(423 days)
The Unimicro Trocar kit,Model: Auto-Locking Trocar, and Bladeless Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.
The Auto-Locking Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Auto-Locking Trocar is available in three (3) sizes: 5mm, 10mm and 12mm. The cannula assembly has a universal seal ,a valve,and a stopcock.This device has a bladed tip with an internal shield, which is designed to cover the cutting edges once the body cavity has been entered.
The Hasson Trocar has application in a variety of endoscopic procedures to provide a port for entry for endoscopic instruments. The Hasson Trocar is available in two (2) sizes: 10mm and 12mm.This device has a blunt tip, which is designed for open Laparoscopy. The cannula assembly has a fixation device, a universal seal, a valve, and a stopcock.
The Bladeless Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Bladeless Trocar is available from 5-12mm: The cannula assembly (10mm to 12mm type) has a universal seal, a valve, and a stopcock. The cannula assembly (5mm type) has a stopcock.
The document is a 510(k) summary for the Unimicro Trocar Kit. It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (implied/general) | Reported Device Performance |
|---|---|---|
| Obturator Compatibility | Met requirements of compatibility with the cannula | All test results demonstrate Unimicro Trocar kit meet the requirements of its pre-defined acceptance criteria |
| Insertion & Cannula Stability | Met requirements for stable insertion and cannula position | All test results demonstrate Unimicro Trocar kit meet the requirements of its pre-defined acceptance criteria |
| Air Leakage | Device effectively prevents air leakage | All test results demonstrate Unimicro Trocar kit meet the requirements of its pre-defined acceptance criteria |
| Biological Safety (ISO 10993 series) | Biocompatibility requirements met | Tests conducted in accordance with ISO 10993-1, ISO 10993-5, ISO 10993-7, ISO 10993-10, ISO 10993-12 |
| Sterilization (ISO 11135-1) | Sterilization effectiveness met | Tests conducted in accordance with ISO 11135-1 |
Note: The document states "All the test results demonstrate Unimicro Trocar kit meet the requirements of its pre-defined acceptance criteria and intended uses." However, the specific numerical or qualitative acceptance criteria for each performance test (Obturator Compatibility, Insertion & Cannula Stability, Air Leakage) are not explicitly stated in this summary. It only indicates that they were met.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "A series of safety tests were performed" and "The performance testing conducted on subject device and predicate device," but does not provide specific numbers for the devices tested.
- Data Provenance: The tests were non-clinical ("non-clinical testing") and likely conducted in-house or by a third-party lab affiliated with the manufacturer, Unimicro Medical Systems (ShenZhen) Co., Ltd. The manufacturer is based in Shenzhen, Guangdong Province, China. The data would therefore be retrospective in the context of the 510(k) submission, meaning the tests were completed before the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a medical instrument (trocar kit), not a diagnostic algorithm or image analysis device that requires expert ground truth for its performance evaluation in the way medical AI would. The performance is assessed through engineering and biocompatibility testing.
4. Adjudication Method for the Test Set
Not applicable. As this is not a diagnostic or AI-driven device, there is no "ground truth" established by human experts that would require adjudication. Performance is determined by objective physical and biological tests against established technical standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. The Unimicro Trocar Kit is a physical medical device, not an AI or diagnostic tool that would involve human readers or image interpretation.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The Unimicro Trocar Kit is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the performance of the Unimicro Trocar Kit is established through adherence to recognized international standards (e.g., ISO 10993 series for biological evaluation, ISO 11135-1 for sterilization) and pre-defined engineering acceptance criteria for functional performance (e.g., obturator compatibility, insertion/cannula stability, air leakage). This is a technical ground truth, not an "expert consensus," "pathology," or "outcomes data" in the typical sense for diagnostic devices.
8. Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for this device.
§ 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.