(126 days)
Disposable biopsy forceps are used to obtain mucosal tissue samples for pathology using monopolar energy, including the avulsion technique, during endoscopic procedures in the gastrointestinal tract, for example the esophagus, stomach, small intestine and colon. Tissue samples will be submitted for pathologic review.
This product is intended only for adult populations.
The Avulsion Forceps is used during endoscopic procedures in the gastrointestinal tract. The avulsion technique in Endoscopy involves using both mechanical forces as well as high energy cutting current to tear the tissue away from the gastrointestinal tract.
The Avulsion Forceps consists of a handle on the proximal end that actuates two toothed jaws on the distal end. An Olympus-style active cord connector is included that allows the Avulsion Forceps to be connected to an electrosurgical generator for use with monopolar energy. The device also includes a spring sheath catheter housing the drive cable which transfers the linear motion of the handle slider to open and close the jaws.
The provided text describes the acceptance criteria and the summary of verification activities for the STERIS Avulsion Forceps, a medical device. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Structural Integrity Testing | All Avulsion Forceps structural components must, minimally, meet or exceed the structural integrity limits by the predicate hot biopsy forceps. | PASS |
| Dimensional | All Avulsion Forceps dimensional components must meet the dimensional specification for each forceps. | PASS |
| Functional Testing | The Avulsion Forceps must function as intended in tortuous conditions. | PASS |
| Simulation Testing | The Avulsion Forceps retrieve tissue samples. | PASS |
| Electrical Testing | All Avulsion Forceps electrical requirements must meet current industry standards according to IEC 60601-2-2 (3rd Edition). | PASS |
| Biocompatibility Testing | The patient contacting components of the device must be biologically safe to use in accordance with ISO-10993-1. | PASS |
| Shelf-life | The Avulsion Forceps must maintain device performance through a shelf life of 1 year. | PASS |
2. Sample size used for the test set and the data provenance:
The document does not specify the individual sample sizes for each test in the test set. It only states that verification activities were performed. The data provenance is not explicitly mentioned as retrospective or prospective, nor are the countries of origin for the data. This information would typically be detailed in the full study reports, not in this 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not mention the use of experts to establish ground truth for the test set. These are engineering and performance tests, not clinical evaluations that would typically involve expert review of cases.
4. Adjudication method for the test set:
Not applicable, as expert adjudication is not mentioned for these types of engineering and performance tests.
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:
No. This document describes a medical device (Avulsion Forceps) for biopsy, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. The device is a physical instrument, not an algorithm.
7. The type of ground truth used:
For the tests described:
- Structural Integrity: Ground truth is based on the structural integrity limits of the predicate device.
- Dimensional: Ground truth is based on dimensional specifications.
- Functional: Ground truth is based on the intended function in tortuous conditions.
- Simulation Testing: Ground truth is the successful retrieval of tissue samples.
- Electrical: Ground truth is compliance with IEC 60601-2-2 (3rd Edition) industry standards.
- Biocompatibility: Ground truth is compliance with ISO-10993-1 for biological safety.
- Shelf-life: Ground truth is maintaining device performance for 1 year.
These are primarily engineering and performance standards, not clinical diagnostic ground truth like pathology or outcome data.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not a machine learning model 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 type of device.
§ 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).