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.

AI/ML Overview

The document does not describe the acceptance criteria and study for an AI/ML powered device. Instead, it is a 510(k) premarket notification for a medical device called the "Arthrex Vortex™ Threaded Bone Marrow Recovery Needle." This device is a manual instrument for aspirating bone marrow and does not involve AI or machine learning. Therefore, the requested information (acceptance criteria for AI, sample size for AI test set, expert qualifications for ground truth, adjudication method, MRMC study, standalone performance, ground truth type, and training set details) is not applicable to this submission.

The document focuses on demonstrating substantial equivalence to a predicate device (Ranfac Bone Marrow Aspiration Needle) through comparison of design, materials, indications for use, and mechanical performance testing.

However, I can extract the general performance data presented, which serves to demonstrate the device meets its intended function, analogous to "acceptance criteria" for a non-AI device.

Here's the information extracted from the provided text, structured to best fit your request, but acknowledging the device type:

Device: Arthrex Vortex™ Threaded Bone Marrow Recovery Needle
Intended Use: Aspiration of bone marrow.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied from testing)	Reported Device Performance (Arthrex Vortex™ Threaded Bone Marrow Recovery Needle)	Predicate Device Performance (Ranfac Bone Marrow Aspiration Needle)
Functional Performance:
No visible signs of leakage or disassembly during aspiration	No instances of leakage/clogging observed when aspirating the test solution.	No instances of leakage/clogging observed when aspirating the test solution.
No signs of deformation or prevention of aspiration capabilities after hammer insertion	No failures observed during hammer insertion testing. No signs of mechanical deformation or prevention of aspiration capabilities after hammer insertion testing.	No failures observed during hammer insertion testing. No signs of mechanical deformation or prevention of aspiration capabilities after hammer insertion testing.
Material Safety & Sterility:
No material mediated pyrogenicity	No evidence of material mediated pyrogenicity (performed on a comparable device).	Not explicitly stated for predicate in comparison table, but assumed predicate would meet similar standards.
Bacterial endotoxin levels meet standards	Meets 20 EU/device for routine monitoring of sterile products (in accordance with AAMI ST72 2019).	Not explicitly stated for predicate in comparison table.
Biocompatibility in accordance with ISO 10993-1:2018	Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, Implantation, and Material Characterization testing performed in accordance with ISO 10993-1:2018. (Implies successful completion for clearance).	Not explicitly stated for predicate in comparison table, but assumed predicate would meet similar standards.
Sterility Assurance Level (SAL)	10-6 (Gamma Irradiation)	10-6 (Ethylene Oxide Gas)
Shelf Life	5 years	5 years
Single Use	Yes	Yes

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the "sample size" in terms of the number of tested devices or "test set" for the performance testing (e.g., how many needles were subjected to hammer insertion). It mentions "testing on the proposed device and predicate (K131157)" so a comparison was made.

Sample Size: Not explicitly stated as a number of devices tested for each performance criterion (e.g., 10 needles for hammer insertion).
Data Provenance: The studies were conducted by Arthrex Inc. as part of their 510(k) submission. The data is prospective in the sense that the studies were performed specifically for this submission to characterize the device's performance. The country of origin for the data is not specified, but Arthrex Inc. is based in Naples, Florida, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device is a manual surgical instrument, not an AI/ML product that requires ground truth establishment by experts for performance evaluation. Performance is assessed through mechanical and material testing.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or decision-making process for the "test set" that would require adjudication. Performance is measured objectively through physical tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was not done. This type of study is relevant for diagnostic or image-based AI devices where human readers' performance with and without AI assistance is compared. This device is a bone marrow aspiration needle.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a manual surgical instrument with no algorithm or AI component.

7. The Type of Ground Truth Used

Not applicable in the context of AI/ML. For this mechanical device, "ground truth" equates to the objective outcomes of physical and material tests (e.g., "no leakage," "no deformation," "material biocompatibility").

8. The Sample Size for the Training Set

Not applicable. This device does not use an AI/ML model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. This device does not use an AI/ML model, so there is no "training set" or "ground truth for the training set."

