The SIGN Pediatric Fin Nail is indicated for internal fixation of diaphyseal fractures of the femur, osteotomies, correction of malunions and nonunions on patients who are anatomically suited to receive the device.

Device Description

SIGN Pediatric Fin Nail is an Intramedullary Fixation Rod designed to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments The SIGN Pediatric Fin Nails are available in a variety of lengths, shaft diameters, and fin diameters to accommodate a variety of patient anatomies. Each nail has a proximal bend and a slot at the proximal end to accept a solid 4.5mm diameter cortical bone screw for fixation and uses rigid distal fins for rotational stability. The Pediatric Fin Nail may be removed upon fracture healing. The Pediatic Fin Nail is a single use device, supplied non-sterile, and manufactured from stainless steel in accordance with ASTM F 138.

AI/ML Overview

This document describes the SIGN Pediatric Fin Nail, an intramedullary fixation rod designed for femur fracture fixation in pediatric patients. The study supporting its acceptance is a non-clinical performance (bench) testing.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Test Performed	Reported Device Performance
Mechanical Performance	Compression Bench Testing	Met all acceptance criteria; device is functionally safe for intended use.
	Torsion Bench Testing	Met all acceptance criteria; device is functionally safe for intended use.
	Fatigue Tests (simulating walking gait)	Validated that the design can withstand patient use until fracture consolidation occurs.

Note: The document states that the device "met all acceptance criteria" for the mechanical performance tests, but does not provide specific numerical values for the acceptance criteria or reported values.

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

Test Set Sample Size: Not specified in the provided text. The tests were "bench testing" of the device itself, implying a number of manufactured devices were tested.
Data Provenance: Non-clinical setting (bench testing). No information on country of origin or whether it was retrospective/prospective is applicable as it's not human subject data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. This device is a mechanical implant, and the testing was non-clinical bench testing. Ground truth in this context typically refers to the physical properties and mechanical behavior of the device under specific loads, which are measured using scientific instrumentation and engineering standards, not expert human interpretation.

4. Adjudication Method for the Test Set:

Not applicable. As described in point 3, the evaluation was based on objective mechanical measurements against engineering standards, not human interpretation requiring adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

No. This type of study (MRMC) assesses the performance of humans, often with and without AI assistance, in interpreting medical images or data. It is not relevant for the evaluation of a mechanical orthopedic implant.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study:

Yes, in a way. The performance testing described is standalone in that it evaluates the mechanical properties and performance of the device itself (the "algorithm" equivalent for a physical product) without any human interaction being part of the primary functional assessment. The device's ability to withstand compression, torsion, and fatigue was assessed directly.

7. Type of Ground Truth Used:

The ground truth used was based on engineering standards and predetermined mechanical performance specifications for orthopedic implants, specifically intramedullary rods for fracture fixation. The tests evaluated the device's axial strength, rotational stability, and ability to withstand fatigue under simulated physiological loading.

8. Sample Size for the Training Set:

Not applicable. As a manufactured physical medical device, there is no "training set" in the sense of machine learning algorithms. The design and manufacturing processes are informed by engineering principles, material science, and prior knowledge of similar devices, but not through a "training set" of data.

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

Not applicable. (See answer to point 8). The design parameters, material selection, and manufacturing specifications are established through engineering design processes, material science research, and adherence to relevant ASTM standards (e.g., ASTM F138 for stainless steel). The "ground truth" for its design is rooted in established biomechanical principles and regulatory requirements for implantable devices.

Summary

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K122823(1/3)

APR 1 6 2013

451 Hills St, Suite B · Richland, WA 99354 P (509) 371-1107 · F (509) 371-1316

510(k) Summary

510(k) Submitter:

SIGN Fracture Care International 451 Hills Street, Suite B Richland, WA 99354 3034525

Establishment #:

Contact Person:

Doug Donnelly, Regulatory Affairs Manager Phone: 509-371-1107 Fax: 509-371-1316 E-Mail: doug donnelly@signfracturecare.org

Date Prepared: Regulatory Class: Panel: Trade Name: Common Name: Classification Name: Device Product Code: August 1, 2012 Class II Orthopedic SIGN Pediatric Fin Nail Pediatric Intramedullary Rod Rod, Fixation, Intramedullary and Accessories 21 CFR 888.3020 HSB

Substantial Equivalence Information

Biomet, Inc., Titanium Pediatric Femoral Nail (K993956) SIGN Fin Nail (K043200)

Device Description

Image /page/0/Picture/17 description: The image shows the logo for SIGN Fracture Care International. The logo features a stylized figure of a person in motion on the left. To the right of the figure, the word "SIGN" is written in large, bold letters. Below "SIGN", the words "FRACTURE CARE INTERNATIONAL" are written in smaller letters.

