(137 days)
Not Found
No
The description focuses on mechanical components and testing, with no mention of AI/ML terms or functionalities.
Yes
The device is described as "implantable titanium alloy bone plates and fasteners used for the repair of fractures, osteotomies, and non-unions of upper extremity diaphyses," which directly indicates its use in the treatment and healing of medical conditions, thereby serving a therapeutic purpose.
No
This device is described as an implantable system of plates and fasteners for repairing fractures and non-unions, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states that the system consists of implantable titanium alloy bone plates and fasteners, as well as specialized stainless steel instrumentation. These are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is intended for the repair of fractures, osteotomies, and non-unions of upper extremity diaphyses. This is a surgical/implantable device used directly on the patient's body.
- Device Description: The description clearly states it consists of implantable bone plates and fasteners, along with instrumentation for installation. This is consistent with a surgical implant system.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) for structural support and repair.
N/A
Intended Use / Indications for Use
The WOLF® Long Bone Plate system is indicated for fractures, osteotomies, and non-unions of upper extremity diaphyses.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The TOBY® WOLF® Long Bone Plate system consists of implantable titanium alloy bone plates and fasteners used for the repair of fractures, osteotomies, and non-unions of upper extremity diaphyses. The system includes specialized stainless steel instrumentation that is provided to assist with the installation of the bone plates and fasteners.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper extremity diaphyses
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)
Substantial equivalence is demonstrated between the TOBY @ WOLF® Long Bone Plate system and the predicate device systems listed above through the review of various performance data. Substantial equivalence has been determined through a 20-point comparison of technological features and a multiparameter comparison of mechanical performance. The design features are similar in the device systems, as are the indications for use. Results from stiffness. strength and fatigue testing per ASTM F382-99, and screw pullout testing, demonstrate that the WOLF® Long Bone Plate system is safe and effective, and substantially equivalent to the predicate devices.
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.
Synthes LCP System - K082807, Synthes 1/3 Tubular DCL Plate - K011335, Acumed Congruent Bone Plate System - K012655, K102998
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
§ 888.3030 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.
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Image /page/0/Picture/0 description: The image shows the logo for Toby Orthopaedics. The logo consists of a stylized letter "T" inside a circle on the left, followed by the word "TOBY" in bold, sans-serif font. Below the word "TOBY" is the word "ORTHOPAEDICS" in a smaller, sans-serif font. The logo is black and white.
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K131834 page 1 of 2
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510(k) Summary
| Submitted By: | Toby Orthopaedics
401 SW 42nd Ave, Suite 200
Miami, FL 33134 USA
Phone: (866) 979-8629
Fax: (305) 768-0269 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name: | Eric Neyhard |
| Date Prepared: | June 18th, 2013 |
| Trade Name: | WOLF® Long Bone Plate System |
| Common Name: | Bone Plate |
| Classification: | 21 CFR 888.3030 - Single / multiple component
metallic bone fixation appliances and accessories |
| Predicate Devices: | Synthes LCP System - K082807
Synthes 1/3 Tubular DCL Plate - K011335
Acumed Congruent Bone Plate System - K012655,
K102998 |
| Device Description: | The TOBY® WOLF® Long Bone Plate system consists
of implantable titanium alloy bone plates and fasteners
used for the repair of fractures, osteotomies, and non-
unions of upper extremity diaphyses. The system
includes specialized stainless steel instrumentation that
is provided to assist with the installation of the bone
plates and fasteners. |
| Intended Use: | The WOLF® Long Bone Plate system is indicated for
fractures, osteotomies, and non-unions of upper
extremity diaphyses. |
| Technological
Characteristics: | A comparison of the technological characteristics and
performance characteristics of the WOLF® Long Bone
Plate system and the predicate devices was performed.
The devices were found to be substantially equivalent.
NOV 04 2013 |
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Image /page/1/Picture/0 description: The image shows the logo for TOBY Orthopaedics. The logo consists of a stylized letter "T" inside of a circle on the left, followed by the word "TOBY" in bold, sans-serif font. Below the word "TOBY" is the word "ORTHOPAEDICS" in a smaller, sans-serif font.
Performance Data:
The TOBY @ WOLF & Long Bone Plate system complies with the requirements of listed FDA Recognized Consensus Standards.
- · ASTM F136-12a, Standards Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
- · ASTM F899-12b, Standard Specification for Wrought Stainless Steels for Surgical Instruments
The implantable and tissue contact materials used to fabricate the WOLF® Long Bone Plate system components have a long history of safe usage in medical devices. The materials of construction are safe and effective, and similar to those used in the predicate device system.
Substantial equivalence is demonstrated between the TOBY @ WOLF® Long Bone Plate system and the predicate device systems listed above through the review of various performance data. Substantial equivalence has been determined through a 20-point comparison of technological features and a multiparameter comparison of mechanical performance. The design features are similar in the device systems, as are the indications for use. Results from stiffness. strength and fatigue testing per ASTM F382-99, and screw pullout testing, demonstrate that the WOLF® Long Bone Plate system is safe and effective, and substantially equivalent to the predicate devices.
2
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The words are arranged on a single line and centered.
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle emblem to the right of the department's name, which is arranged in a circular fashion. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The eagle emblem is composed of three curved lines that form the shape of an eagle's head and wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 4. 2013
TOBY ORTHOPAEDICS Mr. Eric Neyhard Chief Operating Officer 1805 Ponce de Leon Boulevard, Suite 501 Coral Gables, Florida 33134
Re: K131834
Trade/Device Name: WOLF® Long Bone Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Date: October 3, 2013 Received: October 4, 2013
Dear Mr. Neyhard:
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
3
Page 2 - Mr. Eric Neyhard
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Erin DKeith
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): __K131834
Device Name: WOLF® Long Bone Plate System
Indications For Use: The WOLF® Plate system is indicated for fractures, osteotomies, and non-unions of upper extremity diaphyses.
× 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth L. Frank -S
Page 1 of 1
Division of Orthopedic Devices