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

The clip is pre-installed at the front of the chuck releaser, the chuck releaser is delivered by the conveyor duct through the endoscope to the Gastrointestinal (GI) tract system finds the bleeding site, thumb ring releases the chuck, so that the clip clamps the bleeding site to stop the bleeding.

The proposed device is a sterile, single-use endoscopic clipping device. It is consisted of two main components: the delivery system and the HC series. The delivery system is available in three different working length. The clip is deployed from the delivery system during use. The hemoclip jaws can be opened and closed no more than five times prior to deployment, aiding in repositioning of the clip at the lesion site.

There are 30 models of Disposable Hemoclip.The main structure and material of each specification model are completely consistent. The outer tube of the plastic wrap type has one more layer of plastic than that of the ordinary type. The material is PE, but the other is the same.

AI/ML Overview

This document describes the premarket notification for the "Disposable Hemoclip" (K213217) and its substantial equivalence to a predicate device. The information details non-clinical tests conducted to demonstrate the device meets acceptance criteria.

Table of acceptance criteria and the reported device performance:

Item	Acceptance Criteria	Reported Device Performance
Release the performance	The clip of the tissue clamp shall be able to open and close smoothly, and the slider shall be pushed and pulled to successfully complete the clamping action. After the clip assembly is disengaged from the device, the remaining part can be manually removed from the analog endoscope tube. The force to remove the clip from the endoscope tube is not more than 5N.	Meet the requirements (Based on the description of steps to test smooth opening/closing, successful clamping action, and manual removal of the disassembled clip from the analog endoscope tube, implying successful demonstration against the acceptance criteria). Explicitly, the test involved inserting the clip into a simulated clamp channel, aligning with isolated pig stomach tissue, clamping, and then deploying, followed by removing the remaining part from the analog endoscope tube. No specific force value for removal was reported, but stated as "Meet the requirements", implying it was ≤5N.
Clamping force	After the tissue clamp is used to clamp the isolated pig stomach tissue, 100g weight is applied to the clamp seat, and it shall not be separated for 1min.	Meet the requirements (Based on the description of clamping isolated pig stomach tissue, applying a 100g weight and the clip assembly not separating for 1min).
Get out of the strength	The force required to remove a deployed clip from the tissue model should be between 0.9N and 2.5N.	Meet the requirements (Based on the description of fixing isolated porcine gastric tissue and the device, then measuring the force required to remove the clip from the tissue model with an electronic universal testing machine). No specific force value was reported, but stated as "Meet the requirements", implying it was within the 0.9N to 2.5N range.
Surface roughness	The surface roughness parameter Ra of clamps shall not be greater than 0.5µm.	Meet the requirements (Based on comparison with sample block). No specific Ra value reported, but stated as "Meet the requirements", implying it was ≤0.5µm.
Hardness	The hardness of the clip shall be ≥260HV0.2.	Meet the requirements (Based on the Vickers hardness test). No specific HV0.2 value reported, but stated as "Meet the requirements", implying it was ≥260HV0.2.
Corrosion resistance	Corrosion resistance of metal caps and clamps shall not be lower than class b requirements of class b of boiling water test method.	Meet the requirements (Based on immersion in boiling water and observation).
Rotation performance	Visually observe that the clip assembly should follow the handle to rotate 360° left and right, and the rotation should be smooth without jamming.	Meet the requirements (Based on rotating the handle with the outer tube bent, and visual observation).
Repositionability	The clamp shall be able to open normally and separate from the tissue. It shall be able to withstand repeated operation for 5 times.	Meet the requirements (Based on repeated opening and closing with isolated pig stomach tissue for 5 times).
Hemoclip assembly mechanical integrity	Visually observe that the clip assembly should fall off as a whole, and the connecting parts between clip assemblies should not fall off or become loose.	Meet the requirements (Based on clamping isolated pig stomach tissue and visual observation after deployment).
Clamping release force	The force separating the clamp assembly from the outer tube after biting and locking shall be greater than 20N.	Meet the requirements (Based on force measurement to separate the clamp assembly from the outer tube). No specific force value reported, but stated as "Meet the requirements", implying it was >20N.
Open and Close of hemoclip	Push the slider towards the far end, and the clip should be able to open. Pull the slider towards the near end, and the clip shall be closed. This method should be able to withstand repeated operation for 5 times.	Meet the requirements (Based on pushing/pulling the slider to open/close and repeated operation for 5 times).
Reducing substances	The difference in consumption of 0.002mol/L potassium permanganate solution should be less than 2.0mL as compared to the same batch of blank control liquid at the same volume.	0.9ml (This value is less than 2.0mL, meeting the requirement).
Extractable metal content	The total extractable metal content in the test solution shall not exceed 5 µg/mL, and the cadmium content shall be less than 0.1 µg/mL.	Meet the requirements (Based on colorimetric tube comparison).
pH	The pH difference between the test solution and the same batch of blank solution shall not exceed 1.0.	0.7 (This value is not exceeding 1.0, meeting the requirement).
Evaporation residue	The total amount of dry residue should not exceed 5mg.	0.56mg (This value is not exceeding 5mg, meeting the requirement).
Ultraviolet absorbance	Within the wavelength range of 250nm to 320nm, the absorbance of the test solution shall not be greater than 0.1.	0.046 (This value is not greater than 0.1, meeting the requirement).
SAL (Sterility Assurance Level)	≤10-6	Aseptic growth (This implies sterility was achieved, meeting the SAL requirement. Test method cited: USP31-NF26 sterility test).
EO residue	≤10µg/g	3.72 µg/g (This value is less than 10µg/g, meeting the requirement. Test method cited: ISO 10993-7:2008).
Shelf life	3 years	Meet the requirements (Test method cited: ASTM F 1980-16 for accelerated aging to support the reported shelf life).
In vitro Cytotoxicity	Under the condition of the test, no potential cytotoxicity.	Under the condition of the test, no potential cytotoxicity (Test method cited: ISO 10993-5 Third edition 2009-06-01).
Intradermal reactivity	Under the condition of the test, no potential intracutaneous reactions.	Under the condition of the test, no potential intracutaneous reactions (Test method cited: ISO 10993-10 Third Edition 2010-08-01).
Skin Sensitization	Under the condition of the test, no potential sensitization.	Under the condition of the test, no potential sensitization (Test method cited: ISO 10993-10 Third Edition 2010-08-01).
Acute Systemic Toxicity	Under the condition of the test, no acute toxicity.	Under the condition of the test, no acute toxicity (Test method cited: ISO 10993-11:2017).
Material-mediated Pyrogens	Under the condition of the test, no pyrogen.	Under the condition of the test, no pyrogen (Test method cited: ISO 10993-11:2017).
Sub-acute Systemic Toxicity	Under the condition of the test, no sub-acute toxicity.	Under the condition of the test, no sub-acute toxicity (Test method cited: ISO 10993-11:2017).

