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.

Device Description

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.

AI/ML Overview

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

Acceptance Criteria Category	Specific Test/Evaluation	Acceptance Criteria (Implicit from "meets predefined acceptance criteria and complied with design specification")	Reported Device Performance (Summary)
Electrical Safety	IEC 60601-1:2005+AMD1:2012+AMD2:2020	Complies with standard for basic safety & essential performance.	Met: Evaluated against and complied with the specified international standard.
Electromagnetic Compatibility (EMC)	IEC 60601-1-2:2014+AMD1:2020, IEC 60601-2-18:2009	Complies with standards for EMC.	Met: Evaluated against and complied with the specified international standards.
Biocompatibility	ISO 10993-1:2018 (and FDA Guidance on ISO 10993-1)	Demonstrates biocompatibility based on specific tests.	Met: Completed tests for Acute Systemic Toxicity, Skin Sensitization, Intracutaneous Reactivity, Pyrogen Test, and In Vitro Cytotoxicity.
Bench Testing - Fluidics	Fluid flow rate of Irrigation tube	Specific flow rate targets (not detailed in summary, but assumed to match predicate/clinical need).	Met: Test results met predefined acceptance criteria and complied with design specifications.
Bench Testing - Pressure	Negative pressure resistance of suction	Specific pressure resistance targets (not detailed).	Met: Test results met predefined acceptance criteria and complied with design specifications.
Bench Testing - Sealing	Sealing of irrigation tube	Leakage prevention (not detailed).	Met: Test results met predefined acceptance criteria and complied with design specifications.
Sterilization	Ethylene Oxide Sterilization Performance Qualification	Achieves a Sterility Assurance Level (SAL) of 10⁻⁶.	Met: Performance qualification demonstrated SAL of 10⁻⁶.
Material Compatibility	Materials used (304 Stainless Steel, ABS, PVC)	Compatible with intended use and biological contact.	Met: Materials are similar to predicate device.
Single Use / Reusable Status	Single Use	Designed for single use, sterile.	Met: Confirmed as single use and sold sterile.

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.

Summary

FDA 510(k) Clearance Letter - K250124

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

August 6, 2025

Hangzhou Viction Medical Technology Co.,Ltd
Zhicong Luo
General Manager
First Floor ,No.1 Building, No.95 Binwen Road,
Binjiang District
Hangzhou, Zhejiang 310051
China

Re: K250124
Trade/Device Name: Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532, VC-IRC0523, VC-IRD0532, VCIRD0532)
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: GCJ
Dated: January 17, 2025
Received: January 17, 2025

Dear Zhicong Luo:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

August 6, 2025

Hangzhou Viction Medical Technology Co.,Ltd
Zhicong Luo
General Manager
First Floor ,No.1 Building, No.95 Binwen Road,
Binjiang District
Hangzhou, Zhejiang 310051
China

Re: K250124
Trade/Device Name: Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532, VC-IRC0523, VC-IRD0532, VC-IRD0532)
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: GCJ
Dated: January 17, 2025
Received: January 17, 2025

Dear Zhicong Luo:

U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K250124 - Zhicong Luo Page 2

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn

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K250124 - Zhicong Luo Page 3

(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Julie A. Morabito -S

Julie Morabito, Ph.D.
Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Indications for Use

Submission Number (if known)
K250124

Device Name
Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523VC-IRC0532, VC-IRC0523, VC-IRD0532, VC-IRD0532)

Indications for Use (Describe)
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.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 5

510(K) Summary

K250124

This summary of 510(K)safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
Type of submission: Traditional
The date the summary was prepared: June8, 2025

I. SUBMITTER

Hangzhou Viction Medical Technology Co.,Ltd
First floor, No.1 Building, No.95 Binwen Road, Binjiang District, Hangzhou City, Zhejiang Province, China.MD310051
Contact Person: Yu Gu
Phone: +86-057188305089
Email: guyu@victionmed.com
Date Prepared: February 11, 2025

II. Device

Name of Device: Viction Disposable Suction Irrigation Catheter, (VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532,VC-IRC0523,VC-IRD0532, VC-IRD0532)
Common or Usual Name: Suction Irrigation Catheter
Classification Name: Endoscope And Accessories( 21 CFR876.1500 )
Regulatory Class: 2
Product Code: GCJ

III. PREDICATE DEVICE

CORE E3 Suction/Irrigator （K202303）, manufactured by ConMed Corporation. Located in 525 French Road Utica. This predicate has not been subjected to a design-related recall. No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

Page 6

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.

