(29 days)
The PADLOCK CLIP™ EFTR Device is an electrosurgical device that is designed for a flexible endoscope. It is intended for diagnostic tissue acquisition and full thickness resection through the removal of lesions in the colon and rectum.
The PADLOCK CLIP™ EFTR Device is indicated for the resection of lesions less than 3cm in the colon and rectum. Resection sizes may be less than 3cm due to targeted tissue thickness and degree of fibrosis.
The disposable RAPTOR Grasping Device is intended to be used to grasp tissue and/or retrieve foreign bodies, excised tissue and stents during endoscopic procedures.
The TOUCHSOFT Coagulator is used to provide monopolar therapeutic hemostasis and tissue ablation in the gastrointestinal tract through a flexible endoscope by a trained physician or clinician.
The PADLOCK CLIP Endoscopic Full Thickness Resection (EFTR) Device is an electrosurgical, single use tissue resection system. The system is part of a kit that consists of a preloaded, radiopaque, Super Elastic NiTi (Nitinol) single use clip within a mechanical delivery system along with a preloaded snare for tissue resection. The PADLOCK CLIP EFTR Device is mounted over the distal tip of a flexible endoscope. The linking cables run along the outside of the endoscope and are attached to the handle. The PADLOCK CLIP EFTR Device includes a tissue chamber that resides on the distal tip of the endoscope.
The kit's two additional devices, the TOUCHSOFT Coagulator Monopolar Single Use Device, and RAPTOR Grasping Device are used in conjunction with the PADLOCK CLIP EFTR Device through the flexible endoscope's accessory channel. The TOUCHSOFT Coagulator Monopolar Single Use Device (ablation device) will be used to mark a lesion by ablating the lesion's perimeter, thereby indicating the area for resection. Instructions for Use for the TOUCHSOFT Coagulator Monopolar Single Use Device are included within the kit. The RAPTOR Grasping Device will be used to grasp and retract the target lesion into the tissue chamber. Instructions for Use for the RAPTOR are included within the kit.
These devices are used for colorectal lesions that would otherwise not be resectable by standard polypectomy techniques.
The PADLOCK CLIP EFTR Device includes a resection clip made of super elastic nitinol and a snare made of stainless steel. The PADLOCK CLIP EFTR Device also includes handle components molded from ABS material, Stainless Steel drive wires, HDPE catheter, and a scope attachment assembly made of TPE and Polycarbonate.
This document is a 510(k) clearance letter for a medical device (PADLOCK CLIP EFTR Kit). It does not contain information about an AI/ML medical device, clinical study performance metrics, or the specific details typically requested for AI/ML device approval. The 510(k) is for a physical electrosurgical device and states that the proposed device is "the same device with an updated Instructions for Use" as its predicate.
Therefore, many of the requested points related to AI/ML device study design, such as expert ground truth, MRMC studies, training set details, etc., are not applicable to this document.
However, based on the provided text, I can extract the following information about the device's acceptance criteria and the (non-AI/ML) study that proves it meets those criteria:
Acceptance Criteria and Device Performance for PADLOCK CLIP EFTR Kit
This document describes the 510(k) clearance for a physical electrosurgical device, not an AI/ML-driven device. Therefore, the "study" described is verification testing for a physical modification (updated Instruction for Use) rather than a clinical performance study with human readers or AI.
1. Table of Acceptance Criteria and Reported Device Performance
| Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Verification Testing | Clip deploys, and the snare closes on the simulated tissue. | Pass. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes "Verification Testing" on "simulated tissue." It does not specify a numerical sample size for this test. Since it's a physical device verification using simulated tissue and not clinical data, "data provenance" in terms of country of origin or retrospective/prospective is not applicable.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not Applicable. This is a physical device verification, not a study requiring expert ground truth for diagnostic or interpretative tasks. The "ground truth" here is the objective functional success of the device (clip deploys and snare closes on simulated tissue).
4. Adjudication Method for the Test Set
Not Applicable. This is a physical device verification test. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in image interpretation studies, which is not relevant here. The "Pass" result suggests direct observation of the device's functionality.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for AI/ML devices or diagnostic tools where human interpretation is a key component. This document pertains to a physical electrosurgical device used for tissue resection.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not Applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used was the functional success of the device's mechanical actions on simulated tissue. Specifically, the acceptance criterion was whether the "Clip deploys, and the snare closes on the simulated tissue."
8. The Sample Size for the Training Set
Not Applicable. This is a physical medical device, not an AI/ML model that requires a training set. The "testing" referred to is product verification testing to ensure the device performs as intended with updated instructions, not the training of a predictive model.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no AI/ML model or training set, there is no corresponding ground truth establishment process.
§ 876.4400 Hemorrhoidal ligator.
(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.