(53 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) submission for the C2 CryoBalloon Ablation System. The submission claims substantial equivalence to a predicate device (K190194) and focuses on modifications to the reprocessing instructions for the Controller and Foot Pedal components.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Cleaning Validation | "All testing results met the acceptance criteria identified in the study protocol." |
| Disinfection Validation | "All testing results met the acceptance criteria identified in the study protocol." |
| Usability | "All testing results met the acceptance criteria identified in the study protocol." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes for the cleaning, disinfection, or usability test sets. It also does not explicitly state the data provenance (e.g., country of origin, retrospective/prospective). These types of details are typically found in the full study protocols, which are not included in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. For cleaning and disinfection validation, "ground truth" would typically be established by laboratory standards and microbial assays validated by experts in microbiology and sterilization. For usability testing, it would involve user feedback and observation, potentially analyzed by human factors experts. However, these specific details are absent.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set. Adjudication is more commonly associated with studies involving subjective interpretation (e.g., image reading), which is not the primary focus of the performance data described here (cleaning, disinfection, usability).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The performance data focuses on cleaning validation, disinfection validation, and usability, not on the clinical effectiveness of the device as interpreted by multiple readers. The submission primarily argues for substantial equivalence based on the device's design being the same as the predicate, with only reprocessing instructions modified.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to the C2 CryoBalloon Ablation System. This is a medical device for cryosurgery, not an AI algorithm. Therefore, there is no "standalone algorithm" performance to report.
7. The Type of Ground Truth Used
- Cleaning Validation: The ground truth for cleaning validation would typically be established by predefined standards of cleanliness (e.g., residual protein, hemoglobin levels) as measured by laboratory assays. These standards are based on scientific evidence and regulatory guidelines aimed at ensuring the device is safe for reuse.
- Disinfection Validation: The ground truth for disinfection validation would be established by demonstrating a specified reduction in microbial load (e.g., a certain log reduction of specific microorganisms) to render the device safe for patient use. This is determined using standardized microbiological testing methods.
- Usability: The ground truth for usability would be based on user feedback, observation of task completion, and adherence to established human factors principles, indicating that the device can be used safely and effectively as intended.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of an algorithm or AI. The performance data described relates to validation studies (cleaning, disinfection, usability) for a physical medical device. These types of studies often use a number of devices or cycles to demonstrate robustness, but not in the sense of a "training set" for machine learning.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the context of an algorithm, this question is not applicable. The basis for the validation processes (cleaning, disinfection, usability) is established through recognized industry standards, regulatory guidance documents, and scientific principles.
§ 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.