(700 days)
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 |
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.