Coldplay CryoBalloon® Ablation System

K153541 · C2 Therapeutics, Inc. · GEH · Jan 7, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K153541
• Device Name: Coldplay CryoBalloon® Ablation System
• Applicant: C2 Therapeutics, Inc.
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Jan 7, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Coldplay CryoBalloon® Ablation System is intended for use as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications.

Device Story

The Coldplay CryoBalloon® Ablation System is an endoscopic cryosurgical device used to ablate unwanted tissue. The system consists of a sterile, single-use catheter with a distal balloon, a reusable handle, and a single-use nitrous oxide cartridge. The catheter is inserted through the working channel of a standard endoscope. The physician visualizes the treatment site through the pre-inflated balloon, positions the device using the handle, and triggers the release of nitrous oxide. The gas inflates the balloon and cools it to extreme temperatures, freezing and destroying the target tissue. The nitrous oxide is exhausted through the handle. The device is intended for use in clinical settings by trained physicians. It provides a minimally invasive method for tissue ablation, potentially reducing the need for more invasive surgical procedures.

Clinical Evidence

Bench testing only. Design verification testing was performed to evaluate physical, reliability, and safety specifications to support substantial equivalence.

Technological Characteristics

Cryosurgical unit using nitrous oxide-cooled balloon. Components: sterile single-use catheter, reusable handle, single-use cartridge. Compatible with endoscopes (min 3.7mm ID, max 100cm length). Features 8mm diameter distal balloon. Battery-operated handle controller with software. User-controlled trigger for cryogen release.

Indications for Use

Indicated for destruction of unwanted tissue in general surgery via endoscopic application.

Regulatory Classification

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.

Predicate Devices

• Coldplay CryoBalloon® Full Ablation System (K151054)

Submission Summary (Full Text)

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January 7, 2016

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

C2 Therapeutics, Inc. Theresa Brandner-Allen VP Of Regulatory Affairs And Quality Assurance 303 Convention Way, Suite 1 Redwood City, California 94063

Re: K153541

Trade/Device Name: Coldplay CryoBalloon® Ablation System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit And Accessories Regulatory Class: Class II Product Code: GEH Dated: December 9, 2015 Received: December 10, 2015

Dear Theresa 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 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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerelv vours.

Joshua

Binita S. Ashar, M.D., M.B.A., F.A.C.S. For 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) K153541

Device Name

Coldplay CryoBalloon® Ablation System

### Indications for Use (Describe)

The Coldplay CryoBalloon® Ablation System is intended for use as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications.

| Type of Use (Select one or both, as applicable) | |
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| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
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| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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#### 5. 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: [phone] Fax: [phone]

| Contact Person: | Theresa Brandner-Allen |
|-----------------|------------------------------------------------|
| | VP of Regulatory Affairs and Quality Assurance |
| Date Prepared: | December 09, 2015 |

#### II. DEVICE

Name of Device: Coldplay 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

Coldplay CrvoBalloon® Full Ablation System, K151054

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

#### IV. DEVICE DESCRIPTION

The modified device is the Catheter used as part of a cryosurgical unit with a nitrous oxide cooled balloon that is compatible with commercially available endoscopes with a minimum working channel inner diameter (ID) of 3.7 mm and maximum length of 100 cm. The modified Catheter is part of a system comprised of three components including a Catheter (sterile, single use), Handle (non-sterile, reusable), and Cartridge (non-sterile, single use).

The modified device is used to ablate unwanted tissue by application of extreme cold. The balloon at the distal end of the Catheter is comes in contact with tissue and is

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inflated with nitrous oxide. Tissue is visualized through the pre-inflated balloon, and the treatment site is selected is by adjusting the endoscope and Handle. The nitrous oxide spray cools the balloon to ablate the unwanted tissue, and the nitrous oxide exhausts through the Handle. A detailed comparison of the modified device to the predicate device is presented in detail in Section 11 and Section 12.

#### V. INDICATIONS FOR USE

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.

### 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 Coldplay CryoBalloon® Full 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 Catheter was modified to have a smaller (8mm diameter) distal balloon. .
#### VII. PERFORMANCE DATA

Performance data were provided in support of the substantial equivalence determination. Design verification testing was performed on the Coldplay CryoBalloon® Ablation System to evaluate physical, reliability, and safety specifications.

# VII. CONCLUSION

The modified Coldplay CryoBalloon® Ablation System has the same clinical attributes, technological characteristics, and expected performance as the legally marketed Coldplay CryoBalloon® Full Ablation System (K151054) predicate. The

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performance data results demonstrate that the modified 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.