Small Bone Nail Implant by VILEX IN TENNESSEE, INC

This document is a 510(k) premarket notification for a medical device called the "Small Bone Nail Implant System." It is a regulatory submission to the FDA, not a study report. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and device performance from a clinical study.

Specifically, the document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and proving performance through a new clinical or standalone study.

Here's why the requested information cannot be extracted from this document:

Acceptance Criteria and Reported Device Performance: This document does not present acceptance criteria for a study or report specific performance metrics of the new device. Instead, it states that the device's "technological characteristics are similar to the characteristics of the predicate devices" and that "comparisons confirmed that the Small Bone Nail Implant is as safe, as effective and should perform as well as or better than the predicate devices." This is a qualitative statement of equivalence, not a quantitative measure against pre-defined acceptance criteria.
Sample Size for Test Set and Data Provenance: No test set or associated data provenance is mentioned. The submission relies on comparison to predicate devices.
Number of Experts for Ground Truth and Qualifications: Not applicable, as there's no diagnostic performance study involving expert ground truth.
Adjudication Method: Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC study is described. The comparison is against predicate devices in terms of design and intended use, not a human reader performance study.
Standalone Performance: No standalone performance study (algorithm only) is described, as this is a physical medical implant, not an AI/software device.
Type of Ground Truth Used: Not applicable, as there's no diagnostic performance study requiring ground truth.
Sample Size for Training Set: Not applicable, as this is not a machine learning device.
How Ground Truth for Training Set was Established: Not applicable.

In summary, this document is a regulatory filing asserting substantial equivalence of a physical medical implant (Small Bone Nail Implant System) to existing products. It does not describe a study involving acceptance criteria, test sets, expert ground truth, or performance metrics in the way your prompt anticipates for a diagnostic or AI-driven device.

Summary

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

October 29, 2015

Vilex, Incorporated % Abraham Lavi, Ph.D. Consultant 8374 Market Street, #167 Lakewood Ranch, Florida 34202

Re: K151456

Trade/Device Name: Small Bone Nail Implant Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: September 28, 2015 Received: September 29, 2015

Dear Dr. Lavi:

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 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

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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/Resourcesfor You/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

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

Enclosure

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K151456 - Page 1 of 1

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INDICATIONS FOR USE

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510(k) Number: K151456

DEVICE NAME: Small Bone Nail Implant (SBNI)

INDICATIONS FOR USE

The Tapered Small Bone Nail Implant (SBNI) is indicated for use in fractures and osteotomies of the fibula, radius, and ulna.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (DOE)

Page 1 of 1

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ADVANCE WITH US >>>

510(k) Summary Small Bone Nail Implant System K151456

Sponsor:	Vilex, Inc.111 Moffitt StreetMcMinnville, TN 37110Phone: (931) 474-7550Fax: (931) 474-7551
Contact:	Abraham Lavi
Date Prepared:	September 22, 2015
Trade Name:	Small Bone Nail Implant System
Common Name:	Intramedullary Fixation Rod
ClassificationName:	21 CFR Section 888.3020 Rod, Fixation, Intramedullary And Accessories
	Device Class:
Product Code:	HSB/ Orthopedics
PredicateDevices:	Acumed Small Bone Locking Rod System (K031438 and K071944)Biomet Titanium Intramedullary Rods-Various Styles (K982953) andKirschner (now Biomet, Inc.) Intramedullary Nail System (K854338)Arthrex Opening Wedge Osteotomy System (K973812)Arthrex Low Profile Plate and Screw System (K052614)
Description ofDevice:	The Vilex Small Bone Nail Implant System includes Tapered Nails (straightor bowed) and Locking Screws.
Indications forUse:	The Tapered Small Bone Nail Implant (SBNI) is indicated for use infractures and osteotomies of the fibula, radius, and ulna.
TechnologicalCharacteristics:	The technological characteristics for the Small Bone Nail Implant Systemare similar to the characteristics of the predicate devices. The sizes includedin the Small Bone Nail Implant System are similar to the range of offeringsof the predicate devices and the designs of the Small Bone Nail ImplantSystem are similar to the predicate devices. The materials used tomanufacture the Small Bone Nail Implant System are implant gradematerials appropriate for intramedullary nails.
SubstantialEquivalence:	The design features of the Small Bone Nail Implant are substantiallyequivalent to the design features of other predicate devices previously clearedfor market. The claim of substantial equivalence of the Small Bone NailImplant System to the predicate devices is based on the comparison of theintended use, product technical characteristics and performancecharacteristics. Comparisons confirmed that the Small Bone Nail Implant isas safe, as effective and should perform as well as or better than the predicatedevices. While the Small Bone Nail Implant System is not identical to thepredicate devices, comparisons of the subject and predicate devicesconfirmed that any differences between the subject device and predicates donot render the device NSE as there is not a new intended use; and anydifferences in technological characteristics do not raise different questions ofsafety and effectiveness than the predicate devices. Therefore, it is concludedthat the Small Bone Nail Implant System is substantially equivalent to thepredicate devices as outlined previously.
Conclusions:	While the devices in the Small Bone Nail Implant System are not identical tothe predicate devices, any differences that may exist do not significantlyaffect device safety and effectiveness. In addition, the differences do not addnew or increased risks and complications. Therefore, it is concluded that theSmall Bone Nail Implant System is substantially equivalent to the predicatedevices as outlined previously and should not render the subject device NSE.

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151456 - Page 2 of 2 510(k) Summary Small Bone Nail Implant System K151456

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.