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The C2 CryoBalloon™ EndoGrip is intended to provide access for endoscopic device passage and exchange throughout the endoscopic procedure.

The C2 CryoBalloon™ EndoGrip is an accessory product that is used in conjunction with therapeutic endoscopes and therapeutic catheters (the C2 CryoBalloon™ Catheter of the C2 CryoBalloon™ Ablation System). The C2 CryoBalloon™ EndoGrip consists of a Clip Base, Rubber Grip, and Compression Spring. This is supplied non-sterile. The EndoGrip is used to anchor catheters in place relative to the scope. In a clinical application, once the endoscope is delivered into the gastric anatomy and positioned at its desired location the physician may insert the catheter through the endoscope. When the catheter is located properly in its axial position, the EndoGrip is positioned against the biopsy valve by depressing the clip mechanism and sitting the catheter on the rubber grips. The revised design allows for placing the EndoGrip after the CryoBalloon catheter is in place in the scope and for repositioning without having to completely withdraw and reinsert the catheter. The C2 CryoBalloon™ EndoGrip is designed for one-time, continuous application use (single patient) in conjunction with a therapeutic endoscope (3.7mm accessory channel ID) or a C2 Sidecar (FG -1011), which serves as an external channel for therapeutic devices when a therapeutic endoscope is unavailable for use.

The PENTAX Medical C2 CryoBalloon™ EndoGrip (K193036) is an accessory for endoscopic procedures. The information provided in the 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through performance testing rather than an AI/ML-driven study. Therefore, sections typically relevant to AI/ML device studies (such as MRMC studies, effect size of AI assistance, sample size for training sets, etc.) are not applicable here.

Here's a breakdown of the available information regarding acceptance criteria and performance testing:

1. A table of acceptance criteria and the reported device performance

• Withstands 10 endoscopic delivery cycles.
• Compatible with endoscopic devices.
• Resists dislodgement forces.
• Resists kinking. | All tests passed and met predetermined acceptance criteria. The device performs as intended in the specified use conditions and performs comparably to the legally marketed predicate device. |
  | Usability Testing | Validation of user needs. | All tests passed and met predetermined acceptance criteria. |

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample size for the test set for dimensional verification, simulated use, and usability testing. It refers to these as "evaluations" and "testing" without providing numerical details for the quantity of devices or cycles tested.

3. Number of experts used to establish the ground truth for the test set and their qualifications

This information is not provided. The performance testing appears to be primarily engineering and functional verification, rather than clinical efficacy studies requiring expert ground truth for interpretation of medical images or data.

4. Adjudication method for the test set

Not applicable. The described tests are functional and physical performance evaluations where outcomes are objective (e.g., successful attachment, resistance to dislodgement) rather than subjective assessments requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. The document describes performance testing for an endoscopic accessory, not an AI/ML-driven diagnostic or therapeutic device that would typically involve human-in-the-loop performance evaluation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, this is not applicable. The device is a physical accessory (EndoGrip), not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant.

7. The type of ground truth used

The "ground truth" for the performance testing cited would be direct physical measurements and engineering specifications, or the successful completion of specified functional tasks. For example:

• Physical characteristic evaluations: Ground truth would be the design specifications and manufacturing tolerances.
• Simulated use, performance, and reliability testing: Ground truth would be the defined functional requirements (e.g., "device can be attached," "withstand 10 cycles," "resist dislodgement").
• Usability testing: Ground truth would be the user needs and successful completion of tasks by users.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML system that requires a training set.

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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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 and marketed predicate 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 and marketed predicate 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 Catheter The nitrous oxide spray cools the balloon to ablate the unwanted tissue, and the nitrous oxide exhausts through the Controller.

The PENTAX Medical 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.

Here's an analysis of the provided information regarding acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document is a 510(k) summary for a medical device seeking substantial equivalence to a predicate device. It doesn't present a specific table of quantitative acceptance criteria for clinical performance that would typically be found in a clinical trial report. Instead, the "acceptance criteria" are implied to be the successful completion of various design verification and validation tests, ensuring the device performs as intended and is as safe and effective as its predicate.

2. Sample Size Used for the Test Set and Data Provenance:

The document describes preclinical (bench) performance testing, not a clinical study with a "test set" of patients. Therefore, information regarding human sample size and data provenance (country of origin, retrospective/prospective) is not applicable or provided in this 510(k) summary. The testing performed was related to design verification and validation of the device's physical, reliability, and safety specifications.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable, as this document refers to preclinical engineering and safety testing, not a clinical study requiring expert ground truth for patient data.

4. Adjudication Method for the Test Set:

Not applicable for the reasons stated above.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence to a predicate device through preclinical performance testing, not a comparative clinical trial with human readers.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):

This device is not an AI algorithm. It is a cryosurgical tool. Therefore, the concept of "standalone performance" for an algorithm is not applicable. The performance discussed relates to the device's physical and functional operation.

7. Type of Ground Truth Used:

For the performance data discussed (sterilization, biocompatibility, EMC, electrical safety, and design verification/validation), the "ground truth" is established through:

• Standardized testing procedures: Adherence to recognized national and international standards (e.g., ISO 11135, ISO 10993-1, IEC 60601-1-2, ES60601-1).
• Engineering specifications and design requirements: The device's performance is measured against predefined engineering and design specifications.
• Comparison to the predicate device: The performance is also judged in the context of being similar to the legally marketed predicate device.

8. Sample Size for the Training Set:

Not applicable, as this is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as this is not an AI/machine learning device.

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