(25 days)
The Acquire S Fine Needle Biopsy Device is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
The Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device is an endoscopic ultrasound biopsy 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 device sheath length can be adjusted to accommodate different model echoendoscopes. The need to acquire samples from lesions within and adjacent to the digestive system's major lumens that can be identified and targeted using the echoendoscope. Both the sheath and needle length can be adjusted based on distance to the target lesion. The sheath and needle length adjustments are set and locked by the physician by using the locking knob mechanisms on the handle of the device. A sample is obtained by penetrating the lesion with the needle while applying suction and manipulating the needle in a back and forth motion to acquire a sample. The sample can be prepared per normal institutional protocol. The Acquire™ Needle has echogenic (visible under ultrasound) features at the distal end to facilitate real time visualization of the device under ultrasound.
Syringe and stopcock are accessories to provide and control the vacuum suction to aspirate the sample.
This document describes the Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device (K223616) and its substantial equivalence to a predicate device. This is a medical device submission, not an AI/ML device submission, and therefore, the acceptance criteria and study detailed below relate to the physical device's performance, not an algorithm's.
Here's the information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a physical medical device and the submission focuses on demonstrating substantial equivalence to a predicate, the "acceptance criteria" are generally that the device performs as intended and is safe and effective for its indicated use, similar to the predicate. The performance reported here refers to the results of non-clinical testing.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Non-clinical performance bench testing | Bench Testing included: |
- Device Durability: All testing was passing.
- Stylet Removal Force: All testing was passing.
- Needle Extension Length: All testing was passing.
- Adjustable Catheter Length: All testing was passing.
- Stylet Cap Tensile: All testing was passing.
Overall: ""All testing was passing and demonstrates the device's ability to fulfill non-clinical performance bench testing...requirements." |
| Simulated use testing | Performed. All testing was passing. (Implied by the summary statement: "All testing was passing...") |
| Biocompatibility | Performed per the requirements of ISO 10993. All testing was passing. (Implied by the summary statement: "All testing was passing...") |
| Sterilization validation | Performed per the requirements of ISO 11135. All testing was passing. (Implied by the summary statement: "All testing was passing...") |
| Substantial Equivalence | Demonstrated to the currently cleared Acquire™ Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device (K160845). |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical data or patient samples. The testing described is non-clinical performance bench testing, simulated use testing, biocompatibility, and sterilization validation. Therefore, there are no details about sample size for a patient test set or data provenance (country of origin, retrospective/prospective). The closest equivalent of "samples" would be the number of devices or components tested in the bench/simulated use tests, which is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. The "ground truth" for a physical device like this is its mechanical and material performance against established engineering and medical standards, not diagnostic accuracy requiring expert interpretation.
4. Adjudication method for the test set
This information is not applicable and not provided. The testing involves objective mechanical and material properties, not subjective assessments 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
An MRMC comparative effectiveness study is not applicable as this is a physical medical device, not an AI/ML diagnostic tool used for image interpretation. No such study was mentioned or performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to AI/ML device performance. This device is a physical biopsy needle, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by engineering and quality standards, and predefined performance specifications for mechanical properties (durability, force, length adjustments) and biological safety (biocompatibility, sterility). The goal is to ensure the device performs reliably and safely, analogous to the predicate.
8. The sample size for the training set
This is not applicable as this is a physical medical device, not an AI/ML system requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as this is a physical medical device, not an AI/ML system requiring a training set.
§ 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.