(276 days)
The use of the product is indicated in endoscopic procedures, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula for the purpose of ligating vessels and tubular structures.
The Clip Applier consists of a handle piece and implantable titanium clips. The Clip Applier handle piece consists of a molded handle and trigger, a 360 degrees rotational knob, a cartridge housing shaft and a pair of jaws which provide secured placement of the clip to the desired vessel. The design enables the surgeon to apply several clips during a laparoscopic procedure without the need for withdrawing and reinserting the Clip Applier each time a clip is put in place and closed. The Clip Applier is designed to be used with a black loaded, sterile cartridge supplied in a sterile pouch. The single use disposable clip cartridge sits inside the shaft of the Clip Applier handle piece. While fully squeezing the hand piece trigger, the cartridge is inserted into the shaft through a slot located in the instrument rear.
This device is a surgical CLIP PLUS Disposable Clip Applier, ML and L models, used in endoscopic procedures for ligating vessels and tubular structures. The document is a 510(k) premarket notification letter from the FDA, approving the device for marketing.
Here’s an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" but rather presents a comparison of the subject device's performance against a predicate device. The performance data is presented as a comparison, implying that the subject device's results needed to be comparable or equivalent to the predicate.
| Performance Metric | Acceptance Criteria (Implied: Comparable to Predicate) | Reported Device Performance (CLIP PLUS) | Predicate Device Performance (MICROLINE PENTAX, K013695) |
|---|---|---|---|
| Clip Formation | All clips properly formed | All clips properly formed | "Pass" (Implied: properly formed) |
| Clip Gap Measurement | No significant difference from predicate | $0.215 \pm 0.024$ mm | $0.223 \pm 0.005$ mm |
| Perpendicular Clip Pull | Similar to predicate (not easily dislodged) | $315 \pm 11$ g | $305 \pm 11$ g |
| Parallel Clip Pull | Similar to predicate (not easily sliding) | $627 \pm 41$ g | $622 \pm 52$ g |
| Airtight Capability | No air leakage (15 to 30 PSI) | No air leakage (silicone tube 3.0 & 2.0 mm O.D. at 15-30 PSI) | "Pass" (Implied: no air leakage) |
| Biocompatibility | Meet ISO 10993 requirements | Passed ISO 10993 tests | (Standard materials, thoroughly tested in the past) |
| Sterilization (Gamma) | Meet ISO 11137-2:2012 VD max25 method for SAL of 10^-6 | Successful, met ISO 11137-2:2012 VD max25 for SAL of 10^-6 | (Not explicitly stated for predicate in this context) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample size for the performance tests (clip formation, clip gap, pull tests, airtight capability). It refers to "the clips" and "tested clips" without providing numbers.
- Data Provenance: The document does not explicitly state the country of origin of the data. However, the submitter is "TAIWAN SURGICAL CORPORATION" located in Hsinchu County, Taiwan, suggesting the testing likely occurred in Taiwan. The study appears to be retrospective in the sense that it's a bench test comparison against an existing predicate, not a prospective clinical trial.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This section is not applicable as the document describes a medical device (clip applier) and its mechanical and material performance, not an AI/algorithm-based diagnostic device requiring expert ground truth for interpretation. The "ground truth" for these tests is based on objective physical measurements and established international standards (e.g., ISO 10993, ISO 11137-2).
4. Adjudication Method for the Test Set
Not applicable for this type of device and performance testing. Adjudication methods like 2+1 or 3+1 are typically used for assessing disagreements among human readers or experts in diagnostic studies, which is not the case here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks, which is not applicable to a surgical clip applier.
6. Standalone (Algorithm Only) Performance
Not applicable. This is a physical medical device (a clip applier), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. Type of Ground Truth Used
The ground truth used for the performance evaluation includes:
- Objective Measurements: For clip gap, perpendicular clip pull, and parallel clip pull, the "ground truth" is the measured physical property of the clips and their strength.
- Pass/Fail Criteria based on expectations/standards: For clip formation and airtight capability, the "ground truth" is a binary outcome (Pass/Fail) based on whether the clips functioned as intended and prevented air leakage.
- International Standards: For biocompatibility (ISO 10993) and sterilization (ISO 11137-2), the "ground truth" is compliance with these recognized international standards.
- Predicate Device Performance: The primary comparison for "ground truth" or acceptable performance is explicitly stated as the performance of the legally marketed predicate device (MICROLINE PENTAX, K013695).
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its design and performance are based on engineering principles, material science, and mechanical testing.
9. How Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML algorithm, the concept of establishing ground truth for a training set is not relevant.
§ 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.