(90 days)
The EISNER USA Hemostatic Clip is designed for the intended use of ligating blood vessels. The clip has been specially designed to insure occlusion of vessels and prevent any slippage once applied. The Clip has applications in many types of surgical procedures where hemostasis is required or radiographic marking is necessary.
The clips are composed exclusively of titanium and are supplied sterile in various sizes (small, medium/large, and large) six clips per disposable holder. The titanium used meets all the requirements of the American Society for Testing and Materials (ASTM) standard specification F-67 95 "Unalloyed Titanium for Surgical Implant Applications", Grade I.
The provided 510(k) summary for K972745, the Titanium Hemostatic Clip by EISNER USA, is for a pre-amendment device type and does not contain detailed performance studies with acceptance criteria in the manner typically found in more recent submissions for novel or higher-risk devices.
Instead, the submission largely relies on a claim of substantial equivalence to predicate devices and the established safety and efficacy of the material (titanium) for long-term implantation. Therefore, many of the requested fields cannot be directly extracted from the provided text.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from Text) | Reported Device Performance (from Text) |
|---|---|
| Material composition meets ASTM F-67 95, Grade I Titanium. | "The titanium used meets all the requirements of the American Society for Testing and Materials (ASTM) standard specification F-67 95 'Unalloyed Titanium for Surgical Implant Applications', Grade I." |
| Device manufactured according to cGMP's, AAMI, ASTM, ISO 9002/EN 46002. | "Devices are manufactured according to cGMP's, AAMI and ASTM requirements, and applicable Harmonized Standards ISO 9002/ EN 46002." |
| Functionally equivalent to predicate devices for ligation of blood vessels. | "In function, the clips are the same as the predicate devices." |
| Disposable holder made of polycarbonate plastic, equivalent to predicate devices. | "The disposable holder is a polycarbonate plastic equivalent to the predicate devices." |
| Safe and effective for long-term implant. | "The titanium itself is well recognized as being safe and effective for long term implant. The millions of clips applied yearly and the years in use (since 1963) attest to the wide acceptance of this method of Hemostatic control." |
| Insure occlusion of vessels and prevent slippage once applied. | "The clip has been designed to insure occlusion of vessels and prevent any slippage once applied." (This is a design claim, not a reported performance metric from a specific test in the provided text). |
| Biologically inert. | "The tissue to be occluded fits completely within the jaws of the clip allowing for free compression without sequela as it is biologically inert." (Claim on material property). |
| Low magnetic susceptibility, safe for MRI environment up to 2 Tesla, main field gradients up to 500 gauss per centimeter. | "it has low magnetic susceptibility and is safe for use in the present clinical MRI environment with main Magnetic fields up to 2 Tesla and main Magnetic field gradients up to 500 gauss per centimeter." |
| Produces less artifact than non-titanium clips in CT Scanning. | "As the clip is made of Commercially Pure - GRADE I, Implant Titanium... it also produces less artifact than non-titanium clips in CT Scanning." |
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 does not describe a specific "test set" for a performance study in the context of clinical or in-vitro validation of the device's functional performance (e.g., clip retention strength, occlusion efficacy). Instead, the submission relies on:
- Manufacturing standards compliance: "Devices are manufactured according to cGMP's, AAMI and ASTM requirements, and applicable Harmonized Standards ISO 9002/ EN 46002." These involve quality control and material testing, which would use representative samples, but specific sample sizes are not detailed for a dedicated "test set" demonstrating clinical performance.
- Material properties: The claim about ASTM F-67 95 Grade I Titanium is based on the material specification itself, not a specific study conducted for this submission.
- Historical use/predicate device data: "The millions of clips applied yearly and the years in use (since 1963) attest to the wide acceptance of this method of Hemostatic control." This refers to retrospective, broad-based clinical experience with similar devices, not a controlled study with a defined sample size for this specific device.
Therefore, no specific sample size or data provenance for a test set (in the typical sense of a clinical or rigorous bench performance study) is provided.
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. No performance study requiring expert ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No performance study requiring adjudication is described.
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 medical device (hemostatic clip), not an AI/imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For material properties, the "ground truth" is defined by ASTM standard specifications (ASTM F-67 95). For safety and effectiveness for its intended use, the "ground truth" is implicitly derived from historical clinical outcomes and wide acceptance of predicate devices and the material itself.
8. The sample size for the training set
Not applicable. This is a medical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a medical device, not an algorithm that requires a training set.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.