The C2 Therapeutics CryoBalloon Ablation System is intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications.

Device Description

The CryoBalloon Ablation System ("System") is used to destroy unwanted tissue by application of extreme cold. Upon activation by a physician, the balloon probe at the end of the catheter is simultaneously inflated and cooled with nitrous oxide. The balloon probe comes in contact with the wall of the esophagus and ablates unwanted tissue. Nitrous oxide is fully contained within the balloon probe and does not contact the esophagus. The nitrous oxide gas exits the patient through the proximal end of the catheter. The CryoBalloon Ablation System is designed for one time, continuous application use (single patient) in conjunction with a therapeutic endoscope (3.7mm accessory channel ID). The System is comprised of the following main components:

CryoBalloon Ablation Catheter (REF FG-1000) consists of a connector, catheter . shaft, balloon probe, and protective sheath. This is supplied sterile.
CryoBalloon Ablation Handle (REF FG-1001) contains the cartridge heater and . refrigerant delivery valve which is controlled via the trigger. The unit is internally powered (9VDC non-replaceable lithium battery pack) and supplied non-sterile.
CryoBalloon Ablation Cartridge (REF FG-1002) contains liquid nitrous oxide. The . Cartridge is supplied non-sterile and contains enough refrigerant for one to two ablation sites.

AI/ML Overview

The provided document is a 510(k) summary for the C2 Therapeutics CryoBalloon Ablation System. It details the device's description, indications for use, and a comparison to predicate devices to establish substantial equivalence. However, it does not contain acceptance criteria in the traditional sense of specific performance metrics with PASS/FAIL thresholds.

Instead of acceptance criteria, the document states that "Biocompatibility, performance and animal test results demonstrated the safety and effectiveness of the CryoBalloon Ablation System." This general statement indicates that various tests were conducted to support the device's safety and effectiveness, which are the overall goals of such studies rather than specific numerical acceptance criteria.

Therefore, many of your requested items cannot be extracted directly from this document due to the nature of a 510(k) summary, which often summarizes testing without providing explicit raw data or detailed methodologies.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Inferred/General Goals)	Reported Device Performance
Safety	Demonstrated by biocompatibility, performance, and animal test results.
Effectiveness	Demonstrated by biocompatibility, performance, and animal test results.
Substantial Equivalence to Predicates	Achieved, based on similar indications for use, device operation, and technical/functional capabilities.

Rationale: The document states: "Biocompatibility, performance and animal test results demonstrated the safety and effectiveness of the CryoBalloon Ablation System." This implies these were the overarching "acceptance criteria" met by the studies, but no specific numerical targets (e.g., "temperature must reach X within Y seconds") are provided. The primary goal of the 510(k) in this context is to show substantial equivalence, which was "found."

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in the provided text. The document mentions "biocompatibility, performance and animal test results," implying multiple tests, but the number of animals or test samples is not given.
Data Provenance: Not specified. It doesn't mention the country of origin or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This type of information is typically relevant for studies involving human assessment, like image interpretation or clinical outcomes judged by specialists. The document refers to "biocompatibility, performance and animal test results," which are usually evaluated against engineering specifications, biological standards, or observed physiological responses, not typically "ground truth" established by human experts in the same way an AI diagnostic device would.

4. Adjudication method for the test set:

Not Applicable. Similar to point 3, adjudication methods like N+1 consensus are used when multiple human evaluators assess subjective or semi-subjective data (e.g., image findings). This is not described for the "biocompatibility, performance and animal test results."

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:

No. An MRMC study is not mentioned. This type of study is specifically designed for evaluating diagnostic devices, especially those involving AI for human readers. The CryoBalloon Ablation System is a surgical tool, not an AI diagnostic device, so an MRMC study is not relevant to its type of evaluation.

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

No. The device described is a physical surgical tool (CryoBalloon Ablation System) that is operated by a physician ("Upon activation by a physician"). It does not involve an "algorithm" in the sense of a standalone AI software. Therefore, standalone algorithm performance is not applicable.

7. The type of ground truth used:

For biocompatibility: Ground truth would typically be established by standardized cytotoxicity, sensitization, irritation, and systemic toxicity tests, often comparing results against established biological safety limits.
For performance: Ground truth would be based on engineering specifications (e.g., temperature achieved, inflation pressure, cryogen flow rate, ablation zone size).
For animal test results: Ground truth would be based on histological examination of tissue, observation of physiological responses, and measurement of ablation effects and potential damage to surrounding tissue, usually compared against desired therapeutic outcomes and safety margins.

8. The sample size for the training set:

Not Applicable. The CryoBalloon Ablation System is a physical medical device, not an AI/machine learning model. Therefore, it does not have a "training set" in the context of AI development.

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

Not Applicable. As there is no AI training set, this question is not relevant.

