(88 days)
The SureClip Repositionable Hemostasis Clip is indicated for Endoscopic clip placement within the Gastrointestinal tract in adult patients only via a straight or side viewing flexible endoscope for the purpose of :
(1) Endoscopic marking;
(2) Hemostasis for
(a) Mucosal / sub-mucosal defects
The proposed device SureClip™ Repositionable Hemostasis Clip is a sterile, single-use endoscopic clipping device in adult patients only via a straight or side viewing flexible endoscope, intended to be used for endoscopic marking, hemostasis for mucosal/submucosal defects in digestive tract. It consists of two main components, delivery system and clip assembly. And it is offered in different dimensions.
The provided text is a 510(k) summary for the Micro-Tech (Nanjing) Co., Ltd. SureClip™ Repositionable Hemostasis Clip (K182556). This document is a premarket notification to the FDA for a medical device and typically focuses on demonstrating substantial equivalence to a predicate device through bench testing rather than extensive clinical studies or AI algorithm performance.
Therefore, many of the requested sections regarding AI device performance metrics, expert consensus, and specific clinical study details are not applicable or cannot be extracted from this type of document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format requested for an AI device. Instead, it lists various bench tests performed to demonstrate substantial equivalence to the predicate device. The general acceptance criterion implied is that the proposed device performs comparably to the predicate device, thereby meeting safety and effectiveness requirements.
| Bench Test Performed | Reported Device Performance |
|---|---|
| Dimension | Demonstrated equivalence |
| Release Force | Demonstrated equivalence |
| Clamping Strength | Demonstrated equivalence |
| Mechanical Integrity of Clip Assembly | Demonstrated equivalence |
| Tensile Strength | Demonstrated equivalence |
| Clip Assembly Repeated Open/Close | Demonstrated equivalence |
| Clip Open and Close Force | Demonstrated equivalence |
| Rotation | Demonstrated equivalence |
| Scope Compatibility/Usability | Demonstrated equivalence |
| Endoscope Damage | Demonstrated equivalence |
| Torque | Demonstrated equivalence |
| Biopsy Valve Compatibility | Demonstrated equivalence |
| Clip Approach | Demonstrated equivalence |
| Coil to Handle Tensile | Demonstrated equivalence |
| Biocompatibility | Meets ISO 10993-1, ISO 10993-7 |
| Sterilization | Meets ISO 11135 |
Note: The document states that "The testing performed demonstrated that the proposed device and predicate device are equivalent." Specific quantitative performance values for each test are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This device is a physical medical device (hemostasis clip), not an AI algorithm evaluated on a data set. The "test set" would refer to the physical devices subjected to bench testing. The document does not specify the number of devices tested for each bench test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not an AI device, and no ground truth established by experts on a test set is discussed.
4. Adjudication Method for the Test Set
Not applicable. This is not an AI device, and no adjudication method for an AI test set is mentioned.
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 not an AI device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.
7. The Type of Ground Truth Used
Not applicable. For a physical device, performance is evaluated against engineering specifications and regulatory standards rather than a "ground truth" derived from expert consensus or pathology on medical images/data. The "ground truth" here is the expected performance based on the predicate device and established safety/effectiveness standards.
8. The Sample Size for the Training Set
Not applicable. This is not an AI device, so there is no training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI device, so there is no training set or associated ground truth.
§ 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.