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The InstaFAN device is intended for sampling targeted submucosal and extramural lesions within or adjacent to the gastrointestinal tract through the accessory channel of a curvilinear echo-endoscope. Use only with EUS endoscopes.

InstaFAN is an endoscopic ultrasound-guided fine needle aspiration/fine needle biopsy device that collects several samples from different locations in a single pass. The InstaFAN can be coupled to the biopsy channel of a Curvilinear Array (CLA) Echoendoscope and delivered to the gastrointestinal tract. The InstaFAN device is comprised of a central single 19-gauge needle and five peripheral 25-gauge needles. The device has a single handle design that contains two moving parts. The distal section of the handle controls the central needle, which can be activated first on its own or together with the proximal section of the handle to deploy all five needles simultaneously. The needles are used to acquire samples from lesions within and adjacent to the digestive system's major lumens that can be identified and targeted using the echoendoscope. Aspiration/biopsy samples are obtained by penetrating the lesion with the needle(s) while applying suction with the syringe.

The provided FDA 510(k) clearance letter for the InstaFAN device explicitly states that "Clinical testing was not required for the subject device; therefore, this section is not applicable." This means the document does not contain information about acceptance criteria, actual device performance (in terms of clinical outcomes), sample sizes for test or training sets, ground truth establishment methods, or details related to multi-reader multi-case (MRMC) studies.

The clearance was based on:

1. Non-Clinical Performance Testing:

   • Verification of needle performance (tensile, elasticity, bend strength).
   • Verification of overall device performance (EUS connection force, bend strength, force required to move needles, insertion force, and needle orientation).
   • The results showed the device met its specifications.

2. Animal Studies:

   • Conducted on the InstaFAN device.
   • Results met the safety and performance criteria to demonstrate substantial equivalence to the predicate.

Therefore, I cannot populate the requested tables or provide details based on a clinical study for this device, as one was not required or described in the provided text for its 510(k) clearance.

If this were a device requiring clinical data, the information you requested would typically be found in dedicated sections of the submission detailing the clinical study protocol, results, and statistical analysis.

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