(20 days)
The PRECISION Endoscopic Infrared Coagulator with single-use disposable MAXiguide flexible light guide is intended for treatment of hemorrhoids and other lesions in the colon and rectum when used as an accessory to a flexible colonoscope, flexible sigmoidoscope, or other flexible gastrointestinal endoscope.
This device is designed to coagulate blood and tissue, specifically for treatment of hemorrhoids and small lesions in the colon and rectum, when used as an accessory to a flexible endoscope.
The provided text describes a 510(k) summary for the K122593 device. Based on this document, here's an analysis of the acceptance criteria and study information:
Key Takeaways:
- This 510(k) submission is for a device that is essentially identical to a previously cleared predicate device (K083275).
- The nature of the submission is a "design and labeling change" that does not alter intended use, indications for use, or performance specifications.
- Therefore, the primary study to demonstrate substantial equivalence was verification testing and bench testing to confirm that the changes did not negatively impact safety or effectiveness, essentially showing it still performs like the predicate. There were no clinical studies (e.g., studies involving human subjects, AI performance, or even animal studies) required or discussed for this specific 510(k).
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| Substantial Equivalence to Predicate Device (K083275) | Bench testing performed to verify that the submission device is substantially equivalent to the predicate device. | The submission claims "no technology differences" and "no change in performance specifications." |
| Safety and Effectiveness not affected by design/labeling changes | All verification testing results for design changes passed. Bench testing confirmed changes do not affect safety and effectiveness. | This confirms the device performs as expected and similarly to the predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of clinical data. The "test set" here refers to the specific units or components of the device undergoing verification/bench testing. The document does not specify the number of units tested.
- Data Provenance: Not applicable for design verification and bench testing. These are laboratory-based tests performed by the manufacturer.
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. The ground truth for this submission was based on engineering specifications and the functional performance of the device against established benchmarks (i.e., its predicate). No expert human readers or clinicians were involved in establishing "ground truth" for a test set in the traditional sense of a diagnostic device study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication was used.
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 device is an electrosurgical unit, not an AI-assisted diagnostic tool. An MRMC study is not relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an AI algorithm; it's a medical device for coagulation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission was the established performance characteristics and safety profile of the legally marketed predicate device (K083275). The verification and bench testing aimed to prove the new device performs identically to the predicate and that the minor changes did not introduce new safety or effectiveness concerns.
8. The sample size for the training set
- Not applicable. No training set was used as this is not an AI or machine learning device.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
§ 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).