(129 days)
The EasyTac Anchor and delivery system is indicated for approximation of soft tissues and fixation of surgical mesh to tissues during laparoscopic surgical procedures such as hernia repair.
The EasyTac Anchor device is an endoscopic or open surgical stapler composed of a disposable delivery instrument and resorbable fixation devices. The EasyTac Anchor Delivery System consists of an ergonomic handle, trigger, locking and unlocking mechanism, totation knob, shaft containing a cartridge of five to fifteen fixation devices, and retractable hollow needle.
The provided text is a 510(k) summary for the MedChannel EasyTac Anchor, a medical device. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study proving the device meets specific acceptance criteria through a clinical trial or performance study comparing it against a predefined set of metrics.
Therefore, the document does not contain the information requested regarding detailed acceptance criteria, a specific study proving the device meets those criteria, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC comparative effectiveness study results.
The 510(k) summary focuses on:
- Intended Use & Indications: For approximation of soft tissues and fixation of surgical mesh during laparoscopic surgical procedures like hernia repair.
- Description: An endoscopic/open surgical stapler with a disposable delivery instrument and resorbable fixation devices.
- Predicate Devices: Lists one predicate device, "Trannon," but no specific performance data for comparison is provided.
- Standards Achieved: Mentions compliance with FDA Quality Systems Regulation (21 CFR § 820), ISO 10993:1 (biological evaluation), AAMI 11135 (sterilization), and ISO 13485 (quality management).
The core of a 510(k) submission is to assert "substantial equivalence" to a predicate device, as explicitly stated in the summary: "In summary, the MedChannel EasyTac Anchors are substantially equivalent to legally marketed devices. Quality System Controls assure the device is substantially equivalent to the predicate devices with respect to its performance, safety, and effectiveness." This means the device relies on the established safety and effectiveness of its predicate, rather than presenting a new study with explicit acceptance criteria for performance.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.