(75 days)
The Suction Irrigation Set is available with an array of probe designs to facilitate lavage during laparoscopic surgery. This device has applications in laparoscopic gynecologic, general, thoracic and urology procedures to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.
The Suction Irrigation Set is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver-sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris from the surgical site.
The suction irrigation set consists of a hand piece equipped with two trumpet style valves,a probe, and connecting lines of tubing, one set designed to attach to a supply of irrigation fluid, and the other designed to attach to an aspiration pump. The valves allow controlled irrigation and aspiration during a surgical procedure.
The hand piece of the suction irrigation is designed to allow instruments to be introduced through the suction irrigation probe to reach the operative site. The instrument adapter is adjustable to allow a variety of instruments and diameters. It is a single use, disposable device and is sold sterile.
The provided document is a 510(k) summary for a medical device called "Suction Irrigation Set". This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed clinical study demonstrating the device's performance against specific acceptance criteria in a robust clinical setting.
Therefore, the requested information regarding detailed acceptance criteria and a study proving the device meets them, especially in the context of AI/ML or diagnostic performance, is not available in this document. The tests described are primarily non-clinical, focusing on safety and functional equivalence to a predicate device.
However, I can extract the available information regarding the non-clinical testing performed and the general statement about meeting acceptance criteria.
Here's a breakdown of what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
- Available: The document states that "All the test results demonstrate the performance of Suction Irrigation set meets the requirements of its pre-defined acceptance criteria and intended uses." However, the specific numerical acceptance criteria and the quantitative reported performance for each test are not provided. Only the types of tests are listed.
| Test Performed | Acceptance Criteria (Not Detailed) | Reported Device Performance (Not Detailed) |
|---|---|---|
| Air Tightness Test | Meets pre-defined requirements (specific values not provided) | Performed, and results demonstrate performance meets requirements (specific results not provided) |
| Smooth test | Meets pre-defined requirements (specific values not provided) | Performed, and results demonstrate performance meets requirements (specific results not provided) |
| Tensile strength | Meets pre-defined requirements (specific values not provided) | Performed, and results demonstrate performance meets requirements (specific results not provided) |
| Tubing Collapse Test | Meets pre-defined requirements (specific values not provided) | Performed, and results demonstrate performance meets requirements (specific results not provided) |
| Irrigation Fluid / Aspiration Fluid Flow Test | Meets pre-defined requirements (specific values not provided) | Performed, and results demonstrate performance meets requirements (specific results not provided) |
| Biocompatibility (Cytotoxicity) | Meets pre-defined requirements | Performed, and results contribute to safety and effectiveness determination |
| Biocompatibility (Sensitization) | Meets pre-defined requirements | Performed, and results contribute to safety and effectiveness determination |
| Biocompatibility (Intracutaneous reactivity) | Meets pre-defined requirements | Performed, and results contribute to safety and effectiveness determination |
| Biocompatibility (Acute systemic toxicity) | Meets pre-defined requirements | Performed, and results contribute to safety and effectiveness determination |
| Biocompatibility (Material-Mediated Pyrogenicity) | Meets pre-defined requirements | Performed, and results contribute to safety and effectiveness determination |
| Sterilization validation | Per ISO 11135:2014 requirements | Performed per ISO 11135:2014, and results contribute to safety and effectiveness determination (specific results not provided) |
2. Sample size used for the test set and the data provenance:
- Not available in explicit detail. The document mentions "A series of tests" but does not specify sample sizes for each test. Data provenance (country of origin, retrospective/prospective) is not relevant for these non-clinical, bench-level tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not available. These are non-clinical, engineering/materials tests. There is no "ground truth" established by human experts in the context of a diagnostic or interpretative device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not available. Adjudication methods are relevant for expert-driven diagnostic assessments, not for the physical/chemical tests described.
