The Renovo Life Small Bone IM Nail System is indicated for fixation of fractures where the canal is narrow or flexibility of the implant is paramount, including the fibula, radius, and ulna, upper extremity fractures in all patients and lower extremity fractures in small-stature patients. This system is also intended to treat metaphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones.

Device Description

The Renovo Life Small Bone IM Nail System nails are available in diameters ranging from 2.5 mm to 4.5 mm with a length of 150 mm and either solid or cannulated and materials are surgical grade stainless steel or titanium. Renovo Life Screws are 3.5 mm in diameter and are available in lengths from 10mm to 34 mm in materials of surgical grade stainless steel or titanium. The Renovo Life Small Bone IM Nail System is provided non-sterile and are intended for single use only.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called the "Renovo Life Small Bone IM Nail System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving independent performance or safety through extensive clinical trials for novel devices.

Therefore, the acceptance criteria and study information requested, particularly regarding performance metrics, sample sizes for training/test sets, expert ground truth, and AI-related studies, are not applicable to this document because it describes a traditional medical device demonstrating substantial equivalence, not an AI/ML-driven device with performance metrics.

Here's a breakdown based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or provide performance metrics in the way an AI/ML device submission would. Instead, it relies on demonstrating mechanical equivalence to predicate devices.

Acceptance Criteria (Implicit)	Reported Device Performance
Conformance to ASTM F136 (Titanium) or ASTM F138 (Stainless Steel)	Device made of surgical grade stainless steel or titanium conforming to these standards.
Substantial equivalence in design, materials, and intended use to predicate devices	Demonstrated through comparative testing (ASTM 1264-14, cadaveric implant trial, rotational resistance test) showing substantial equivalence in static and dynamic four-point bend tests, static torsion test, and compliance tests.
Meeting general controls provisions of the Act (e.g., registration, labeling, GMP)	Implied by the FDA's substantial equivalence determination, subject to ongoing compliance.

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

Test Set Sample Size: Not applicable. The "test set" here refers to mechanical testing, not a dataset of patient cases. The document mentions "comparative testing" with a predicate device.
Data Provenance: Not applicable in the context of patient data. The testing involved mechanical tests and a cadaveric implant trial. No information on the provenance of cadaveric material is provided.

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

Not applicable. Ground truth in this context refers to the expected mechanical behavior according to standards, not expert interpretations of clinical images or patient outcomes.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 are for reconciling expert disagreements in clinical data labeling. Mechanical tests are typically performed according to established protocols with objective measurements.

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

No. This type of study is specifically for evaluating the impact of AI on human reader performance. This device is not an AI/ML device.

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

No. This device is a physical intramedullary nail system, not an algorithm.

7. The Type of Ground Truth Used:

For the mechanical testing, the "ground truth" would be the established performance characteristics and behavior of the predicate device and the specified ASTM standards.

8. The Sample Size for the Training Set:

Not applicable. No training set is involved as this is not an AI/ML device.

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

Not applicable. No training set or associated ground truth for training.

In summary, the provided document is a 510(k) summary for a conventional medical device (intramedullary nail system). It demonstrates substantial equivalence primarily through material specifications and mechanical testing against a predicate device, rather than through clinical performance metrics or AI/ML specific evaluations.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, arranged in a way that resembles a bird in flight.

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

November 7, 2016

Renovo Life LLC % Mr. Donald Guthner Regulatory Consultant Orgenix, LLC 111 Hill Road Douglassville, Pennsylvania 19518

Re: K161254

Trade/Device Name: Renovo Life Small Bone IM Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: October 11, 2016 Received: October 12, 2016

Dear Mr. Guthner:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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" (21 CFR 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K161254

Device Name Renovo Life Small Bone IM Nail System

Indications for Use (Describe)

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

Manufacturer:	Renovo Life LLC1104 Spruce StreetBelmont, NC 28012
Date:	October 10, 2016
Submitted by:	Renovo Life LLC
Company Contact	Harold Crowder+1(704) 224-4136hcrowder@renovolife.com
US Agent InformationOfficial Correspondent	Orgenix LLCMr. Donald W. Guthner111 Hill RoadDouglassville, PA 19518+1-646-460-2984+1-484-363-5879 (FAX)dg@orgenix.com
Proprietary Name:	Renovo Life Small Bone IM Nail System
Performance standards:	The Renovo Life Small Bone IM Nail System is made of surgical gradestainless steel conforming to ASTM F138 or surgical grade Titaniumalloy conforming to ASTM F136.
Regulation:Common/Usual Name:Classification name:Review Panel:Product Code:Device Class:	21 CFR 888.3020Rod, Fixation, Intramedullary and AccessoriesIntramedullary Fixation RodOrthopedicHSBClass II
Substantial Equivalence:	Substantial equivalence for the Renovo Life Small Bone IM NailSystems is based on its similarities in indications for use, design features,operational principles and material composition when compared to thepredicate devices.
Predicate Devices:	K043185 Synthes Cortex ScrewK081452 Synthes Stainless Steel Elastic Intramedullary Nail SystemK143276 Accumed Small Bone IM Nail System

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The subject device is substantially equivalent to similar previously cleared devices.

Device Description:	The Renovo Life Small Bone IM Nail System nails are available indiameters ranging from 2.5 mm to 4.5 mm with a length of 150 mm andeither solid or cannulated and materials are surgical grade stainless steelor titanium.Renovo Life Screws are 3.5 mm in diameter and are available in lengthsfrom 10mm to 34 mm in materials of surgical grade stainless steel ortitanium.The Renovo Life Small Bone IM Nail System is provided non-sterile andare intended for single use only.
Intended Use:	The Renovo Life Small Bone IM Nail System is indicated for fixation offractures where the canal is narrow or flexibility of the implant isparamount, including the fibula, radius, and ulna, upper extremityfractures in all patients and lower extremity fractures in small-staturepatients. This system is also intended to treat metaphyseal and epiphysealfractures, such as radial neck fractures and is intended for fixation of smalllong bones, such as carpal and tarsal bones.
Summary of TechnologicalCharacteristics	The Renovo Life Small Bone IM Nail System designed for fixation ofstable and unstable fractures in the fibula, radius and ulna.
Non-Clinical Testing	The Renovo Life Small Bone IM Nail System has undergone comparativetesting with a predicate device conducted as per ASTM 1264-14, acadaveric implant trial and a rotational resistance test. The test datashowed the Renovo Life Small Bone IM Nail was substantially equivalentto the predicate device in a static and dynamic four-point bend tests, statictorsion test and compliance tests, as described herein.
Clinical Testing	No clinical testing was performed.
Conclusion	The Renovo Life Small Bone IM Nail Systems have the same intended useand similar indications, principles of operation, and technologicalcharacteristics as the predicate devices.Thus, the Renovo Life Small Bone IM Nail Systems are substantiallyequivalent to the predicate devices.

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.