(14 days)
The ENDO CLIP™ III 5mm Clip Applier is primarily indicated for patients undergoing laparoscopic surgical procedures involving dissection and occlusion of blood vessels, ducts and other tubular structures, and for radiographic marking.
The ENDO CLIP™ III 5mm Clip Applier contains 16 titanium clips. The applier is designed for introduction and use through an appropriately sized trocar sleeve, or larger with the use of a converter. The ENDO CLIP™ III 5mm Clip Applier consists of a trigger handle, shaft rotation knob, clip counter window and a 33 cm shaft with jaws at its distal end. Squeezing the handle places a titanium clip in the jaws and closes the jaws to close the clip on the vessel or structure.
The provided document is a 510(k) Premarket Notification for a medical device (ENDO CLIP™ III 5mm Clip Applier). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than establishing specific acceptance criteria and detailed study results in the way a clinical trial for a new drug or high-risk device might.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria with corresponding performance metrics in a tabular format typically found in detailed performance studies. Instead, it lists a series of in-vitro and ex-vivo tests designed to demonstrate that the new device is "substantially equivalent" to the predicate device (ENDO CLIP™ III 5mm Clip Applier - K071406) and "performed as intended."
The listed tests cover aspects like:
- Mechanical Performance: Insertion/Removal force, Counter Reliability, Firing Force/Clip Formation, Interlocking Break Force, Clip Formation, Perpendicular/Parallel Clip Pulls, Jaw Deflection Resistance, Jaw Twist Resistance, Clip next to clip proximity.
- Physiological Performance (Ex Vivo/In Vivo): Burst Evaluation, Hemostasis Evaluation, Jaw Trauma, Blunt Dissection Evaluation, Clip Trauma.
The conclusion states: "Based on the testing data, substantial equivalence has been established." This implies that the results of all these tests met a pre-defined range of acceptable performance that was either comparable to the predicate device or within specified engineering tolerances for safe and effective use. However, the specific numerical values of these criteria and the measured performance are not detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample sizes used for each of the in-vitro, ex-vivo, or in-vivo tests. It simply lists the types of tests performed.
- Data Provenance: The tests are described as in-vitro (performed in a controlled environment, e.g., lab bench testing), ex-vivo (performed on excised animal tissue or organs), and in-vivo (performed on living organisms, likely animal models given the context of a 510(k) for a surgical clip applier). No information on the country of origin for the data is provided, nor is it explicitly stated whether the data is retrospective or prospective, though performance testing for a 510(k) is typically prospective for the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (number and qualifications of experts for ground truth) is not applicable to this submission. The tests described are primarily engineering and functional performance tests for a mechanical device. They involve objective measurements (e.g., force, burst pressure, visual assessment of clip formation) rather than subjective interpretation by medical experts to establish a "ground truth" for a diagnostic outcome, for example.
4. Adjudication Method for the Test Set
Again, an adjudication method (like 2+1, 3+1) is not applicable as the tests are objective performance measurements. There is no subjective interpretation requiring consensus among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic imaging or AI systems where human readers interpret cases, often with and without AI assistance. The ENDO CLIP™ III 5mm Clip Applier is a surgical instrument, and its performance is evaluated through mechanical and physiological tests, not human interpretation of cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable because the device is a mechanical surgical instrument, not an algorithm or an AI system. Therefore, the concept of "standalone performance" for an algorithm does not apply.
7. The Type of Ground Truth Used
For the in-vitro and ex-vivo tests, the "ground truth" is generally based on objective physical measurements (e.g., force measurements, visual inspection criteria for proper clip formation, burst pressure in vessels, hemostasis, absence of trauma). For example, a clip successfully occludes a vessel or structure, or an interlocking break force meets a specified value. These are engineering and biological endpoints, not expert consensus on a diagnostic finding or pathology.
For the in-vivo tests, the ground truth would be direct observation of physiological effects such as effective hemostasis, lack of significant trauma, and proper functioning within a living system.
8. The Sample Size for the Training Set
This question is not applicable. The ENDO CLIP™ III 5mm Clip Applier is a mechanical medical device, not a machine learning or AI algorithm that requires a "training set" of data. Its design and performance are based on engineering principles and materials science, validated through the described performance tests.
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the same reason as point 8.
§ 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.