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:
- Not applicable. This device is a manual suction irrigation set, not an AI/ML-powered diagnostic or assistive device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. For the physical/chemical tests conducted, the "ground truth" would be established by objective measurements against engineering specifications and industry standards (e.g., ISO for sterilization).
8. The sample size for the training set:
- Not applicable. This device does not involve a "training set" as it is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. This device does not involve a "training set."
In summary: The provided document is a regulatory submission for a traditional Class II medical device, demonstrating substantial equivalence through non-clinical testing. It does not contain information typically found in studies for AI/ML or diagnostic devices, which involve clinical performance and human reader assessment.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA. On the right is the logo for the FDA U.S. Food & Drug Administration. The FDA logo is in blue.
November 29, 2017
WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd. Haobin Li General Manager TangJiao XingWang Street LiLin Town, ZhongKai Hi-Tech Zone Huizhou, GuangDong, 516000 China
Re: K172794
Trade/Device Name: Suction Irrigation Set, Model: WS/105280T, WS/105330T, WS/105450T Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: September 13, 2017 Received: September 15, 2017
Dear Haobin Li:
We have reviewed vour 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 (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. 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.
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.
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 of medical device-related adverse events) (21 CFR 803); good
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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Jennifer R. Stevenson -S For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K172794
Device Name
Suction Irrigation Set, models :WSI105280T, WSI105330T, WSI105450T
Indications for Use (Describe)
The Suction Irrigation Set is available with an array of probe designs to facilitate lavage during laparoscopic surgery. This device has applications in laparoscopic gynecologic, general, thoracic and urology procedures to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.
| 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) |
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510(K) SUMMARY
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 assigned 510(K) number is: K172794
The date the summary was prepared: November 19, 2017
1. Submitter information:
Manufacturer Name: WickiMed(Huizhou)Medical Equipment Manufacturing Co.,Ltd.
Address: TangJiao XingWang Street, LiLin Town, ZhongKai Hi-Tech Zone, HuiZhou,GuangDong, China.
Tel : 0086-0752-3860807
Fax : 0086-0752-3863017
Establishment Registration Number:3010601992
2. Contact person:
Haobin Li (General Manager)
WickiMed(Huizhou)Medical Equipment Manufacturing Co.,Ltd
TangJiao XingWang Street, LiLin Town, ZhongKai Hi-Tech Zone, HuiZhou,GuangDong, China.
Tel : 0086-0752-3860807
Fax : 0086-0752-3863017
E-mail: mac_lai@wickimed.com
3. Identification of the Device :
Trade Name: Suction Irrigation set Common Name: Suction Irrigation Model: WSI105280T, WSI105330T, WSI105450T
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| Classification Name | ProductCode | RegulationNumber | RegulatoryClass | Review Panel |
|---|---|---|---|---|
| Laparoscope,General & PlasticSurgery | GCJ | 21CFR876.1500 | II | General & PlasticSurgery |
4. Identification of the Predicative Device
| Device | Common | Manufacturer | Classification | Classification | 510(k) |
|---|---|---|---|---|---|
| Name | Name | and Code | regulation | number | |
| UnimicroSuctionIrrigationTubing set | SuctionIrrigation | UnimicroMedicalSystems(ShenZhen) Co.,Ltd. | Class II ,GCJ | 21CFR876.1500 | K141592 |
5. Intended Use and Indications for Use of the subject device
The Suction Irrigation Set is available with an array of probe designs to facilitate lavage during laparoscopic surgery.
This device has applications in laparoscopic gynecologic, general, thoracic and urology procedures to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.
6. Device Description
The Suction Irrigation Set is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver-sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris from the surgical site.
The suction irrigation set consists of a hand piece equipped with two trumpet style valves,a probe, and connecting lines of tubing, one set designed to attach to a supply of
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irrigation fluid, and the other designed to attach to an aspiration pump. The valves allow controlled irrigation and aspiration during a surgical procedure.
