(48 days)
The Expandacell Instrument Wipe is a sterile, soft, lintless instrument wipe used to clean delicate instruments during a surgical procedure.
The Expandacell Instrument Wipe is a sterile, soft, lintless instrument wipe.
I am sorry, but based on the provided text, there is no information about acceptance criteria, study details, sample sizes, ground truth, or an MRMC comparative effectiveness study.
The document consists of a 510(k) premarket notification letter from the FDA to Shippert Medical Technologies Corporation regarding their EXPANDACELL™ Instrument Wipe. It primarily addresses the device's regulatory classification and substantial equivalence to existing devices.
The key points from the provided text are:
- Device Name: EXPANDACELL™ Instrument Wipe
- Regulatory Classification: Class I
- Product Code: GEC (Manual surgical instrument for general use)
- Substantial Equivalence: The FDA determined the device is substantially equivalent to devices marketed prior to May 28, 1976.
- Basis for Equivalence: The summary of safety and effectiveness information (page 4) states that the device is "identical to existing medical devices" (K920355, K791736, and others by Ultracell, SomedMerocel, and Smith and Nephew) and is "identical in intended use, materials, anatomic model... population, physical safety, biocompatibility and performance to the predicate device."
- Indication for Use: "The Expandacell Instrument Wipe is a sterile, soft, lintless instrument wipe used to clean delicate instruments during a surgical procedure."
The document does not contain the specific information requested about acceptance criteria, study design, sample sizes, expert qualifications, or detailed performance metrics. It relies on the claim of substantial equivalence to previously cleared devices rather than providing new performance study data.
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 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 § 878.9.