AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a recognizable symbol of the agency's role in regulating and overseeing food and drug products in the United States. Micro-Tech (Nanjing) Co., Ltd. Sally He R A Engineer No. 10 Gaoke Third Road, Nanjing National Hi-tech Industrial Development Zone Nanjing, Jiangsu Province 210032 China Re: K213060 Trade/Device Name: AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: KTI Dated: June 17, 2022 Received: June 21, 2022 Dear Sally He: 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. {1}------------------------------------------------ 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) 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. Brandon Blakely Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) Device Name Endobronchial Ultrasound Aspiration Needle Type of Use (Select one or both, as applicable) Indications for Use (Describe) The Endobronchial Ultrasound Aspiration Needle is used with ultrasound endoscope to sample targeted submucosal and extramural lesions of the tracheobronchial tree. | <div> <span>☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | |--------------------------------------------------------------------------|-------------------------------------------------------------------------| |--------------------------------------------------------------------------|-------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The logo appears to be designed to give a sense of depth and solidity. ## 510K Summary This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92. The assigned 510(k) Number: K213060 ## 1. Sponsor Identification ## Micro-Tech (Nanjing) Co., Ltd. No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial Development Zone, Nanjing, Jiangsu Province, PRC Establishment Registration Number: 3004837686 Contact Person: Sally He Position: RA Engineer Tel: +86-25-58646395 Fax: +86-25-58350006 Email: RA.Micro-Tech@outlook.com ### 2. Identification of Proposed Device Product Name: Endobronchial Ultrasound Aspiration Needle ## Trade Name: Areus™ Endobronchial Ultrasound Aspiration Needle Trident™ Endobronchial Ultrasound Aspiration Needle ## Common Name: Aspiration Needle ## Regulatory Information Classification Name: Bronchoscope (flexible or rigid) and accessories Classification: 2 Product Code: KTI Regulation Number: 874.4680 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be leaning slightly to the right. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo. The logo has a modern and corporate feel. ### Identification of Predicate Device 3. Predicate Device : 510(k) Number: K163469 Device Name: Vizishot 2 Flex Manufacture: Olympus Surgical Technologies America Reference Device 1: 510(k) Number: K163248, K151895 Device Name: Aquire™ Pulmonary Endobronchial Ultrasound Fine Needle Biopsy (FNB) Device Manufacture: Boston Scientific Corporation Note: This reference device is used to as a reference for the FNB needle of proposed device. Reference Device 2: 510(k) Number: K190239 Device Name: Single Use Aspiration Needle Manufacture: Olympus Surgical Technologies America Note: This reference device is used to as a reference for the 25G needle of proposed device. Reference Device 3: 510(k) Number: K172309 Device Name: Endoscopic Ultrasound Aspiration Needle Manufacture: Micro-Tech (Nanjing) CO, Ltd. Note: This reference device is used to as a reference for the selected acceptance criteria of puncture force of proposed device. ### 4. Indications for Use The Endobronchial Ultrasound Aspiration Needle is used with ultrasound endoscope to sample targeted submucosal and extramural lesions of the tracheobronchial tree. {5}------------------------------------------------ ## Device Description 5. The proposed device Endobronchial Ultrasound Aspiration Needle is a sterile, single-use bronchoscopic device, is designed to sample targeted submucosal and extramural lesions of the tracheobronchial tree. The Endobronchial Ultrasound Aspiration Needle consists of an Aspiration Needle, Adaptors and Negative suction device (Stopcock and Syringe). Wherein, the Aspiration Needle consists of a handle, sheath, needle, and stylet. The handle is connected to the channel port of a bronchoscope via the proper adaptor. The needle is deployed in the sheath and projected from the sheath to penetrate the target lesion to serve sample by advancement of handle. The stylet is in place in order to provide protection to the inside of the needle tube and sheath during device passage, and also used to expel the sample after the procedure. The adaptors are provided different bronchoscopes with