(185 days)
Not Found
No
The device description and summary of performance studies focus on the mechanical properties and surgical instrumentation, with no mention of AI or ML.
Yes
This device, an intramedullary nail system, is used to fix fractures in the femur, which is a therapeutic intervention for orthopaedic conditions.
No
The device is an intramedullary nail system used for fixation of femoral fractures, which is a therapeutic rather than a diagnostic purpose.
No
The device description clearly details physical components like intramedullary nails, locking screws, and ancillary instrumentation, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "orthopaedic intramedullary nailing procedures" to fix femoral fractures. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical implant (intramedullary nail and screws) and associated surgical instruments. These are used to mechanically stabilize bone fractures.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The description of the Revolution Femoral Intramedullary Nail System does not involve any such testing or analysis of biological samples.
Therefore, the Revolution Femoral Intramedullary Nail System is a surgical implant and associated instrumentation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
HSB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 2010 | ||
| Minnetonka, MN 55343 | ||
| Contact Person: | Scott P. Youngstrom | |
| VP, Finance & COO | ||
| phone: (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/Antegrade | ||
| Femoral Nail EXPERT System | Synthes | K033618 |
| T2 Femoral Nailing System | Stryker Corp. | K912930 |
Device Description 6.1
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.
1
DGIMed Ortho, Inc. Traditional 510(k) Premarket Notification: Revolution Femoral Intramedullary Nail
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..
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.
2
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
3
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
4
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:
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.
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
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