(171 days)
The Unimax 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 Unimax 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, and smoke 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 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 irrigator 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 Unimax Suction Irrigation Set is a medical device used for suction and irrigation during laparoscopic surgery. The 510(k) summary indicates that non-clinical testing was performed to assess its safety and effectiveness.
Here's a breakdown of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria & Reported Device Performance
| Test Type | Acceptance Criteria | Reported Performance |
|---|---|---|
| Non-clinical Testing (In vitro & In vivo) | Meets requirements of pre-defined acceptance criteria for safety and effectiveness, as per IEC 60601-2-2 and other relevant standards. | "All the test results demonstrate the performance of Unimax Suction Irrigation Set meets the requirements of its pre-defined acceptance criteria and intended uses." |
| "The results of the non-clinical testing demonstrate that the Unimax Suction Irrigation Set is as safe and effective as the predicate devices." | ||
| "The result of bench testing indicates that the new device is as safe and effective as the predicate device." | ||
| Biocompatibility | Must pass various biocompatibility tests. | * Cytotoxicity test: Passed (Same as predicate) |
| * Intracutaneous test: Passed (Same as predicate) | ||
| * Maximization sensitization test: Passed (Same as predicate) |
2. Sample size used for the test set and the data provenance:
The document mentions "a series of in vitro and in vivo preclinical physical, mechanical and biocompatibility tests." However, it does not specify the sample size for the test sets (e.g., how many devices were tested for each specific non-clinical test) or the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The testing described appears to be primarily bench/laboratory testing and biocompatibility assessments, which typically do not involve expert ground truth establishment in the same way clinical imaging or diagnostic AI studies would.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable and not provided. The described tests are laboratory-based and do not involve human adjudication of results in the context of diagnostic performance.
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:
This is not applicable and not provided. The device is a physical surgical instrument (suction irrigation set), not an AI diagnostic or assistance tool. Therefore, an MRMC study comparing human reader performance with or without AI assistance is irrelevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable and not provided. The device is a physical surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical tests, the "ground truth" would be established by pre-defined technical specifications, engineering standards (e.g., IEC 60601-2-2), and regulatory requirements for device performance and safety (e.g., fluid flow rates, suction power, material strength, biocompatibility standards). For biocompatibility, the ground truth is the biological response observed in standardized tests against accepted thresholds.
8. The sample size for the training set:
This is not applicable and not provided. The device is not an AI/machine learning model, so there is no concept of a "training set" in the context of this 510(k) submission.
9. How the ground truth for the training set was established:
This is not applicable and not provided for the same reason as point 8.
§ 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.