The Flow-Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric, and high subtrochanteric fractures and combinations of these fractures. The Flow-Nail can also be used to deliver injectable bone void fillers to a surgical site.

Device Description

The Flow-Nail is a dynamic compression trochanteric nail system and includes an intramedullary nail, a sliding fenestrated lag screw, anti-rotation screws, a cap and accompanying surgical instruments. The Flow-Nail components are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136.

AI/ML Overview

Acceptance Criteria and Study for Flow-Nail (K140601)

The Flow-Nail is an intramedullary fixation rod intended to treat stable and unstable proximal femur fractures and to deliver injectable bone void fillers. The device's substantial equivalence to predicate devices was established through a comparison of various attributes, including mechanical performance.

1. Table of Acceptance Criteria and Reported Device Performance

Criteria	Description	Acceptance Criteria	Reported Device Performance
Mechanical Performance	The ability of the Flow-Nail to withstand static and dynamic compression bending loads.	The Flow-Nail must demonstrate substantial equivalence in mechanical performance to the identified predicate devices (Zimmer Natural Nail System, Stryker Gamma 3 Nail System, AOS Trochanteric Nail).	"Mechanical testing demonstrates the substantial equivalence of the Flow-Nail relative to the identified predicates when subjected to static and dynamic compression bending loads." (K140601, Page 1)
BVF Delivery	The ability of the device to deliver injectable bone void fillers (BVF).	The Flow-Nail must be capable of delivering injectable bone void fillers.	"Yes" (Flow-Nail row under BVF Delivery) (K140601, Page 1)
BVF Delivery System Qualification	Qualification testing for the bone void filler delivery system.	Qualification testing (Injectability, Experimental Void Fill Imaging, Static Extraction Torque, BVF Property characterization) performed with specified BVF.	"The qualification testing (i.e., Injectability Testing, Experimental Void Fill Imaging Studies, Static Extraction Torque, BVF Property characterization), was performed with ETEX Beta-bsm and CarriGen (K062630, K072355, K090242, K101557)." (K140601, Page 1)

2. Sample Size and Data Provenance for Test Set

The provided document (K140601 510(k) Summary) does not explicitly detail the sample size or data provenance (e.g., country of origin, retrospective/prospective) for the test set used in the mechanical performance studies. The study primarily relies on a comparative mechanical testing approach rather than clinical trial data.

3. Number of Experts and Qualifications for Ground Truth of Test Set

This type of submission (510(k) for an intramedullary fixation rod) does not typically involve human expert adjudication for a "test set" in the context of clinical outcomes or imaging classification. The evaluation is based on engineering and material science standards and physical testing. Therefore, the concept of "experts establishing ground truth" as it would apply to, for example, image interpretation, is not relevant here. The "experts" would be the engineers and scientists conducting the mechanical tests and comparing the results to established standards and predicate device performance.

4. Adjudication Method for the Test Set

Given the nature of the mechanical performance studies for a medical device like an intramedullary nail, there is no adjudication method described or typically applied in the way it would be for a clinical diagnostic study (e.g., 2+1 or 3+1). The evaluation is based on objective measurements from standardized mechanical tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for evaluating the impact of AI on human readers in diagnostic tasks, which is not applicable to the Flow-Nail's pre-market submission which focuses on substantial equivalence through mechanical and material testing.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Not applicable. The Flow-Nail is a physical medical device, not an AI algorithm. Therefore, "standalone performance" in the context of an algorithm without human-in-the-loop is not relevant.

7. Type of Ground Truth Used

The "ground truth" for the Flow-Nail's substantial equivalence is based on engineering standards, material specifications, and the established performance of existing predicate devices through standardized mechanical testing. This includes:

ASTM F136 for titanium alloy composition.
Static and dynamic compression bending loads for mechanical performance.
Qualification testing for BVF delivery (Injectability Testing, Experimental Void Fill Imaging Studies, Static Extraction Torque, BVF Property characterization).

8. Sample Size for the Training Set

Not applicable. The concept of a "training set" is relevant for machine learning algorithms. The Flow-Nail is a physical medical device, and its development and testing do not involve a training set in this context.

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

Not applicable, as there is no "training set" for this physical device.

