INTRAMEDULLARY FIXATION ROD (IFS)

• K Number: K083458
• Device Name: INTRAMEDULLARY FIXATION ROD (IFS)
• Manufacturer: NOVALIGN ORTHOPAEDICS, INC
• Date Cleared: 2009-02-09 ( 80 days)
• Product Code: HSB
• Regulation Number: 888.3020
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: N/A
• Predicate For: N/A

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.

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.

AI/ML Overview

This document is a 510(k) summary for the NovaLign™ Intramedullary Fixation System, which is a device for fixing long bone fractures. It states that the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the provided text in relation to your request about acceptance criteria and study details:

The provided text is a 510(k) summary for a medical device (intramedullary fixation system), NOT a study report for an AI/CADe device.

Therefore, it does not contain any of the information you requested regarding acceptance criteria and a study proving device performance for an AI/CADe device. This type of device (an intramedullary fixation system) is a physical implant, not a software or AI-based diagnostic tool.

To explicitly answer each point based on the provided document:

1. A table of acceptance criteria and the reported device performance: Not applicable. This document is for a physical orthopedic implant. There are no performance metrics like sensitivity, specificity, AUC, or other typical metrics for AI/CADe devices.
2. Sample sized used for the test set and the data provenance: Not applicable. There is no test set in the context of an AI/CADe device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth establishment in this context.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/CADe device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/CADe device.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

This 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for physical medical devices, and does not involve the type of performance studies relevant to AI/CADe systems.

Summary

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510(k) Summary 5.

Company:	NovaLign™ Orthopaedics, Inc.5885 Ridgeway Center Parkway - Suite 210Memphis, TN 38120Phone: [phone]Fax: [phone]	FEB - 9 2009
Contact:	Jeffrey G. RobertsPresident & CEO
Prepared By:	Musculoskeletal Clinical Regulatory Advisers, LLC1331 H Street, NW, 12th FloorWashington, DC 20005Phone: [phone]Fax: [phone]
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 asegmented, intramedullary nail intended for long bonefracture fixation. The device is intended to function as aflexible intramedullary nail during device placement, butwill be made rigid at the completion of the surgicalimplantation procedure.
Intended Use:	The NovaLign™ Intramedullary Fixation System isintended 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 (ASTMF136) and Nitinol (ASTM F2063)

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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.

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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 [phone]. 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 [phone] or [phone] 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

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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

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.