C2 CryoBalloon Ablation System

K212814 · Pentax of America, Inc. · GEH · Nov 29, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K212814
• Device Name: C2 CryoBalloon Ablation System
• Applicant: Pentax of America, Inc.
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Nov 29, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Cryosurgical system for endoscopic tissue ablation; utilizes nitrous oxide-cooled balloon. System components: sterile single-use catheter, reusable controller, reusable foot pedal, single-use cartridge. Physician inserts catheter through endoscope (min 3.7mm channel) to target site; balloon inflated with nitrous oxide; tissue visualized through balloon; controller manages cryogen spray to freeze/ablate unwanted tissue; cryogen exhausted through controller. Used in clinical settings by physicians. Modifications to controller hardware/software address random resets, improve operational reliability, update RF encryption, replace motor encoders, and fix software bugs. Output is controlled cryoablation; enables targeted treatment of Barrett's Esophagus.

Clinical Evidence

Bench testing only. Design verification and validation testing confirmed physical, reliability, and safety specifications. EMC and electrical safety testing performed per IEC 60601-1-2:2014. Software verification and validation testing confirmed performance equivalence to the predicate.

Technological Characteristics

Cryosurgical unit; nitrous oxide cryogen; compliant balloon diffuser. Compatible with endoscopes (min 3.7mm channel, max 105cm length). Controller-based system with foot pedal activation. Software-activated controller. Electrical safety/EMC per IEC 60601-1-2:2014.

Indications for Use

Indicated for patients requiring endoscopic cryosurgical ablation of Barrett's Esophagus with dysplasia.

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

• C2 CryoBalloon Ablation System (K203024)

Submission Summary (Full Text)

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November 29, 2021

PENTAX Medical William Goeller Vice President, Quality Assurance and Regulatory Affairs 303 Convention Way, Suite 1 Redwood City, California 94063

Re: K212814

Trade/Device Name: C2 CryoBalloon Ablation System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit And Accessories Regulatory Class: Class II Product Code: GEH Dated: August 31, 2021 Received: September 3, 2021

Dear William Goeller:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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

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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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K212814

Device Name C2 CryoBalloon Ablation System

Indications for Use (Describe)

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.

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

PENTAX Medical A Division of PENTAX of AMERICA, Inc. 303 Convention Way, Suite 1 Redwood City, CA 94063

| Contact Person: | William Goeller |
|-----------------|----------------------------------------------------------|
| | Vice President, Quality Assurance and Regulatory Affairs |
| | PENTAX of America, Inc. |
| | 3 Paragon Drive |
| | Montvale, New Jersey, 07645-1782 |
| | O: 201-571-2300 Ext 2318 C: 848-482-0481 |
| | T: 800-431-5880 Ext 2318 F: 201-799-4117 |
| | Email: [e-mail] |

Date Prepared: November 02, 2021

## DEVICE

| Name of Device: | C2 CryoBalloon Ablation System |
|----------------------|-----------------------------------------------------------------------|
| Common Name: | Cryosurgical Unit, Cryogenic Surgical Device |
| Classification Name: | Cryosurgical Unit, Cryogenic Surgical Device<br>21 CFR§878.4350(a)(2) |
| Regulatory Class: | Class II |
| Product Code: | GEH |

#### II. PREDICATE DEVICE: C2 CryoBalloon Ablation System, PENTAX Medical (K203024)

#### III. DEVICE DESCRIPTION

The subject device is a cryosurgical unit with a nitrous oxide cooled balloon that is compatible with commercially available endoscopes with a minimum working channel inner diameter of 3.7 mm and maximum length of 105 cm. The subject device is a cryosurgical system comprised of four components including a Catheter (sterile, single use), Controller (non-sterile, reusable), Foot Pedal (non-sterile, reusable), and Cartridge (non-sterile, single use).

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The subject device is used to ablate unwanted tissue by application of extreme cold. The balloon at the distal end of the Catheter comes in contact with tissue and is inflated with nitrous oxide. Tissue is visualized through the pre-inflated balloon, and the treatment site is selected is by adjusting the endoscope and Controller. The nitrous oxide spray cools the balloon to ablate the unwanted tissue, and the nitrous oxide exhausts through the Controller.

#### IV. INDICATIONS FOR USE

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.

### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE V. 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 device are based on the same endoscopic instrumentation 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.

The subject C2 CryoBalloon™ Ablation System has the same technological characteristics to the legally marketed predicate device (K203024). The subject devices and predicate/reference devices are based on the following same technological elements:

- Inserted through an endoscope to access the treatment site
- Application of cryogen to ablate (freeze) the unwanted tissue
- Use of a compliant balloon to position the treatment diffuser and to contain and 0 exhaust the cryogen
- User-controlled (trigger/foot pedal) to release cryogen 0
- o Software activated Controller

The only modifications that are being made are to the C2 CryoBalloon Controller hardware and software to correct the controller random reset issues and to improve the handheld controller unit operational reliability. In addition, controller software has been updated to log data periodically to a log file, improve the RF encryption algorithm, replace the motor encoders and address open software bugs.

The changes in the subject device have been evaluated through performance testing and raise no issue of safety and effectiveness of the device as these differences have no effect on the performance, function or general intended use of the device.

There are no changes to the reprocessing (cleaning) of the Controller and Foot Pedal components. The subject device and predicate device are both intended to be cleaned and disinfected by the user between patient use.

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#### VI. PERFORMANCE DATA

Performance data was provided in support of the substantial equivalence determination. Design verification and validation testing was performed on the subject PENTAX Medical C2 CryoBalloon™ Ablation System to evaluate physical, reliability, and safety specifications. The acceptance criteria have been satisfied for all tests.

#### VII. EMC AND ELECTRICAL SAFETY

The acceptable level of electromagnetic compatibility (EMC) and electrical safety (ES) for the PENTAX Medical C2 CryoBalloon™ Ablation System were confirmed by the testing to the following standards: IEC 60601-1-2:2014 4th Edition and ANSI/AAMI/IEC/EN 60601-1-2:2014

## VIII. SOFTWARE

The modified controller of the C2 CryoBalloon Ablation System was subjected to the Software Verification and Validation testing to show that the performance of the device is substantially equivalent to the predicate device. The subject device successfully met all the acceptance criteria for the software verification and validation testing.

#### IX. CONCLUSION

The subject C2 CryoBalloon Ablation System has the same clinical attributes, technological characteristics, intended use, and expected performance as the legally marketed predicate device, C2 CryoBalloon Ablation System (K203024). The performance testing results demonstrate that the subject C2 CryoBalloon Ablation System with modified Controller hardware and software changes should perform as intended in the specified use conditions and should perform comparably to the legally marketed predicate device that is currently marketed for the same intended use.