compatibility and attached onto the channel port as the middleware between a bronchoscope and the aspiration needle. The negative suction device is connected to the proximal end of the handle to aspirate the removed tissue. The Endobronchial Ultrasound Aspiration Needle has echogenic features and is visible under ultrasound at the distal end to facilitate real time visualization of the device under ultrasound. The proposed device has six models, and the main differences of these models are diameter and tip type of the needle. The Endobronchial Ultrasound Aspiration Needle offers 19G, 22G, 25G needles by size or gauge to respond various clinical options of accessing and sampling. There are two kinds of different tip design (bevel and trident) of needles for FNA (Fine Needle Aspiration) and FNB (Fine Needle Biopsy). The device is identified as is Areus™ Endobronchial Ultrasound Aspiration Needle and Trident™ Endobronchial Ultrasound Aspiration Needle by trade name. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10th and placed in a sterility maintenance package to ensure a shelf life of 3 years. ### 6. Comparison of Technological Characteristics The Endobronchial Ultrasound Aspiration Needle incorporates substantially equivalent device materials, design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in the predicate device Vizishot 2 Flex (K163469). ## Comparison to Predicate Devices: {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are bold and appear to be interconnected, creating a sense of unity and strength. A registered trademark symbol is located in the upper right corner of the logo. | Item | Proposed Device<br>Endobronchial Ultrasound<br>Aspiration Needle | Predicate Device<br>Vizishot 2 Flex (K163469) | Remark | |----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | KTI | KTI | Identical | | Regulation No. | 874.4680 | 874.4680 | Identical | | Class | 2 | 2 | Identical | | Indications for<br>Use | The Endobronchial Ultrasound<br>Aspiration Needle is used with<br>ultrasound endoscope to sample<br>targeted submucosal and<br>extramural lesions of the<br>tracheobronchial tree. | The ViziShot 2 FLEX has been<br>designed to be used with<br>ultrasound endoscopes for<br>ultrasound guided fine needle<br>aspiration (FNA) of submucosal<br>and extramural lesions of the<br>tracheobronchial tree. Do not use<br>this device for any purpose other<br>than its intended use. | SE | | Use Condition | Surgical suite, endoscopy or<br>bronchoscopy suite, used with a<br>bronchoscope | Surgical suite, endoscopy or<br>bronchoscopy suite, used with a<br>bronchoscope | SE | | Mechanics of<br>Action | Manual | Manual | SE | | Mode of Action | Single/multiple puncture and<br>aspirate | Single/multiple puncture and<br>aspirate | SE | | General<br>Configuration | Needle Assebly: Handle, Sheath, Needle, Stylet; Syringe with stopcock Adapter | Needle Assebly: Handle, Sheath, Needle, Stylet; Syringe with stopcock Adapter | SE | | Main Materials | PVDF, Nitinol | Stainless Steel, PTFE,<br>PEBAX, Nitinol | Different, the<br>material of proposed<br>device meet the<br>requirement of ISO<br>10993 series standard | | Needle Gauge | 19G, 22G, 25G | 19G | Different, more | | Needle Diameter<br>/mm | 1.1, 0.7, 0.5 | 1.1 | options than<br>predicate device. For | | Needle Tip | Bevel, Trident | Bevel | the different models,<br>reference 1 and<br>reference 2 were used | | Item | Proposed Device<br>Endobronchial Ultrasound<br>Aspiration Needle | Predicate Device<br>Vizishot 2 Flex (K163469) | Remark | | | | | and the side-by-side<br>comparison testing<br>was conducted to<br>ensure the safety and<br>effectiveness. | | Stylet OD (inch) | 0.030, 0.016, 0.011 | 0.020 | Different, different<br>needle gauge match<br>different stylet.<br>Note: the Stylet OD<br>of predicate device is<br>tested by us. | | Maximum Needle<br>Length /mm | 40 | 40 | SE | | Working Length<br>/mm | 720-760 | 700 | SE | | Maximum<br>Insertion Portion<br>Diameter /mm | 1.8 | 2.1 | Different, smaller<br>sheath diameter can<br>match smaller | | Compatible<br>endoscopy<br>working channel | Minimum 2.0mm | Minimum 2.2mm | endoscopy working<br>channel. More<br>options than<br>predicate device. | | Single Use | Yes | Yes | SE | | Supplied in<br>Sterile | Yes | Yes | SE | | Packaging | Needle assembly, syringe with<br>stopcock and adapter are placed in<br>tray with snap downs. Tray placed<br>in pouch. Pouch placed in case<br>box for sterilization. | Needle assembly in tray with snap<br>downs. Tray placed in pouch.<br>Pouch placed in shelf box (dust<br>cover) for sterilization.