(67 days)
The Expect™ Slimline (SL) Needle is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
The Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle is an endoscopic ultrasound aspiration needle that can be coupled to the biopsy channel of a Curvilinear Array (CLA) Echoendoscope with a standard luer connection and delivered into the digestive tract. The needle is used to acquire aspiration samples from lesions within and adjacent to the digestive system's major lumens that can be identified and targeted using the echoendoscope. An aspiration sample is obtained by penetrating the lesion with the needle while applying suction.
This 510(k) summary describes a medical device called the Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle. This submission is for a modified version of an already cleared device, focusing on a new handle design. Therefore, the performance data provided relates to the mechanical and physical characteristics of this new design rather than clinical performance (e.g., diagnostic accuracy or clinical outcomes). The document explicitly states that "Bench Testing has been performed... which demonstrates that the modified handle design met the required specifications for completed design verification tests." This indicates that the acceptance criteria are based on engineering specifications and the study is bench testing.
Here's the information extracted from the provided text, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Required Specifications) | Reported Device Performance |
|---|---|
| Device Durability | Met required specifications |
| Needle and Sheath Adjustment Locking Force | Met required specifications |
| Handle (Needle) Actuation Force | Met required specifications |
| Device Handle Tensile Test | Met required specifications |
| Locking Knob Retention | Met required specifications |
| Smooth Actuation of Handle | Met required specifications |
| Needle Extension Length | Met required specifications |
| Device (Handle) Resistance to Torque | Met required specifications |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated. The document refers to "Bench Testing" but does not provide details on the number of units tested for each criterion.
- Data Provenance: The study was "Bench Testing" conducted by Boston Scientific Corporation. This is a controlled laboratory environment, not human or animal data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. The ground truth for this type of bench testing is based on engineering specifications and objective measurements (e.g., force, length, durability tests) rather than expert interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is bench testing against objective engineering specifications, not a subjective assessment requiring adjudication.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a mechanical medical instrument (an aspiration needle), and the study described is bench testing of its mechanical characteristics. It does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the bench testing was engineering specifications and objective measurements. The device's performance was compared against predetermined design requirements for its mechanical functions.
8. The sample size for the training set:
- Not applicable. This device is a mechanical medical instrument, not a machine learning model requiring a training set. The "design verification tests" are likely derived from historical data and industry standards, but there isn't a "training set" in the AI sense.
9. How the ground truth for the training set was established:
- Not applicable. As noted above, there is no training set in the context of this device and study. The "ground truth" for the acceptance criteria (required specifications) would have been established through device design processes, engineering standards, and potentially regulatory benchmarks for similar devices.
§ 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.