(30 days)
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 20 mm 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.
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 three-year shelf life.
The provided text describes a 510(k) premarket notification for the "Instinct Plus Endoscopic Clipping Device." This is a regulatory submission for a medical device, where the manufacturer demonstrates that their new device is substantially equivalent to a legally marketed predicate device. The information presented is primarily focused on demonstrating this equivalence rather than a full clinical study report on diagnostic accuracy or comparative effectiveness of an AI product.
Therefore, many of the requested items (e.g., sample sizes for training/test sets, number of experts for ground truth, MRMC study results, standalone performance of an AI algorithm, etc.) are not applicable to this type of document, as it concerns a physical medical device (an endoscopic clipping device) and not an AI-based diagnostic tool. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and performance specifications of the physical device and bench testing results, not a clinical study to establish diagnostic performance.
However, I can extract the relevant information regarding the device's technical specifications and the non-clinical testing performed.
1. Table of Acceptance Criteria and Reported Device Performance
The document focuses on demonstrating substantial equivalence to a predicate device (K192697) by tightening dimensional specifications and performing non-clinical bench testing. The "acceptance criteria" here relate to the device's functional performance during these tests.
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Deployment Consistency | Consistent deployment of the clip (to fulfill intended use) | Enabled consistent deployment of the clip |
| Strength of Distal Coil Cath Tabs | Met acceptance criteria | Confirmed to have met acceptance criteria during validation testing |
| Shelf Life | No impact on shelf life despite a change in the supported duration (3 years vs 1 year for predicate) | Supported for three-year shelf life based on the same method as the predicate, with no impact from the modification. |
| Dimensional Specification and Tolerance (Proximal end of catheter attach component) | Improved deployment consistency and addressed events related to inability to deploy clip observed in clinical use. | The change successfully addressed these issues. |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not explicitly stated as a number of devices or clinical cases. The "test set" here refers to devices used in bench testing.
- Data provenance: The testing was "non-clinical bench testing" and "validation testing" performed by the manufacturer, Cook Medical Inc. This is not clinical data (e.g., country of origin, retrospective/prospective) in the context of human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This pertains to an AI/diagnostic product that requires expert-annotated ground truth. This document describes a physical medical device and its engineering performance.
4. Adjudication method for the test set
- Not applicable. This pertains to expert review and consensus for AI/diagnostic product ground truth.
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
- Not applicable. This is a physical medical device, not an AI product or a diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an AI algorithm.
7. The type of ground truth used
- Engineering specifications and functional performance criteria. The "ground truth" for this device's performance is whether it meets its design requirements and functional specifications (e.g., consistent clip deployment, strength of components). This is established through engineering and quality control procedures, not expert consensus on medical images or pathology.
8. The sample size for the training set
- Not applicable. This document describes a physical medical device and its engineering performance, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This document describes a physical medical device and its engineering performance.
§ 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.