FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Resolution" Hemostasis Clipping Device is a sterile, single-use, endoscopic clipping device consisting of two main components: the delivery system and the clip. The delivery system is made up of a handle and delivery catheter. The delivery system is constructed using thermoplastic elastomers, stainless steel, polyethylene, and polyester materials. The Resolution™ Hemostasis Clipping Device delivery system is offered in 155cm and 235cm working lengths. The clip consists of a stainless steel capsule, and clip arms, a Cobalt Chrome Yoke, and a styrene tension breaker. The clip is deployed from the delivery system during use. The Resolution clip jaws are engineered such that they can be opened and closed up to five times, aiding in repositioning of the clip at the lesion site. Opening and closing capability may be limited by clinical circumstances and patient anatomy, among other factors. There are no associated accessories included with this device.

AI/ML Overview

This document describes the Acceptance Criteria and the studies that prove the Resolution™ Hemostasis Clipping Device meets those criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Clinical Effectiveness: Stent Anchoring	Resolution Clips should significantly reduce stent migration compared to non-clipped stents when affixing fully covered esophageal self-expanding metal stents (SEMSs).	Study by Vanbiervliet G et al. (2012): - Stent migration was significantly less (p=0.003) when Resolution Clips were used to anchor stents (13%) compared to non-anchored stents (57%). - This met the acceptance criteria, demonstrating the effectiveness of the device in reducing stent migration.
Clinical Effectiveness: Hemostasis (Prophylactic Clipping)	Prophylactic clip closure for post-polypectomy defects should significantly reduce the risk of delayed bleeding.	Study by Liaquat, H et al. (2013): - Multivariate analysis indicated that non-clipped lesions were 6 times more likely to have a delayed bleed (95% CI, 2.0-18.5; p=0.002) than fully clipped lesions. - Partially clipped lesions were not significantly (p=0.17) more likely to have delayed bleeding compared with fully clipped lesions. - Fisher Exact test comparing prophylactically clipped (complete and partial) to non-clipped defects showed a statistically lower rate of delayed bleeding in the Resolution Clip group (2.5%) compared to the non-clip group (9.7%) (p=0.006). - These results met the acceptance criteria, supporting the safety and effectiveness of prophylactic clipping in reducing delayed post-polypectomy hemorrhage.
Safety (General)	Absence of complications in clinical use.	Study by Vanbiervliet G et al. (2012): - No complications were observed in either the clipped or non-clipped groups for stent anchoring. Study by Liaquat, H et al. (2013): - The study's findings regarding reduced delayed bleeding also implicitly support the safety of the device for this indication. - These findings support the safety profile of the device in clinical use.
Biocompatibility	The device must meet the requirements of ISO 10993 for biological evaluation.	The proposed device meets the requirements of ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing". This was asserted because the design and materials remain unchanged from the predicate device (K122660). No new performance data was required for this submission specifically for biocompatibility because of the substantial equivalence assertion.
Sterilization Efficacy	The device must meet the requirements of ISO 11135-1 for ethylene oxide sterilization.	The proposed device meets the requirements of ISO 11135-1 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices". This was asserted because the design and materials remain unchanged from the predicate device (K122660). No new performance data was required for this submission.
Sterilization Residuals	The device must meet the requirements of ISO 10993-7 for ethylene oxide sterilization residuals.	The proposed device meets the requirements of ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals". This was asserted because the design and materials remain unchanged from the predicate device (K122660). No new performance data was required for this submission.

2. Sample Sizes Used for the Test Set and Data Provenance

Study by Vanbiervliet G, Filippi J, Karimdjee BS, et al. (2012):
- Sample Size: The document does not explicitly state the total number of patients or stents included. It references a "pilot comparative study," suggesting a smaller sample size typical of pilot studies. The percentages of migration (13% vs. 57%) are given, implying a comparison between two groups (clipped vs. non-clipped SEMSs).
- Data Provenance: Prospective study. The country of origin is not specified in the provided text.
Study by Liaquat, H, Rohn E, Rex DK (2013):
- Sample Size:
  - Clipped lesions: 277 large sessile or flat colorectal lesions were prophylactically clipped.
  - Control lesions: 247 control lesions (non-clipped).
- Data Provenance: Experience from the specified authors, implying a retrospective analysis of clinical records. The country of origin is not specified in the provided text.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

The provided text does not contain information about the number or qualifications of experts used to establish ground truth for the test sets. The studies referenced are clinical studies reporting outcomes (stent migration, delayed bleeding) rather than evaluations of device performance against expert-derived ground truth.

4. Adjudication Method for the Test Set

The provided text does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test sets. The clinical studies likely rely on objective clinical observations and outcomes as reported by treating physicians.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted or described in the provided text. The studies are clinical outcome studies comparing device use to non-use, not studies evaluating human readers' diagnostic performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone (i.e., algorithm only without human-in-the-loop performance) study was not conducted or described. The Resolution™ Hemostasis Clipping Device is a physical medical device, not an AI algorithm. Its performance is directly tied to its use by a clinician.

7. Type of Ground Truth Used

Clinical Outcomes/Events:
- For the Vanbiervliet G et al. study: The ground truth was the objective occurrence of stent migration.
- For the Liaquat, H et al. study: The ground truth was the objective occurrence of delayed post-polypectomy hemorrhage.

8. Sample Size for the Training Set

The provided text does not mention any training set. Since this is a physical medical device and not an AI algorithm, the concept of a "training set" for an algorithm is not applicable here. The device itself was developed and validated through engineering design and possibly pre-clinical testing, but not typically through "training" on a specific dataset like an AI model.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no "training set" described for this physical device.

Summary

Regulation Number and Section

§ 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.