Disposable Veress Needles

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. December 14, 2023 Hangzhou Kangji Medical Instrument Co., Ltd. % Esther Zhang Official Correspondent Shanghai Ling Fu Technology Co., Ltd. 4F No. 585-2. Wanyuan Rd. Minhang District Shanghai, Shanghai 201102 China Re: K232401 Trade/Device Name: Disposable Veress Needles Regulation Number: 21 CFR§ 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: II Product Code: HIF Dated: November 13, 2023 Received: November 16, 2023 Dear Esther Zhang: 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 (the 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 available 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. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. {2}------------------------------------------------ 3 For comprehensive regulatory information about mediation-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, # Jason Roberts -S Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K232401 Device Name Disposable Veress Needles ### Indications for Use (Describe) Disposable Veress Needles The Disposable Veress Needles are intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars opic procedures. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|----------------------------------------| | Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 1em;">☑</span> | | 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." {4}------------------------------------------------ # 510(k) Summary Disposable Veress Needles K232401 #### 1. Submitter Information Hangzhou Kangji Medical Instrument Co., Ltd. No. 1668 Chunjiang East Road Economic Development Zone, Tonglu, Hangzhou, 311501 China Contact person: Martin Sun Manager of Regulatory Affairs Phone: +86-0571-69901712 Fax: +86-0571-69901712 Email: martin.sun@kangji.com #### 2. Submission Correspondent Shanghai Ling Fu Technology Co., Ltd. 4F No. 585-2, Wanyuan Rd. Minhang District, Shanghai, P.R. China Contact person: Esther Zhang Email: Esther.zhang@llins-tech.com #### 3. Date Prepared December 13, 2023 #### 4. Device Identification | Trade Name of Device: | Disposable Veress Needles | |-----------------------|---------------------------------| | Common Name: | Veress Needle | | Model: | I, II | | Regulation Name: | Laparoscopic Insufflator | | Regulation Number: | 884.1730 | | Product Code: | HIF (Insufflator, Laparoscopic) | | Class: | Class II | #### 5. Legally Marketed Predicate Device | Trade Name: | Unimicro Veress Needle | |--------------------|-----------------------------------------------| | Common Name: | Veress Needle | | Manufacturer: | Unimicro Medical Systems (ShenZhen) Co., Ltd. | | Regulation Name: | Laparoscopic Insufflator; | | Regulation Number: | 884.1730 | | Product Code: | HIF, FHO | {5}------------------------------------------------ 510(k) number: K150068 Class: 11 The predicate device has not been subject to a design-related recall. #### 6. Device Description The Disposable Veress Needles are composed of needle, inner core, handle and made of medical grade stainless steel, PC, PE, ABS, and Model II has a silicone sleeve on the handle. The device is packed in Tyvek dialysis bag with 4058B Tyvek dialysis paper and ESE film. The contact duration is less than 24 hours. The device is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures. The device is sterilized by EO and is intended for single-use only. The proposed device is available in a variety of needle lengths. There are two models for Disposable Veress needles: I, II. The difference between the two models is that the model II has a blue silicone sleeve outside the handle. #### 7. Indication for Use The Disposable Veress Needles are intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to placement of trocars during laparoscopic procedures. #### 8. Comparison of technological characteristics with the predicate device | | Disposable Veress Needles | Unimicro Veress Needle<br>K150068 | Discussion | |---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| | Manufacturer | Hangzhou Kangji Medical<br>Instrument Co., Ltd. | Unimicro Medical Systems<br>(ShenZhen) Co., Ltd. | | | Product Code | HIF | HIF, FHO | Same | | Regulation Number | 884.1730 | 884.1730, 876.1500 | Same | | Class | Class II | Class II | Same | | Indications for Use | The Disposable Veress<br>Needles are intended for<br>percutaneous insertion into<br>the peritoneal cavity for the<br>purpose of insufflation with<br>carbon dioxide to establish<br>pneumoperitoneum prior to<br>the placement of trocars<br>during laparoscopic<br>procedures. | The Unimicro Veress Needle is<br>intended for percutaneous<br>insertion into the peritoneal<br>cavity for the purpose of<br>insufflation with carbon<br>dioxide to establish<br>pneumoperitoneum prior to<br>the placement of trocs during<br>laparoscopic procedures | Same | | Conditions of Use | Rx Only; Single Use Only | Rx Only; Single Use Only | Same | | Sterilization | Ethylene Oxide | Ethylene Oxide | Same | | Models | I, II | MDN 11200, MND 11500 | Different: The subject<br>device is available in<br>different models than<br>the predicate device | #### Table 1. Comparison of Characteristics {6}------------------------------------------------ | | | | based on length and,<br>for Model II of the<br>subject device, a<br>silicone sleeve on the<br>handle. This difference<br>does not raise different<br>questions of safety and<br>effectiveness (S&E). | |----------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Lengths | 110±4mm, 120±4mm,<br>130±4mm, 140±4mm,<br>150±4mm | 120mm, 150mm | Different: The subject<br>device is available in<br>more lengths than the<br>predicate. This<br>difference does not<br>raise different<br>questions of S&E. | | Components | Needle, Inner core, Handle,<br>and Valve | Veress Needle, Obturator | Same | | Needle Material | Stainless Steel | Stainless Steel | Same | | Handle Material | PC | ABS | Different: The subject<br>device handle material<br>is different than the<br>predicate device. This<br>does not raise different<br>questions of S&E. | | Principles of<br>Operation | Connect the device to the<br>insuffators with tubing,<br>insufflate with carbon dioxide<br>to establish<br>pneumoperitoneum. | Connect the device to the<br>insuffators with tubing,<br>insufflate with carbon dioxide<br>to establish<br>pneumoperitoneum. | Same | As shown in the table above, there are differences in the lengths and materials of the subject and predicate devices. However, as stated in the table, the differences in technological features do not raise different questions of safety and effectiveness. #### 9. Summary of Non-Clinical Testing The tests listed below have demonstrated that the subject device performs as well as the predicate device based on the acceptance criteria: - -Tip Pull Test - -Switch Operation - -Spring Obturator Operation - -Needle Puncture Force Test #### Biocompatibility testing Biocompatibility of the Disposable Veress Needles was evaluated in accordance with ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process. Testing included: {7}------------------------------------------------ | Cytotoxicity | ISO 10993-5:2009 | |---------------------------|-------------------| | Skin Sensitization | ISO 10993-10:2021 | | Intracutaneous Reactivity | ISO 10993-23:2021 | | Acute Systemic Toxicity | ISO 10993-11:2017 | | Pyrogenicity | ISO 10993-11:2017 | #### Sterilization Validation and Shelf-life Testing Sterilization was validated in accordance with ISO 11135:2014. Sterilant residuals were evaluated in accordance with ISO 10993-7:2019. Combined simulated shipping distribution, stability, and packaging integrity testing was performed in accordance with the 2016 FDA guidance document, Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff. Testing included: Simulated distribution testing ASTM D4169 Packaging integrity testing ASTM F1886/F1886M-16 ASTM F88/F88M-15 ASTM F1929-15 The 3 year shelf-life of the device was determined based on stability of package integrity and performance testing after aging per ASTM F1980-21. #### 10. Statement of Substantial Equivalence The Disposable Veress Needles are substantially equivalent to the predicate device (Unimicro Veress Needle). The technological differences between the predicate and subject device do not raise different questions of safety or effectiveness. The results of the performance testing described above demonstrate that the subject device is as safe and effective as the predicate device.