(49 days)
Not Found
No
The summary describes a mechanical surgical instrument (trocar) and its performance and biocompatibility testing, with no mention of AI or ML capabilities.
No
The device is a surgical instrument used to create a port of entry for other endoscopic instruments, which is a procedural function, not a therapeutic one that treats or cures a disease or condition.
No
The Disposable Trocar is described as a surgical instrument used to provide a port of entry for endoscopic instruments during procedures. Its function is to facilitate access for other instruments, not to diagnose conditions. The "Intended Use / Indications for Use" and "Device Description" sections clearly state its purpose as an access device for instruments, and the "Key Metrics" section explicitly states "Not Applicable (This is a surgical instrument, not a diagnostic device)".
No
The device description clearly outlines physical components (Obturator with bladeless tip, Outer Seal Release Lever, Trocar Stability Sleeve, Obturator Locking Button, etc.) and the performance studies focus on physical characteristics and biocompatibility, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a port of entry for endoscopic instruments during surgical procedures. This is a surgical tool used in vivo (within the body), not a device used in vitro (outside the body) to examine specimens from the body for diagnostic purposes.
- Device Description: The description details the physical components of a surgical instrument designed for insertion into the body.
- Lack of Diagnostic Function: There is no mention of analyzing biological samples, detecting markers, or providing any form of diagnostic information.
- Performance Studies: The performance studies focus on the physical and biological properties of the device for surgical use (insertion force, leakage, biocompatibility, sterilization, shelf life), not on diagnostic accuracy or performance metrics like sensitivity or specificity.
An IVD device is used to examine specimens (like blood, urine, tissue) obtained from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This disposable trocar does not perform any such function.
N/A
Intended Use / Indications for Use
The Disposable Trocar has applications in endoscopic procedures to provide a port of entry for endoscopic instruments.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
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.
The Disposable Trocar is mainly composed of Obturator with bladeless tip, Outer Seal Release Lever, Trocar Stability Sleeve, Obturator Locking Button, etc.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, thoracic and gynecologic
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)
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.
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 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.