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.

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 < -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. Cryosurgery is stopped by the user closing the Valve. Once the Cryoprobe has thawed, it can be safely removed. Additional cycles can be initiated per the physician's discretion.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the ClariFix Device.

It's important to note that this document is a 510(k) summary for a medical device that has been re-classified with an expanded indication for use (cryosurgical tool including in adults with chronic rhinitis). It is not a standalone AI/software as a medical device (SaMD) submission. Therefore, some of the requested information, particularly around AI-specific elements like "test set," "training set," "ground truth establishment," and "MRMC studies," is not directly applicable or reported in the context of this traditional medical device submission.

The "device" in question is a cryosurgical tool, not an AI algorithm. The study described is a clinical trial to demonstrate the safety and effectiveness of the device for a specific clinical indication, not to prove the performance of an AI algorithm against acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for a device and not an AI algorithm, the acceptance criteria are framed in terms of clinical safety and effectiveness for its intended use, rather than typical AI performance metrics like sensitivity, specificity, or AUC.

Acceptance Criteria Category	Specific Criteria (Implicit from study design)	Reported Device Performance (Summary)	Met?
Safety	Frequency of device/procedure-related Serious Adverse Events (SAEs)	No device or procedure-related SAEs reported within 90 days.	Yes
	Frequency of device/procedure-related Adverse Events (AEs)	One moderate nasal bleeding (remotely related, controlled, healed by Day 7). Other transient/mild AEs resolved by Day 90.	Yes
Effectiveness	Improvement in subject-reported Total Nasal Symptom Score (rTNSS)	Average rTNSS improved 56% (from 6.2 to 2.7) at 90 days.	Yes
	Improvement in subject-reported Visual Analog Scale (VAS)	Average VAS improved 53% (from 7.6 to 3.7) at 90 days.	Yes
	Investigator evaluation of ease of use	Rated "easy" to "moderately easy" in 89% (24/27) of subjects.	Yes
	Investigator evaluation of nasal congestion score	Average nasal congestion score improved 67% (from 1.5 to 0.5) at 90 days.	Yes
	Investigator rating of bleeding, swelling, crusting	Average rating of 0 at 90 days.	Yes
Subject Experience	Subject satisfaction/comfort with cryosurgery. No explicit pass/fail, but reported.	59% reported uncomfortable (53% somewhat, 6% very), 41% reported comfortable (29% somewhat, 12% very).	N/A

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

Again, this is not an AI algorithm evaluation with a "test set" in the traditional sense.

Test Set (Clinical Study Population): 27 subjects (total for safety evaluation). 24 subjects (for 90-day effectiveness follow-up).
Data Provenance: Prospective, multicenter clinical study conducted in the United States.

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

Number of Experts: Not explicitly stated as "experts establishing ground truth" in the AI sense. However, the study involved "investigators" who performed endoscopic evaluations and rated ease of use, nasal congestion, bleeding, swelling, and crusting. These would be medical professionals (likely ENT specialists) who are experts in the field.
Qualifications: Not explicitly stated, but assumed to be qualified clinicians (e.g., otolaryngologists) conducting the clinical trial.

4. Adjudication Method for the Test Set

Adjudication method: Not applicable as it's not a study involving multiple interpretations for a "ground truth" establishment in the AI context. The study reports subjective patient outcomes (rTNSS, VAS, satisfaction) and objective investigator assessments (ease of use, endoscopic findings). Adverse events would typically be assessed by the study investigators.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating human reader performance, especially when assisted by AI. This submission concerns a physical device, not an AI system.
Effect Size of Human Readers with vs. without AI Assistance: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study: No, a standalone algorithm performance study was not done. The device is a physical cryosurgical tool and inherently involves human-in-the-loop operation.

7. Type of Ground Truth Used

Ground Truth: For this device, "ground truth" is established through:
- Patient-Reported Outcomes (PROs): rTNSS and VAS scores.
- Investigator Assessments: Endoscopic evaluations, ratings of ease of use, nasal congestion, bleeding, swelling, and crusting.
- Adverse Event Monitoring: Clinical observation and reporting.
- Literature Review: Comparison of device performance with published literature on cryosurgery in the nasal passageway.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable. This is not an AI/machine learning device. The "training" for the device would be the extensive research and development prior to the clinical study, but not in the sense of a dataset used to train an algorithm.

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

Ground Truth for Training Set: Not applicable, as there is no "training set" for an AI algorithm.

Summary

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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

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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.

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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) 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)
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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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510(k) Summary (K162608)

I. Submitter Information
Submitter name:	Arrinex, Inc1755 Bayshore Rd, Suite 26Redwood City, CA 94063
Contact person:	Vahid SaadatCEO408.802.2052
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:

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, including in adults with chronic rhinitis.

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VI. Comparison of Intended Use, Indications for Use and Technological Characteristics with the Predicate Device

Cryoablation is the fundamental technological principle for the ClariFix subject device and the predicate, the ClariFix Device (K160669). The intended use for the ClariFix Device, destruction of tissue with extreme cold, remains unchanged for the subject device.

