Arthrex Vortex Threaded Bone Marrow Recovery Needle

K213213 · Arthrex, Inc. · KNW · Nov 19, 2021 · Gastroenterology, Urology

Device Facts

• Record ID: K213213
• Device Name: Arthrex Vortex Threaded Bone Marrow Recovery Needle
• Applicant: Arthrex, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Nov 19, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The Arthrex Vortex™ Threaded Bone Marrow Recovery Needle is intended for use in aspirating bone marrow.

Device Story

Single-use aspiration needle; 304 stainless steel cannula and stylet with ABS plastic handles. Distal cannula end threaded with vent holes for marrow recovery; available in 8G/13G sizes; open or closed tip configurations. Operated by clinician; inserted into bone via hammering or twisting; depth controlled by threaded distal portion. Standard syringe attaches to Luer-lock handle; negative pressure applied to aspirate marrow. Used in clinical settings for bone marrow collection; provides access to marrow cavity for aspiration; threaded design allows precise depth control.

Clinical Evidence

Bench testing only. Evaluated insertion/removal torque, fatigue, failure torque, and hammer insertion. Leakage and clogging testing performed; no failures or mechanical deformation observed. Biocompatibility testing (cytotoxicity, sensitization, irritation, genotoxicity, systemic toxicity, implantation) conducted per ISO 10993-1:2018. Bacterial endotoxin testing per AAMI ST72:2019.

Technological Characteristics

Materials: 304 stainless steel cannula/stylet, ABS plastic handles. Threaded distal cannula tip with vent holes. Sizes: 8G, 13G. Sterilization: Gamma irradiation. Single-use. Mechanical operation via manual insertion and syringe-based negative pressure aspiration.

Indications for Use

Indicated for aspiration of bone marrow from sites including iliac crest, vertebral bodies, femur, humerus, and calcaneus.

Regulatory Classification

Identification

A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Predicate Devices

• Ranfac Bone Marrow Aspiration Needle (K131157)

Reference Devices

• Ranfac Marrow Cellution Bone Marrow Aspiration Needle (K150563)
• Arthrex Bone Marrow Aspirate Kit (K062365)

Submission Summary (Full Text)

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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. 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

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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 [phone] 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 Ouality Center for Devices and Radiological Health

Enclosure

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#### 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)

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# 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>[e-mail] |
| 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. |

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| 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. | | | |

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| | 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. |