(54 days)
The retrieval net is intended for use in endoscopic retrieval of foreign objects, food bolus, tissue fragments and excised tissue such as polyps.
The EndoChoice Retrieval Net is a disposable, single-use sterile device comprised of a flexible wire cable and snare loop with net which can be extended and retracted form the flexible outer sheath using a three ring handle. Objects are retrieved by advancing the finger rings of the handle to open the retracted net. The net is then endoscopically manipulated over the foreign object, food bolus, tissue fragment or excised tissue, in which the finger rings of the handle are retracted to close the net once the article has been retrieved.
This document, a 510(k) premarket notification, describes the "EndoChoice Retrieval Net," a retrieval device intended for use in endoscopic procedures. The document aims to demonstrate the device's substantial equivalence to a legally marketed predicate device.
Acceptance Criteria and Device Performance:
The document focuses on demonstrating substantial equivalence to a predicate device, the Roth Net® retriever product line (K122462). The core acceptance criterion is that the new device performs at least as safely and effectively as the predicate, based on comparable characteristics.
While a formal table of "acceptance criteria" with specific quantitative targets and reported performance isn't explicitly provided, the substantial equivalence table (Section 7.5) serves this purpose by comparing key characteristics of the new device to the predicate. The "reported device performance" is implicitly that the device meets or matches the predicate in the listed attributes.
| Characteristic | Acceptance Criteria (Predicate: Roth Net® retriever product line K122462) | Reported Device Performance (EndoChoice Retrieval Net) |
|---|---|---|
| Product Code | FDI, GCJ | FDI, GCJ |
| Regulation No. | 21CFR § 876.4300 | 21CFR § 876.4300 |
| Classification | Endoscopic electrosurgical unit and accessories | Endoscopic electrosurgical unit and accessories |
| Supplied Sterile | Yes | Yes |
| Sheath length | 160cm, 230cm (at least one matching) | 230cm |
| Single use | Yes | Yes |
| Sheath diameter | 2.5mm, 3.0mm (at least one matching) | 2.5mm |
| Compatibility | 2.8mm, 3.2mm endoscope channel (at least one matching) | 2.8mm endoscope channel |
| Net Size | 3 x 6 cm, 2 x 4.5 cm, 4 x 5.5 cm, 4 x 8 cm (at least one matching) | 3 x 6 cm |
| Configuration | Oval, Octagonal, Hexagonal (at least one matching) | Oval |
| Indications for use | Intended for use in endoscopic retrieval of excised polyps, tissue samples, foreign bodies and calculi during flexible and rigid endoscopy procedures. | Intended for use in endoscopic retrieval of foreign objects, food boluses, tissue fragments and excised tissue such as polyps. |
| Packaging | Single-use pouch | Single-use pouch |
Study Information:
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Sample size used for the test set and the data provenance:
The document does not describe a clinical performance study with a "test set" in the traditional sense of evaluating diagnostic accuracy or a specific outcome. Instead, it relies on non-clinical testing (sterilization, shelf-life, biocompatibility, and general performance testing) to demonstrate that the device functions as intended and is safe. No specific sample sizes for these tests are provided in the summarized information, nor is data provenance (country of origin, retrospective/prospective) for a clinical test set. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This submission does not involve a "test set" requiring expert ground truth in the context of diagnostic or interpretive performance. The non-clinical tests rely on established scientific methods and standards. -
Adjudication method for the test set:
Not applicable. There is no clinical "test set" or expert review process described for adjudication. -
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. The device is a physical retrieval tool, not an AI-assisted diagnostic or interpretive product. Therefore, an MRMC study related to AI assistance for human readers is not relevant. -
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, and intrinsically requires human operation. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical tests:- Sterilization and Shelf-Life: Ground truth is established by adherence to recognized international standards (ISO 11135:2014, AAMI ANSI ISO 11737-2:2009, AAMI ANSI ISO 11138-1:2006).
- Biocompatibility: Ground truth is established by adherence to AAMI ANSI ISO 10993-1:2009.
- Performance Testing: While details are not given, this would typically involve engineering tests against internal specifications or industry standards to confirm functional performance (e.g., net opening/closing, retrieval capability, material integrity).
-
The sample size for the training set:
Not applicable. As this is not an AI/machine learning device, there is no "training set." -
How the ground truth for the training set was established:
Not applicable, as there is no training set.
§ 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).