Sample size used for the test set and the data provenance:
- Sample size: The document does not explicitly state the numerical sample size for each performance test. It refers to "a piece of 10cm*10cm isolated pig stomach tissue" for certain tests (e.g., Release the performance, Clamping force, Repositionability, Hemoclip assembly mechanical integrity) and "sample block comparison" for surface roughness. For other tests like reducing substances, extractable metal content, pH, evaporation residue, and UV absorbance, it references using specific volumes of test solutions (e.g., "0.2g sample", "1ml of water", "10mL of the test solution", "25mL of the test solution", "50 mL of the test solution"). The biological tests (cytotoxicity, skin sensitization, acute systemic toxicity, pyrogens, sub-acute systemic toxicity) would have their own sample sizes as per the ISO standards cited, but these are not provided in this summary.
- Data provenance: The data is based on non-clinical testing conducted by the manufacturer, Beijing ZKSK Technology Co., Ltd., in China. The tissue model used in several tests is "isolated pig stomach tissue," indicating an ex-vivo or in-vitro animal tissue model. All results are from laboratory tests performed on the device itself or its materials, not human clinical trials. Thus, the data provenance is retrospective (tests already performed) and from the manufacturer's facility in China.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission is for a medical device (hemoclip) and relies on objective, quantifiable performance and biocompatibility testing against established standards, not on expert-adjudicated ground truth like in diagnostic imaging with AI. The "ground truth" here is derived directly from the physical properties of the device and its interaction with test materials, measured according to recognized test methodologies and standards.
Adjudication method for the test set:
- Not applicable. As described above, the evaluation is based on objective measurements and adherence to specific numerical or qualitative criteria (e.g., "Meet the requirements", specific values for chemical tests, visual observation of functionality), not on human expert adjudication.
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 device is a manual endoscopic tool, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-only device. It is a physical medical device. The "standalone" performance testing refers to the device's inherent mechanical, material, and functional properties as evaluated in the non-clinical tests.
The type of ground truth used:
- The "ground truth" for the non-clinical tests is established by:
  - Standardized measurement methodologies: Testing performed according to recognized international and national standards (ISO, ASTM, USP).
  - Objective performance criteria: Specific quantitative thresholds (e.g., force values, concentration limits, roughness parameters) and qualitative observations (e.g., smooth rotation, no separation, no cytotoxicity) defined in the acceptance criteria.
  - Material properties and chemical analysis results: Direct measurements of material hardness, chemical residues, extractables, pH, and UV absorbance.
  - Functional demonstrations: Observing the device's ability to open, close, clamp, release, and rotate as intended with a tissue model (isolated pig stomach tissue).
The sample size for the training set:
- Not applicable. This submission concerns a physical medical device, not an AI model requiring a training set.
How the ground truth for the training set was established:
- Not applicable, as no training set was used.

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.