(16 days)
The devices presented in this submission are intended for use in endoscopic and/or open surgery for ligating and marking vessels and tubular structures whenever a ligating clip is used/indicated.
Aesculap's Clip Appliers are reusable stainless steel instruments. The clip appliers can be used in either laparoscopic or open surgery. The laparoscopic appliers are available in either a 10 or 12mm diameter with a length of 310mm. The Clip Appliers are a nonmodular, one-piece, design for single fire use.
The Open Surgery Appliers are available in lengths of 150mm (small) to 280mm (Xlarge) with jaw angles of 25, 65, and 90 degrees. The handles of the open surgery appliers will be color coded for easy identification of the matching clip size.
Both types of appliers are designed for use with a disposable clip magazine. The new clip magazine cartridge hold either 8, 6, or 2 clips per cartridge based on the size of the clip.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified. | The device is considered "substantially equivalent" to the predicate device (Aesculap Endoscopic Clip Appliers, K962493). |
Explanation: The document states, "No applicable performance standards have been promulgated under Section 514 of the Food, Drug, and Cosmetic Act for these devices." Therefore, explicit acceptance criteria in terms of quantitative performance metrics are not provided. The basis for clearance is substantial equivalence to a predicate device.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This 510(k) submission relies on demonstrating substantial equivalence to a predicate device, not on a new clinical study with a test set of data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. See point 2.
4. Adjudication Method for the Test Set
Not applicable. See point 2.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document does not describe an MRMC comparative effectiveness study. The submission focuses on demonstrating substantial equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical device (endoscopic clip system), not an AI algorithm.
7. The Type of Ground Truth Used
Not applicable. The clearance is based on substantial equivalence, implying that the new device's design, materials, and intended use are similar enough to a previously cleared device. The "ground truth" in this context is the established safety and effectiveness of the predicate device.
8. The Sample Size for the Training Set Not applicable. This is a medical device, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See 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.