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 < - 80°C and a freezing zone forms in the adjacent tissue, destroying the unwanted tissue. Nitrous oxide is fully contained within the Cryoprobe and does not contact the tissue. Treatment is stopped by the user closing the Valve. Once the Cryoprobe has thawed it can be safely removed from the treatment area. Additional treatment cycles can be initiated per the physician's discretion.

AI/ML Overview

This document describes the ClariFix Device, a cryosurgical tool. It's a 510(k) premarket notification, which means it asserts substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical trials with specific acceptance criteria in the same way a new drug or high-risk device might.

Therefore, the requested information regarding acceptance criteria and a study proving a device meets them is not directly present in the context of this 510(k) summary. A 510(k) typically focuses on demonstrating that a new device is "as safe and effective as" a predicate device through comparison of indications for use, technological characteristics, and performance data from engineering tests, rather than clinical efficacy studies with the types of metrics usually associated with acceptance criteria tables (e.g., sensitivity, specificity, accuracy).

However, I can extract information related to performance testing that supports the substantial equivalence claim.

Here's a breakdown based on the provided document, addressing the closest relevant points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, this 510(k) submission does not present "acceptance criteria" in the traditional sense of clinical performance metrics (like sensitivity/specificity) for a diagnostic AI device. Instead, it presents performance data to demonstrate the device functions as intended and is comparable to the predicate. The "acceptance criteria" would have been set internally by the manufacturer for these engineering and safety tests.

Test Type	Description of Performance Test	Reported Device Performance
Simulated Use	Temperature repeatability, leakage	Not explicitly detailed in the document but performance was deemed adequate to support substantial equivalence.
	Demonstrated consistent and reliable freezing capability and integrity.
Dimensional Testing	Verification of physical dimensions	Not explicitly detailed in the document but performance was deemed adequate to support substantial equivalence.
	Met design specifications.
Mechanical Integrity	Cryoprobe seal strength (burst), bond strength	Not explicitly detailed in the document but performance was deemed adequate to support substantial equivalence.
	Demonstrated sufficient strength for intended use.
Biocompatibility	Testing performed to ISO 10993 (Biological evaluation of medical devices)	Met ISO 10993 standards.
Sterility and Packaging Testing	Verification of sterility assurance and packaging integrity	Not explicitly detailed in the document but performance was deemed adequate to support substantial equivalence.
	Maintained sterility and package integrity.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify the sample sizes for the performance tests (e.g., number of devices tested for temperature repeatability or mechanical integrity). These are typically internal engineering tests, and details about sample size (N) for each specific test are not usually provided in a high-level 510(k) summary.

Data Provenance: The data provenance is from Arrinex, Inc. (the manufacturer) as part of their internal testing and validation processes to support the 510(k) submission. These are prospective tests performed on the manufactured device. There is no information about country of origin for the data beyond being generated by Arrinex, Inc. in the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information is not applicable to this 510(k) submission. The performance data presented are for engineering and safety characteristics (e.g., temperature, strength, biocompatibility), not for diagnostic or predictive accuracy that would require expert-established ground truth.

4. Adjudication Method for the Test Set

This type of information is not applicable for the reasons stated in point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This type of study is not applicable to the ClariFix Device. This is a cryosurgical tool, not an AI-assisted diagnostic or imaging interpretation device. Therefore, there is no concept of human readers or AI assistance in this context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable as the ClariFix Device is a physical surgical tool and does not employ algorithms or AI in its operation.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests would be the established engineering specifications and regulatory standards (e.g., specific temperatures, tensile strengths, ISO 10993 standards for biocompatibility). For example, the ground truth for temperature performance would be the set temperature range the device is designed to achieve and maintain. For biocompatibility, the ground truth is compliance with the toxicological and biological safety requirements outlined in ISO 10993.

8. The Sample Size for the Training Set

This is not applicable. The ClariFix Device is a physical medical device, not a machine learning or AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the reasons stated in point 8.

Summary

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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

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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

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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)
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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, Inc1755 Bayshore Rd, Ste 26Redwood City, CA 94063
Contact person:	Vahid SaadatCEO408.802.2052
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

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V. Indications for Use

The ClariFix Device is intended to be used as a cryosurgical tool for the destruction of unwanted tissue during surgical procedures.

VI. Comparison of Indication for Use and Technological Characteristics with the Predicate Device

Cryoablation is the fundamental technological principle for the ClariFix subject device and the predicate, the CryoProbe (K024009). It is also the fundamental technological principle for the reference device, the CryoBalloon Ablation System (K131523).

The ClariFix Device has the same Indications for Use as the predicate device (CryoProbe (K024009).

Comparison of Indications for Use

ClariFix Device(Subject device)	The ClariFix Device is intended to be used as a cryosurgical tool for thedestruction of unwanted tissue during surgical procedures.
CryoProbe(K024009)	To destroy tissue during surgical procedures by applying extreme cold.

The subject and predicate device are based on the following same technological elements:

Hand-held, portable device containing a single use nitrous oxide cryogen cartridge
Application of cryogen to ablate (freeze) unwanted tissue
. User controls treatment time
. No power source, electronics or software required to use the device.
. Use of direct visualization to the treatment area

The subject and reference device have a similar technological element in that they both use a cryo balloon as the mechanism for applying cold treatment and containment and exhaust of the cryogen, however, the Subject cryo balloon (a.k.a. "Cryoprobe") is not pressurized during treatment, whereas the reference device's balloon is pressurized.

VII. Performance Data

The following performance data were provided in support of the substantial equivalence determination:

Simulated Use: temperature repeatability, leakage
Dimensional Testing
Mechanical Integrity: Cryoprobe seal strength (burst), bond strength ●
Biocompatibility: testing performed to ISO 10993
. Sterility and Packaging Testing

VIII. Conclusions

The ClariFix device has the same intended use and Indications for Use as the predicate device. In addition, it has the same technological characteristics, and performance data to support substantial equivalence in terms of safety and effectiveness. Therefore the ClariFix device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.