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510(k) Data Aggregation
(700 days)
MedicloseTM System
The Mediclose™ System is a single-use indicated for approximation of tissues and percutaneous suturing of port-site fascia wounds following laparoscopic surgery.
The Mediclose™ System is an Automatic Trocar Closure (ATC) device supplied with one or more Mediclose™ Adaptors, supplied sterile for single use. The combination of the Mediclose™ Device and one Mediclose™ Adaptor results in a minimally invasive surgical system which aids surgeons in closing trocar wounds following a laparoscopic procedure. In laparoscopic surgery, trocars are used to gain access to the body in a minimally invasive way. This means that these procedures are performed through incisions of approximately 12 mm, compared to traditional open surgery which needs a large wound across the abdomen. The Mediclose™ Device is available in one size and configuration, designed for single-handed use, to which each of three Mediclose™ Adaptors can be fitted, at the user's option, depending on the make/model of trocar being used. The Mediclose™ System is intended to pass a suture through the soft-tissue laver (fascia) of a trocar wound after laparoscopic surgery. This is done with the end-goal of closing the trocar-induced wound by pulling needles through the fascia and subsequently closing the wound. The Mediclose™ System has two items: The Mediclose™ Device, which incorporates the suture and needle set; The Mediclose™ Adaptor, three color-coded models are available separately from the Mediclose™ . Device which are compatible with a specific brand/model of 12 mm trocar sleeves that are legally cleared for marketing in the USA, viz: Ethicon EndoPath Covidien VersaOne Applied Medical Kii The Mediclose™ Device also contains a needle-suture set manufactured by Assut Europe composed of two straight cylindrical needles attached to Glicofil Lac, a braided, coated, violet PGLA absorbable suture. The suture and needles are mounted into the device at the time of manufacture, making it ready to use upon opening the packaging.
The provided FDA 510(k) summary for the Mediclose™ System focuses on non-clinical testing for substantial equivalence, rather than a study proving performance against clinical acceptance criteria. The device is a suturing device, and the evaluation is primarily based on mechanical and biocompatibility tests.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents extensive non-clinical testing with acceptance criteria. No clinical performance acceptance criteria are mentioned as no clinical studies were submitted. The table below summarizes the non-clinical acceptance criteria and reported results.
| Test Purpose | Acceptance Criteria | Result |
|---|---|---|
| Sterilization Validation | Sterile after half ETO cycle | Pass |
| Shelf Life Validation: | ||
| a) Transportation test | Packaging is fully functional and undamaged | Pass |
| b) Sterile pack seal integrity | No dye penetration | Pass |
| c) Sterile pack seal strength | >1.5 N/15mm | Pass |
| d) Suture needle/thread strength | Average >14.7 N; Single result >4.41 N | Pass |
| e) Suture knot pull strength | Average >38.2 N | Pass |
| Biocompatibility: | ||
| a) Cytotoxicity | ≥70% of the control mean % viability | Pass |
| b) Sensitization | Positive response in 0.5 degC | Pass |
| f) LAL bacterial endotoxicity | 15 N | Pass |
| b) Mediclose folding part to handle tensile | >30 N | Pass |
| c) Mediclose folding part to handle compression | >30 N | Pass |
| d) Needle retention force | >15 N 30 N | Pass |
| f) Adaptor security tensile | >30 N | Pass |
| g) Operating button spring resistance |
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