(102 days)
This device is used for endoscopic histological sampling or electrocoagulation of various tissues, within the gastrointestinal and bronchial tracts, via the operating channel of endoscopic instruments.
The proposed device Disposable Hot Biopsy Forceps is a sterile, single-use endoscopic device, intended to be used for endoscopic histological sampling or electrocoagulation of various tissues, within the gastrointestinal and bronchial tracts, via the operating channel of endoscopic instruments.
It consists of a flexible wire cable and loop which can be extended and retracted from the snare's flexible outer sheath using a handle. When passed through an endoscope the forceps can be activated to deliver a monopolar electrical current to cut polyp with the loop.
The main component of the proposed device is jaws, spring sheath and handle. The proposed device is used for endoscopic histological sampling or electrocoagulation of various tissues, within the gastrointestinal and bronchial tracts, via the operating channel of endoscopic instruments.
The proposed device has two (2) specifications, HBF55-11023180 and HBF55-11023230. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10 ° and placed in a sterility maintenance package to ensure a shelf life of 3 years.
The provided document is a 510(k) summary for the Micro-Tech (Nanjing) Co., Ltd. Disposable Hot Biopsy Forceps. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing acceptance criteria and a study proving the device meets those criteria in the context of a new, innovative medical device relying on clinical performance metrics.
Instead, the document details physical and performance characteristics to argue that the proposed device is similar enough to an already approved device. Therefore, a direct answer to the request regarding acceptance criteria and a study that proves the device meets the acceptance criteria as would be typical for a clinical trial or performance study of a diagnostic or treatment effectiveness device, cannot be fully provided from this document.
Here's an analysis based on the information available:
The core "acceptance criteria" here are that the proposed device performs as well as the predicate and is substantially equivalent. The "study" is a series of bench tests comparing the proposed device against established performance benchmarks or implicitly, the performance of the predicate device (though explicit comparative data is not provided in detail).
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device performs "as well as the predicate" | "The Disposable Hot Biopsy Forceps performs as well as the predicate and is substantially equivalent to the predicate devices." |
| Meets standards for Dimensions | "Dimension Testing Report" completed |
| Meets standards for Cutting Performance | "Cutting Performance Testing" completed |
| Meets standards for Tensile Strength | "Tensile Strength Testing" completed |
| Meets standards for Package Integrity | "Package Integrity" testing completed |
| Meets standards for Electrode Contact Impedance | "Electrode Contact Impedance Testing" completed |
| Meets standards for Pushability | "Pushability Testing" completed |
| Meets standards for Jaws Misalignment | "Jaws Misalignment Testing" completed |
| Maintains sterility and function for specified shelf life (3 years) | "Shelf Life Testing" completed; "shelf life of 3 years" mentioned in Device Description. |
| Sterility Assurance Level (SAL) of 10^-6 | "EO sterilized to achieve the Sterility Assurance Level (SAL) of 10^-6" |
2. Sample size used for the test set and the data provenance:
The document does not specify numerical sample sizes for any of the bench tests (e.g., how many forceps were tested for cutting performance). The data provenance is implied to be from in-vitro bench testing conducted by Micro-Tech (Nanjing) Co., Ltd. There is no mention of country of origin of data in a patient context, as no clinical data was used. All testing appears to be prospective testing of the manufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This type of information is not applicable to the provided document. The "ground truth" for these bench tests would be engineering specifications and validated test methods, not expert clinical consensus or interpretation for a diagnostic device.
4. Adjudication method for the test set:
This is not applicable as the testing performed was bench testing against engineering specifications, not clinical outcomes requiring adjudication.
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:
This is not applicable. The device is a physical surgical instrument (hot biopsy forceps), not an AI-powered diagnostic or treatment assistance tool. No MRMC study was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical instrument, not an algorithm.
7. The type of ground truth used:
For the bench testing, the "ground truth" would be engineering specifications, material properties, and performance standards relevant to medical devices of this type, likely derived from recognized consensus standards (e.g., ISO, ASTM) and the performance characteristics of the predicate device.
8. The sample size for the training set:
This is not applicable. There is no machine learning or AI algorithm being developed; therefore, there is no "training set."
9. How the ground truth for the training set was established:
This is 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).