(90 days)
The device is designed to sample targeted submucosal and extraluminal gastrointestinal lesions through the accessory channel of suitable ultrasound videoendoscope in adult patients only.
The proposed Endoscopic Ultrasound Aspiration Needle is a sterile single-use device, designed to sample targeted submucosal and extraluminal gastrointestinal lesions through the accessory channel of suitable ultrasound videoendoscope. The Endoscopic Ultrasound Aspiration Needle consists of an Aspiration Needle and negative suction device. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and placed in a sterility maintenance package to ensure a shelf life of 2 years.
The provided text describes a 510(k) summary for a medical device and does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details for an AI/ML powered device.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device through:
- Comparison of technological characteristics: This involves a table (Table 7.1) comparing various features of the proposed device (Adapt Endoscopic Ultrasound Aspiration Needle) and the predicate device (Endoscopic Ultrasound Aspiration Needle, K172309).
- Performance data (bench testing): A list of bench tests performed to ensure the device works as intended. These tests are:
- Smooth Actuation of Handle
- Leakage
- Ultrasound Visibility
- Puncture Force
- Stiffness
- Durability
- Stylet Removal Force
- Locking Force of Handle
- Tensile Strength
- Shelf-life and packaging integrity testing: Based on accelerated aging and ISO standards.
- Sterilization validation: In accordance with ISO 11135.
- Biocompatibility evaluation: In accordance with ISO 10993-1 and FDA guidance, including tests for Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity, and Hemolysis.
The text explicitly states that no animal study and no clinical study were included in the submission. This implies that no human-in-the-loop performance, standalone algorithm performance, or clinical effectiveness data would be available from this document.
Therefore, I cannot fulfill your request for the specific information you asked for, as the provided text pertains to a traditional medical device (an aspiration needle) and its regulatory submission, not an AI/ML powered device with related performance metrics.
§ 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.