Arthrex Vortex Threaded Bone Marrow Recovery Needle

{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: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The FDA acronym is in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. November 19, 2021 Arthrex Inc. Mr. Nick Moore, MBA Principal. Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945 Re: K213213 Trade/Device Name: Arthrex Vortex Threaded Bone Marrow Recovery Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology-Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: September 27, 2021 Received: September 29, 2021 Dear Mr. Moore: 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. 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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). 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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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use 510(k) Number (if known) K213213 Device Name Arthrex Vortex™ Threaded Bone Marrow Recovery Needle Indications for Use (Describe) The Arthrex Vortex™ Threaded Bone Marrow Recovery Needle is intended for use in aspirating bone marrow. Type of Use (Select one or both, as applicable) > 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 the salleding of information of areasons of nours per response, including the 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 | Date<br>Prepared | November 18, 2021 | |--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter | Arthrex Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 | | Contact<br>Person | Mr. Nick Moore, MBA<br>Principal, Regulatory Affairs<br>1-239-643-5553, ext. 71883<br>nick.moore@arthrex.com | | Name of<br>Device | Arthrex Vortex™ Threaded Bone Marrow Recovery Needle | | Common<br>Name | Gastroenterology-urology biopsy instrument | | Product<br>Code | KNW | | Classification<br>Name | 21 CFR 876.1075 Gastroenterology-urology biopsy instrument | | Regulatory<br>Class | II | | Predicate<br>Devices | K131157 Ranfac Bone Marrow Aspiration Needle | | Reference<br>Device | K150563 Ranfac Marrow Cellution Bone Marrow Aspiration Needle<br>K062365: Arthrex Bone Marrow Aspirate Kit | | Purpose of<br>Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for the<br>Arthrex Vortex™ Threaded Bone Marrow Recovery Needle. | | Device<br>Description | The Arthrex Vortex™ Threaded Bone Marrow Recovery Needle is a single-use aspiration<br>needle comprised of a 304 stainless steel (SS) cannula with a molded plastic Acrylonitrile<br>Butadiene Styrene (ABS) handle, and a 304 stainless steel stylet with a molded plastic<br>(ABS) handle which mates with the cannula handle when the stylet is inserted through<br>the cannula. The distal end of the cannula is threaded and has vent holes for bone<br>marrow aspirate recovery. The needle will be offered in 8G and 13G sizes. It will also be<br>offered in an open tip configuration as well as a closed tip configuration.<br>The Arthrex Vortex™ Threaded Bone Marrow Recovery Needle can be hammered or<br>twisted into the bone to access the marrow. A standard syringe (not included) will be<br>attached to the Luer-lock portion of the ABS handle and negative pressure is applied to<br>withdraw the bone marrow aspirate. The device can be used anywhere bone marrow<br>aspirate can be collected such as the iliac crest, vertebral bodies, femur, humerus and/<br>or the calcaneus. The threaded the portion on the distal end of the cannula will allow<br>for precise depth control of the device while performing the aspiration. | {4}------------------------------------------------ | Indications<br>for Use | The Arthrex Vortex™ Threaded Bone Marrow Recovery Needle is intended for use in<br>aspirating bone marrow. | | | | |--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|------------------------------------------------------------------------------| | Technology<br>Comparison | The Arthrex Vortex™ Threaded Bone Marrow Recovery Needle has the same<br>technological characteristics and design as the predicate device cleared in K131157<br>except for the following differences: threaded distal end, gauge diameter and<br>sterilization method.<br><br>Side by side comparison of the proposed device and the predicate device provided<br>below: | | | | | Item | Proposed Device | Predicate Device<br>K131157 | Equivalence | | | Indications for use | The Arthrex Vortex™<br>Threaded Bone Marrow<br>Recovery Needle is<br>intended for use in<br>aspirating bone marrow. | The Ranfac Bone Marrow<br>Aspiration Needle is<br>intended for use in<br>aspirating bone marrow | | | | Regulation<br>Number | 876.1075 | 876.1075 | Identical | | | Regulation<br>name | Gastroenterology-urology<br>biopsy instrument | Gastroenterology-urology<br>biopsy instrument | Identical | | | Regulatory<br>Class | Class II | Class II | Identical | | | Product Code | KNW | KNW | Identical | | | Classification<br>Panel | Gastroenterology/Urology | Gastroenterology/Urology | Identical | | | Material | 304 SS/ ABS | 304 SS/ ABS | Identical | | | Sizes | 8G and 13G | 8G and 11G | Proposed<br>device: 8G<br>and 13G | | | | Performance<br>characteristics | Needle bores into bone to<br>access marrow cavity | Needle bores into bone to<br>access marrow cavity | Predicate<br>device: 8G<br>and 11G<br>Minor<br>difference<br>in<br>geometry. | | | Sterilization<br>method | Gamma Irradiation | Ethylene Oxide Gas | Proposed<br>device:<br>Gamma<br><br>Predicate<br>Device: EO | | | SAL | $10^{-6}$ | $10^{-6}$ | Identical | | | Shelf Life | 5 years | 5 years | Identical | | | Single Use | Yes | Yes | Identical | | | Performance<br>testing results | Needle clog testing: No<br>visible signs of leakage or<br>disassembly | Needle clog testing: No<br>visible signs of leakage or<br>disassembly | Identical | | | | Hammer insertion testing:<br>No signs of deformation<br>or prevention of<br>aspiration | Hammer insertion testing:<br>No signs of deformation<br>or prevention of<br>aspiration | | | Performance<br>Data | Arthrex completed testing on the proposed device and predicate (K131157) to<br>demonstrate the performance. Insertion and removal torque, fatigue, failure torque<br>and hammer insertion were tested on the proposed device. Testing for leakage and<br>clogging as well as hammer insertion was performed on the predicate device (K131157).<br>Failure torque testing was also performed on predicate device for characterization only.<br>No instances of leakage/clogging were observed when aspirating the test solution for<br>the proposed device or for the predicate. No failures were observed during hammer<br>insertion testing for the proposed device or for the predicate. Additionally, after<br>hammer insertion testing, both the proposed device and predicate device showed no<br>signs of mechanical deformation or prevention of aspiration capabilities.<br><br>Material Mediated Pyrogenicity was performed on a comparable device. Based on the<br>results of the study the test article showed no evidence of material mediated<br>pyrogenicity. In addition, bacterial endotoxin testing is conducted in accordance with<br>AAMI ST72 2019 and meets the 20EU/device for routine monitoring of sterile products. | | | | {5}------------------------------------------------ {6}------------------------------------------------ | | Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, Implantation, and<br>Material Characterization testing was conducted on the Arthrex Vortex™ Threaded<br>Bone Marrow Recovery Needle in accordance with ISO 10993-1:2018. | |------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Conclusion | The Arthrex Vortex™ Threaded Bone Marrow Recovery Needle is substantially<br>equivalent to the predicate device in which the basic design features and intended uses<br>are the same. Any differences between the proposed device and the predicate device<br>are considered minor and do not raise different questions concerning safety or<br>effectiveness.<br>The submitted mechanical testing data demonstrates that the proposed device is<br>substantially equivalent to that of the predicate device for the desired indications.<br>Based on the indications for use, technological characteristics, and the summary of data<br>submitted, Arthrex Inc. has determined that the proposed device is substantially<br>equivalent to the currently marketed predicate device. |