V. INDICATION FOR USE

VI. COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATED DEVICE

The Viction Disposable Suction Irrigation system is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance.

Predicate device name: CORE E3 Suction/Irrigator
510(K) number: K202303
Common Name: Suction Irrigation
Manufacturer: ConMed Corporation.

The following table shows similarities and differences of indications for use between our device and the predicate devices. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.

Item	Predicate device	Subject device	Comparison
Trade Name	CORE E3 Suction/Irrigator	Viction Disposable Irrigation and suction catheter	Similar product, different name
510(K) Number	K202303	K250124	/
Classification regulation	21 CFR 876.1500	21 CFR 876.1500	same
Classification and Code	ClassⅡ, GCJ	ClassⅡ, GCJ	same

Page 7

Device Classification Name	Laparoscope, General & Plastic Surgery	Laparoscope, General & Plastic Surgery	same
Design	Battery-powered pump, dual tubing, trumpet handpiece, and optional probe.	Battery-powered pump, dual tubing, handpiece, and four types of probe.	Different; subject device's probe has different shapes, but it can't change, do not have optional Probes.
materials	304 Stainless Steel, Polycarbonate, 420 Stainless Steel, EPDM Rubber, ABS, and PVC. Six (6) AAA alkaline batteries.	304 Stainless Steel, ABS, and PVC. Nine (9) AA alkaline batteries.	Similar
Sterilization	Ethylene Oxide Sterility Assurance Level (SAL) of 10⁻⁶	Ethylene Oxide Sterility Assurance Level (SAL) of 10⁻⁶	same
Single Use / Reusable	Single Use	Single Use	same
Principle of Operation	Battery powered mechanical pumping system	Battery powered mechanical pumping system	same
Environment Use	Healthcare facility/hospital	Healthcare facility/hospital	same

Conclusion
Based on the comparison of indications of use and other product performances. The Viction Disposable Suction Irrigation system manufactured by"Hangzhou Viction Medical Technology Co., Ltd."is substantial equivalent to its predicate devices.

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Electrical safety and electromagnetic compatibility
Electrical safety and EMC testing were conducted on the device.

Electromagnetic compatibility is evaluated following IEC 60601-1-2:2014+AMD

Page 8

1:2020,IEC 60601-2-18:2009.
Electrical safety is evaluated following IEC 60601-1: 2005: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. Apply with standard IEC606011:2005+AMD1:2012+AMD2:2020

Biocompatibility testing
The Biocompatibility evaluation for the CORE E3 device was conducted in accordance with ISO 10993- 1:2018 Biological evaluation of medical devices – Part-1: Evaluation and testing within a risk management process and application of applicable principles detailed in FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and Testing within a Risk Management Process" (June 16, 2016). The following tests were completed:

Acute Systemic Toxicity
Skin Sensitization Test
Intracutaneous Reactivity Test
Pyrogen Test
In Vitro Cytotoxicity Test

Bench Testing

Fluid flow rate of Irrigation tube
Negative pressure resistance of suction
Sealing of irrigation tube

Sterilization
Performance qualification for ethylene oxide sterilization

Clinical Testing
Not applicable to this submission

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.

VIII. CONCLUSIONS

Based upon the intended use and known technical information provided in this pre-market notification the Viction Disposable Irrigation and Suction Catheter has been shown to be substantially equivalent to currently marketed predicate device K202303.

Regulation Number and Section

§ 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.