(41 days)
The DeRoyal Industries Disposable Laparoscopic Clip Applier with Implantable Titanium Clips is intended for use in a variety of laparoscopic procedures to occlude tubular structures and vessels. The tissue being ligated should be consistent with the size of the clip.
The DeRoyal Disposable Laparoscopic Clip Applier with Implantable Titanium Clips is a disposable single patient use device fabricated from biocompatible stainless steels and biocompatible medical grade polymers. The Disposable Clip Applier contains up to 20 implantable titanium clips. The closed clip length is approximately 9 mm. The intended use of the device is to occlude vessels and other tubular structures during laparoscopic surgical procedures. The clip applier jaws, with the open clip in the jaws, is placed around the vessel or other tubular structure. Actuation/compression of the clip applier handle/trigger drives a mechanism within the device to close the jaws, thereby forming the clip securely around the vessel. Release/decompression of the clip applier handle/trigger allows the jaws to open and release the clip. The automatic feed feature releases the next clip into the jaws for another application. The shaft of the applier is sized to fit through a 10 mm cannula. The overall shaft length is approximately 33 mm and consistent with other endoscopic instruments.
Acceptance Criteria and Study for DeRoyal Industries, Inc. Disposable Laparoscopic Clip Applier with Implantable Titanium Clips (K981239)
This 510(k) summary provides limited information regarding specific acceptance criteria and detailed study data. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria through a dedicated study.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided information, the acceptance criteria are implicitly defined by the characteristics of the predicate devices, and the "reported device performance" is the statement of "Same" for these characteristics. No quantitative performance metrics are provided.
| Characteristic | Acceptance Criteria (Predicate Device) | Reported Device Performance (DeRoyal Industries) |
|---|---|---|
| Intended Use | Endoscopic procedures to achieve occlusion of vessels and other tubular structures. | Same |
| Clip Surface | Textured | Same |
| Laparoscopic Intro. Size | $\cong 10$ MM | Same |
| Clip Dimensions | $\cong 9$ MM | Same |
| Sterility | Sterile | Same |
| Materials | Polymers, stainless steel, and black chrome coating. | Same |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not describe a separate "test set" in the context of a performance study with a specific sample size. The comparison is made against the characteristics of existing predicate devices. Therefore, the concept of data provenance (country of origin, retrospective/prospective) for a test set is not applicable here as no specific test data are presented from a separate study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
No specific performance study with a test set requiring expert ground truth establishment is described in this 510(k) summary. The "ground truth" for the comparison is the established characteristics and performance of the predicate devices themselves, as understood and accepted in the medical device field at the time.
4. Adjudication Method for the Test Set
As no specific test set requiring adjudication is mentioned, this information is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No MRMC comparative effectiveness study is mentioned or implied in the 510(k) summary. The submission focuses on device characteristics and intended use comparison, not on improvements to human reader performance with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This device is a physical laparoscopic clip applier, not an algorithm or AI-driven system. Therefore, the concept of "standalone (algorithm only)" performance is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating substantial equivalence is the established characteristics, intended use, and safety/effectiveness profiles of the legally marketed predicate devices. This is a regulatory concept rather than a data-driven ground truth in a clinical study context. The FDA's assessment is based on a comparison to these existing devices.
8. The Sample Size for the Training Set
This device is not an AI/ML algorithm that requires a training set. The concept of a "training set" is not applicable here.
9. How the Ground Truth for the Training Set was Established
As this is not an AI/ML device, there is no training set and therefore no ground truth establishment for 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.