Suction Irrigation Set

K172794 · Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd · GCJ · Nov 29, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K172794
• Device Name: Suction Irrigation Set
• Applicant: Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Nov 29, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended 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.

Device Story

Single-use, sterile suction irrigation set for laparoscopic surgery; consists of handpiece with two trumpet-style valves, probe, and tubing lines. Connects to external irrigation fluid supply and aspiration pump. Physician operates handpiece to control fluid delivery and suction evacuation of blood/debris from operative site. Adjustable instrument adapter allows introduction of surgical instruments through probe. Facilitates visualization during gynecologic, general, thoracic, and urology procedures.

Clinical Evidence

Bench testing only. Performance validated via air tightness, smoothness, tensile strength, tubing collapse, and flow rate testing. Biocompatibility confirmed via cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, and material-mediated pyrogenicity testing. Sterilization validated per ISO 11135:2014.

Technological Characteristics

Materials: SUS304 stainless steel, ABS, PVC, Silicone, PC+ABS. Principle: Manual trumpet-valve controlled suction/irrigation. Form factor: Handpiece with probe (5mm diameter; 28cm, 33cm, 45cm lengths). Connectivity: None. Sterilization: Ethylene Oxide (EO) per ISO 11135-1:2014.

Indications for Use

Indicated for patients undergoing laparoscopic gynecologic, general, thoracic, or urology surgical procedures requiring lavage, suction, and irrigation to flush blood and tissue debris for improved visualization.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Unimicro Suction Irrigation Tubing set (K141592)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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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 : [phone]

Fax : [phone]

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 : [phone]

Fax : [phone]

E-mail: [e-mail]

### 3. Identification of the Device :

Trade Name: Suction Irrigation set Common Name: Suction Irrigation Model: WSI105280T, WSI105330T, WSI105450T

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| Classification Name | Product<br>Code | Regulation<br>Number | Regulatory<br>Class | Review Panel |
|----------------------------------------------|-----------------|----------------------|---------------------|------------------------------|
| Laparoscope,<br>General & Plastic<br>Surgery | GCJ | 21CFR<br>876.1500 | II | General & Plastic<br>Surgery |

#### 4. Identification of the Predicative Device

| Device | Common | Manufacturer | Classification | Classification | 510(k) |
|-------------------------------------------------|-----------------------|-----------------------------------------------------------|-------------------|-------------------|---------|
| Name | Name | | and Code | regulation | number |
| Unimicro<br>Suction<br>Irrigation<br>Tubing set | Suction<br>Irrigation | Unimicro<br>Medical<br>Systems<br>(ShenZhen) Co.,<br>Ltd. | Class II ,<br>GCJ | 21CFR<br>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

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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 Irrigation<br>Tubing set | Suction Irrigation Set |
| 510(K)<br>Submitter | Unimicro Medical Systems<br>(ShenZhen) Co.,Ltd. | WickiMed(Huizhou)Medic<br>al Equipment<br>Manufacturing Co.,Ltd |
| 510(K) Number | K141592 | - |
| Classification<br>regulation | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Classification<br>and Code | Class II ,<br>GCJ | Class II ,<br>GCJ |
| Device<br>Classification<br>Name | Laparoscope, General &<br>Plastic Surgery | Laparoscope, General &<br>Plastic Surgery |
| Indications for<br>Use | The device is available with<br>an array of probe designs<br>to facilitate lavage during<br>laparoscopic surgery.<br>This device has<br>applications in<br>laparoscopic gynecologic,<br>general, thoracic and<br>urology procedures to<br>provide suction and<br>irrigation functions to help<br>flush blood and tissue<br>debris from the operative | The device is available<br>with an array of probe<br>designs to facilitate<br>lavage during<br>laparoscopic surgery.<br>This device has<br>applications in<br>laparoscopic gynecologic,<br>general, thoracic and<br>urology procedures to<br>provide suction and<br>irrigation functions to<br>help flush blood and |
| | site during laparoscopy to<br>aid visualization. | tissue debris from the<br>operative site during<br>laparoscopy to aid<br>visualization. |
| Function | The tubing one set designed to<br>attach to a supply of irrigation<br>fluid, and the other designed<br>to attach to an aspiration<br>pump.<br>The valves allow controlled<br>irrigation and aspiration<br>during a surgical procedure. | The tubing one set designed<br>to attach to a supply of<br>irrigation fluid, and the other<br>designed to attach to an<br>aspiration pump.<br>The valves allow controlled<br>irrigation and aspiration<br>during a surgical procedure. |
| Stainless steel<br>Infusion/Suction<br>probe specification<br>(Diameter×Length ) | 5mm×28cm<br>5mm×33cm<br>5mm×45cm | 5mm×28cm<br>5mm×33cm<br>5mm×45cm |
| Patient<br>Contacting<br>Material | Stainless steel | SUS304 |
| | ABS | ABS |
| | PVC | PVC |
| | Silicone | Silicone |
| | PC+ABS | PC+ABS |
| Biocompatibility | Cytotoxicity Test;<br>Intracutaneous Reactivity<br>Test;<br>Maximization Sensitization<br>Test | Cytotoxicity Test;<br>Intracutaneous Reactivity<br>Test;<br>Maximization Sensitization<br>Test;<br>Acute systemic Toxicity Test;<br>Material-mediated<br>pyrogenicity Test |
| Sterilization | EO Sterilized<br>ISO 11135 | EO Sterilized<br>ISO 11135-1 :2014 |
| Disposable | Yes | Yes |
| Additional<br>accessories | 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.