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Image /page/1/Picture/1 description: The image is a logo for SIGN Fracture Care International. On the left side of the logo is a black square with a white silhouette of a person running. To the right of the square is the word "SIGN" in large, bold, black letters, with the letter "I" stylized to look like a bone. Below the word "SIGN" are the words "FRACTURE CARE INTERNATIONAL" in smaller, black letters.

451 Hills St, Suite B . Richland, WA 99354 P (509) 371-1107 • F (509) 371-1316

Indications for Use

Substantial Equivalence

The SIGN Pediatric Fin Nail is substantially equivalent to the Biomet, Titanium Pediatric Femoral Nail and the SIGN Fin Nail in design, performance, function and intended use. The safety and effectiveness of the SIGN Pediatric Fin Nail is also based on a long history of use of this type of device in the marketplace.

The differences of indication to the predicate devices are not critical to the surgical use of the device. Osteotomies can be described as deliberate diaphyseal fractures, which was already included as an indication of the predicate device. Also, malunions and nonunions are treated with a similar surgical approach as diaphyseal fractures. These differences do not affect the safety and effectiveness of the device because it is still being used in the same manner; to hold bone parts in alignment while they heal.

Comparison of Technological Characteristics

The predicate and proposed devices have a similar intended use and basic fundamental scientific technology and share the following similarities:

- Similar indications for use
- Similar design features
- Incorporate the same or similar materials
- Equivalent mechanical performance, based on intended use

Though the proposed device has features largely similar to those of the predicate devices, all of its features are not present on either predicate independently. This prompted non-clinical performance testing. For example, the SIGN Pediatric Fin Nail has similar length, material and fixation technique as the SIGN Fin Nail but the Nail diameter and semi-rigid design feature are similar to the Titanium Pediatric Femoral Nail

2. Performance Testing

The SIGN Pediatric Fin Nail was tested in a non-clinical setting (bench testing) to assess that no safety and effectiveness issues were raised with this device. The testing met all acceptance criteria and the results indicate that the SIGN Pediatric Fin Nail is functionally safe for its intended use. Specific testing performed included compression and torsion bench testing to evaluate the axial strength and rotational stability. In addition, fatigue tests simulating walking gait were performed to validate that the SIGN Pediatric Fin Nail design can withstand patient use until fracture consolidation occurs.

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K122823(3/3)

Image /page/2/Picture/1 description: The image shows the logo for SIGN Fracture Care International. The logo features a stylized silhouette of a person in motion on the left. To the right of the silhouette, the word "SIGN" is written in large, bold letters. Below "SIGN", the words "FRACTURE CARE INTERNATIONAL" are written in smaller letters.

451 Hills St, Suite B · Richland, WA 99354 P (509) 371-1107 • F (509) 371-1316

The SIGN Pediatric Fin Nail is used with screws that are identical to screws cleared for other systems. Therefore, no new screw testing was needed to support substantial equivalence.

Conclusion

The data and information provided in this submission support the conclusion that the SIGN Pediatric Fin Nail is substantially equivalent to its predicate devices with respect to indications for use and technological characteristics.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an abstract design of an eagle or bird-like figure with three curved lines representing its wings or body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the seal.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

April 16, 2013

SIGN Fracture Care International % Mr. Douglas Donnelly Manager, Regulatory Affairs 451 Hills St. Suite B Richland, Washington 99354

Re: K122823

Trade/Device Name: SIGN Pediatric Fin Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: March 29, 2013 Received: April 16, 2013

Dear Mr. Donnelly:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Douglas Donnelly

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/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (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/MedicalDevices/Safety/ReportalProblem/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 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/4/Picture/6 description: The image shows the name "Erin I.D. Keith" in a stylized font. The first part of the name, "Erin," is in a simple, bold font. The letters "I.D." are designed with a maze-like pattern, and the last name, "Keith," also has a decorative design with lines and patterns within the letters.

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

Enclosure

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Indications for Use

510(k) Number (if known): K 122823

SIGN Pediatric Fin Nail Device Name:

Indications for Use: The SIGN Pediatric Fin Nail is indicated for internal fixation of diaphyseal fractures of the femur, osteotomies, correction of malunions and nonunions on patients who are anatomically suited to receive the device.

Prescription Use X (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)

Casey L. Hanley, Ph.D.
Division of Orthopedic Devices

Page _ 1 of _1

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.