(42 days)
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.
§ 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.