K Number

Device Name

Arthrex Vortex Threaded Bone Marrow Recovery Needle

Manufacturer

Arthrex Inc.

Date Cleared

2021-11-19

(51 days)

Product Code

KNW

Regulation Number

876.1075

Intended Use

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

Device Description

The Arthrex Vortex™ Threaded Bone Marrow Recovery Needle is a single-use aspiration needle comprised of a 304 stainless steel (SS) cannula with a molded plastic Acrylonitrile Butadiene Styrene (ABS) handle, and a 304 stainless steel stylet with a molded plastic (ABS) handle which mates with the cannula handle when the stylet is inserted through the cannula. The distal end of the cannula is threaded and has vent holes for bone marrow aspirate recovery. The needle will be offered in 8G and 13G sizes. It will also be offered in an open tip configuration as well as a closed tip configuration. The Arthrex Vortex™ Threaded Bone Marrow Recovery Needle can be hammered or twisted into the bone to access the marrow. A standard syringe (not included) will be attached to the Luer-lock portion of the ABS handle and negative pressure is applied to withdraw the bone marrow aspirate. The device can be used anywhere bone marrow aspirate can be collected such as the iliac crest, vertebral bodies, femur, humerus and/or the calcaneus. The threaded the portion on the distal end of the cannula will allow for precise depth control of the device while performing the aspiration.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K131157 Ranfac Bone Marrow Aspiration Needle

Reference Devices

K150563, K062365

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical aspects and material properties of a bone marrow aspiration needle. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

The device is intended for aspirating bone marrow, which is a diagnostic or collection procedure, not a treatment or therapy.

Diagnostic

The device is a needle used to aspirate bone marrow, which is a collection process, not a diagnostic one in itself. While the aspirated bone marrow may be used for diagnostic purposes later, the needle itself is for specimen collection.

SaMD (Software as a Medical Device)

The device description clearly outlines physical components made of stainless steel and plastic, and the performance studies focus on mechanical properties and biocompatibility, indicating a hardware-based device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Arthrex Vortex™ Threaded Bone Marrow Recovery Needle is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is "for use in aspirating bone marrow." This describes a procedure to collect a biological sample from the body.
Device Description: The description details a needle designed for physically accessing and withdrawing bone marrow. It's a tool for sample collection.
Lack of In Vitro Testing: The description and performance studies focus on the physical performance of the needle itself (insertion, removal, fatigue, leakage, clogging, biocompatibility). There is no mention of the device being used to perform tests on the collected bone marrow sample outside of the body (in vitro). IVD devices are designed to analyze biological samples to provide diagnostic information.

The device is a tool for obtaining a sample that could then be used for in vitro diagnostic testing, but the needle itself is not performing the diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

KNW

Device Description

The Arthrex Vortex™ Threaded Bone Marrow Recovery Needle is a single-use aspiration needle comprised of a 304 stainless steel (SS) cannula with a molded plastic Acrylonitrile Butadiene Styrene (ABS) handle, and a 304 stainless steel stylet with a molded plastic (ABS) handle which mates with the cannula handle when the stylet is inserted through the cannula. The distal end of the cannula is threaded and has vent holes for bone marrow aspirate recovery. The needle will be offered in 8G and 13G sizes. It will also be offered in an open tip configuration as well as a closed tip configuration.
The Arthrex Vortex™ Threaded Bone Marrow Recovery Needle can be hammered or twisted into the bone to access the marrow. A standard syringe (not included) will be attached to the Luer-lock portion of the ABS handle and negative pressure is applied to withdraw the bone marrow aspirate. The device can be used anywhere bone marrow aspirate can be collected such as the iliac crest, vertebral bodies, femur, humerus and/ or the calcaneus. The threaded the portion on the distal end of the cannula will allow for precise depth control of the device while performing the aspiration.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

iliac crest, vertebral bodies, femur, humerus and/ or the calcaneus

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Arthrex completed testing on the proposed device and predicate (K131157) to demonstrate the performance. Insertion and removal torque, fatigue, failure torque and hammer insertion were tested on the proposed device. Testing for leakage and clogging as well as hammer insertion was performed on the predicate device (K131157). Failure torque testing was also performed on predicate device for characterization only. No instances of leakage/clogging were observed when aspirating the test solution for the proposed device or for the predicate. No failures were observed during hammer insertion testing for the proposed device or for the predicate. Additionally, after hammer insertion testing, both the proposed device and predicate device showed no signs of mechanical deformation or prevention of aspiration capabilities.

Material Mediated Pyrogenicity was performed on a comparable device. Based on the results of the study the test article showed no evidence of material mediated pyrogenicity. In addition, bacterial endotoxin testing is conducted in accordance with AAMI ST72 2019 and meets the 20EU/device for routine monitoring of sterile products.

Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, Implantation, and Material Characterization testing was conducted on the Arthrex Vortex™ Threaded Bone Marrow Recovery Needle in accordance with ISO 10993-1:2018.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K131157 Ranfac Bone Marrow Aspiration Needle

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K150563 Ranfac Marrow Cellution Bone Marrow Aspiration Needle, K062365: Arthrex Bone Marrow Aspirate Kit

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 876.1075 Gastroenterology-urology biopsy instrument.

