(196 days)
Endoplus Hand held Laparosopic instruments are intended for grasping, cutting, clamping, biopsy, and/or cauterization of tissue. The devices are used in conjunction with a laparoscopic procedures. Instruments should be used only by personnel completely familiar with their operation. Using an instrument improperly for a task which it was not intended may result in a damaged or broken instrument.
The devices are commonly named hand held laparoscopic instruments. Specifically, each instrument has a different tip or jaw to define the functional use, such as scissors, forceps, graspers, biopsy, dissectors or needle holders. The devices are designed to be used through a portal, the opening maintained by an introducer or cannula which allows for insertion and removal of the device without damage to surrounding soft tissue. The devices have a linkage mechanism connecting the working tips, or jaws to a handle. This allows the surgeon to cut, dissect, grasp, clamp, cauterize, palpate, or retract at the operating site in conjunction with a laparoscope.
The provided document is a 510(k) Summary for the Endoplus Hand-held Laparoscopic Instruments. This type of document is for demonstrating substantial equivalence to a predicate device, not typically for reporting on detailed clinical studies with specific acceptance criteria, sample sizes, and expert adjudications as might be found for a novel AI/software medical device.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a diagnostic or AI-driven device is not applicable to this document.
The document focuses on comparing the Endoplus instruments to a predicate device (Pajunk GmbH Medizintechnologie's disposable inserts for handled instrument and HF Electrodes, K062072) based on indications for use, technological characteristics, and various safety and performance testing.
Here's a summary of the information that is available in the document, framed in relation to product validation rather than AI performance:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not present a table of specific acceptance criteria in the sense of quantitative thresholds for performance metrics. Instead, it lists various "Safety Testing" and "Performance Testing" studies that were conducted to demonstrate the device's safety and effectiveness and its substantial equivalence to the predicate. The "reported device performance" is implicitly that the device met the requirements of these tests, leading to the conclusion of substantial equivalence.
| Category | Specific Tests Performed | Implied "Acceptance Criteria" / Performance |
|---|---|---|
| Safety Testing | Electrical and EMC Testing: - IEC 60601-1: 2012 3rd edition - IEC 60601-1-2 Edition 3: 2007-03 - IEC 60601-2-2: 2009 | Complies with IEC standards |
| Cleaning & Sterilization | - Manual cleaning validation study and Laparoscopic Instrument Rack TOC analysis (AAMI TIR30:2011) - Manual cleaning validation study and Laparoscopic Instrument Rack Protein analysis - Steam Pre-vacuum Efficacy Validation Study - Steam Sterilization Validation Study - Shelf Life Protocol | Demonstrates effective cleaning and sterilization; maintains integrity over shelf life. |
| Biocompatibility | (In accordance with ISO 10993-1, for externally communicating devices in contact with circulating blood for |
§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.
(a)
Identification. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.(b)
Classification. Class II (performance standards).