(75 days)
Not Found
No
The description focuses on mechanical components and fluid management, with no mention of AI/ML terms or functions.
No
Explanation: The device is used to facilitate visualization during laparoscopic surgery by flushing blood and tissue debris, and it delivers irrigation fluids and evacuates debris. These functions are supportive and aid the primary surgical procedure rather than directly treating a disease or condition. While essential for the procedure, its primary role is to assist the surgeon in performing the therapeutic act, not to be a therapeutic device itself.
No
The device is described as aiding visualization by flushing blood and tissue debris, and delivering irrigation fluids and evacuating waste during surgery. It does not perform any diagnostic function such as identifying, assessing, or monitoring a medical condition.
No
The device description clearly outlines physical components such as a hand piece, probe, tubing, and valves, and the performance studies focus on physical properties and functions like air tightness, tensile strength, and fluid flow. There is no mention of software as a component or function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is used during laparoscopic surgery to deliver irrigation fluids and remove blood and tissue debris from the operative site. This is a surgical tool used in vivo (within the body) to aid visualization and clear the surgical field.
- No Mention of Samples or Testing: There is no mention of the device being used to analyze samples or perform diagnostic tests on bodily fluids or tissues.
The device is a surgical instrument used for irrigation and suction during laparoscopic procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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and review the collection of information. Send comments regarding this burden estimate or any other aspect
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information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
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
4
| Classification Name | Product
Code | Regulation
Number | Regulatory
Class | Review Panel |
|----------------------------------------------|-----------------|----------------------|---------------------|------------------------------|
| Laparoscope,
General & Plastic
Surgery | GCJ | 21CFR
876.1500 | II | General & Plastic
Surgery |
4. Identification of the Predicative Device
| Device | Common | Manufacturer | Classification | Classification | 510(k) |
|---|---|---|---|---|---|
| Name | Name | and Code | regulation | number | |
| Unimicro | |||||
| Suction | |||||
| Irrigation | |||||
| Tubing set | Suction | ||||
| Irrigation | Unimicro | ||||
| Medical | |||||
| Systems | |||||
| (ShenZhen) Co., | |||||
| Ltd. | Class II , | ||||
| GCJ | 21CFR | ||||
| 876.1500 | 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
5
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.
6
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 Irrigation | |
| Tubing set | Suction Irrigation Set | |
| 510(K) | ||
| Submitter | Unimicro Medical Systems | |
| (ShenZhen) Co.,Ltd. | WickiMed(Huizhou)Medic | |
| al Equipment | ||
| Manufacturing Co.,Ltd | ||
| 510(K) Number | K141592 | - |
| Classification | ||
| regulation | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Classification | ||
| and Code | Class II , | |
| GCJ | Class II , | |
| GCJ | ||
| Device | ||
| Classification | ||
| Name | Laparoscope, General & | |
| Plastic Surgery | Laparoscope, General & | |
| Plastic Surgery | ||
| Indications for | ||
| Use | The device 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 | The device 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 | ||
| site during laparoscopy to | ||
| aid visualization. | tissue debris from the | |
| operative site during | ||
| laparoscopy to aid | ||
| visualization. | ||
| Function | The 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 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. | ||
| Stainless steel | ||
| Infusion/Suction | ||
| probe specification | ||
| (Diameter×Length ) | 5mm×28cm | |
| 5mm×33cm | ||
| 5mm×45cm | 5mm×28cm | |
| 5mm×33cm | ||
| 5mm×45cm | ||
| Patient | ||
| Contacting | ||
| Material | Stainless steel | SUS304 |
| ABS | ABS | |
| PVC | PVC | |
| Silicone | Silicone | |
| PC+ABS | PC+ABS | |
| Biocompatibility | Cytotoxicity Test; | |
| Intracutaneous Reactivity | ||
| Test; | ||
| Maximization Sensitization | ||
| Test | Cytotoxicity Test; | |
| Intracutaneous Reactivity | ||
| Test; | ||
| Maximization Sensitization | ||
| Test; | ||
| Acute systemic Toxicity Test; | ||
| Material-mediated | ||
| pyrogenicity Test | ||
| Sterilization | EO Sterilized | |
| ISO 11135 | EO Sterilized | |
| ISO 11135-1 :2014 | ||
| Disposable | Yes | Yes |
| Additional | ||
| accessories | Yes | None |
Table 2 : Comparison to Predicate Device
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8
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.