(98 days)
Not Found
No
The document describes a mechanical implant for bone fixation and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is intended to repair a fracture, mal-union, or non-union of the clavicle, which is a therapeutic purpose.
No
Explanation: The device is described as an intramedullary fixation system used to repair fractures, indicating it is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it is comprised of an "intramedullary fixation device" and a "proximal cross screw," which are physical hardware components. The performance studies also focus on mechanical testing of these physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "repair an acute fracture, mal-union or non-union of the clavicle." This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is an "intramedullary fixation device" designed to be implanted within the bone. This is a surgical implant, not a device used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of blood, urine, tissue, or other biological samples. It focuses on the mechanical properties and function of the implant for bone fixation.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The Flex-Thread Clavicle Pin System is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.
Product codes (comma separated list FDA assigned to the subject device)
HSB, JDW
Device Description
The Flex-Thread Clavicle Pin System is comprised of an intramedullary fixation device with a flexible threaded distal tip to engage the curved medial portion of a clavicle, and a proximal cross screw to further enhance stability and fixation to the lateral portion of the clavicle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle
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)
Nonclinical Testing:
All necessary testing has been performed for the worst-case Flex-Thread Clavicle Pin and Cross Screw to assure substantial equivalence to its predicates and to demonstrate the subject device performs as intended. All testing was performed on test units representative of finished devices.
The Flex-Thread Clavicle Pin System performance was characterized through the following tests:
- Insertion & Removal Testing
- Static & Fatigue 4-Point Bending Testing
- Tensile Testing
- Torsion Testing
- Implant Tip Flexibility Testing
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.
K971783, K053105, K042135, K081452, K082148, K143204, K081832, K100112
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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 20, 2017
Intrafuse LLC Robert Hoy Director of Research 124 South 600W, Suite 100 Logan, Utah 84321
Re: K163488
Trade/Device Name: Flex-Thread Clavicle Pin System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, JDW Dated: February 16, 2017 Received: February 17, 2017
Dear Mr. Hoy:
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 devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education 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,
Lori A. Wiggins -S
for 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)
Device Name Flex-Thread Clavicle Pin System
Indications for Use (Describe)
The Flex-Thread Clavicle Pin System is intended to be used to repair an acute fracture, mal-union of the clavicle.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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5. 510(k) Summary
| Device Trade Name: | Flex-Thread Clavicle Pin System |
|---|---|
| Manufacturer: | IntraFuse LLC |
| 124 South 600 West, Suite 100 | |
| Logan, UT 84321 | |
| Contact: | Mr. Robert Hoy |
| Director of Research | |
| Phone: (614) 448-6358 | |
| Fax: (435) 213-4878 | |
| bob@surgicalfrontiers.com | |
| Prepared by: | Musculoskeletal Clinical Regulatory Advisers, LLC |
| 1331 H Street NW, 12th Floor | |
| Washington, DC 20005 | |
| Phone: (202) 552-5800 | |
| Fax: (202) 552-5798 | |
| Date Prepared: | December 12, 2016 |
| Common Name: | Rod, fixation, intramedullary and accessories; |
| Pin, fixation, threaded | |
| Classification: | 21 CFR 888.3020, 21 CFR 888.3040 |
| Class: | II |
| Product Codes: | HSB, JDW |
Indications for Use:
The Flex-Thread Clavicle Pin System is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.
Device Description:
The Flex-Thread Clavicle Pin System is comprised of an intramedullary fixation device with a flexible threaded distal tip to engage the curved medial portion of a clavicle, and a proximal cross screw to further enhance stability and fixation to the lateral portion of the clavicle.
Predicate Devices:
The Synthes (USA) Elastic Intramedullary Nail (K971783, K053105, K042135, K081452, K082148), AOS Clavicle Intramedullary Device (K143204) and Sonoma
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Orthopedic Products CRx Clavicle Fracture Repair Device (K081832, K100112) serve as the predicate devices.
Technological Characteristics Comparison:
The Flex-Thread Clavicle Pin System and its predicates are similar in design, function and size. Each device is designed to fix fractures from within the intramedullary canal. In addition, the subject and predicate device designs possess the ability to engage curved regions of the intramedullary canal. The CRx Clavicle Fracture Repair Device System, AOS Clavicle Intramedullary Device, and the subject device system contain cross screws as well.
The Flex-Thread Clavicle Pin System subject device implants and the Elastic Intramedullary Nail and CRx Clavicle Fracture Repair Device predicate device implants all contain stainless steel, a material with well-established biocompatibility and a long history of use in many previously cleared permanent implants. In addition the Flex-Thread Clavicle Pin implant contains polyetheretherketone (PEEK) conforming to ASTM F2026. The biocompatibility of this material has been established per ISO 10993-1. The mechanical testing demonstrates that the design differences between the Flex-Thread Clavicle Pin and the Elastic Intramedullary Nail introduce no new issues of safety or effectiveness.
Nonclinical Testing:
All necessary testing has been performed for the worst-case Flex-Thread Clavicle Pin and Cross Screw to assure substantial equivalence to its predicates and to demonstrate the subject device performs as intended. All testing was performed on test units representative of finished devices.
The Flex-Thread Clavicle Pin System performance was characterized through the following tests:
- Insertion & Removal Testing
- o Static & Fatigue 4-Point Bending Testing
- Tensile Testing ●
- Torsion Testing o
- o Implant Tip Flexibility Testing
Clinical data were not needed to support the safety and effectiveness of the subject device.
Substantial Equivalence:
Side-by-side performance testing demonstrates the substantial equivalence of the Flex-Thread Clavicle Pin System to the Elastic Intramedullary Nail predicate device. The Flex-Thread Clavicle Pin System is substantially equivalent to the Elastic Intramedullary Nail (K971783, K053105, K042135, K081452, K082148), AOS Clavicle Intramedullary Device (K143204) and CRx Clavicle Fracture Repair Device (K081832, K100112) with respect to its indications for use, design, performance and function.