Who is the manufacturer of Trocar?

Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd filed the 510(k) submission for Trocar (K172038).

What is the FDA product code for Trocar?

GCJ. It is classified under 21 CFR 876.1500 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for Trocar?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Trocar?

Unimicro Trocar Kit (K141594); Unimax Trocar System (K112358).

Who can help prepare an FDA 510(k) submission like Trocar?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Trocar

K172038 · Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd · GCJ · Oct 27, 2017 · Gastroenterology, Urology

Device Facts

Record ID	K172038
Device Name	Trocar
Applicant	Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd
Product Code	GCJ · Gastroenterology, Urology
Decision Date	Oct 27, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1500
Device Class	Class 2

Intended Use

The Trocar, Model: Auto-Locking Trocar, Bladeless Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.

Device Story

Disposable surgical trocar/cannula system; used in endoscopic procedures to create port of entry for instruments. Available in Auto-Locking (bladed with shield), Bladeless, and Visible (blunt tip for open laparoscopy) models. Sizes range 5-12mm. Cannula assembly includes universal seal, valve, and stopcock. Operated by surgeons in clinical settings. Device inserted into skin incision, punctured into abdominal cavity; puncture cone removed to establish surgical channel. Universal seal accommodates various instrument diameters without converters. Provides safe, rapid access for endoscopic instrumentation.

Clinical Evidence

Bench testing only. Performance testing included obturator compatibility, insertion/cannula stability, air leakage, and insertion/removal force. Biocompatibility testing performed per ISO 10993 standards (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity). Sterilization validated per ISO 11135.

Technological Characteristics

Materials: Stainless steel, PC, ABS. Energy: Mechanical. Form factor: 5-12mm diameter cannula with universal seal, valve, and stopcock. Sterilization: Ethylene Oxide (EO). Standards: ISO 10993-1, 5, 7, 10, 11, 12; ISO 11135.

Indications for Use

Indicated for use in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.

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 Trocar Kit (K141594)
Unimax Trocar System (K112358)