Summary

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101825

CONFIDENTIAL

Section 5-510(k) Summary or 510(k) Statement

I. General Information

Submitter: C2 Therapeutics, Inc. SEP 2 9 2010 303 Convention Way, Suite 1 Redwood City, CA 94063 Contact Person: Anne Worden Regulatory Consultant 925-895-1200 Summary Preparation Date: 6/30/2010

II. Names

Device Names: CryoBalloon Ablation System

Primary Classification Names: Cryosurgical unit with a nitrous oxide cooled balloon probe and accessories

III. Predicate Devices

CryMed Technologies SprayGenix™ Ablation System K060555 .
CSA Medical CryoSpray Ablation System K070893 .
GI Supply Polar Wand Cryotherapy System K021387 .
Barrx Medical HALO360 Coagulation System - K051168 .

IV. Product Description

CryoBalloon Ablation Catheter (REF FG-1000) consists of a connector, catheter . shaft, balloon probe, and protective sheath. This is supplied sterile.
CryoBalloon Ablation Handle (REF FG-1001) contains the cartridge heater and . refrigerant delivery valve which is controlled via the trigger. The unit is internally powered (9VDC non-replaceable lithium battery pack) and supplied non-sterile.
CryoBalloon Ablation Cartridge (REF FG-1002) contains liquid nitrous oxide. The . Cartridge is supplied non-sterile and contains enough refrigerant for one to two ablation sites.

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V. Indications for Use

VI. Rationale for Substantial Equivalence

The CryoBalloon Ablation System shares the same or similar indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent for use to the predicate devices as a cryosurgical unit with a nitrous oxide cooled balloon probe and accessories.

In addition, comparative performance test data demonstrated adequate device performance and safety.

ComparisonCharacteristic	K10	K070893 & K060555	K021387	K051168
Brand Name	CryoBalloonAblation System	CryoSpray Ablation™& SprayGenix™ Cryo	Polar WandCryotherapy System	HALO 360Coagulation System
Intended Use
Intended Use	Destruction ofunwanted tissue withextreme cold	Destruction ofunwanted tissue withextreme cold	Ablation of unwantedtissue with extreme cold	RF for tissuecoagulation
Indications forUse	Intended to be used asa cryosurgical tool fordestruction ofunwanted tissue inthe field of generalsurgery, specificallyfor endoscopicapplications.	Intended to be used as acryosurgical tool fordestruction of unwantedtissue in the field ofgeneral surgery,specifically forendoscopic applications.	Used for ablation ofunwanted tissue in thefields of dermatology,gynecology, generalsurgery, urology, andgastroenterology. Thesystem may be usedwith a variety ofcryogens, e.g. carbondioxide, nitrous oxide,argon, krypton	Indicated for use in thecoagulation of bleedingand non-bleeding sitesin the gastrointestinaltract including but notlimited to theesophagus. Indicationsinclude EsophagealUlcers, Mallory-Weisstears, ArteriovenousMalformations,Angiomata, Barrett'sesophagus, DieulafoyLesions, andAngiodysplasia.
Key Technical Characteristics
Control	User	User	User	User
Method ofAction	Thermal	Thermal	Thermal	Thermal
Endoscopicprocedure	Yes	Yes	Yes	Yes

See Table 9 - Substantial Equivalence Comparison of Intended Use and Technical Characteristics for comprehensive analysis of Technical Characteristics.

Safety and Effectiveness Information VII.

The review of the indications for use and technical characteristics provided demonstrates that the CryoBalloon Ablation System is substantially equivalent to the predicate devices.

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Biocompatibility, performance and animal test results demonstrated the safety and effectiveness of the CryoBalloon Ablation System.

VIII. Conclusion

The CryoBalloon Ablation System was found to be substantially equivalent to the predicate devices.

The CryoBalloon Ablation System shares identical indications for use, similar design features, and functional features with, and thus is substantially equivalent to, the predicate devices.

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

SEP 2 9 2010

C2 Therapeutics, Inc. % Mr. Peter Garcia-Meza President and CEO 303 Convention Way, Suite 1 Redwood City, California 94063

Re: K101825

Trade/Device Name: CyroBalloon Ablation System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: June 30, 2010 Received: July 01, 2010

Dear Mr. Garcia-Meza:

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

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Page 2 - Mr. Peter Garcia-Meza

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 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 go to http://www.fda.gov/AboutFDA/CentersQffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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CONFIDENTIAL

Indications for Use Statement

510(k) Number (if known): K10 | 82 ・

Device Name: CryoBalloon Ablation System

Indications for Use:

Prescription Use	✓
(Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number	K10/825

Page 1 of 1C2 Therapeutics Premarket Notification 510(k) Submission for: CryoBalloon Ablation System

Section 4: Indications for Use - Page 4-2

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.