(230 days)
The PADLOCK CLIP™ EFTR Device is a 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 lesson'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.
The provided document is a 510(k) summary for the PADLOCK CLIP EFTR Kit, which is a medical device for endoscopic full-thickness resection. The document outlines verification, validation, animal, and other testing to demonstrate substantial equivalence to a predicate device.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Category | Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Simulated Use | Endoscope Detachment Force | Meets Design Requirements | Pass |
| Transparent Housing Verification | Meets Design Requirements | Pass | |
| Clip and Snare Deployment | Meets Design Requirements | Pass | |
| Over the Scope Attachment Verification | Meets Design Requirements | Pass | |
| Safety Cap Verification | Meets Design Requirements | Pass | |
| Handle Stay Visual Verification | Meets Design Requirements | Pass | |
| Safety Cap Visual Verification | Meets Design Requirements | Pass | |
| Snare Proximal to Clip Visual Verification | Meets Design Requirements | Pass | |
| Packaging Requirements | Peel Seal Strength Verification | Meets Design Requirements | Pass |
| Clip Deployment Force | Meets Design Requirements | Pass | |
| MAX Handle Snare Retraction Force | Meets Design Requirements | Pass | |
| Snare Continuity Test | Meets Design Requirements | Pass | |
| Pusher Compression Force | Meets Design Requirements | Pass | |
| Spool Compression Force | Meets Design Requirements | Pass | |
| Clip Pusher OD Measurement | Meets Design Requirements | Pass | |
| Device Working Length Measurement | Meets Design Requirements | Pass | |
| Tissue Chamber Depth Measurement | Meets Design Requirements | Pass | |
| Tissue Chamber Distal ID Measurement | Meets Design Requirements | Pass | |
| Component Force and Functional Requirements | Active Cord Detachment Force | Meets Design Requirements | Pass |
| Catheter (110302) to Housing Force | Meets Design Requirements | Pass | |
| Catheter (110052) to Housing Force | Meets Design Requirements | Pass | |
| Catheter (110303) to Pusher Force | Meets Design Requirements | Pass | |
| Drive Cable to Snare Loop Force | Meets Design Requirements | Pass | |
| Tissue Retention Force | Meets Design Requirements | Pass | |
| Clip Closure Force | Meets Design Requirements | Pass | |
| Actuator to Catheter (110302) Force | Meets Design Requirements | Pass | |
| Actuator to Catheter (110052) Force | Meets Design Requirements | Pass | |
| Drive Cable to Connector Force | Meets Design Requirements | Pass | |
| Scope Attachment to Housing Force | Meets Design Requirements | Pass | |
| Legibility of Markings | Meets Design Requirements | Pass | |
| Validation Testing | Clip Deployment and Snare Resection Validation | Meets Design Requirements | Pass |
| Straight and Articulated Endoscope Position Use Validation | Meets Design Requirements | Pass | |
| Visualization in the Lower GI Tract Validation | Meets Design Requirements | Pass | |
| Endoscope Compatibility Validation | Meets Design Requirements | Pass | |
| Safety Feature for Deployment of Clip Validation | Meets Design Requirements | Pass | |
| Animal Test - Design Validation | The PADLOCK CLIP™ EFTR Device Clip must facilitate healing after the removal of lesions up to 3cm in the GI tract | Meets Design Requirements | Pass |
| Additional Testing | MRI Testing | Meets the Requirements of ASTM F2052-21, ASTM F2182-19, ASTM F2119-2013 (17) | Pass |
| Electrical testing | Meets the Requirements of IEC 60601-1:2005 Ed.3 + A1; A2, IEC 60601-2-2:2017 Ed.6 and, IEC 60601-2-18:2009 Ed.3 | Pass | |
| Biocompatibility | Meets the requirements of ISO 10993-5:2009 Ed.3, 10993-12:2021 Ed.5, 10993-11:2017 Ed.3 & 10993-23:2021 Ed.1, 10993-1:2018, 10993-6 Ed. 3, 10993-18:2020 | Pass | |
| Human Factors | Meet Predetermined Critical Tasks | Pass | |
| EMC Testing | Meets the Requirements of 60601-1-2:2014+A1:2020 and 60601-4-2:2016; Meets the Requirements of EMC clauses 201.17/202 of ANSI AAMI IEC 60601-2-2:2017; Meets the Requirements of EMC clauses of 201.17/202 of IEC 60601-2-18 Ed. 3 2009-08 | Pass |
2. Sample Size Used for the Test Set and the Data Provenance:
The document summarizes the types of tests performed (Simulated Use, Packaging Requirements, Component Force and Functional Requirements, Validation Testing, Animal Test - Design Validation, MRI Testing, Electrical Testing, Biocompatibility, Human Factors, EMC Testing) and their outcomes ("Pass"). However, it does not provide details on the specific sample sizes used for each test set within these categories.
Similarly, the document does not mention the data provenance (e.g., country of origin, retrospective or prospective nature) for any of the non-clinical tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
The document does not specify the number of experts used or their qualifications for establishing ground truth for any of the tests. The acceptance criteria are generally phrased as "Meets Design Requirements" or conformity to international standards, implying compliance with engineering specifications and regulatory benchmarks rather than a human-expert-derived ground truth.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method like 2+1 or 3+1. The tests listed are primarily performance-based and compliance-based, with results indicated as "Pass," suggesting a direct comparison to pre-defined specifications rather than expert consensus requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
The document does not mention or describe a multi-reader multi-case (MRMC) comparative effectiveness study. The PADLOCK CLIP EFTR Kit is a mechanical and electrosurgical device, not an AI-powered diagnostic or assistive tool, so such a study would not be relevant in this context.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done:
This question is not applicable as the PADLOCK CLIP EFTR Kit is a physical medical device, not an algorithm or software requiring standalone performance testing in the typical sense of AI/software. Its performance is evaluated through a series of engineering, functional, and biological tests.
7. The Type of Ground Truth Used:
The ground truth for most of the tests appears to be engineering design requirements, predefined specifications, and compliance with established international standards (e.g., ASTM, IEC, ISO). For the animal study, the "ground truth" for success was the device's ability to "facilitate healing after the removal of lesions up to 3cm in the GI tract," which would be assessed by veterinary or pathology evaluation of the animal tissue post-procedure.
8. The Sample Size for the Training Set:
The concept of a "training set" is typically associated with machine learning or AI models. Since the PADLOCK CLIP EFTR Kit is a physical medical device, there is no mention of a training set in this context. The non-clinical tests are verification and validation efforts, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established:
Again, as there is no "training set" in the context of this device, this question is not applicable. The ground truth for the device's performance is established through adherence to design specifications and regulatory standards.
§ 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.