(102 days)
Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare is used endoscopically in the removal of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract. Disposable Polypectomy Snare shall be used with monopolar diathermic energy. Disposable Polypectomy Hybrid Snare shall be used with or without monopolar diathermic energy.
The Disposable Polypectomy Snare is available in two different types with rotating snare and non-rotating snare. The cutting wire diameter of the snares is 0.4mm. The catheter diameters are 1.8mm and 2.4mm the depending on the version. The snares are available in different forms, lengths and openings depending on the type.
- Non-rotating snares: available in six different loop shape: Oval, Hexagon, Lune, Combination, Multiple and Composite. Opening widths 10mm, 15mm, 20mm, 25mm,30mm, 35mm. Working lengths 1800mm and 2300mm.
- Rotatable snares: available in six different loop shape: Oval, Hexagon, Lune, Combination, Multiple and Composite. Opening widths 10mm, 15mm, 20mm.25mm. 30mm. 35mm. Working lengths 1800mm and 2300mm.
The Disposable Polypectomy Hybrid Snare is available in two different types with rotating snare and non-rotating snare. Only one available loop shape is Hybrid. The cutting wire diameter of the snares is 0.4mm. The catheter diameters is 2.4mm. The snares are available in different forms, lengths and openings depending on the type.
- Non-rotating snares: available in the opening widths 10mm, 15mm. Working lengths 1800mm and 2300mm.
- Rotatable snares: available 10mm, 15mm. Working lengths 1800mm and 2300mm.
The provided text is a 510(k) summary for a Disposable Polypectomy Snare and Hybrid Snare. This document primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and non-clinical performance data, rather than presenting a study to prove a device meets specific clinical acceptance criteria for a new AI or diagnostic device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not applicable or not provided in this type of submission.
Here's an explanation based on the provided text:
- No clinical study was conducted or included in this submission. The device is being cleared based on substantial equivalence to a legally marketed predicate device, primarily through bench testing and comparison of technical specifications.
- The summary explicitly states: "No Clinical Study is included in this submission." (Section 5.8)
However, I can extract the "Non-clinical Performance Data" which serves as the basis for demonstrating safety and effectiveness for this type of medical device submission.
1. Table of Acceptance Criteria and Reported Device Performance (Non-clinical)
Based on the "Non-clinical Performance Data" section (5.7), the acceptance criteria are generally adherence to recognized international standards and satisfactory results from specific bench tests.
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing" (10993-1) | Comply with ISO 10993-1 |
| Sterilization | Compliance with ISO 11135-1 "Sterilization of Health Care products Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices" | EO Sterilization; SAL:10-6 (Same as predicate) |
| Ethylene Oxide Residuals | Compliance with ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals" | Comply with ISO 10993-1 (Implied compliance with 10993-7 given general 10993 compliance) |
| Physical Properties / Bench Testing | Satisfactory performance for "Appearance" and "Physical properties" tests (implied acceptance) | The results of all testing were passing. |
| Shelf Life | 3 years | 3 years (Same as predicate) |
| Material/Design equivalence to predicate | Differences do not raise questions of safety and effectiveness | Differences listed and deemed "Substantially equivalent" or "Similar" |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for the bench tests. Typically, regulatory submissions for physical devices include testing on a representative number of units to ensure consistency and performance across the product line.
- Data Provenance: The tests were performed on the Disposable Polypectomy Snare and Disposable Polypectomy Hybrid Snare (the proposed device). The provenance of the raw data (e.g., country of origin, retrospective/prospective) is not detailed in this summary. These are typically controlled laboratory tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This submission relies on objective physical and chemical testing standards (ISO standards, bench tests) rather than expert-derived ground truth.
4. Adjudication method for the test set
- Not applicable. This submission relies on objective physical and chemical testing standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a physical medical instrument (polypectomy snare), not an AI or diagnostic device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used
- For biocompatibility and sterilization, the "ground truth" is defined by adherence to internationally recognized ISO standards.
- For physical properties, the "ground truth" is adherence to pre-defined specifications and satisfactory performance in bench tests.
8. The sample size for the training set
- Not applicable. No machine learning or AI component, thus no training set.
9. How the ground truth for the training set was established
- Not applicable. No machine learning or AI component, thus no training set or its associated ground truth establishment.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).