(75 days)
The Suction Irrigation Set is available with an array of probe designs to facilitate lavage during laparoscopic surgery. This device has applications in laparoscopic gynecologic, general, thoracic and urology procedures to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.
The Suction Irrigation Set is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver-sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris from the surgical site.
The suction irrigation set consists of a hand piece equipped with two trumpet style valves,a probe, and connecting lines of tubing, one set designed to attach to a supply of irrigation fluid, and the other designed to attach to an aspiration pump. The valves allow controlled irrigation and aspiration during a surgical procedure.
The hand piece of the suction irrigation is designed to allow instruments to be introduced through the suction irrigation probe to reach the operative site. The instrument adapter is adjustable to allow a variety of instruments and diameters. It is a single use, disposable device and is sold sterile.
The provided document is a 510(k) summary for a medical device called "Suction Irrigation Set". This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed clinical study demonstrating the device's performance against specific acceptance criteria in a robust clinical setting.
Therefore, the requested information regarding detailed acceptance criteria and a study proving the device meets them, especially in the context of AI/ML or diagnostic performance, is not available in this document. The tests described are primarily non-clinical, focusing on safety and functional equivalence to a predicate device.
However, I can extract the available information regarding the non-clinical testing performed and the general statement about meeting acceptance criteria.
Here's a breakdown of what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
- Available: The document states that "All the test results demonstrate the performance of Suction Irrigation set meets the requirements of its pre-defined acceptance criteria and intended uses." However, the specific numerical acceptance criteria and the quantitative reported performance for each test are not provided. Only the types of tests are listed.
| Test Performed | Acceptance Criteria (Not Detailed) | Reported Device Performance (Not Detailed) |
|---|---|---|
| Air Tightness Test | Meets pre-defined requirements (specific values not provided) | Performed, and results demonstrate performance meets requirements (specific results not provided) |
| Smooth test | Meets pre-defined requirements (specific values not provided) | Performed, and results demonstrate performance meets requirements (specific results not provided) |
| Tensile strength | Meets pre-defined requirements (specific values not provided) | Performed, and results demonstrate performance meets requirements (specific results not provided) |
| Tubing Collapse Test | Meets pre-defined requirements (specific values not provided) | Performed, and results demonstrate performance meets requirements (specific results not provided) |
| Irrigation Fluid / Aspiration Fluid Flow Test | Meets pre-defined requirements (specific values not provided) | Performed, and results demonstrate performance meets requirements (specific results not provided) |
| Biocompatibility (Cytotoxicity) | Meets pre-defined requirements | Performed, and results contribute to safety and effectiveness determination |
| Biocompatibility (Sensitization) | Meets pre-defined requirements | Performed, and results contribute to safety and effectiveness determination |
| Biocompatibility (Intracutaneous reactivity) | Meets pre-defined requirements | Performed, and results contribute to safety and effectiveness determination |
| Biocompatibility (Acute systemic toxicity) | Meets pre-defined requirements | Performed, and results contribute to safety and effectiveness determination |
| Biocompatibility (Material-Mediated Pyrogenicity) | Meets pre-defined requirements | Performed, and results contribute to safety and effectiveness determination |
| Sterilization validation | Per ISO 11135:2014 requirements | Performed per ISO 11135:2014, and results contribute to safety and effectiveness determination (specific results not provided) |
2. Sample size used for the test set and the data provenance:
- Not available in explicit detail. The document mentions "A series of tests" but does not specify sample sizes for each test. Data provenance (country of origin, retrospective/prospective) is not relevant for these non-clinical, bench-level tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not available. These are non-clinical, engineering/materials tests. There is no "ground truth" established by human experts in the context of a diagnostic or interpretative device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not available. Adjudication methods are relevant for expert-driven diagnostic assessments, not for the physical/chemical tests described.
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 manual suction irrigation set, not an AI/ML-powered diagnostic or assistive device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. For the physical/chemical tests conducted, the "ground truth" would be established by objective measurements against engineering specifications and industry standards (e.g., ISO for sterilization).
8. The sample size for the training set:
- Not applicable. This device does not involve a "training set" as it is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. This device does not involve a "training set."
In summary: The provided document is a regulatory submission for a traditional Class II medical device, demonstrating substantial equivalence through non-clinical testing. It does not contain information typically found in studies for AI/ML or diagnostic devices, which involve clinical performance and human reader assessment.
§ 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.