Instinct Plus Endoscopic Clipping Device

• K Number: K192697
• Device Name: Instinct Plus Endoscopic Clipping Device
• Manufacturer: Cook Endoscopy
• Date Cleared: 2020-03-05 ( 161 days)
• Product Code: PKL
• Regulation Number: 876.4400
• Type: Traditional
• Panel: GU
• Reference & Predicate Devices: K151802 , K132809

Intended Use

This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of

• 1. Endoscopic marking,
• 2. Hemostasis for
  • · Mucosal/submucosal defects less than 3 cm
  • · Bleeding ulcers,
  • · Arteries less than 2 mm,
  • · Polyps less than 1.5 cm in diameter,
  • · Diverticula in the colon, and
  • · Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection,
• 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel,

4. As a supplementary method for closure of GI tract luminal perforations less than 20mm that can be treated conservatively
5. Anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus in patients with fistulas, leaks, perforations, or disunion.

Device Description

The Instinct Plus Endoscopic Clipping Device is a sterile, single use metallic clip used for tissue approximation and hemostasis in the gastrointestinal tract. The metallic clip is 14.4 mm long and has an opening span of 16 mm. The clip is preloaded on a 230 cm long introducer comprised of a coated coil spring, drive wire and deployment handle. The clip may be deployed to the site of interest using a straight viewing flexible endoscope with a minimum accessory channel of 2.8 mm, or side viewing flexible endoscope with a minimum accessory channel of 4.2 mm. The clip can be rotated for positioning by rotating the handle of the introducer and may be reopened and closed up to five times prior to deployment.

The Instinct Plus Endoscopic Clipping Device is supplied sterilized by ethylene oxide gas in a peel-open package and intended for one-time use. The product is packaged with one-year shelf life.

AI/ML Overview

This is a 510(k) premarket notification for the Instinct Plus Endoscopic Clipping Device. The document claims substantial equivalence to two predicate devices: the K151802 Resolution™ 360 Clip and the K132809 Instinct Endoscopic Hemoclip.

Here's an analysis of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists "design input requirements" that performance testing was conducted to meet. These essentially serve as acceptance criteria. However, explicit numerical or categorical acceptance values for each criterion are not provided in the summary. Instead, it generally states that the device "met the design input requirements."

Table: Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Design Input Requirement)	Reported Device Performance
1. Sterility	Met design input requirements
2. Packaging	Met design input requirements
3. Biocompatibility	Met design input requirements
4. Advance device into the GI tract through a compatible endoscope	Met design input requirements
5. Position and approximate target site	Met design input requirements
6. Deploy clip onto targeted GI tissue	Met design input requirements
7. Removal of device from the endoscope	Met design input requirements
8. Force of clip retention at tissue	Met design input requirements
9. Force of clip compression at tissue	Met design input requirements
10. Strength of clip assembly	Met design input requirements
11. Strength of clip housing	Met design input requirements
12. MRI Testing	Met design input requirements
13. Corrosion testing	Met design input requirements
14. Force to deploy clip on tissue handle	Met design input requirements
15. Strength of Introducer Coil Cath	Met design input requirements
16. Strength of Handle and Drivewire	Met design input requirements

2. Sample Size Used for the Test Set and Data Provenance:

The document is a 510(k) summary and does not provide specific details on the sample sizes used for each performance test. It mentions "performance testing was conducted," but no numbers of devices tested, number of simulated cases, or specific patient data are given. As this filing is for a mechanical device and discusses performance data but does not explicitly mention clinical studies using patient data, it is highly likely that the testing involved lab-based, benchtop, or simulated use testing of the device's physical and functional characteristics. Therefore, there is no mention of retrospective or prospective data or country of origin for a clinical test set.

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

Since the testing described is primarily focused on mechanical and functional performance (e.g., strength, deployment, retention), the concept of "ground truth" established by human experts for diagnostic accuracy studies (like radiologists) is not applicable here. The "ground truth" for these performance tests would be defined by engineering specifications, material properties, and functional benchmarks derived from predicate devices or established standards.

4. Adjudication Method for the Test Set:

Not applicable, as this is primarily a performance and mechanical testing summary, not a study involving human interpretation or diagnostic accuracy where adjudication would be necessary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC study was not done. The document describes performance testing of the device itself, not a comparative effectiveness study involving human readers with and without AI assistance (which is typical for AI/CAD devices).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

Not applicable. This is not an AI/CAD device.

7. The Type of Ground Truth Used:

For the performance data, the "ground truth" would be established by:

• Engineering Specifications: Pre-defined design limits and tolerances for force, dimensions, durability, etc.
• Material Standards: Compliance with known material properties.
• Predicate Device Performance: Benchmarking against the known performance characteristics of the legally marketed predicate devices.
• Established Test Methods: Adherence to validated laboratory testing protocols.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable. This is not a machine learning or AI device.

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.