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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:

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."

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The U-Blade Veress Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

The U-Blade Veress Needle is a slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a surgical/radiological procedural method. It is used for percutaneous insertion into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

The device consists of an external stainless steel needle tube with a sharp point to puncture tissue. It is also equipped with an internal spring-loaded round-tipped obturator that extends from the tube when the device does not encounter resistance (i.e., when the cavity has been reached) to prevent damage to internal organs from the sharp point. The subject device also has a handle with a red indicator mark to verify when the spring-loaded obturator is retracted and a valve connector which connects to an insufflation pump.

As described in the following table, the U-Blade Veress Needle is available in 120mm and 150mm needle lengths and two types of handles with different shapes (U shape and Bugle).

This is a sterile and single-use device.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "U-Blade Veress Needle." It outlines the device's intended use, description, non-clinical testing, and a comparison to a predicate device to establish substantial equivalence.

Based on the information provided in the document, here's a breakdown regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document states that "The performance test results demonstrate that the U-Blade Veress Needle meet its acceptance criteria." However, the specific numerical acceptance criteria and the reported device performance values for each test are not quantitatively detailed in this summary. Instead, it lists the types of performance tests conducted:

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for the non-clinical performance tests (Tip Pull, Switch Operation, Spring Obturator Operation, Needle Puncture Force Tests). It also does not mention the country of origin of the data or whether the studies were retrospective or prospective. Given that this is a 510(k) submission from "Tianjin UWell Medical Device Manufacturing Co. Ltd." located in China, it's highly probable the testing was conducted in China, but this is not explicitly stated as the data provenance.

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)

This section is not applicable to the type of testing described in the document. The studies were non-clinical performance (mechanical/material) tests of a physical device, not studies involving human subjects, image interpretation, or diagnostic accuracy where expert consensus or ground truth would be established by medical professionals.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This is not applicable to the non-clinical performance tests conducted. Adjudication methods are typically used in clinical studies or studies involving subjective assessments (e.g., image interpretation) to resolve disagreements among reviewers.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as part of this submission. This type of study is relevant for AI-powered diagnostic devices, which the U-Blade Veress Needle is not. It is a physical surgical instrument.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

A standalone algorithm performance study was not conducted. This device is not an algorithm or software. It is a manually operated surgical instrument.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical performance tests, the "ground truth" (or reference standard) would be the specific engineering and material specifications of the device and relevant industry standards (e.g., ISO, ASTM). For example, the "Needle Puncture Force Test" would have an expected range of force for successful puncture, defined by engineering requirements, rather than expert consensus or pathology. The document lists compliance with several ISO standards (ISO 10993-1, -5, -10, -12; ISO 11137-1, -2) which serve as the "ground truth" for biocompatibility and sterilization.

8. The sample size for the training set

There is no mention of a training set because this is not an AI/ML device. The testing described is for a physical medical instrument.

9. How the ground truth for the training set was established

This is not applicable as there is no training set for this type of device.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria was a series of non-clinical performance tests and biocompatibility tests.

• Non-Clinical Performance Tests: These included "Tip Pull Test," "Switch Operation Test," "Spring Obturator Operation Test," and "Needle Puncture Force Test." The document states that these tests were performed and their results "demonstrate that the U-Blade Veress Needle meet its acceptance criteria." However, the actual numerical acceptance criteria and the quantitative test results are not provided in this summary document.
• Biocompatibility Tests: These tests were conducted in accordance with ISO 10993 series standards, specifically ISO 10993-1 (general), -5 (cytotoxicity), -10 (irritation and sensitization), and -12 (sample preparation). The device was categorized as an external communicating device with limited contact duration (

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