(73 days)
The A.M.I. FiXcision device is intended to be used by qualified physicians to provide access of internal structures and for manipulating soft tissue (cutting) for treatment of simple anal fistulae.
FiXcision is an EO-sterilized, single use, multi-part, manual cutting instrument for use during anal fistula surgery in coloproctology. FiXcision enables circumferential tissue removal for the treatment of simple anal fistulae. The four components include the following:
- Probe: Component made of stainless steel that passes through the fistula tract.
- Guide: Component made of stainless steel that compresses tissue within the fistula tract.
- Base Plate: Component made of stainless steel that acts as a stop for the Circular Cutter.
- Circular Cutter: Component made of stainless steel and polyvinyl chloride (PVC-U). The Circular Cutter cuts tissue from fistula tract. The distal end of the Circular Cutter has a protective cap made of silicone that is removed prior to use.
The provided text describes a medical device called FiXcision, a manual cutting instrument for use during anal fistula surgery. However, the text does not contain information about acceptance criteria for device performance, nor does it describe a study that proves the device meets such criteria.
The document discusses:
- Indications for Use: The A.M.I. FiXcision device is intended to be used by qualified physicians to provide access to internal structures and for manipulating soft tissue (cutting) for the treatment of simple anal fistulae.
- Device Description: It's an EO-sterilized, single-use, multi-part, manual cutting instrument consisting of a Probe, Guide, Base Plate, and Circular Cutter.
- Predicate Device: K760715, Flexible Cutting Scissors / V. Mueller O.V. Baxter Healthcare Corp.
- Summary of Non-Clinical Testing:
- Sterilization and shelf life validation
- Biocompatibility testing (Cytotoxicity, Sensitization, Irritation per ISO 10993-5 and 10993-10)
- Performance testing (bench):
- Design validation: Wear of the cutting edge, Tensile force of the Circular Cutter, Bending test for the Probe, Strength of screwed end of the Guide.
- Usability per IEC 62366-1
The text explicitly states: "No FDA performance standards have been established for FiXcision." Therefore, there are no acceptance criteria, and consequently, no study described to prove the device meets them, in the typical sense of clinical performance metrics like sensitivity, specificity, or accuracy.
The non-clinical testing performed is to demonstrate equivalence to the predicate device and ensure safety and basic functionality, not to establish performance against specific acceptance criteria for diagnostic or treatment effectiveness.
Therefore, I cannot populate the requested table or answer the specific questions regarding acceptance criteria and performance studies because that information is not present in the provided document. The document focuses on regulatory clearance based on substantial equivalence to a predicate device through non-clinical testing.
§ 876.4730 Manual gastroenterology-urology surgical instrument and accessories.
(a)
Identification. A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop. A manual surgical instrument that is intended specifically for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures are classified under § 884.4910 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.