(39 days)
The LySonix Cannulas are instruments used for suction of fluids and tissue and for infusion of fluids during a variety of surgical procedures.
The LySonix Suction/Aspiration and Infusion Cannulas are hollow stainless steel tubes, with a blunt, bullet, or spatula-shaped tip. The cannulas are provided with an attached handle. The Suction and Infusion Cannulas are each available in three cannula lengths and four diameters. The LySonix Suction/Aspiration and Infusion Cannulas will be provided non-sterile.
The provided document is a 510(k) summary for the LySonix Suction/Aspiration and Infusion Cannulas. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and performance data for the device itself.
Therefore, many of the requested sections (e.g., acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of submission.
The core of this 510(k) is to show that the new device has the same technological characteristics and intended use as legally marketed predicate devices, implying that it would perform similarly and thus be as safe and effective. It does not contain a study designed to quantify the performance of the device against predefined acceptance criteria in the way one might find for a diagnostic or AI device.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material Composition | Not explicitly stated but implied to be "biocompatible metal" (stainless steel) for cannulas and aluminum for handles, matching predicates. | LySonix cannulas are stainless steel, handles are aluminum. |
| Technological Characteristics | Implied to be "same technological characteristics" as predicate devices. | "No new technology is being introduced... design is similar to the predicate Suction Aspiration Cannulas already on the market." This includes lengths, diameters, and tip shapes/styles within the same ranges. |
| Intended Use | Same as predicate devices: for suction of fluids/tissue and infusion of fluids during surgical procedures. | "instruments used for suction of fluids and tissue and for infusion of fluids during a variety of surgical procedures." |
| Sterility | Non-sterile, with predicate devices also offered non-sterile (and some as sterile options). | Provided non-sterile. |
Note: The 510(k) process for this type of device relies heavily on substantial equivalence to existing devices, rather than establishing new performance metrics. Performance is assumed to be acceptable if it matches that of the legally marketed predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable / Not Provided: This 510(k) summary does not describe a performance study with a test set of data in the context of diagnostic or AI device evaluation. The assessment is based on a comparison of design, materials, and intended use to predicate devices. There is no "test set" of patient data in this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable / Not Provided: There was no "ground truth" derived from expert review of a test set, as this device submission does not involve a diagnostic or AI algorithm requiring such validation.
4. Adjudication Method for the Test Set
- Not Applicable / Not Provided: No test set or expert adjudication was performed for this 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No: This document does not describe an MRMC study. This type of study is typically conducted for diagnostic devices (especially imaging-based AI) to assess the impact of the device on human reader performance. This product is a surgical tool, not a diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This product is a physical surgical instrument (cannulas), not an algorithm or AI. Therefore, the concept of "standalone performance" for an algorithm is not relevant.
7. The Type of Ground Truth Used
- Not Applicable: For this type of medical tool that is claiming substantial equivalence, the "ground truth" is effectively the established safety and effectiveness profile of the predicate devices. There is no specific outcome data, pathology, or expert consensus used as ground truth for a new performance claim, as no new performance claim is being made.
8. The Sample Size for the Training Set
- Not Applicable / Not Provided: This submission does not involve a machine learning or AI model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not Applicable / Not Provided: As there is no training set, this question is not relevant.
§ 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.