(63 days)
The Sureline™ Laparoscopic Clip Applier with Implantable Titanium clips is intended for use in a variety of laparoscopic procedures to occures to occures and blood vessels. The tissue being ligated should be consistent with the size of the clip.
The Sureline TM 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 product is also available as a reusable clip applier and disposable clip cartridge. The disposable clip applier and disposable clip cartridge contain 20 titanium clips. The clip cartridge is attached to the clip applier handle via a lock/release mechanism, and inserted through a trocar to gain a lockrelease moonamamic clip cartridge jaws with the open clip in the jaws is placed around the vessel or other tubular structure. 13 placed around the clip applier handle/trigger drives a Actuation/oomproom.com/close the cartridge jaws, thereby mechanism within the ourinessel. Release/decompression of forming the clip securely around the jaws of the cartridge to open and the clip applici nandio.ingger all.ge jaws. The automatic feeding cartridge releases the next clip into the jaws for another application. The cartridge is sized to fit through a 10 mm cannula. The overall shaft The cartridge is sized to in through andle is approximately 33 mm, consistent with other endoscopic instruments.
This submission (K044602) for the Sureline™ Laparoscopic Clip Applier with Implantable Titanium Clips does not contain the details of a study with acceptance criteria and reported device performance.
The document is a 510(k) summary, which is typically a declaration of substantial equivalence to a predicate device. It focuses on the device's description, intended use, technological characteristics, and a conclusion of substantial equivalence.
Here's a breakdown of why the requested information cannot be provided from the given text:
- No performance data is presented. The document explicitly states that "The new device has the same intended use and the same basic technology as the predicates identified in the premarket notification... and does not pose any new questions concerning safety and effectiveness" (Section 7). This implies that a new performance study to establish acceptance criteria was likely not a primary component of this 510(k) submission, as it relies on the known performance and safety of the predicate devices.
- The document is a summary. A 510(k) summary is designed to provide an overview and publicly available information, not the full details of any internal testing or validation studies that might have been conducted.
Therefore, since the provided text does not contain the specific information requested about acceptance criteria and the study proving it, I cannot complete the table or answer the specific questions.
Information that is available:
- Device Name: Sureline™ Laparoscopic Clip Applier with Implantable Titanium Clips
- Intended Use: For use during laparoscopic surgery to occlude a variety of vessels or other tubular structures.
- Predicate Devices: Vitalitec International (K981645), Microsurge Sureline (964109), United States Surgical Corporation (K883081, K890941), Ethicon Endosurgery (K920387), Pilling Weck (K851251, K905837)
- Basis for regulatory clearance: Substantial equivalence to predicate devices, implying similar design, materials, and intended use as devices already on the market.
§ 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.