The C2 CryoBalloon™ Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett's Esophagus with dysplasia.

Device Description

The C2 CryoBalloon Ablation System is a cryosurgical device, which consists of four (4) components: (i) a single-use, sterile balloon Catheter that is inserted through the working channel of an endoscope with a minimum inner diameter (ID) of 3.7 mm and a maximum working length of 100 cm; (ii) a hand-held reusable Controller with a liquid crystal display (LCD) touch screen interface; (iii) a reusable Foot Pedal that is plugged into mains, provides power for the Controller, and allows the user to operate system functions such as ablation targeting, nitrous oxide flow control, and balloon deflation; and (iv) single-use Nitrous Oxide Cartridge that provides users with cryogen for each treatment.

The C2 CryoBalloon Ablation System uses nitrous oxide as a cryogen to cause necrosis of targeted tissue in a controlled manner. The low operating pressure inflates the compliant balloon against the lumen ID. Nitrous oxide is directed at the targeted tissue and it evaporates on the inner surface of the balloon and freezes the tissue. The nitrous oxide is fully contained within the balloon and the resultant gas exhausts through the Catheter shaft and vents through the Controller.

There are four (4) Catheter configurations that distribute nitrous oxide focally (focal diffuser), over a quarter of the lumen circumference (90° diffuser), over half of the lumen circumference (180° diffuser), or over the full circumference of the lumen (360° diffuser). The user selects the Catheter with the desired diffuser type, removes it from the sterile packaging and inserts it through the working channel of an endoscope until the balloon portion exits the distal end of the endoscope.

The connector portion of the Catheter is inserted into the Controller and the radiofrequency identification (RFID) communication system in the Catheter connector and the Controller allows the Controller to perform functions specific to the Catheter. The LCD touch screen allows the user to set desired dosimetry, and communicates system status to the user.

The user tightens the Controller Cap against the Controller, which pierces the nitrous oxide Cartridge. Nitrous oxide is contained in the Controller until the user steps on the Foot Pedal to allow the Controller to release it into the Catheter. The user visualizes the targeting and ablation via the inflated balloon and the images provided by the endoscope. The balloon is held in contact with the treatment area during the ablation. Upon conclusion of the procedure the balloon is deflated and withdrawn into the endoscope.

AI/ML Overview

The provided text describes the C2 CryoBalloon Ablation System and its performance data submitted to the FDA for 510(k) clearance. However, the document does not contain information about an AI-powered device or a study involving human readers with and without AI assistance. It focuses on the physical, electrical, software, and biological safety and efficacy of the cryoablation system itself.

Therefore, I cannot extract the information required to answer your prompt, as it is predicated on the device being an AI-powered system and the study being an MRMC comparative effectiveness study with human readers.

The document describes the device, its intended use, comparison to predicate devices, and the results of various non-clinical (bench) tests to demonstrate safety and effectiveness.

Here's what can be inferred from the provided text regarding device acceptance criteria and performance, as it relates to the physical cryoablation system, not an AI:

1. A table of acceptance criteria and the reported device performance:

The document doesn't provide a specific table of quantitative acceptance criteria with corresponding performance metrics in a pass/fail format within the "Performance Data" section. Instead, for each "Testing Type," it lists "Objectives" which can be interpreted as the acceptance criteria, and then "Results," which state whether the objectives were met.

For example, for "Bench Testing":

Testing Type	Objectives (Acceptance Criteria - Implicit)	Reported Device Performance
Bench Testing	- Verify temperature uniformity and depth of penetration during cryogen application. - Verify system hold pressure is maintained with no leakage. - Verify controller reliability after 1-year of reuse. - Verify balloon and Catheter dimensions. - Verify Catheter able to pass through 3.7mm or larger accessory channel. - Verify rated burst pressure of balloon is sufficiently greater than nominal operating pressure. - Tensile test all of the Catheter bonds. - Verify balloon reliability after repeated inflations.	The subject C2 CryoBalloon Ablation System passed all functional testing and met all product specification requirements. (This implies all objectives were met).
Software	Perform testing to verify conformance to Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Guidance for Industry and FDA Staff, May 11, 2005.	The subject C2 CryoBalloon Ablation System met all software test requirements for software with a Major Level of Concern.
Electrical Safety	Perform testing to verify conformance to ES 60601-1:2005/(R)2012 And A1:2012, IEC 60601-1-2:2007, IEC 60601-1-6 Edition 3.1 2013 10.	The subject C2 CryoBalloon Ablation System met the electrical safety, electromagnetic compatibility, and coexistence test requirements and is fully compliant with all of the listed standards.
Controller Reprocessing	Perform testing to verify conformance to Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and FDA Staff, March 17, 2015. Perform microbial ingress testing to confirm contaminated (interior and exterior) Controller does not cross-contaminate the Catheter.	The subject C2 CryoBalloon Controller's intermediate level cleaning and disinfection processes have been validated per FDA guidance. The microbial ingress testing demonstrated that a contaminated Controller does not cross-contaminate the Catheter.
Biocompatibility	Perform testing to verify conformance to ISO 10993-1, ISO 10993-5:2009, ISO 10993-10:2010.	The subject C2 CryoBalloon Ablation System met the cytotoxicity, irritation, and sensitization requirements. The subject device materials are the same as the predicate devices.
Catheter Sterilization	Perform testing to verify conformance to ISO 11135:2014.	The subject C2 CryoBalloon Catheter met the sterilization and residuals requirements.
Packaging/Shelf Life	Perform testing to verify conformance to ISO 11607-1:2006 (Catheter only), ASTM D4332-14, ASTM D4169-14, ASTM F2096-11 (Catheter only), ASTM F88-15 (Catheter only), ASTM F1929-15 (Catheter only).	The subject C2 CryoBalloon Ablation System met the packaging test requirements.
Usability	Perform testing to verify conformance to Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and FDA Staff, February 3, 2016.	The subject C2 CryoBalloon Ablation System was found to be safe and effective for the intended user, uses, and use environment. Residual risks do not require device modification.

