(251 days)
It is indicated for Endoscopic clip placement within the Gastromtestinal 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 is a sterile, single-use endoscopic clipping device. It is consisted of two main components: the delivery system and the clip. The delivery system include: metal cap, spring sheath, pulling wire component, coating layer, protective tube, core rod, and slider. The clip include: clip components and sleeve, and it is deployed from the delivery system during use. The hemoclip can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. The device is available in four clip opening widths, which are 9mm, 11mm, and the device effective length is available in 1600mm, 1800mm, 2600mm, 2600mm.
The provided text describes a 510(k) submission for a Disposable Endoscopic Hemoclip (K222146) and compares it to a predicate device (K182556). The submission focuses on demonstrating substantial equivalence through non-clinical testing rather than clinical trials or AI/algorithm performance. Therefore, many of the requested details about acceptance criteria, clinical studies, and AI performance cannot be found in the provided document.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance.
The document does not explicitly present a table of "acceptance criteria" for clinical performance. Instead, it lists the results of various non-clinical (bench) tests and biological evaluations, aiming to show compliance with standards and equivalence to the predicate. The "performance" is generally described as "passed" or "complies with standards."
| Acceptance Criteria Category | Specific Test/Evaluation | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity (ISO 10993-5) | No cytotoxicity (Same as predicate) |
| Irritation (ISO 10993-10) | No irritation (Same as predicate) | |
| Skin Sensitization (ISO 10993-10) | No skin sensitization (Same as predicate) | |
| Acute Systemic Toxicity (ISO 10993-11) | No acute toxicity (Same as predicate) | |
| Pyrogenicity (USP , USP 43 ) | Below 20 EU/device (Same as predicate) | |
| Implantation Test (ISO 10993-6) (Clip component only) | Passed (Local effects after implantation) | |
| Chemical Characterization Study (Clip component only) | Conducted | |
| Sterilization | Method (ISO 11135:2014) | Ethylene oxide (Same as predicate) |
| Sterility Assurance Level (SAL) | 10^-6 (Same as predicate) | |
| Ethylene Oxide and Ethylene Chlorohydrin Residuals (ISO 10993-7) | Below specified limits | |
| Packaging & Shelf-life | Seal Leaks in porous medical packaging (ASTM F1929-15) | Passed (by dye penetration) |
| Seal Strength (ASTM F88/F88M-15) | Passed | |
| Integrity of Seals by Visual Inspection (ASTM F1886/F1886M-16) | Passed | |
| Shipping Containers and Systems Performance Testing (ASTM D4169:2016) | Passed | |
| Shelf-life (Accelerated Aging of Sterile Barrier Systems - ASTM F1980 -16) | 3-years validated (supports proposed 5-year shelf-life) | |
| Device Performance (Bench Tests) | Dimension Test | Passed |
| Rotation Test | Passed | |
| Relocation Test | Passed | |
| Mechanical Integrity Test | Passed | |
| Tensile Strength Test | Passed | |
| Release Force Test | Passed | |
| Clamping Strength Test | Passed | |
| MR Safety | Measurement of Magnetically Induced Displacement Force (ASTM F2052-15) | Passed |
| Measurement of Magnetically Induced Torque (ASTM F2213-17) | Passed | |
| Measurement of Radio Frequency Induced Heating (ASTM F2182-19 e2) | Passed | |
| Evaluation of MR Image Artifacts from Passive Implants (ASTM F2119-07(Reapproved 2013)) | Passed |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "No clinical study is included in this submission." All tests described are non-clinical (bench tests, biocompatibility, sterilization, packaging, MR safety). Therefore, there is no "test set" in the context of clinical data, sample size for clinical evaluation, or data provenance from a retrospective or prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical studies or human-in-the-loop performance evaluations were conducted or reported.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical studies or human-in-the-loop performance evaluations were conducted or reported.
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 device is a physical medical device (hemoclip), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical tests conducted, the "ground truth" would be the specific requirements and specifications defined by the relevant ISO and ASTM standards. For example, for a tensile strength test, the "ground truth" is a defined force threshold that the device must withstand. For sterilization, it's achieving a SAL of 10^-6. These are objective measures against predefined engineering and biological standards.
8. The sample size for the training set
Not applicable, as no clinical studies or AI/algorithm development (with a training set) were conducted or reported.
9. How the ground truth for the training set was established
Not applicable, as no clinical studies or AI/algorithm development were conducted or reported.
§ 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.