(139 days)
The U-IGNITE Bladeless Trocar has applications in endoscopic procedures to provide a port of entry for endoscopic instruments.
It is a rigid hand-held surgical instrument with a rounded conical point used to manually puncture a bodily entry point to assist in the location and positioning of gently part the surrounding soft tissue. The trocar assembly punctures the muscle and tissue layers in the body. The trocar assembly's obturator is removed leaving the cannula to provide a port through which laparoscopes and other laparoscopic instruments can be introduced. The cannula sealing system shall be able to maintain pneumoperitoneum.
The U-IGNITE Bladeless Trocar is a sterile single patient use instrument consisting of a radiolucent sleeve and obturator in various sizes diameter. The obturator contains a clear, taped optical element. The obturator accommodate an appropriate sized 0 degree endoscope and provide visibility of individual tissue layers during insertion. Basic type do not have the optical element for its obturator.
In addition, the U-IGNITE Bladeless Trocar with Endo-assistant part is a design enhancement that reduces the incidence of trocar-induced endoscope lens smudging during endoscope insertion. Endoscope smudging occurs when bodily fluids and debris smear across the endoscope lens during a laparoscopic procedure. Trocarinduced smudging occurs when these bodily fluids and debris are deposited within the trocar's seal system when an endoscope or instrument has been exchanged through the trocar.
The trocar sleeves for the 12 mm devices contain two seals, an outer integrated removable self-adjusting seal that accommodates instruments ranging from 5mm to 12 mm in diameter where indicated and an internal seal. Together, these two seals minimize gas leakage when instruments are inserted or withdraw through the trocar. The 5 mm trocar sleeve does not contain an integrated removable outer seal and accommodates only 5 mm instruments.
A stopcock valve is compatible with standard luer lock fitting and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.
This is an irradiation sterilized single use disposable device to avoid cross infection.
The provided text describes the U-IGNITE Bladeless Trocar and its substantial equivalence to predicate devices, but it does not contain a table of acceptance criteria and reported device performance for a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study, nor does it provide sample sizes, ground truth details for such studies.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study results with specific acceptance criteria and performance metrics for an AI/algorithm-based device.
Here's a breakdown of what is available in the text regarding acceptance criteria and studies for the U-IGNITE Bladeless Trocar, specifically focusing on its non-clinical performance:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states: "All the test results demonstrate U-IGNITE Bladeless trocar meet the requirements of its predefined acceptance criteria and intended uses." However, it does not provide a specific table detailing these acceptance criteria alongside the quantitative reported device performance for each test. The "Performance Testing Item" section lists the types of tests conducted:
| Performance Testing Item | Reported Device Performance Statement |
|---|---|
| Obturator & Cannula Compatibility | Met predefined acceptance criteria. |
| Insertion & Cannula Stability | Met predefined acceptance criteria. |
| Air Leakage as a whole device | Met predefined acceptance criteria. |
| Trocar System Puncture Performance | Met predefined acceptance criteria. |
| Trocar sleeve retention force | Met predefined acceptance criteria. |
| Air Leakage with obturator withdrawn | Met predefined acceptance criteria. |
| Endoscope Visualization Image Quality | Met predefined acceptance criteria. |
| Endo-Assistant Part Liquid Absorbing Performance | Met predefined acceptance criteria. |
2. Sample Sizes and Data Provenance (for test set of performance tests):
The document mentions "animal simulation test" for "Trocar System Puncture Performance" and "Trocar sleeve retention force". However, it does not specify the sample sizes (number of animals or test replicates) used for these or any other performance tests.
The data provenance is not explicitly stated beyond "animal simulation test", but given it's a premarket submission from Tianjin UWell Medical Device Manufacturing Co. Ltd. (China), the tests were likely conducted internally or by a contracted lab. It is a retrospective summary of non-clinical bench testing.
3. Number of Experts and Qualifications:
Not applicable to the non-clinical performance tests mentioned. These are bench tests, not expert-read image analysis.
4. Adjudication Method:
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned for human readers improving with AI vs. without AI assistance. This device is a surgical instrument, not an AI-enabled diagnostic tool.
6. Standalone (Algorithm Only) Performance:
No standalone algorithm performance study was done, as this is a physical medical device (trocar), not a software algorithm.
7. Type of Ground Truth Used (for performance tests):
For the performance tests, the "ground truth" would be established by the physical and engineering properties being measured against predefined specifications or industry standards. For example:
- Obturator & Cannula Compatibility: Physical fit and function.
- Air Leakage: Measurement against specified leakage rates.
- Puncture Performance/Retention Force: Measurement against biomechanical force thresholds.
- Endoscope Visualization: Likely subjective assessment or objective measurement of clarity/obstruction.
The document does not detail the exact methodology for establishing these ground truths, but they would derive from engineering specifications and testing protocols.
8. Sample Size for Training Set:
Not applicable, as this is not an AI/ML device.
9. How Ground Truth for Training Set Was Established:
Not applicable.
Summary of what the document focuses on:
The entire document (510(k) summary) serves as a study to demonstrate substantial equivalence to existing legally marketed predicate devices, particularly the ENDOPATH XCEL Bladeless Trocar with OPTI VIEW Technology (Ethicon Endo-Surgery, LLC) and the Unimicro Trocar Kit (Unimicro Medical Systems). This is achieved through:
- Comparison of Indications for Use, design, materials, dimensions, and classification.
- Demonstration of compliance with biocompatibility standards (ISO 10993 series).
- Conducting a series of non-clinical performance tests on the subject device and the predicate device to show comparable performance. These tests include Obturator & Cannula Compatibility, Insertion & Cannula Stability, Air Leakage, Puncture Performance, Trocar sleeve retention force, Endoscope Visualization Image Quality, and Endo-Assistant Part Liquid Absorbing Performance.
The "acceptance criteria" referred to are the predefined internal specifications and expected performance benchmarks for these non-clinical tests, which the device "met." The "study" proving this involves the execution of these listed performance tests and the declaration that the results "demonstrate U-IGNITE Bladeless trocar meet the requirements of its predefined acceptance criteria and intended uses."
§ 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.