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The Carbon Medical Technologies Injection Needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissue during an endoscopic procedure

The Carbon Medical Technologies Endoscopic Injection Needle consists of a stainless steel needle attached to a plastic insertion tube. The needle length and gauge will be identified on the label. The luer lock hub, which is molded onto the proximal end of the device, is designed to accommodate a standard syringe.

The CMT Endoscopic Injection Needle is intended for use as an accessory for currently marketed endoscopes and provides delivery of injectable materials during an endoscopic procedure. The type of material to be injected is dependent on the nature of the procedure, but may include delivery of injectable bulking agent during endoscopic procedures, sclerosing agents during esophagoscopic and gastroscopic procedures, local anesthetics during cystoscopic or laryngoscopic procedures, or saline or contrast media during colonoscopic procedures.

The CMT Endoscopic Injection Needle is provided sterile and is intended for single use only.

This looks like a 510(k) premarket notification for a medical device. The provided text describes the device, its intended use, and the FDA's determination of substantial equivalence to a predicate device.

However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone). This type of detailed study data is typically found in the clinical or non-clinical performance sections of a 510(k) submission, which are not present in the excerpt.

Therefore, I cannot fulfill your request for the specific details of acceptance criteria and the study that proves the device meets them based on the given input.

Based on the provided text, I can only state the following:

• Device Name: Carbon Medical Technologies Endoscopic Injection Needle
• Intended Use: An accessory for currently marketed endoscopes to allow delivery of injectable materials into tissues during an endoscopic procedure.
• Basis for Clearance: Substantial equivalence to predicate devices (Scerotherapy Needle - Medi-Glove (K955558) and CMT Endoscopic Injection Needle - Carbon Medical Technologies, Inc. (K982890)). The substantial equivalence was based on "design, materials, methods of fabrication and indications for use."

To answer your request, I would need additional sections of the 510(k) submission that detail performance testing and clinical evaluations, if any were required for this type of device.

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