(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Summary

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. 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

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,

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

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

Prepared	November 18, 2021
Submitter	Arthrex Inc.
1370 Creekside Boulevard
Naples, FL 34108-1945
Contact
Person	Mr. Nick Moore, MBA
Principal, Regulatory Affairs
1-239-643-5553, ext. 71883
nick.moore@arthrex.com
Name of
Device	Arthrex Vortex™ Threaded Bone Marrow Recovery Needle
Common
Name	Gastroenterology-urology biopsy instrument
Product
Code	KNW
Classification
Name	21 CFR 876.1075 Gastroenterology-urology biopsy instrument
Regulatory
Class	II
Predicate
Devices	K131157 Ranfac Bone Marrow Aspiration Needle
Reference
Device	K150563 Ranfac Marrow Cellution Bone Marrow Aspiration Needle
K062365: Arthrex Bone Marrow Aspirate Kit
Purpose of
Submission	This Traditional 510(k) premarket notification is submitted to obtain clearance for the
Arthrex Vortex™ Threaded Bone Marrow Recovery Needle.
Device
Description	The Arthrex Vortex™ Threaded Bone Marrow Recovery Needle is a single-use aspiration
needle comprised of a 304 stainless steel (SS) cannula with a molded plastic Acrylonitrile
Butadiene Styrene (ABS) handle, and a 304 stainless steel stylet with a molded plastic
(ABS) handle which mates with the cannula handle when the stylet is inserted through
the cannula. The distal end of the cannula is threaded and has vent holes for bone
marrow aspirate recovery. The needle will be offered in 8G and 13G sizes. It will also be
offered in an open tip configuration as well as a closed tip configuration.
The Arthrex Vortex™ Threaded Bone Marrow Recovery Needle can be hammered or
twisted into the bone to access the marrow. A standard syringe (not included) will be
attached to the Luer-lock portion of the ABS handle and negative pressure is applied to
withdraw the bone marrow aspirate. The device can be used anywhere bone marrow
aspirate can be collected such as the iliac crest, vertebral bodies, femur, humerus and/
or the calcaneus. The threaded the portion on the distal end of the cannula will allow
for precise depth control of the device while performing the aspiration.

| Indications
for Use | The Arthrex Vortex™ Threaded Bone Marrow Recovery Needle is intended for use in
aspirating bone marrow. | | | |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Technology
Comparison | The Arthrex Vortex™ Threaded Bone Marrow Recovery Needle has the same
technological characteristics and design as the predicate device cleared in K131157
except for the following differences: threaded distal end, gauge diameter and
sterilization method.

Predicate
Device: EO |
| | SAL | $10^{-6}$ | $10^{-6}$ | Identical |
| | Shelf Life | 5 years | 5 years | Identical |
| | Single Use | Yes | Yes | Identical |
| | Performance
testing results | Needle clog testing: No
visible signs of leakage or
disassembly | Needle clog testing: No
visible signs of leakage or
disassembly | Identical |
| | | Hammer insertion testing:
No signs of deformation
or prevention of
aspiration | Hammer insertion testing:
No signs of deformation
or prevention of
aspiration | |
| Performance
Data | Arthrex completed testing on the proposed device and predicate (K131157) to
demonstrate the performance. Insertion and removal torque, fatigue, failure torque
and hammer insertion were tested on the proposed device. Testing for leakage and
clogging as well as hammer insertion was performed on the predicate device (K131157).
Failure torque testing was also performed on predicate device for characterization only.
No instances of leakage/clogging were observed when aspirating the test solution for
the proposed device or for the predicate. No failures were observed during hammer
insertion testing for the proposed device or for the predicate. Additionally, after
hammer insertion testing, both the proposed device and predicate device showed no
signs of mechanical deformation or prevention of aspiration capabilities.

Material Mediated Pyrogenicity was performed on a comparable device. Based on the
results of the study the test article showed no evidence of material mediated
pyrogenicity. In addition, bacterial endotoxin testing is conducted in accordance with
AAMI ST72 2019 and meets the 20EU/device for routine monitoring of sterile products. | | | |

| | Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, Implantation, and
Material Characterization testing was conducted on the Arthrex Vortex™ Threaded
Bone Marrow Recovery Needle in accordance with ISO 10993-1:2018. |
|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | The Arthrex Vortex™ Threaded Bone Marrow Recovery Needle is substantially
equivalent to the predicate device in which the basic design features and intended uses
are the same. Any differences between the proposed device and the predicate device
are considered minor and do not raise different questions concerning safety or
effectiveness.
The submitted mechanical testing data demonstrates that the proposed device is
substantially equivalent to that of the predicate device for the desired indications.
Based on the indications for use, technological characteristics, and the summary of data
submitted, Arthrex Inc. has determined that the proposed device is substantially
equivalent to the currently marketed predicate device. |