(201 days)
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.
| Acceptance Criteria | Reported Device Performance (as stated or implied met) |
|---|---|
| Irrigation Flow Rate | No less than 160 ml/min |
| Suction Flow Rate | No less than 600 ml/min |
| Ethylene Oxide Residue | ≤10 μg/g (indicating sterility) |
| Maximum Negative Pressure Withstand | 60 kPa |
| Sealing of irrigation tube | Met predefined acceptance criteria (details not specified) |
| Coating Adhesion | Complied with standard 3B Per ASTM D3359-23 |
| Particulate Contamination Index | Met predefined acceptance criteria (details not specified) |
| Biocompatibility | Tested and passed for Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, and Pyrogenicity. |
| Sterilization Validation | Ethylene Oxide Sterilization Validation met (details not specified) |
| Packaging Validation | Met (details not specified) |
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.
§ 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.