(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.
§ 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.