AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle

Q: Who is the manufacturer of AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle?

Micro-Tech (Nanjing) Co., Ltd. filed the 510(k) submission for AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle (K213060).

Q: What is the FDA product code for AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle?

KTI. It is classified under 21 CFR 874.4680 as a Class 2 device in the Ear, Nose, Throat panel.

Q: What is the regulatory pathway for AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle?

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

Q: Who can help prepare an FDA 510(k) submission like AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle?

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.

K213060 · Micro-Tech (Nanjing) Co., Ltd. · KTI · Jul 20, 2022 · Ear, Nose, Throat

Device Facts

Record ID	K213060
Device Name	AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle
Applicant	Micro-Tech (Nanjing) Co., Ltd.
Product Code	KTI · Ear, Nose, Throat
Decision Date	Jul 20, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.4680
Device Class	Class 2

Intended Use

The Endobronchial Ultrasound Aspiration Needle is used with ultrasound endoscope to sample targeted submucosal and extramural lesions of the tracheobronchial tree.

Device Story

Device is sterile, single-use aspiration needle for bronchoscopy; used with ultrasound endoscope to sample submucosal/extramural tracheobronchial lesions. Components include handle, sheath, needle, stylet, adaptors, and negative suction device (syringe/stopcock). Physician operates device in surgical/endoscopy suite; handle connects to bronchoscope channel port. Needle deploys from sheath to penetrate lesion; negative suction applied via syringe to aspirate tissue. Echogenic features provide real-time ultrasound visualization. Available in 19G, 22G, 25G sizes with bevel or trident tips for FNA/FNB. Output is tissue sample for diagnostic evaluation. Benefits include minimally invasive access to targeted lesions for biopsy.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via dimension, insertion/withdrawal force, puncture force, ultrasound visibility, locking force, tensile strength, durability, and aspiration capability testing. Biocompatibility per ISO 10993-1; sterilization per ISO 11135; shelf-life/packaging per ASTM F1980-16 and ISO 11607.

Technological Characteristics

Materials: PVDF, Nitinol. Manual operation. Sterile, single-use. Echogenic needle tip for ultrasound visibility. Available in 19G, 22G, 25G gauges; bevel or trident tip designs. EO sterilized (SAL 10^-6). 3-year shelf life. Packaging validated per ISO 11607-1/2.

Indications for Use

Indicated for patients requiring sampling of submucosal and extramural lesions of the tracheobronchial tree via ultrasound-guided fine needle aspiration or biopsy.

Regulatory Classification

Identification

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.

Predicate Devices

Vizishot 2 Flex (K163469)

Reference Devices

Aquire™ Pulmonary Endobronchial Ultrasound Fine Needle Biopsy (FNB) Device (K163248, K151895)
Single Use Aspiration Needle (K190239)
Endoscopic Ultrasound Aspiration Needle (K172309)

Related Devices

K142909 — Flexible 19G EBUS Needle · Spiration, Inc. · Apr 24, 2015
K151315 — Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle · Boston Scientific Corporation · Nov 10, 2015
K190239 — Single Use Aspiration Needle · Olympus Medical Systems Corp. · Dec 10, 2019
K251664 — Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022) · Olympus Medical Systems Corporation · Jul 29, 2025
K160098 — Single Use Aspiration Needle NA-U401SX · Olympus Medical Systems Corp. · Mar 22, 2016

Submission Summary (Full Text)

{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> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | |--------------------------------------------------------------------------|-------------------------------------------------------------------------| |--------------------------------------------------------------------------|-------------------------------------------------------------------------| 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 ServicesFood 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a logo with the letters "MT" in a stylized, three-dimensional block font. The letters are in a dark blue color, and the logo has a registered trademark symbol (®) in the upper right corner. 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 Endobronchial Ultrasound Aspiration Needle | Predicate Device Vizishot 2 Flex (K163469) | Remark | |----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | KTI | KTI | Identical | | Regulation No. | 874.4680 | 874.4680 | Identical | | Class | 2 | 2 | Identical | | Indications for Use | The Endobronchial Ultrasound Aspiration Needle is used with ultrasound endoscope to sample targeted submucosal and extramural lesions of the tracheobronchial tree. | The ViziShot 2 FLEX has been designed to be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree. Do not use this device for any purpose other than its intended use. | SE | | Use Condition | Surgical suite, endoscopy or bronchoscopy suite, used with a bronchoscope | Surgical suite, endoscopy or bronchoscopy suite, used with a bronchoscope | SE | | Mechanics of Action | Manual | Manual | SE | | Mode of Action | Single/multiple puncture and aspirate | Single/multiple puncture and aspirate | SE | | General 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, PEBAX, Nitinol | Different, the material of proposed device meet the requirement of ISO 10993 series standard | | Needle Gauge | 19G, 22G, 25G | 19G | Different, more | | Needle Diameter /mm | 1.1, 0.7, 0.5 | 1.1 | options than predicate device. For | | Needle Tip | Bevel, Trident | Bevel | the different models, reference 1 and reference 2 were used | | Item | Proposed Device Endobronchial Ultrasound Aspiration Needle | Predicate Device Vizishot 2 Flex (K163469) | Remark | | | | | and the side-by-side comparison testing was conducted to ensure the safety and effectiveness. | | Stylet OD (inch) | 0.030, 0.016, 0.011 | 0.020 | Different, different needle gauge match different stylet. Note: the Stylet OD of predicate device is tested by us. | | Maximum Needle Length /mm | 40 | 40 | SE | | Working Length /mm | 720-760 | 700 | SE | | Maximum Insertion Portion Diameter /mm | 1.8 | 2.1 | Different, smaller sheath diameter can match smaller | | Compatible endoscopy working channel | Minimum 2.0mm | Minimum 2.2mm | endoscopy working channel. More options than predicate device. | | Single Use | Yes | Yes | SE | | Supplied in Sterile | Yes | Yes | SE | | Packaging | Needle assembly, syringe with stopcock and adapter are placed in tray with snap downs. Tray placed in pouch. Pouch placed in case box for sterilization. | Needle assembly in tray with snap downs. Tray placed in pouch. Pouch placed in shelf box (dust cover) for sterilization. After sterilization, the sterile pouched syringe and sterile pouched adapter will be added to the dust cover. | Different, the packaging of proposed device have passed the packaging validation according to ISO 11607-1 and ISO 11607-2 | | Item | Proposed Device Endobronchial Ultrasound Aspiration Needle | Predicate Device 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).