← Product Code [GCJ](/productcode/GCJ) · K202931 # Disposable Trocar (K202931) _Wuxi Shukang Medical Appliance Co., Ltd. · GCJ · Nov 17, 2020 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K202931 ## Device Facts - **Applicant:** Wuxi Shukang Medical Appliance Co., Ltd. - **Product Code:** [GCJ](/productcode/GCJ.md) - **Decision Date:** Nov 17, 2020 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Indications for Use The Disposable Trocar has applications in endoscopic procedures to provide a port of entry for endoscopic instruments. ## Device Story Disposable trocar used in minimally invasive abdominal, thoracic, and gynecologic surgery; establishes port of entry for endoscopic instruments. Device consists of obturator with bladeless tip, outer seal release lever, and stability sleeve. Surgeon manually inserts obturator through abdominal wall to create incision; trocar sleeve follows to maintain access; allows gas insufflation into cavity. Used in OR by surgeons. Provides stable access channel for endoscopic tools; facilitates minimally invasive approach; reduces trauma compared to open surgery. ## Clinical Evidence No clinical data. Substantial equivalence supported by bench performance testing (visual inspection, insertion/removal force, leakage, penetration force, retention force) and biocompatibility testing (ISO 10993-5, -10, -11). ## Technological Characteristics Materials: PC, ABS. Principle: Bladeless obturator for incision expansion and sleeve insertion. Dimensions: 3-15mm diameter, 80-150mm length. Sterilization: Gamma irradiation. Connectivity: None (mechanical device). ## Regulatory 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. In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period. ## Predicate Devices - U-IGNITE Bladeless Trocar ([K162387](/device/K162387.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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. November 17, 2020 Wuxi Shukang Medical Appliance Co., Ltd. Xiaoqing Yuan Sales Manager No.83, Haitang West Road, Zhakou, Heqiao Town Yixing, Jiangsu 214216 China Re: K202931 Trade/Device Name: Disposable Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: September 10, 2020 Received: September 29, 2020 Dear Xiaoqing Yuan: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K202931 Device Name Disposable Trocar Indications for Use (Describe) The Disposable Trocar has applications in 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 Paperwork 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 Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary #### 1. Contact Information #### 1.1. Applicant Applicant Name: Wuxi Shukang Medical Appliance Co., Ltd. Address: No. 83, Haitang West Road, Zhakou Heqiao Town, Yixing, Jiangsu, 214216 China Contact Person: Xiaoqing Yuan Title: Sales Manager Telephone: 0086-510-87881818 E-mail: info@surkonmed.com #### 1.2. Designated Submission Correspondent Company: Sinow Medical AS Address: Vestre Fantoft åen 44, 5072, Bergen, Norway Contact Person: Huifang Zhao Telephone: +86 13961151430 Email: zhao@bergemed.com ### 2. Device information Trade Name: Disposable Trocar Common Name: Disposable Surgical Trocar Classification: II Product Code: GCJ Regulation: 21 CFR 876.1500 #### 3. Legally Marketed Primary Predicate Device Product name: U-IGNITE Bladeless Trocar 510K Number: K162387 Product Code: GCJ Manufacture: Tianjin UWell Medical Device Manufacturing Co., Ltd. ## 4. Device Description The disposable Trocar has application in abdominal, thoracic and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions. {4}------------------------------------------------ The Disposable trocar is mainly composed of Obturator with bladeless tip, Outer Seal Release Lever, Trocar Stability Sleeve, Obturator Locking Button, etc. ## 5. Indication for use: The Disposable Trocar has applications in endoscopic procedures to provide a port of entry for endoscopic instruments. # 6. Substantially Equivalent (SE) Comparison | Item | Proposed Device | Primary Predicate Device | Reference Device | |------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------| | Product Code | GCJ | GCJ | GCJ | | Regulation
Number | 21 CFR 876.1500 | 21 CFR 876.1500 | 21 CFR 876.1500 | | Indication for
use | The Disposable Trocar has
applications in endoscopic
procedures to
provide a port of entry for
endoscopic instruments. | The U-IGNITE Bladeless
Trocar has applications in
endoscopic procedures to
provide a port of entry for
endoscopic instruments. | Applicate in a variety
of endoscopic
procedures to provide
a port of entry for
endoscopic
instruments. | | Models | SHTA, SHTB,
SHTC ,SHTD and SHTE
which is bladeless without
Endo-Assistant Part. | Bladeless without
Endo-Assistant Part (BIG &
IG models) | Bladeless Trocar | | Dimension | Diameter: 3-15mm
Length:80-150mm | Diameter: 5-12mm
Length:75-150 mm | Diameter: 3-15mm
Length:65-150mm | | Principles of
operation | During the operation, the
trocar sleeve and the obturator
are used together. The surgeon
uses the obturator to expand
the incision of the abdomen
and penetrates the trocar
sleeve through the abdominal
surface of the human body into
the abdominal cavity, thereby
delivering gas to the
abdominal cavity and
establishing a path of entry for | During the operation, the
trocar sleeve and the obturator
are used together. The surgeon
uses the obturator to expand
the incision of the abdomen
and penetrates the trocar
sleeve through the abdominal
surface of the human body into
the abdominal cavity, thereby
delivering gas to the
abdominal cavity and
establishing a path of entry for | / | | | endoscopic instruments. | endoscopic instruments. | | | Main
Components | Obturator, Sleeve | Cannula Sleeve; Obturator | Cannula
Tip of obturator | | Patient
Contacting
Structure | Obturator
Trocar Sleeve | Obturator
Cannula Sleeve | / | | Patient
Contacting
Material | PC, ABS | PC, ABS | / | | Sterilization | Gamma sterilization | Gamma sterilization | EO Sterilized | Table 1 Comparison of Technology Characteristics {5}------------------------------------------------ #### 7. Non-Clinical Test conclusion Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: (1) Bench Performance test: Performance test was conducted to demonstrate the proposed Disposable Trocar is substantially equivalent to the predicate devices. The performance tests include the following tests: - · Visual Inspection - · Insertion and Removal Force using obturator - · Leakage - · In Vitro Penetration Force - · In Vitro Retention Force (2) Biocompatibility evaluation and test Biocompatibility evaluation conducted in accordance with the FDA's 2016 guidance and ISO10993-1:2018 supports that the subject devices are biocompatible. The biocompatibility test includes the following tests: In Vitro Cytotoxicity Test (ISO 10993-5: 2009 ) Skin Sensitization Test (ISO 10993-10:2010) Intracutaneous reactivity Test (ISO 10993-10:2010 ) Acute Systemic Toxicity (ISO 10993-11:2017) Pyrogen Test (ISO 10993-11:2017) (3) Sterilization and Shelf Life Accelerated Aging Test Aging test report for product performance: Validation report for the sterilization by Gamma irradiation process (ISO 11737-2:2019) Test of Sterile Barrier System 3 Years Shelf Life. {6}------------------------------------------------ # 8. Clinical Test Conclusion No clinical study is included in this submission. # 9. Conclusion Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device. --- **Source:** [https://fda-staging.innolitics.com/device/K202931](https://fda-staging.innolitics.com/device/K202931) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com