(116 days)
These Single-Use Hot Biopsy Forceps are intended to be used through an endoscope to cauterize and remove polyps and/or tissue specimens throughout the alimentary tract. The alimentary tract includes the esophagus, stomach, duodenum, jejunum, ileum and colon.
The Radial Jaw™ 4 Hot Biopsy Forceps (RJ4 Hot) are sterile, single-use devices. The Radial Jaw" 11 Hot Biopsy Forceps have a jaw size compatible with a 2.8mm or larger working channel endoscope and are available with a 240cm working length.
The RJ4 Hot device provides the user the ability to cauterize via an electrical current passed through the device from an electrosurgical generator. The generator is attached to the connector located in the spool. The connector contacts the dual pull wires, which provides an electrical path to the jaws of the device.
To open and close the jaws the user slides the spool back and forth over the handle body. Using the RJ4 Hot device the user can cauterize and remove polyps by opening the jaws, pressing the jaws against the tissue site, closing the jaws, applying an electrical current through the connector and pulling the jaws away from the tissue site.
This K101687 510(k) summary describes a medical device, the Radial Jaw™ 4 Hot Biopsy Forceps, and does not involve AI/ML technology. Therefore, many of the requested categories related to AI/ML study design and performance metrics (e.g., sample size for test set, number of experts, adjudication, MRMC, standalone performance, training set details, ground truth types) are not applicable.
The submission is based on demonstrating substantial equivalence to predicate devices through bench testing and electrical safety testing.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices in design, materials, and manufacturing processes. | "The proposed Radial Jaw™ 4 Hot Biopsy Forceps are nearly identical in design, materials, and manufacturing processes to the predicate Radial Jaw™ Hot Biopsy Forceps (K910964), Radial Jaw™ 3 Hot Biopsy Forceps (K910964) and the Olympus Disposable Hot Biopsy Forceps (K955052)." |
| Meets performance requirements for biopsy devices based on relevant guidance documents. | "Bench testing and Electrical Safety Testing have been performed on the finished Radial Jaw™ 4 Hot Biopsy Forceps device per the direction of the Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology." |
| Demonstrates safety and effectiveness through testing. | "Bench testing and Electrical Safety Testing demonstrated that the proposed device is substantially equivalent to the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This is a traditional medical device submission relying on bench testing and electrical safety testing, not on clinical data or a test set of data points derived from human subjects for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. Ground truth as typically understood in AI/ML contexts (e.g., expert labels on images) is not relevant to this submission. The "ground truth" for this device is its physical and electrical properties conforming to established engineering and safety standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable.
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 is not an AI/ML device and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device. The device's performance is inherently tied to human use (e.g., the endoscopist operating the forceps).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's performance evaluation is adherence to engineering specifications, material properties, electrical safety standards, and functional equivalence to predicate devices, verified through bench testing.
8. The sample size for the training set
Not applicable. This device does not involve machine learning and therefore has no "training set."
9. How the ground truth for the training set was established
Not applicable.
§ 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).