The hand piece of the suction irrigation is designed to allow instruments to be introduced through the suction irrigation probe to reach the operative site. The instrument adapter is adjustable to allow a variety of instruments and diameters. It is a single use, disposable device and is sold sterile.
7. Non-clinical Testing
A series of tests were performed to assess the safety and effectiveness of the subject device compared to the predicate. The biocompatibility tests included Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity and Material-Mediated Pyrogenicity. Sterilization validation was performed per ISO 11135:2014.
The tests listed below evaluated the performance of the subject device.
- Air Tightness Test
- Smooth test
- Tensile strength
- Tubing Collapse Test
- Irrigation Fluid /Aspiration Fluid Flow Test
All the test results demonstrate the performance of Suction Irrigation set meets the requirements of its pre-defined acceptance criteria and intended uses.
The results of the non-clinical testing demonstrate that the Suction Irrigation Set is as safe and effective as the predicate device.
8. Substantial Equivalence Determination
The Suction Irrigation set submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, performance to the cleared Unimicro Suction Irrigation Tubing set which is the subject of K141592.
There are no differences between the two devices and no any new issues of safety or effectiveness.
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The subject device does not provide any additional accessories like the predicate device.
The comparison to predicate device as below Table 2.
| Item | Predicate Device | Proposed Device |
|---|---|---|
| Trade Name | Unimicro Suction IrrigationTubing set | Suction Irrigation Set |
| 510(K)Submitter | Unimicro Medical Systems(ShenZhen) Co.,Ltd. | WickiMed(Huizhou)Medical EquipmentManufacturing Co.,Ltd |
| 510(K) Number | K141592 | - |
| Classificationregulation | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Classificationand Code | Class II ,GCJ | Class II ,GCJ |
| DeviceClassificationName | Laparoscope, General &Plastic Surgery | Laparoscope, General &Plastic Surgery |
| Indications forUse | The device is available withan array of probe designsto facilitate lavage duringlaparoscopic surgery.This device hasapplications inlaparoscopic gynecologic,general, thoracic andurology procedures toprovide suction andirrigation functions to helpflush blood and tissuedebris from the operative | The device is availablewith an array of probedesigns to facilitatelavage duringlaparoscopic surgery.This device hasapplications inlaparoscopic gynecologic,general, thoracic andurology procedures toprovide suction andirrigation functions tohelp flush blood and |
| site during laparoscopy toaid visualization. | tissue debris from theoperative site duringlaparoscopy to aidvisualization. | |
| Function | The tubing one set designed toattach to a supply of irrigationfluid, and the other designedto attach to an aspirationpump.The valves allow controlledirrigation and aspirationduring a surgical procedure. | The tubing one set designedto attach to a supply ofirrigation fluid, and the otherdesigned to attach to anaspiration pump.The valves allow controlledirrigation and aspirationduring a surgical procedure. |
| Stainless steelInfusion/Suctionprobe specification(Diameter×Length ) | 5mm×28cm5mm×33cm5mm×45cm | 5mm×28cm5mm×33cm5mm×45cm |
| PatientContactingMaterial | Stainless steel | SUS304 |
| ABS | ABS | |
| PVC | PVC | |
| Silicone | Silicone | |
| PC+ABS | PC+ABS | |
| Biocompatibility | Cytotoxicity Test;Intracutaneous ReactivityTest;Maximization SensitizationTest | Cytotoxicity Test;Intracutaneous ReactivityTest;Maximization SensitizationTest;Acute systemic Toxicity Test;Material-mediatedpyrogenicity Test |
| Sterilization | EO SterilizedISO 11135 | EO SterilizedISO 11135-1 :2014 |
| Disposable | Yes | Yes |
| Additionalaccessories | Yes | None |
Table 2 : Comparison to Predicate Device
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9. Conclusion
After analyzing bench tests, safety testing data, it can be concluded that:Suction Irrigation set is as safe and effective as the predicate 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.