The Coldplay 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 modified device is a cryosurgical unit with a nitrous oxide cooled balloon probe that is intended for use with commercially available endoscopes with a minimum working channel inner diameter (ID) of 3.7 mm. It is comprised of three components including a Catheter (sterile), Handle (non-sterile), and Cartridge (non-sterile).

The modified device is used to destroy unwanted tissue by application of extreme cold to either a 360° circumference or a 90° circumference. The balloon probe at the end of the catheter is inflated with nitrous oxide gas and comes in contact with tissue. Tissue is visualized through the pre-inflated balloon, and the treatment site is selected is by manipulation of the endoscope and Handle. The liquid nitrous oxide spray ablates the unwanted tissue. Nitrous oxide is fully contained within the balloon probe and does not directly contact the tissue. The nitrous oxide gas exits the patient through the Catheter lumen and exhausts out the Handle.

AI/ML Overview

The provided document is a 510(k) Summary for the Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System. It describes the device, its intended use, and compares it to a predicate device to demonstrate substantial equivalence.

However, the document does not contain specific acceptance criteria or detailed results from a study that proves the device meets those criteria, as one would find in a clinical trial report or a comprehensive validation study. Instead, it provides a general statement about performance data being provided for substantial equivalence determination.

Therefore, many of the requested items cannot be extracted from this document directly. I will provide what is available and note what is not.

Acceptance Criteria and Study for Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System

The provided 510(k) Summary for the Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System states that "Performance data were provided in support of the substantial equivalence determination including. Design verification and validation testing were performed on the Coldplay CryoBalloon Ablation System to evaluate physical, simulated use, reliability, safety, biocompatibility, sterilization, and shelf life specifications. Software verification and validation were performed."

However, this document does not explicitly define specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or detailed results from studies that quantify the device's performance against such criteria. The document's purpose is to establish substantial equivalence to a predicate device (K131523, Cryoballoon Focal Ablation System) based on similar technological characteristics and expected performance, rather than to present a de novo efficacy study with defined acceptance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

As specific, quantifiable acceptance criteria and performance metrics are not detailed in this 510(k) summary, a table cannot be accurately constructed. The document generally states that the device was evaluated for:

Acceptance Criteria Category	Reported Device Performance (as stated)
Physical	Performed as intended
Simulated Use	Performed as intended
Reliability	Performed as intended
Safety	Performed as intended
Biocompatibility	Performed as intended
Sterilization	Performed as intended
Shelf Life	Performed as intended
Software Verification	Performed
Software Validation	Performed

Note: The wording "Performed as intended" indicates successful completion of tests, but does not provide specific numerical outcomes or established thresholds.

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

This information is not provided in the document. The document refers to "Design verification and validation testing" but does not specify the sample sizes (e.g., number of devices, number of simulated use cases) or the provenance of the data (country of origin, retrospective/prospective).

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

This information is not provided in the document. The device is a surgical tool, not an diagnostic imaging algorithm, so "ground truth" in the context of expert review for diagnostic accuracy is not directly applicable here. The validation likely involved engineering and medical professionals for design verification and simulated use, but details are absent.

4. Adjudication Method for the Test Set

This information is not provided in the document, as it focuses on demonstrating substantial equivalence through design and technological comparisons, not on a human-in-the-loop diagnostic study requiring adjudication.

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

This information is not provided in the document. An MRMC study is typically performed for diagnostic or AI-assisted imaging devices to assess the impact of the AI on human reader performance. This device is a cryosurgical ablation system, not a diagnostic imaging tool.

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

This information is not explicitly detailed in the document in terms of defined standalone performance metrics. The mention of "Software verification and validation were performed" implies testing of the algorithm/software component without human intervention, but specific performance results or metrics are not presented. Given it's a therapeutic device, "standalone performance" would likely refer to its ability to reliably deliver cryoablation under various conditions, which falls under the "Design verification and validation testing" mentioned.

