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The Viction Disposable Irrigation and Suction system is intended to provide irrigation and suction functions during general surgery and laparoscopic surgery.It is designed to deliver irrigation fluids to surgical sites and to remove fluid waste and tissue debris.

The Viction disposable Irrigation and suction system are constitutes with Irrigation & suction device and a double tubes(optional accessories).The Irrigation & suction device including an inner/outer stainless steel tubes,On-off Control Button,Conical connectors and Hand-piece. Double tubes constitutes with Irrigation tube、suction tube, and it connects with Yankee joint、Insert needle and Robert Clip.The Viction Disposable Suction Irrigation system is used to deliver sterile irrigation fluids to surgical sites during laparoscopic and endoscopic procedures.

The Irrigation & suction device including an inner/outer stainless steel tubes,On-off Control Button,Conical connectors and Hand-piece. On-off control button on handle-piece can control fluid circuit on and off. It is designed to deliver-sterile irrigation fluids to surgical sites during surgery procedures.

Double tubes constitutes with Irrigation tube,suction tube, and it connects with Yankee joint,Insert needle and Robert Clip.The suction tube is connected to the negative pressure device of the hospital through the Yankee joint, The waste liquid is discharged through a suction tube under the negative pressure environment.Which to improve the surgeon's visibility.

There are 12 models of the product, models VC-FLA0514;VC-FLA0523;VC-FLA0532;VC-FLB0514;VC-FLB0523;VC-FLB0532;VC-FLC0514;VC-FLC0523;VC-FLC0532;VC-FLD0514;VC-FLD0523;VC-FLD0532. All product's Structure are the same, the length of the irrigation suction tubes is the main difference. It is a single use, disposable device and is sold sterile.

The provided FDA 510(k) clearance letter and summary for the "Viction Disposable Irrigation and Suction System" addresses acceptance criteria and the studies performed to meet them. However, it focuses heavily on non-clinical bench testing and comparisons to a predicate device, as is common for medical devices of this classification. It does not present information related to clinical performance metrics involving human readers or AI algorithms, as the device is a physical surgical tool and not an AI-powered diagnostic or assistive system. Therefore, sections related to multi-reader multi-case studies, standalone algorithm performance, and training set details for AI are not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists several performance characteristics and implies that the device met these criteria through bench testing. The specific acceptance criteria values are directly stated for some tests.

2. Sample Size Used for the Test Set and Data Provenance:

The document describes non-clinical bench testing. Therefore, the concept of a "test set" and "data provenance" in the context of human or patient data does not apply. The tests described were performed on physical units of the Viction Disposable Irrigation and Suction System. The origin of the device manufacturer is China.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. The ground truth for the bench tests was established by objective measurements against predefined engineering and safety standards, not by expert interpretation of clinical data.

4. Adjudication Method for the Test Set:

Not applicable, as no expert adjudication was involved in the non-clinical bench testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No. This is a physical device, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. The device is a physical surgical instrument and does not involve any algorithms.

7. The Type of Ground Truth Used:

For the performance tests (flow rates, pressure, sterility, coating adhesion, etc.), the ground truth was based on objective engineering specifications and recognized international standards (e.g., ISO 11135 for sterilization, ASTM D3359-23 for coating adhesion). For biocompatibility, the ground truth was established by adherence to FDA Blue Book Memorandum #G95-1 and ISO10993-1, which define acceptable biological responses.

8. The Sample Size for the Training Set:

Not applicable. The Viction Disposable Irrigation and Suction System is a physical medical device. It does not utilize a training set in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

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The Viction Disposable Irrigation and Suction Catheter is indicated for use in conjunction with the handpiece , dual tubing, and probes to provide controlled powered irrigation during Laparoscopic surgery.

The Viction Disposable Irrigation and suction Catheter is constitutes with Suction/irrigation handpiece , dual tubing, Irrigation device that is a battery-powered mechanical pumping system connect with dual tubing(suction tubing and irrigation tubing) to deliver sterile fluids to surgical sites. Control of the irrigation flow is generated by depressing the on-off Control Button on the handpiece. The mechanical pumping system is powered with nine(9) standard AAlkaline Battery.
Hand piece equipped with pistol style attach to Suction irrigation probes and suction tubing . And it should be used with negative pressure device of the hospital.
There are 8 models of the product, models VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532,VC-IRC0523,VC-IRD0532, VC-IRD0532. All product's Structure are the same, the length of the irrigation suction tubes is the main difference. It is a single use, disposable device and is sold sterile.