For the remaining points, based on the provided text, the answer is that the information is not present or not applicable as the document describes a physical medical device, not an AI system.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / Not provided: The document describes "nonclinical testing" and "bench testing." Sample sizes for these types of tests (e.g., number of catheters tested for burst pressure, number of cycles for controller reliability) are not specified. Data provenance like country of origin or retrospective/prospective is not relevant for these bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Not provided: This concept of "ground truth" established by experts is typically relevant for studies validating diagnostic or AI interpretation devices against a clinical standard. The tests described are engineering and performance characteristic tests of a cryosurgical tool.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Not provided: Adjudication methods are relevant for subjective interpretations, often in clinical studies or AI validation. This document details objective bench testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No: An MRMC comparative effectiveness study was not done. The device is a cryosurgical ablation system, not an AI-assisted diagnostic or interpretative tool. Therefore, there's no comparison of human readers with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable / Not provided: The device is a physical cryosurgical system; it does not involve algorithms for standalone performance in the context of interpretation or diagnosis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable / Not provided: For the bench tests described, the "ground truth" is defined by engineering specifications, validated test methods for mechanical integrity, electrical safety, software functionality, biocompatibility, sterilization, and reprocessing. It's not a clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

Not applicable / Not provided: This device is not an AI/machine learning system, so there is no concept of a "training set" in the context of algorithms learning from data.

9. How the ground truth for the training set was established

Not applicable / Not provided: As above, there is no training set for this type of device.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines above them that resemble a bird's wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 23, 2018

C2 Therapeutics, Inc. Patrick Wu Director of Research and Development 303 Convention Way, Ste. 1 Redwood City, CA 94063

Re: K163684

Trade/Device Name: C2 Cryoballoon Ablation System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryogenic unit and accessories Regulatory Class: Class II Product Code: GEH Dated: December 21, 2017 Received: December 22, 2017

Dear Patrick Wu:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours, Jennifer R. Stevenson -

S3

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) K163684

Device Name

C2 CryoBalloon™ Ablation System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

I. SUBMITTER

C2 Therapeutics, Inc. 303 Convention Way, Suite 1 Redwood City, CA 94063

Phone:	408-368-6043
Fax:	650-556-1145
Contact Person:	Patrick WuDirector of Research and Development
Date Prepared:	January 23, 2018

II. DEVICE

Name of Device:	C2 CryoBalloon™ Ablation System (subject device)
Common Name:	Cryosurgical Unit, Cryogenic Surgical Device
Classification Name:	Cryosurgical Unit, Cryogenic Surgical Device21 CFR§878.4350(a)(2)
Regulatory Class:	Class II
Product Code:	GEH

III. PREDICATE DEVICE

Predicate Devices:	Primary:
	C2 Therapeutics, Inc. (K161202)
	C2 CryoBalloon™ Ablation System

Secondary: C2 Therapeutics, Inc. (K152329) Coldplay CryoBalloon™ Focal Ablation System Coldplay CryoBalloon™ Full Ablation System Coldplay CryoBalloon™ Swipe Ablation System

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IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

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VL. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Cryoablation is the fundamental technological principle for both the subject C2 CryoBalloon™ Ablation System and the predicate C2 CryoBalloon™ Ablation System. Both the subject device and predicate devices are based on the same endoscopic instrumentation for accessing targeted sites and visualization.

The subject device has the same Indications for Use as the predicate devices.