Related Devices

K141594 — Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar · Unimicro Medical Systems (Shenzhen) Co., Ltd. · Aug 10, 2015
K112358 — UNIMAX TROCAR SYSTEM · Unimax Medical Systems, Inc. · Oct 17, 2011
K232866 — Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars) · Jiangsu Channel Medical Device Co., Ltd. · Nov 7, 2023
K974763 — DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA · Deroyal Industries, Inc. · Jul 10, 1998
K223593 — Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar · Taiwan Surgical Corporation · Mar 22, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 27, 2017 WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. Haobin Li General Manager Tang Jiao XingWang Street, LiLin Town Zhongkai Hi-Tech Zone HuiZhou, GuangDong, China 516000 Re: K172038/S001 Trade/Device Name:Trocar, Model: Auto-Locking Trocar, Bladeless Trocar, Visible Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: September 21, 2017 Received: September 26, 2017 Dear Haobin Li: 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 (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 manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): {1}------------------------------------------------ and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. > Sincerely, Jennifer R. Stevenson -S3 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}------------------------------------------------ ### Indications for Use #### 510(k) Number (ifknown) #### K172038 #### Device Name Trocar, models: Auto-Locking Trocar, Bladeless Trocar, Visible Trocar #### Indications for Use (Describe) The Trocar, Model: Auto-Locking Trocar, Bladeless Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------|-----------------------------------------------| | [X] 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 Paperwor1< 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 Food and Drug Administration Office of Chief information Officer Paperwor1< Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a parson is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(K) SUMMARY This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements 21 CFR §807.92. Type of submission: Traditional The assigned 510(K) number is: K172038 The date the summary was prepared: September 20 ,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: Trocar Model: Auto-Locking Trocar, Bladeless Trocar, Visible Trocar Common Name: Disposable Surgical Trocar /Cannula Classification Name: Laparoscope, General & Plastic Surgery Regulation Number: 876.1500 Device Classification: II Product Code: GCJ {4}------------------------------------------------ ### 4. Identification of the Predicative Device | Device Name | Common Name | Manufacturer | Classification and Code | Classification regulation | 510(k) number | |----------------------------|----------------------------------------------|-----------------------------------------------------------|-------------------------|---------------------------|---------------| | Unimicro Trocar Kit | Disposable Surgical Trocar /Cannula | Unimicro Medical Systems (ShenZhen) Co., Ltd. | Class II , GCJ | 21CFR 876.1500 | K141594 | | Unimax Trocar System | Disposable Surgical Trocar /Cannula | Unimax Medical Systems Inc. | Class II , GCJ | 21CFR 876.1500 | K112358 | ### Table 1: Predicative Device Information #### 5. Intended Use and Indications for Use of the subject device The Trocar Models: Auto-Locking Trocar, Bladeless Trocar and Visible Trocar, has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. ### 6. Device Description The Auto-Locking Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Auto-Locking Trocar is available in three kinds of diameter sizes: 5mm, 10mm and 12mm. The cannula assembly has a universal seal, a valve, and a stopcock. This device has a bladed tip with an internal shield, which is designed to cover the cutting edges once the body cavity has been entered. Auto-Locking Trocar 10 mm can accept 4 mm to 11 mm sized instruments with its built-in universal seal without the use of a converter. Auto-Locking Trocar 12 mm can accept 4 mm to 13 mm sized instruments with its built-in universal seal without the use of a converter. The Bladeless Trocar has application in a variety of endoscopic procedures to provide a {5}------------------------------------------------ port of entry for endoscopic instruments. The Bladeless Trocar is available from 5-12mm: The cannula assembly (10mm to 12mm type) has a universal seal, a valve, and a stopcock. The cannula assembly (5mm type) has a stopcock. The Visible Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. This device has a blunt tip,, which is designed for open Laparoscopy. The visible trocar is available in three sizes: 5mm, 10mm and 12mm. This device allows direct visualization of the abdominal wall layers when the trocar is traversed, which offers a safe and rapid option of primary trocar. The cannula assembly has a universal seal, a valve and a stopcock. #### 7. Substantial Equivalence Determination The Trocar submitted in this 510(k) file is substantially equivalent to the cleared Unimicro Trocar Kit (K141594) and Unimax Trocar System( K112358). The comparison to the predicate device is provided below in Table 2. | Item | Proposed Device | Predicate Device | Predicate Device | | |-------------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------| | | Trocar | Unimicro Trocar Kit K141594 | Unimax Trocar System K112358 | | | Classification regulation | 21 CFR 876.1500 | 21 CFR 876.1500 | 21 CFR 876.1500 | | | Classification and Code | Class II , GCJ | Class II , GCJ | Class II , GCJ | | | Common Name | Disposable Surgical Trocar /Cannula | Disposable Surgical Trocar /Cannula | Disposable Surgical Trocar /Cannula | | | Indications for Use | Applicate in a variety of endoscopic procedures to provide a port of entry for endoscopic | Applicate in a variety of endoscopic procedures to provide a port of entry for endoscopic | Applicate in a variety of endoscopic procedures to provide a port of entry for endoscopic | | | | | | | | | | | instruments. | instruments. | instruments. | | Principles of operation | | Trocar inserted into the skin incision, and punctured into the abdominal cavity. Removed the | Trocar inserted into the skin incision, and punctured into the abdominal cavity. Removed the | Trocar inserted into the skin incision, and punctured into the abdominal cavity. Removed the | | | | puncture cone and made a surgical channel. | puncture cone and made a surgical channel. | puncture cone and made a surgical channel. | | Model | | Auto-Locking Trocar | Auto-Locking Trocar | / | | | | Bladeless Trocar | Bladeless Trocar | / | | | | Visible Trocar | / | Visible Trocar | | Mainly | | Cannula,(blade), | Cannula , (blade), | Cannula, universal | | Structure | | universal seal, valve, | universal seal, valve, | seal, valve, stopcock | | | | stopcock | stopcock | | | Specification | | Diameter :5-12mm | Diameter :5-12mm | Diameter :3-15mm | | | | Length :100mm | Length :70-120mm | Length :65-150mm | | Technology | | The built-in universal | The built-in universal | The built-in universal | | Characteristic | | seal design for Trocar | seal design for Trocar | seal design for Trocar | | | | 10 mm and 12mm | 10 mm and 12mm and | 10 mm and 12mm | | | | and without the use | without the use of a | and without the use | | | | of a converter. | converter. | of a converter. | | Patient- contacting structure | ATR | Blade, Cutting head ,Cannula | Blade, Cutting head ,Cannula | / | | | BTR | Cutting head , Cannula | Cutting head ,Cannula | / | | | VTR | Cutting head , Cannula | / | Cutting head ,Cannula | | Patient- contacting Materials | ATR | Stainless Steel, PC,ABS | Stainless Steel, PC,ABS | / | | | BTR | PC,ABS | PC,ABS | / | | | VTR | PC | / | PC | | Safety standards | | ISO 10993-1 ISO 10993-5 ISO 10993-7 ISO 10993-10 ISO 10993-11 ISO 10993-12 ISO 11135 | ISO 10993-1 ISO 10993-5 ISO 10993-7 ISO 10993-10 ISO 10993-12 ISO 11135-1 | ISO 10993-1 ISO 10993-5 ISO 10993-7 ISO 10993-10 ISO 10993-12 ISO 11135-1 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Performance testing items | | Obturator compatibility Insertion & cannula stability Air leakage Trocar Insertion/ Removal force | Obturator compatibility Insertion & cannula stability Air leakage/ | Obturator compatibility Insertion & cannula stability Air leakage/ | | | | | | | | | | | | | | | | | | | | | | | | | | Sterilization | | EO Sterilized | EO Sterilized | EO Sterilized | Table 2 : Comparison to Predicate Device {6}------------------------------------------------ {7}------------------------------------------------ WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd. The subject and predicate device have the same intended use. The subject and predicate device designs are nearly identical. Both are single-use devices and structure and technology characteristic are identical. The differences in specification between the subject and predicate devices do not raise different questions of safety and effectiveness. #### 8. Non-clinical Testing A series of tests were performed to assess the safety and effectiveness of the Trocar. Biocompatibility tests were conducted in accordance with ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010, ISO 10993-11:2006, and ISO 10993-12:2012. The biocompatibility tests included Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity and Material-Mediated Pyrogenicity. Sterilization validation was performed per ISO 11135:2014. {8}------------------------------------------------ The tests listed below evaluated the performance of the subject device. The performance testing conducted on subject device is listed below: - Obturator Compatibility ● - Insertion & Cannula Stability ● - Air Leakage - Trocar Insertion/ Removal force All the test results demonstrate Trocar meet the requirements of its pre-defined acceptance criteria and intended uses. #### 9. Conclusion Based on the results of the above described performance testing data, it can be concluded that the Trocar is as safe and effective as the predicate devices.