(52 days)
The Unimicro Suction Irrigation Tubing set is available with an array of probe designs to facilitate lavage during laparoscopic surgery. This device has applications in laparoscopic, 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 Unimicro Suction Irrigation Tubing 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 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 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 provided text is related to a 510(k) premarket notification for a medical device called the "Unimicro Suction Irrigation Tubing set." This document is a regulatory submission to the FDA, demonstrating that a new device is as safe and effective as a legally marketed predicate device.
The study described is a non-clinical study for the Unimicro Suction Irrigation Tubing set. The goal is to demonstrate "substantial equivalence" to a predicate device (Unimax Suction Irrigation Set, K103509).
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical and Mechanical Tests: Not explicitly detailed, but generally would include tests for: |
- Integrity of tubing and connections
- Functionality of trumpet valves (irrigation and aspiration)
- Flow rates
- Leakage
- Component strength | "All the test results demonstrate the performance of Unimicro Suction Irrigation Tubing set meets the requirements of its pre-defined acceptance criteria and intended uses." (Specific performance metrics are not provided in this summary.) |
| Biocompatibility Tests: - Cytotoxicity Test
- Intracutaneous Reactivity Test
- Maximization Sensitization Test | The text indicates these tests were performed and imply the results met acceptance criteria for safety, as the conclusion states the device is "safe and effective." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided summary.
- Data Provenance: The tests were performed by "Unimicro Medical Systems (ShenZhen) Co., Ltd." which is based in Shenzhen, Guangdong Province, China. The study appears to be prospective as it's a series of non-clinical tests conducted on the device as part of the submission process.
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. This is a non-clinical performance and biocompatibility study of a medical device (suction/irrigation tubing set), not a diagnostic algorithm that requires expert ground truth establishment for medical image interpretation or clinical outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is a non-clinical performance and biocompatibility study. Adjudication methods are typically used in clinical studies with human assessors or when resolving discrepancies in ground truth establishment for diagnostic algorithms.
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 is a non-clinical study for physical device performance and biocompatibility. It does not involve human readers, AI assistance, or comparative effectiveness in a clinical diagnostic context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical instrument (tubing set), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to the pre-defined technical specifications, performance standards (e.g., flow rates, pressure limits, material strength), and biocompatibility requirements for medical devices. These are typically established through engineering standards, regulatory guidelines (e.g., ISO standards for biocompatibility), and internal product specifications.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI model.
§ 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.