(80 days)
Not Found
Not Found
No
The summary describes a mechanical intramedullary fixation system and contains no mention of AI, ML, image processing, or data-driven performance metrics typically associated with AI/ML devices.
Yes
The device is described as an "intramedullary nail" intended for "fixation of long bone fractures," which implies a medical intervention to treat a condition.
No
The device is described as an "intramedullary nail intended for long bone fracture fixation." Its purpose is to fix fractures, not to diagnose them.
No
The device description clearly states it is a "segmented, intramedullary nail," which is a physical implant used in surgery, not a software-only device.
Based on the provided information, the NovaLign™ Intramedullary Fixation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "fixation of long bone fractures." This is a surgical procedure performed in vivo (within the body) to stabilize broken bones.
- Device Description: The device is described as an "intramedullary nail" which is implanted into the bone. This is a physical implant used for structural support.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose conditions, or monitor treatment. The NovaLign™ system does not perform any of these functions.
Therefore, the NovaLign™ Intramedullary Fixation System is a surgical implant/device used for orthopedic procedures, not an IVD.
N/A
Intended Use / Indications for Use
The NovaLign™ Intramedullary Fixation System is intended for use in the fixation of long bone fractures, including fractures in the humerus, femur and the tibia.
Product codes
HSB
Device Description
The NovaLign™ Intramedullary Fixation System is a segmented, intramedullary nail intended for long bone fracture fixation. The device is intended to function as a flexible intramedullary nail during device placement, but will be made rigid at the completion of the surgical implantation procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humerus, femur and the tibia
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
.
.
510(k) Summary 5.
| Company: | NovaLign™ Orthopaedics, Inc.
5885 Ridgeway Center Parkway - Suite 210
Memphis, TN 38120
Phone: (901) 213-5151
Fax: (901) 213-5155 | FEB - 9 2009 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact: | Jeffrey G. Roberts
President & CEO | |
| Prepared By: | Musculoskeletal Clinical Regulatory Advisers, LLC
1331 H Street, NW, 12th Floor
Washington, DC 20005
Phone: (202) 552-5800
Fax: (202) 552-5798 | |
| Device Name: | Intramedullary Fixation System | |
| Classification: | 21 CFR 888. 3020, Intramedullary fixation rod, Class II | |
| Product Code: | HSB | |
| Device Description: | The NovaLign™ Intramedullary Fixation System is a
segmented, intramedullary nail intended for long bone
fracture fixation. The device is intended to function as a
flexible intramedullary nail during device placement, but
will be made rigid at the completion of the surgical
implantation procedure. | |
| Intended Use: | The NovaLign™ Intramedullary Fixation System is
intended for use in the fixation of long bone fractures,
including fractures in the humerus, femur and the tibia. | |
| Materials: | The implants are made from titanium alloy (ASTM
F136) and Nitinol (ASTM F2063) | |
:
・・・
.
. .
:
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three legs and a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 9 2009
NovaLign Orthopaedics, Inc. % Mr. Jeffrey G. Roberts President & CEO 5885 Ridgeway Center Parkway - Suite 210 Memphis, Tennessee 38120
Re: K083458
Trade/Device Name: Intramedullary Fixation System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulation Class: Class II Product Code: HSB Dated: January 16, 2009 Received: January 16, 2009
Dear Mr. Roberts:
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 such 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); 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.
2
Page 2 - Mr. Jeffrey G. Roberts
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. Commen
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use 4.
510(k) Number (if known):
Device Name: NovaLign™ Intramedullary Fixation System
The NovaLign™ Intramedullary Fixation System is intended for use in the fixation of long bone fractures, including fractures in the humerus, femur and the tibia.
Prescription Use ﺌﮯ (Part 21 CFR 801 Subpart D)
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)
Umm my
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number_ L083458
CONFIDENTIAL