The provided FDA 510(k) clearance letter and summary for the "Viction Disposable Irrigation and Suction Catheter" (K250124) concerns a medical device, specifically an endoscope accessory. It does not involve an AI/ML component for diagnosis or analysis, but rather outlines the substantial equivalence of a physical medical device to a predicate device.

Therefore, many of the requested elements typically relevant to AI/ML software (such as ground truth establishment by experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details, etc.) are not applicable to this submission.

The "acceptance criteria" for this device are demonstrated through bench testing, electrical safety, electromagnetic compatibility, biocompatibility, and sterilization performance against predefined criteria and relevant industry standards, establishing substantial equivalence to a legally marketed predicate device.

Here's the information that can be extracted and presented based on the provided document:

Device Acceptance Criteria and Performance (Based on provided 510(k) Summary)

The device, "Viction Disposable Irrigation and Suction Catheter," demonstrates substantial equivalence to its predicate device, CORE E3 Suction/Irrigator (K202303), primarily through non-clinical performance data and design comparisons.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify a numerical "sample size" for the performance tests (e.g., number of devices tested for flow rate, pressure, etc.). It states "All the test results meets the predefined acceptance criteria..." implying that a sufficient number were tested to demonstrate compliance.
• Data Provenance: Not explicitly stated (e.g., in terms of country of origin of testing facilities), but implies internal testing performed by the manufacturer or a contracted lab. The studies were non-clinical bench and lab tests, not human subject data.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. This is a physical medical device, not an AI/ML diagnostic tool. "Ground truth" in this context refers to established technical standards (e.g., IEC, ISO) and comparison to a predicate device's established performance specifications. There were no human expert readers establishing "ground truth" labels from medical images or clinical data.

4. Adjudication Method for the Test Set

• Not Applicable. There was no human "adjudication" of test results in the sense of resolving disagreements among experts for a diagnostic task. Performance was measured against technical specifications and standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not Applicable. No MRMC study was conducted or is relevant for this device type. This device is a tool for surgery, not an imaging analysis or diagnostic aid requiring human reader performance evaluation.

6. Standalone (Algorithm Only) Performance

• Not Applicable. There is no standalone algorithm. This is a physical device.

7. Type of Ground Truth Used

• The "ground truth" for this device's performance is established by engineering specifications, international consensus standards (IEC, ISO), and the performance characteristics of the legally marketed predicate device. For example, the "truth" for biocompatibility is conformance to ISO 10993, and the "truth" for electrical safety is conformance to IEC 60601-1.

8. Sample Size for the Training Set

• Not Applicable. This is a physical medical device, not an AI/ML system. There is no "training set."

9. How the Ground Truth for the Training Set was Established

• Not Applicable. There is no training set for this device.

Summary of the Study Proving Device Acceptance:

The "study" proving the device meets acceptance criteria is a comprehensive set of non-clinical performance tests and analyses. These include:

• Electrical Safety & EMC Testing: Following IEC 60601-1 and IEC 60601-1-2 standards to ensure the device is electrically safe and compatible within its intended electromagnetic environment.
• Biocompatibility Testing: Following ISO 10993-1 guidelines, including tests for acute systemic toxicity, skin sensitization, intracutaneous reactivity, pyrogenicity, and in vitro cytotoxicity. This demonstrates the materials used are safe for patient contact.
• Bench Testing: Evaluation of critical functional parameters such as fluid flow rate of the irrigation tube, negative pressure resistance of the suction, and sealing integrity of the irrigation tube. These tests confirm the device performs its intended functions effectively.
• Sterilization Validation: Performance qualification for ethylene oxide sterilization to ensure the device achieves a required Sterility Assurance Level (SAL) of 10⁻⁶, rendering it safe for single use in surgical environments.
• Comparative Analysis: A detailed comparison of technological characteristics (intended use, design, materials, specifications) against the predicate device (CORE E3 Suction/Irrigator, K202303) demonstrated substantial equivalence.

The document states, "All the test results meets the predefined acceptance criteria and complied with the design specification of the subject device throughout the use life. The results of the non-clinical testing demonstrate that the viction disposable irrigation and suction catheter is as safe and effective as the predicate device." This statement serves as the conclusion that the device successfully met its acceptance criteria through these documented non-clinical studies. No clinical testing was deemed applicable or necessary for this submission.

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