Summary

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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 (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

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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

DatePrepared	November 18, 2021
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
ContactPerson	Mr. Nick Moore, MBAPrincipal, Regulatory Affairs1-239-643-5553, ext. 71883nick.moore@arthrex.com
Name ofDevice	Arthrex Vortex™ Threaded Bone Marrow Recovery Needle
CommonName	Gastroenterology-urology biopsy instrument
ProductCode	KNW
ClassificationName	21 CFR 876.1075 Gastroenterology-urology biopsy instrument
RegulatoryClass	II
PredicateDevices	K131157 Ranfac Bone Marrow Aspiration Needle
ReferenceDevice	K150563 Ranfac Marrow Cellution Bone Marrow Aspiration NeedleK062365: Arthrex Bone Marrow Aspirate Kit
Purpose ofSubmission	This Traditional 510(k) premarket notification is submitted to obtain clearance for theArthrex Vortex™ Threaded Bone Marrow Recovery Needle.
DeviceDescription	The Arthrex Vortex™ Threaded Bone Marrow Recovery Needle is a single-use aspirationneedle comprised of a 304 stainless steel (SS) cannula with a molded plastic AcrylonitrileButadiene 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 throughthe cannula. The distal end of the cannula is threaded and has vent holes for bonemarrow aspirate recovery. The needle will be offered in 8G and 13G sizes. It will also beoffered in an open tip configuration as well as a closed tip configuration.The Arthrex Vortex™ Threaded Bone Marrow Recovery Needle can be hammered ortwisted into the bone to access the marrow. A standard syringe (not included) will beattached to the Luer-lock portion of the ABS handle and negative pressure is applied towithdraw the bone marrow aspirate. The device can be used anywhere bone marrowaspirate 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 allowfor precise depth control of the device while performing the aspiration.

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Indicationsfor Use	The Arthrex Vortex™ Threaded Bone Marrow Recovery Needle is intended for use inaspirating bone marrow.
TechnologyComparison	The Arthrex Vortex™ Threaded Bone Marrow Recovery Needle has the sametechnological characteristics and design as the predicate device cleared in K131157except for the following differences: threaded distal end, gauge diameter andsterilization method.Side by side comparison of the proposed device and the predicate device providedbelow:
Item	Proposed Device	Predicate DeviceK131157	Equivalence
Indications for use	The Arthrex Vortex™Threaded Bone MarrowRecovery Needle isintended for use inaspirating bone marrow.	The Ranfac Bone MarrowAspiration Needle isintended for use inaspirating bone marrow
RegulationNumber	876.1075	876.1075	Identical
Regulationname	Gastroenterology-urologybiopsy instrument	Gastroenterology-urologybiopsy instrument	Identical
RegulatoryClass	Class II	Class II	Identical
Product Code	KNW	KNW	Identical
ClassificationPanel	Gastroenterology/Urology	Gastroenterology/Urology	Identical
Material	304 SS/ ABS	304 SS/ ABS	Identical
Sizes	8G and 13G	8G and 11G	Proposeddevice: 8Gand 13G
	Performancecharacteristics	Needle bores into bone toaccess marrow cavity	Needle bores into bone toaccess marrow cavity	Predicatedevice: 8Gand 11GMinordifferenceingeometry.
	Sterilizationmethod	Gamma Irradiation	Ethylene Oxide Gas	Proposeddevice:GammaPredicateDevice: EO
	SAL	$10^{-6}$	$10^{-6}$	Identical
	Shelf Life	5 years	5 years	Identical
	Single Use	Yes	Yes	Identical
	Performancetesting results	Needle clog testing: Novisible signs of leakage ordisassembly	Needle clog testing: Novisible signs of leakage ordisassembly	Identical
		Hammer insertion testing:No signs of deformationor prevention ofaspiration	Hammer insertion testing:No signs of deformationor prevention ofaspiration
PerformanceData	Arthrex completed testing on the proposed device and predicate (K131157) todemonstrate the performance. Insertion and removal torque, fatigue, failure torqueand hammer insertion were tested on the proposed device. Testing for leakage andclogging 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 forthe proposed device or for the predicate. No failures were observed during hammerinsertion testing for the proposed device or for the predicate. Additionally, afterhammer insertion testing, both the proposed device and predicate device showed nosigns of mechanical deformation or prevention of aspiration capabilities.Material Mediated Pyrogenicity was performed on a comparable device. Based on theresults of the study the test article showed no evidence of material mediatedpyrogenicity. In addition, bacterial endotoxin testing is conducted in accordance withAAMI ST72 2019 and meets the 20EU/device for routine monitoring of sterile products.

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

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

Conclusion

The Arthrex Vortex™ Threaded Bone Marrow Recovery Needle is substantiallyequivalent to the predicate device in which the basic design features and intended usesare the same. Any differences between the proposed device and the predicate deviceare considered minor and do not raise different questions concerning safety oreffectiveness.The submitted mechanical testing data demonstrates that the proposed device issubstantially equivalent to that of the predicate device for the desired indications.Based on the indications for use, technological characteristics, and the summary of datasubmitted, Arthrex Inc. has determined that the proposed device is substantiallyequivalent to the currently marketed predicate device.

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.