(105 days)
Not Found
No
The 510(k) summary describes a mechanical system for bone fixation and does not mention any software, image processing, or AI/ML terms.
No.
The device is described as providing compression to bones and bone fragments for fracture fixation, fusions, or osteotomies, which is an orthopedic surgical function, not a therapeutic intervention.
No.
The device is used for bone fixation and compression, not for diagnosing medical conditions.
No
The device description explicitly states it consists of physical components (screws, sleeves, and washers) which are implanted, indicating it is a hardware medical device.
Based on the provided information, the Frag-Loc® System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide compression to bones and bone fragments for the fixation of fractures, fusions, or osteotomies." This describes a surgical implant used to treat a physical condition within the body.
- Device Description: The device consists of "screws, sleeves, and washers which are implanted from opposite ends of a bone." This further confirms it's an implantable surgical device.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health. The Frag-Loc® System does not perform this function.
Therefore, the Frag-Loc® System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Frag-Loo® System is intended to provide compression to bones and bone fragments for the fixation of fractures, fusions, or osteotomies.
Product codes
HTN, HWC
Device Description
The Frag-Loc® System consists of various sizes of screws, sleeves, and washers which are implanted from opposite ends of a bone in order to provide compression to bones and bone fragments for the fixation of fractures, fusions, or osteotomies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones and bone fragments
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
The new Frag-Loc® System components were subjected to axial pull-out and 4-point bend testing to characterize their strength. The results demonstrate that the acceptance criteria defined in the Design Control Activities Summary were met.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
| 510(k) Summary | |
|---|---|
| Device Trade Name: | Frag-Loc® System |
| Manufacturer: | Acumed, LLC |
| 5885 NW Cornelius Pass Road | |
| Hillsboro, OR 97124 | |
| Contact: | Ms. Kara Budor |
| Regulatory Specialist | |
| Phone: 503.207.1412 | |
| Fax: 503.520.9618 | |
| 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: | July 22, 2013 |
| Classification: | 21 CFR 888.3030, Single/multiple component metallic bone |
| fixation appliances and accessories | |
| Class: | II |
| Product Codes: | HTN: HWC |
| JUL 2 3 2013 |
Indications For Use:
The Frag-Loo® System is intended to provide compression to bones and bone fragments for the fixation of fractures, fusions, or osteotomies.
Device Description:
The Frag-Loc® System consists of various sizes of screws, sleeves, and washers which are implanted from opposite ends of a bone in order to provide compression to bones and bone fragments for the fixation of fractures, fusions, or osteotomies.
Predicate Device:
The subject Frag-Loc® System is substantially equivalent to the predicate Trans-Osseous Bolt (K982354) with respect to intended use, geometry, and method of fixation. Although the materials in these systems differ, both are made of biocompatible metals and the testing summarized in the Design Control Activities Summary demonstrates that the Frag-Loc® System met the pre-determined acceptance criteria for the verification activities.
1
Preclinical Testing:
The new Frag-Loc® System components were subjected to axial pull-out and 4-point bend testing to characterize their strength. The results demonstrate that the acceptance criteria defined in the Design Control Activities Summary were met.
2
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 23, 2013
Acumed, LLC % Ms. Kara Budor Regulatory Specialist 5885 North West Cornelius Pass Road Hillsboro, Oregon 97124
Re: K130986
Trade/Device Name: Frag-Loc® System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN, HWC Dated: June 7, 2013 Received: June 10, 2013
Dear Ms. Budor:
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 (2 1 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
3
Page 2 - Ms. Kara Budor
forth in the quality systems (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/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 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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Erin |: Keith
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use 4.
510(k) Number (if known): K130986
Device Name: Frag-Loc® System
The Frag-Loc® System is intended to provide compression to bones and bone fragments for the fixation of fractures, fusions, or osteotomies.
ー Prescription Use __ (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lori A. Wiggins
Division of Orthopedic Devices