Summary

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K140601 Page 1 of 2

	510(k) Summary	JUL 02 2014
Device Trade Name:	Flow-Nail
Manufacturer:	Flow-FX, LLC19110 Darvin DriveMokena, Illinois 60448708.390.2290
Prepared by:	Musculoskeletal Clinical Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005202.552.5800
Date Prepared:	June 4, 2014
Common Name:	Intramedullary Fixation Rod
Classification:	21 CFR 888.3020
Class:	II
Product Code:	HSB

Indications for Use:

Device Description:

Predicate Devices:

The Flow-Nail was shown to be substantially equivalent to the Zimmer Natural Nail System (K120715 and K091566), Stryker Gamma 3 Nail System (K032244), and AOS Trochanteric Nail (K103533 and K021008). The Flow-Nail is compatible for use with injectable BVFs.

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Substantial Equivalence:

The table below summarizes the substantial equivalence of the Flow-Nail to predicate devices with respect to its intended use, design, materials, available sizes, mechanical performance, and ability to deliver BVF to a defect site.

	Subject Device	Predicates
	Flow-Nail	Zimmer Natural Nail	Stryker Gamma 3 NailSystem	AOS TrochantericNail System(K021008)
Intended Use	Intended for temporary fracture fixation and stabilization of the bone.
Indicationsfor Use	The FlowNail isintended to treat stableand unstable proximalfractures of the femurincludingpertrochanteric,intertrochanteric, andhigh subtrochantericfractures andcombinations of thesefractures. The Flow-Nail can also be used todeliver injectable bonevoid fillers to a surgicalsite.	Indications for the useof the Cephalomedullarynails include:- Compound and simpleshaft fractures- Proximal, metaphysealand distal shaftfractures- Segmental fractures- Comminuted fractures- Fractures involvingosteopenic andosteoporotic bone- Pathological fractures- Fractures with boneloss- Pseudoarthrosis, non-union, mal-union anddelayed union- Periprosthetic fractures- Surgically createddefects such asosteotomies- Intertrochanteric andsubtrochantericfractures	The intended use of thesubject TrochantericGamma 3 Nail is identicalto that of the predicateTrochanteric Dyax andGamma Nails. Theproduct is intended for usein stabilizing various typesof intertrochantericfractures of the femur.	The AOS TrochantericNail is intended to treatstable and unstableproximal fractures ofthe femur includingpertrochanteric,intertrochanteric, andhigh subtrochantericfractures andcombinations of thesefractures.
Components	IM Nail; Lag Screw	IM Nail; Lag Screw	IM Nail; Lag Screw	IM Nail; Lag Screw
Materials	Titanium Alloy	Titanium Alloy	Titanium Alloy	Titanium Alloy
Nail Sizes	Within predicaterange	A range of sizes toaccommodate variouspatient anatomies	A range of sizes toaccommodate variouspatient anatomies	A range of sizes toaccommodatevarious patientanatomies
Lag ScrewSizes	Within predicaterange	A range of lengths toaccommodate variouspatient anatomies	A range of lengths toaccommodate variouspatient anatomies	A range of lengths toaccommodatevarious patientanatomies
MechanicalPerformance	Mechanical testing demonstrates the substantial equivalence of the Flow-Nail relative to theidentified predicates when subjected to static and dynamic compression bending loads.
BVFDelivery	Yes	No	No	No
BVFDeliverySystem	The qualification testing (i.e., Injectability Testing, Experimental Void Fill Imaging Studies,Static Extraction Torque, BVF Property characterization), was performed with ETEX Beta-bsmand CarriGen (K062630, K072355, K090242, K101557).

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 2, 2014

Flow-FX. LLC % Ms. Michelle McDonough Senior Associate, Regulatory and Clinical Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1331 H Street Northwest, 12th Floor Washington, District of Columbia 20005

Re: K140601

Trade/Device Name: Flow-Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: June 4, 2014 Received: June 5, 2014

Dear Ms. McDonough:

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. 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

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Page 2 - Ms. Michelle McDonough

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Laurence D. Coyne -A

For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. Indications for Use

K140601 510(k) Number (if known):

Device Name: Flow-Nail

The Flow-Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric. intertrochanteric. and high subtrochanteric fractures and combinations of these fractures. The Flow-Nail can also be used to deliver injectable bone void fillers to a surgical site.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

in the color control contrôlean comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices

page 1/1

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.