7. Type of Ground Truth Used

The concept of "ground truth" as typically used for diagnostic algorithms (e.g., pathology, expert consensus) is not directly applicable or stated for this therapeutic device. For a surgical device, ground truth would relate to the successful and safe operation of the system as intended, which would be evaluated through physical, simulated use, and potentially in vivo (animal or human, though not detailed in this 510(k) summary as a new clinical study). The substantial equivalence is based on the predicate device's established safety and effectiveness.

8. Sample Size for the Training Set

This information is not provided in the document. "Training set" typically refers to data used to train an AI algorithm. While software is involved, this document does not describe the development of an AI algorithm in that capacity, nor does it specify any data sets for algorithm training.

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

As there is no mention of a "training set" in the context of AI algorithm development, this information is not provided in the document.

Summary

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

July 7, 2015

C2 Therapeutics Incorporated Ms. Theresa Brandner-Allen Vice President of Regulatory Affairs and Quality Assurance 303 Convention Way, Suite 1 Redwood City, California 94063

Re: K151054

Trade/Device Name: Coldplay Full CryoBalloon Ablation System, Coldplay Swipe CryoBalloon Ablation System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: June 10, 2015 Received: June 11, 2015

Dear Ms. Brandner-Allen:

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/Resourcesfor You/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,

Jennifer R. Stevenson -S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K151054

Device Name

Coldplay Full CryoBalloon Ablation System, Coldplay Swipe 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

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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

	Submitter Name: C2 Therapeutics, Inc.
Address:	303 Convention Way, Suite 1Redwood City, CA 94063
Phone Number:	650-521-5921
Fax Number:	650-556-1145
Contact Person:	Theresa Brandner-AllenVP of Regulatory Affairs and Quality Assurance
Date Prepared:	July 06, 2015

II. DEVICE

Name of Device: Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System

Common Name: Cryosurgical Unit, Cryogenic Surgical Device

Classification Name: Cryosurgical Unit, Cryogenic Surgical Device 21 CFR§878.4350(a)(2)

Regulatory Class: Class II

Product Code: GEH

III. PREDICATE DEVICE

K131523, Cryoballoon Focal Ablation System

This predicate has not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

The modified device is a cryosurgical unit with a nitrous oxide cooled balloon probe that is intended for use with commercially available endoscopes with a minimum working

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channel inner diameter (ID) of 3.7 mm. It is comprised of three components including a Catheter (sterile), Handle (non-sterile), and Cartridge (non-sterile).

A detailed comparison of the modified and predicate devices is presented in detail in Section 11 and Section 12.

V. INDICATIONS FOR USE

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Cryoablation is the fundamental technological principle for both the modified Coldplay CryoBalloon Ablation System and the predicate CryoBalloon Focal Ablation System. Both the modified device and predicate device are based on the same endoscopic instrumentation for removing unwanted tissue using extreme cold.

The modified Coldplay CryoBalloon Ablation System has similar technological characteristics to the legally marketed predicate. The modified device and predicate device are based on the following same technological elements:

Inserted through an endoscope to access the treatment site ●
Apply a cryogen to ablate (freeze) the unwanted tissue ●
Use of a compliant balloon to position the treatment diffuser and to contain and exhaust the cryogen
User-controlled (trigger) activates release of the cryogen ●
. Battery-operated Handle controller and software

The only modifications that were made include:

. The cryogen diffuser was changed from a focal spray a circumferential spray that traverses during treatment
. The Handle software and catheter interface were modified to accommodate the circumferential spray
The cryogen cylinder was changed to a larger cylinder to accommodate the ●

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circumferential spray

PERFORMANCE DATA VII.

Performance data were provided in support of the substantial equivalence determination including. Design verification and validation testing were performed on the Coldplay CryoBalloon Ablation System to evaluate physical, simulated use, reliability, safety, biocompatibility, sterilization, and shelf life specifications. Software verification and validation were performed.

VIII. CONCLUSION

The modified Coldplay CryoBalloon Ablation System has the same clinical attributes, technological characteristics, and expected performance as the legally marketed predicate, CryoBalloon Focal Ablation System (K131523). The performance data results demonstrate that the Coldplay CryoBalloon Ablation System should perform as intended in the specified use conditions and should perform comparably to the legally marketed predicate that is currently marketed for the same intended use.

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.