(87 days)
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.
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). 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.
This document describes a 510(k) summary for the PENTAX Medical C2 CryoBalloon Ablation System. The submission focuses on modifications to the controller's hardware and software. Here's a breakdown of the information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical Specifications | Met acceptance criteria (P. 5, VI) |
| Reliability Specifications | Met acceptance criteria (P. 5, VI) |
| Safety Specifications | Met acceptance criteria (P. 5, VI) |
| Electromagnetic Compatibility (EMC) | Confirmed by testing to IEC 60601-1-2:2014 4th Edition and ANSI/AAMI/IEC/EN 60601-1-2:2014 (P. 5, VII) |
| Electrical Safety (ES) | Confirmed by testing to IEC 60601-1-2:2014 4th Edition and ANSI/AAMI/IEC/EN 60601-1-2:2014 (P. 5, VII) |
| Software Verification and Validation | Successfully met all acceptance criteria (P. 5, VIII) |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Design verification and validation testing was performed" (P. 5, VI) and "The modified controller of the C2 CryoBalloon Ablation System was subjected to the Software Verification and Validation testing" (P. 5, VIII). However, specific sample sizes for the test set or the data provenance (e.g., country of origin, retrospective/prospective) are not provided in this 510(k) summary. The testing appears to be internal validation of hardware and software changes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not explicitly provided. The testing described focuses on engineering validation (physical, reliability, safety, EMC, ES, software verification) rather than clinical validation that would typically involve expert-established ground truth on patient data.
4. Adjudication Method for the Test Set
No adjudication method is mentioned. As noted above, the testing appears to be technical verification and validation, not a study involving human interpretation of clinical outputs that would require adjudication.
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 MRMC comparative effectiveness study was done or mentioned. This submission concerns a cryosurgical ablation system, not an AI-assisted diagnostic or interpretive device. Therefore, the concept of human readers improving with or without AI assistance is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a CryoBalloon Ablation System, meaning it is a medical device that performs a physical action (ablation). It is not an algorithm-only device. Performance evaluation for such devices involves assessing the device's technical specifications and intended function, not standalone algorithm performance.
7. The Type of Ground Truth Used
The "ground truth" for the tests performed appears to be:
- For physical, reliability, and safety: Engineering specifications and performance standards.
- For EMC and electrical safety: Compliance with recognized international standards (IEC 60601-1-2:2014 and ANSI/AAMI/IEC/EN 60601-1-2:2014).
- For software verification and validation: Software requirements and design specifications.
This is not clinical ground truth (e.g., pathology, outcomes data, expert consensus on images).
8. The Sample Size for the Training Set
No training set is mentioned as this is not an AI/machine learning device that requires a training set. The document describes changes to hardware and software of a cryosurgical system.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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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 (1-800-638-2041 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: william.goeller@pentaxmedical.com |
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 Device21 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.
§ 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.