<br>After sterilization, the sterile<br>pouched syringe and sterile<br>pouched adapter will be added to<br>the dust cover. | Different, the<br>packaging of<br>proposed device have<br>passed the packaging<br>validation according<br>to ISO 11607-1 and<br>ISO 11607-2 | | Item | Proposed Device<br>Endobronchial Ultrasound<br>Aspiration Needle | Predicate Device<br>Vizishot 2 Flex (K163469) | Remark | | Shelf Life | Three years | Three years | SE | | Biocompatibility | Conform to ISO 10993-1 | Conform to ISO 10993-1 | SE | | Sterilization | EO Sterilized, SAL:10-6 | EO Sterilized, SAL:10-6 | SE | | Labeling | Conform to 21 CFR part 801 | Conform to 21 CFR part 801 | SE | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows a blue logo with the letters "MT" in a stylized, blocky font. The letters are interconnected and have a three-dimensional appearance, with the left side of the "M" appearing to recede into the background. A registered trademark symbol (®) is positioned in the upper right corner of the logo. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows a logo with the letters 'MT' in a stylized, three-dimensional font. The letters are in a dark blue color. The 'M' is on the left, and the 'T' is on the right, with the 'T' slightly overlapping the 'M'. A circled 'R' trademark symbol is located in the upper right corner of the image. The proposed device is similar in design to Vizishot 2 Flex, the main needle diameter and needle tip of proposed device are different to that of predicate device. For the difference, two reference devices (Aquire™ Pulmonary Endobronchial Ultrasound Fine Needle Biopsy (FNB) Device from Boston Scientific Corporation and Single Use Aspiration Needle from Olympus Surgical Technologies America) was selected. All comparative nonclinical performance testing have been tested and have met the requirements of substantial equivalence to the predicate device/reference device. Therefore, the difference between proposed device and predicated device is considered not to affect the substantially equivalency between the proposed and predicate devices concerning the safety and effectiveness. ### Performance Data 7. The biocompatibility evaluation for the Endobronchial Ultrasound Aspiration Needle was conducted in accordance with FDA Guidance, Use of International Standard ISO-10993-1, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" issued on September 4, 2020, the following tests were conducted: - a) Cytotoxicity - b) Sensitization - C) Irritation - d) Acute System Toxicity - Pyrogen e) - Hemocompatibility (Hemolysis, thrombogenicity and complement activation testing) f) {9}------------------------------------------------ Sterilization validation of Endobronchial Ultrasound Aspiration Needle was carried out in accordance with ISO 11135:2014+A1:2018 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices". Shelf-life testing and packaging integrity testing of Endobronchial Ultrasound Aspiration Needle was conducted based on an accelerated aging test in accordance with ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices and ISO 11607-1:2019: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems and ISO 11607-2:2019: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes. Three-years accelerated aging test have been performed to demonstrate the stability during the shelf life. During design verification, the following bench tests were performed on Endobronchial Ultrasound Aspiration Needle: - > Dimension; - A Sheath and Needle Insertion and Withdrawal force; - > Stylet Insertion and Withdrawal Force; - > Puncture Force; - > Ultrasound Visibility; - > Locking Force of Handle Portion; - Adjustment Length; > - > Attach and Detach Adaptor to Scope; - A Tensile Strength; - > Durability; - A Aspiration Capability. - > Transmission Force - A Needle Deformation Angle The results of all the performance testing demonstrated that the proposed device met the predetermined {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be stacked on top of each other, creating a blocky, geometric design. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo. acceptance criteria and is substantial equivalence to the predicate device Vizishot 2 Flex. ### 8. Animal Test Conclusion No animal study is included in this submission. ### 9. Clinical Test Conclusion No clinical study is included in this submission. ## 10. Substantially Equivalent (SE) Conclusion Based on the indications for use, technological characteristics, and safety and performance testing, the Endobronchial Ultrasound Aspiration Needle has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared predicate device Vizishot 2 Flex (K163469).