The Revolution Femoral Intramedullary Nail System is indicated for use in orthopaedic intramedullary nailing procedures: midline femoral fractures, femoral fractures in multiple trauma patients, fractures in the morbidly obese patient, fractures in osteoporotic bone or malunions and nonunions.

Device Description

The Revolution Femoral Intramedullary Nail System permits an antegrade intramedullary approach for fixation of fractures of the femur. The Revolution Femoral Intramedullary Nail is a closed section, cannulated, thick walled, mirror finished, curved intramedullary fixation device containing two proximal and two distal holes to accept locking screws which thread transversely though the proximal and distal third of the femur. The Nail is available in a variety of diameters and lengths.

Locking screws are also included as a component of the Nail system. The locking screws are designed to reduce the likelihood of shortening and rotation of femoral fractures. The locking screws are available in a single diameter and a variety of lengths.

The ancillary instrumentation include standard orthopedic instruments for accessing the femoral medullary canal, preparing the bone for placement and installation of the intramedullary nail and locking screws, and removal of the intramedullary nail and screws, if required.

AI/ML Overview

Here's an analysis of the provided text regarding the Revolution Femoral Intramedullary Nail System, focusing on acceptance criteria and supporting studies:

This document is a 510(k) Premarket Notification for a medical device. It does not contain the detailed study information typically found for AI/ML-based devices regarding acceptance criteria, sample sizes, expert ground truth, or MRMC studies. The device, an intramedullary nail system, is a traditional orthopedic implant, not an AI/ML-powered diagnostic or treatment planning system. Therefore, the questions related to AI/ML device evaluation are not applicable to this submission.

The "studies" described are non-clinical, meaning they involve engineering testing rather than human clinical trials or data analysis.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of quantitative acceptance criteria or detailed reported device performance metrics in the format usually expected for AI/ML devices (e.g., sensitivity, specificity, AUC). Instead, it makes a general statement:

Acceptance Criterion (Implicit)	Reported Device Performance
Safety and performance as intended	"Results of testing confirm that the Revolution Femoral Intramedullary Nail System reliably performs as intended."
Substantial equivalence to predicate devices	"Revolution Femoral Intramedullary Nail System is substantially equivalent to the currently marketed predicate devices with respect to intended use, materials and technological characteristics."
No new questions of safety or effectiveness	"No new questions of safety or effectiveness have been raised."
Compliance with non-clinical testing requirements	"The safety and performance... have been substantiated through non-clinical testing."

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

This information is not applicable and not provided for this type of device submission. The device is a physical implant. The "test set" would refer to the number of nails or components tested in non-clinical (e.g., mechanical) studies, which is not detailed here. There is no "data provenance" in the context of clinical images or patient data.

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

This information is not applicable to this type of device. There is no "ground truth" established by clinical experts in the context of device performance in non-clinical testing.

4. Adjudication Method for the Test Set

This information is not applicable to this type of device. Adjudication methods are relevant for subjective interpretations of clinical data, which is not the subject of this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

This information is not applicable to this device. An MRMC study is relevant for AI-assisted diagnostic or interpretation systems. This is a physical orthopedic implant.

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

This information is not applicable to this device. A standalone study refers to the performance of an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the Revolution Femoral Intramedullary Nail System's performance is implicitly defined by engineering specifications, material properties, and comparison to legally marketed predicate devices. The testing would likely involve mechanical stress tests, fatigue tests, and material characterization to ensure the device meets predefined physical and performance standards comparable to existing implants. It is not based on expert consensus, pathology, or outcomes data in the sense of clinical study results for a diagnostic or predictive algorithm.

8. The Sample Size for the Training Set

This information is not applicable to this device. There is no "training set" in the context of machine learning for a physical orthopedic implant.

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

This information is not applicable to this device.

Summary

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iC091309

DGIMed Ortho, Inc. Traditional 510(k) Premarket Notification: Revolution Femoral Intramedullary Nail

510(K) SUMMARY AS REQUIRED BY 21 CFR 807.92 6

510(k) Number	Not yet assigned
Date Prepared	May 1, 2009	NOV - 5 2009
Submitter Information	DGIMed Ortho, Inc.12400 Whitewater Drive, Suite 2010Minnetonka, MN 55343
Contact Person:	Scott P. YoungstromVP, Finance & COOphone: (651) 442-6990
Device Information
Trade Name:	Revolution Femoral Intramedullary Nail System
Common Name:	Intramedullary Fixation Rod and Accessories
Classification:	Class II
Product Code:	HSB
Regulation:	21 CFR 888.3020
Panel:	87 - Orthopedic

Predicate Devices

Device	Manufacturer	510(k) Status
Russell-Taylor Femoral Nail	Smith & Nephew	K893377
Cannulated Retrograde/AntegradeFemoral Nail EXPERT System	Synthes	K033618
T2 Femoral Nailing System	Stryker Corp.	K912930

Device Description 6.1

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DGIMed Ortho, Inc. Traditional 510(k) Premarket Notification: Revolution Femoral Intramedullary Nail

6.2 Intended Use

The Revolution Femoral Intramedullary Nail System is indicated for use in orthopedic intramedullary nailing procedures: midline femoral fractures, femoral fractures in multiple trauma patients, fractures in the morbidly obese patient, fractures in osteoporotic bone or malunions and nonunions.

6.3 Summary of Non-clinical Testing

The safety and performance of the Revolution Femoral Intramedullary Nail System have been substantiated through non-clinical testing. Results of testing confirm that the Revolution Femoral Intramedullary Nail System reliably performs as intended. No new questions of safety or effectiveness have been raised.

6.4 Substantial Equivalence

The Revolution Femoral Intramedullary Nail System's product information, technological comparison to predicate products, and test results demonstrate that the Revolution Femoral Intramedullary Nail System is safe and performs as intended. Any differences in technological features raise no new questions of safety or effectiveness. Revolution Femoral Intramedullary Nail System is substantially equivalent to the currently marketed predicate devices with respect to intended use, materials and technological characteristics.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, serif font. The text is centered on the image and is the only element present.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

DGIMed Ortho, Inc. % Mr. Scott Youngstrom 12400 Whitewater Drive, Suite 2010 Minnetonka, MN 55343

NOV - 5 2009

Re: K091309

Trade/Device Name: Revolution Femoral Intramedullary Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: September 25, 2009 Received: September 28, 2009

Dear Mr. Youngstrom:

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.

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 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 go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's

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Page 2 - Mr. Scott Youngstrom

(CDRH's) Office of Compliance. 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/cdrl/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Milkenso

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

Enclosure

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DGIMed Ortho, Inc. Traditional 510(k) Premarket Notification: Revolution Femoral Intramedullary Nail

INDICATIONS FOR USE STATEMENT ನ

Indications for Use

510(k) Number (if known): not yet assigned

Device Name: Revolution Femoral Intramedullary Nail System

Indications for Use:

Prescription Use V (Part 21 CFR 801 Subpart D)

510(k) Number _

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Oasta for mxn

1091309

(Division Sign-Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of 1

CONFIDENTIAL

. Page 12 of 83

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.