device with a handle, cannula, cryoprobe, and uses a cryogen canister. It involves mechanical components and physical interaction with tissue.
Based on the provided information, the ClariFix Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a cryosurgical tool for the destruction of unwanted tissue during surgical procedures." This describes a therapeutic procedure performed directly on a patient's tissue, not a test performed on a sample taken from the body.
- Device Description: The description details a device that physically interacts with tissue to destroy it through freezing. It does not describe a device that analyzes biological samples (like blood, urine, or tissue biopsies) to provide diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, measure a substance in a sample, or provide any information about a patient's health status based on analysis of a biological specimen.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The ClariFix Device is a surgical tool used for treatment.
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.
Product codes (comma separated list FDA assigned to the subject device)
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 the desired nitrous oxide Canister (a.k.a. cryogen Canister) size from two different options.
To perform a treatment, 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 which allows cryogen to flow down the Cannula into the Cryoprobe.
Prior to initiating a treatment, 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, treatment can start.
The Cryoprobe is held in contact with the treatment area during the treatment. 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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 9, 2017
Arrinex, Inc. Vahid Saadat CEO 1755 East Bayshore Rd. Ste 26 Redwood City, California 94063
Re: K160669 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: May 19, 2016 Received: May 23, 2016
Dear Vahid Saadat:
This letter corrects our substantially equivalent letter of June 24, 2016.
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 (reporting of medical
1
device-related 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 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" (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 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 yours,
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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) K160669
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.
| 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)
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Section 5: 510(k) Summary
| I. Submitter Information | |
|---|---|
| Submitter name: | Arrinex, Inc |
| 1755 Bayshore Rd, Ste 26 | |
| Redwood City, CA 94063 | |
| Contact person: | Vahid Saadat |
| CEO | |
| 408.802.2052 | |
| Date Prepared: | 24 June 2016 |
| II. Product Classification | |
| Device Name: | ClariFix Device |
| Common Name: | Cryosurgical Unit and accessories |
| CFR Classification: | 21 CRF 878.4350 |
| Device Class: | 2 |
| Product Code: | GEH |
III. Predicate Device
| Predicate: | H&O Equipment, CryoProbe (K024009) |
|---|---|
| Reference: | C2 Therapeutics, CryoBalloon Ablation System (K131523) |
IV. 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 the desired nitrous oxide Canister (a.k.a. cryogen Canister) size from two different options.
To perform a treatment, 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 which allows cryogen to flow down the Cannula into the Cryoprobe.
Prior to initiating a treatment, 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, treatment can start.
The Cryoprobe is held in contact with the treatment area during the treatment. As cryogen flows into the Cryoprobe, the liquid partially evaporates and the inside of the Cryoprobe cools to