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

. Inserted through an endoscope to access the treatment site
Application of nitrous oxide cryogen to ablate (freeze) the targeted tissue ●
Use of direct visualization to the treatment area ●
Use of a compliant balloon to position the treatment
Use of a balloon to contain the cryogen (gas does not contact tissue)
Use of the Catheter shaft to vent gas out of patient ●
Use of diffuser to direct cryogen on targeted tissue ●
User-controlled release of cryogen
Software activated Controller ●

The Controller is reused after intermediate level cleaning and disinfection.

VII. PERFORMANCE DATA

Performance Data were provided for the C2 CryoBalloon Ablation System and its components in support of substantial equivalence determination. The following was performed on the subject C2 CryoBalloon Ablation System to evaluate physical reliability, safety, and effectiveness.

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Testing Type	Objectives	Results
Bench Testing	The nonclinical testing assessedfunctional performance of thesystem. The following describesthe key aspects of the device thatwere tested:• Simulated Use○ Verify temperatureuniformity and depth ofpenetration during cryogenapplication.○ Verify system hold pressureis maintained with noleakage.○ Verify controller reliabilityafter 1-year of reuse.• Dimensional Testing○ Verify balloon and Catheterdimensions○ Verify Catheter able to passthrough 3.7mm or largeraccessory channel.• Mechanical Integrity○ Verify rated burst pressureof balloon is sufficientlygreater than nominaloperating pressure○ Tensile test all of theCatheter bonds○ Verify balloon reliabilityafter repeated inflations	The subject C2 CryoBalloonAblation System passed allfunctional testing and met allproduct specificationrequirements.
Software	Perform testing to verifyconformance to Guidance for theContent of PremarketSubmissions for SoftwareContained in Medical Devices,Guidance for Industry and FDAStaff, May 11, 2005.	The subject C2 CryoBalloonAblation System met allsoftware test requirements forsoftware with a Major Levelof Concern.
Electrical Safety	Perform testing to verifyconformance to the followingstandards:• ES 60601-1:2005/(R)2012And A1:2012• IEC 60601-1-2:2007• IEC 60601-1-6 Edition 3.12013 10	The subject C2 CryoBalloonAblation System met theelectrical safety,electromagnetic compatibility,and coexistence testrequirements and is fullycompliant with all of thelisted standards
Testing Type	Objectives	Results
ControllerReprocessing	Perform testing to verifyconformance to ReprocessingMedical Devices in Health CareSettings: Validation Methods andLabeling Guidance for Industryand FDA Staff, March 17, 2015.Perform microbial ingress testingto confirm contaminated (interiorand exterior) Controller does notcross-contaminate the Catheter.	The subject C2 CryoBalloonController's intermediatelevel cleaning anddisinfection processes havebeen validated per FDAguidance.The microbial ingress testingdemonstrated that acontaminated Controller doesnot cross-contaminate theCatheter; therefore,Intermediate Level Cleaningand Disinfection areappropriate reprocessingprocesses for the subjectdevice.
Biocompatibility	Perform testing to verifyconformance to the followingstandards:• Use of International StandardISO 10993-1, “Biologicalevaluation of medical devices- Part 1: Evaluation andtesting within a riskmanagement process,”Guidance for Industry andFDA Staff, June 16, 2016• ISO 10993-1:2009• ISO 10993-5:2009• ISO 10993-10:2010	The subject C2 CryoBalloonAblation System met thecytotoxicity, irritation, andsensitization requirements.The subject device materialsare the same as the predicatedevices.
CatheterSterilization	Perform testing to verifyconformance to the followingstandards:• ISO 11135:2014	The subject C2 CryoBalloonCatheter met the sterilizationand residuals requirements.The subject Catheter
Testing Type	Objectives	Results
Packaging/ShelfLife	Perform testing to verifyconformance to the followingstandards:• ISO 11607-1:2006 (Catheteronly)• ASTM D4332-14• ASTM D4169-14• ASTM F2096-11 (Catheteronly)• ASTM F88-15 (Catheter only)• ASTM F1929-15 (Catheteronly)	The subject C2 CryoBalloonAblation System met thepackaging test requirements.
	Usability	Perform testing to verifyconformance to Applying HumanFactors and UsabilityEngineering to Medical Devices,Guidance for Industry and FDAStaff, February 3, 2016.	The subject C2 CryoBalloonAblation System was found tobe safe and effective for theintended user, uses, and useenvironment. Residual risksdo not require devicemodification.

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VIII. CONCLUSIONS

The subject C2 CryoBalloon™ Ablation System (K163684) has the same intended use and indications for use as the predicate C2 CryoBalloon™ Ablation Systems (K161202). The preclinical bench performance data supports the indication for use and demonstrates that the subject device is as safe, effective, and performs as well as the predicate device. The subject device has the equivalent technological characteristics and performance data to support substantial equivalence in terms of safety and effectiveness.

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.