The only modification to the subject device is to update the indications for use to include in adults with chronic rhinitis. Results from a clinical study combined with published literature demonstrated that the reference to adults with chronic rhinitis does not impact safety and effectiveness.

Comparison of Indications for Use

ClariFix Device (Subject)	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
ClariFix Device (Predicate, K160669)	The ClariFix Device is intended to be used as a cryosurgical tool for the destruction of unwanted tissue during surgical procedures

The subject and the legally marketed predicate device share identical technological elements:

Hand-held, portable device containing a single use nitrous oxide cryogen cartridge ●
Application of cryogen to ablate (freeze) unwanted tissue
Use of a cryo balloon as the mechanism for applying cold treatment and containment and ● exhaust of the cryogen
. User controls treatment time
No power source, electronics or software required to use the device.
Use of direct visualization to the target location ●

As such, the intended use, design, materials and function of the Arrinex ClariFix Device are substantially equivalent to the predicate device.

VII. Performance Data

Because there have been no technological changes to the subject device, no additional bench testing, preclinical testing, sterilization or biocompatibility testing was performed,

A prospective, multicenter clinical study was performed in the United States to support the modification of the indications for use statement to include in adults with chronic rhinitis. Twenty seven (27) subjects were enrolled and cryosurgery was successfully performed with the ClariFix device bilaterally (n=54 treatments) while the subjects were awake using local anesthesia. Cryosurgery was well-tolerated and subjects reported an average pain rating of 1.19 on the Wong-Baker FACES pain scale (0 = minimum score, 5 = maximum score).

The primary safety endpoint was the frequency of device and procedure-related serious adverse events (SAEs). No device or procedure-related SAEs were reported throughout the 90-day follow-up duration. The primary effectiveness endpoints were subject-reported outcomes of nasal symptoms using reflective Total Nasal Symptom Score (rTNSS) and Visual Analog Scale (VAS). Three subjects did not return for the 90-day follow-up visit. Of the remaining 24 subjects, the average rTNSS improved 56% from 6.2 at baseline to 2.7 at 90 days (0 = minimum score, 12 = maximum score). The average VAS score improved 53% from 7.6 at baseline to 3.7 at 90 days (0= minimum score, 10 = maximum score).

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The secondary safety endpoint was the frequency of device and procedure-related adverse events (AEs). One subject reported moderate nasal bleeding at Day 27 that was controlled with standard nasal packing and cautery. The investigator deemed it to be remotely related to the device as the target treatment location was completely healed during endoscopic examination at Day 7. Other adverse events commonly associated with healing after cryosurgery in the nasal passageways (pain/discomfort, headache, facial pain, bleeding, dry nose and ear blockage) were observed and by day 90, they had either self-resolved or the remaining events rated as mild with a probable cause relating to pre-existing conditions. The secondary performance endpoint was investigator evaluation of the ease of use of the ClariFix device. Investigators rated cryosurgery using the ClariFix device as "easy" to "moderately easy" in 89% (24/27) of the subjects and "moderately difficult" in 11% (3/27) of the subjects.

Subjects were asked to rate their experience using a subject satisfaction questionnaire. A total of 17 of the 27 subjects responded and fifty nine percent (59%) of the subjects reported cryosurgery to be somewhat (53%) or very (6%) uncomfortable, 41% of the patients felt that it was somewhat (29%) or very (12%) comfortable. Additionally, endoscopic evaluation was performed by the investigators at the follow-up visits, and the average nasal congestion score improved 67% from 1.5 at baseline to 0.5 at 90 days (0 = minimum score, 3 = maximum score). On average, the investigators rated bleeding, swelling and crusting of the treatment site as 0 at 90 days (0 = minimum score, 3 = maximum score) and the average Lund-Kennedy assessment of the entire nasal passageway was 0.21 at 90 days (0 = minimum score, 10 = maximum score) indicating the treatment site was well healed.

A review of published literature over the last four decades was performed to determine clinical outcomes after cryosurgery in the nasal passageway. Eleven clinical studies examined use of various cryoprobes to deliver extreme cold to the nasal mucosal surface in order to treat nasal obstruction or symptoms of rhinitis. Cryosurgical ablation of tissue in the nasal passageways was shown to result in a reduction in rhinitis symptoms with rare reports of major adverse or permanent complications. Minor complications were transient in nature and resolved. There is paucity of studies concerning the vidian neurectomy by means of cryosurgery. Nevertheless, clinical study results demonstrated that both the safety profile and effectiveness results achieved by the ClariFix device in adults with chronic rhinitis are by and large comparable to those published in scientific literature.

The clinical study results demonstrated that when the subject device is used in the nasal passageway according to its Instructions for Use, it is a safe and effective tool for use in destroying unwanted tissue in adults with chronic rhinitis.

VIII. Conclusions

The ClariFix device is substantially equivalent to the predicate device. Clinical study results demonstrated that both the safety profile and effectiveness results achieved by the ClariFix device in adults with chronic rhinitis are comparable to that reported in published literature on cryosurgery in the nasal passageway.

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.