(78 days)
Not Found
No
The summary describes a mechanical device (wires for external fixation) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used to treat various musculoskeletal conditions such as fractures, joint contractures, limb lengthening, and bony/soft tissue defects, indicating a therapeutic purpose.
No
The Ilizarov Drill Tip Wires are intended for surgical fixation and stabilization of bones and joints, not for diagnosing medical conditions.
No
The device is described as "implantable anchorage elements" made of "implant grade stainless steel material" and is subject to "Preclinical bench testing" including "Cutting performance of the wire". This clearly indicates a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes the Ilizarov Drill Tip Wires as implantable anchorage elements used in a surgical external fixation system. Their intended uses are for treating fractures, deformities, and joint issues through mechanical means (fixation, distraction, lengthening).
- Lack of Biological Sample Testing: There is no mention of the device being used to test biological samples or provide diagnostic information based on such testing.
The device is a surgical implant used for mechanical support and manipulation of bone and tissue, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
Ilizarov Drill Tip Wires are intended to be used for the following indications:
Post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; open and closed fracture fixation; pseudoarthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; and infected fractures or nonunions.
Ilizarov Drill Tip Wires are for single use only.
Product codes
KTT
Device Description
The subject Ilizarov Drill Tip Wires are comprised of implantable anchorage elements designed for use in a multilateral (i.e. a circular) fixator assembly comprised of a structurally purposeful arrangement of simple or complex bridge elements, connection elements and anchorage elements. The subject devices are manufactured from implant grade stainless steel material. Compared to the predicate devices, the subject devices will be available in the following configurations:
Device Type: Ilizarov Drill Tip Wire, 1.8mm x 400mm, Diameter: 1.8mm, Length: 400mm
Device Type: Ilizarov Drill Tip Wire with Stopper, 1.8mm x 400mm, Diameter: 1.8mm, Length: 400mm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Pre-clinical bench testing was conducted on the subject Ilizarov Drill Tip Wires. Mechanical test results were compared against predicate devices. The specific type of pre-clinical testing conducted is described as: Cutting performance of the wire including: number of start/stops prior until failure, time to insertion and insertion temperature.
Based on similarities in design and on the results of mechanical testing, the subject device is substantially equivalent to predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K994143, K093047, K870961, K090675, K962808
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
K130479 510(k) Summary of Safety and Effectiveness
| Ilizarov Drill Tip Wires | MAY 14 2013 | ||
|---|---|---|---|
| Submitted By: | Smith & Nephew, Inc. | ||
| Orthopaedic Division | |||
| 1450 Brooks Road | |||
| Memphis, TN 38116 | |||
| Date: | May 10, 2013 | ||
| Contact Person: | David Henley, Regulatory Affairs Project Manager | ||
| Tel: (901) 399-6487 Fax: (901) 566-7079 | |||
| Proprietary Name: | Ilizarov Drill Tip Wires | ||
| Common Name: | Multilateral Fixators and Accessories | ||
| Classification Name and Reference: | 21 CFR 888.3030, single/multiple component metallic bone fixation appliance and accessories - Class II | ||
| Device Product Code and Panel Code: | KTT / Orthopedics / 87 |
Device Description:
The subject Ilizarov Drill Tip Wires are comprised of implantable anchorage elements designed for use in a multilateral (i.e. a circular) fixator assembly comprised of a structurally purposeful arrangement of simple or complex bridge elements, connection elements and anchorage elements. The subject devices are manufactured from implant grade stainless steel material. Compared to the predicate devices, the subject devices will be available in the following configurations:
| Device Type | Diameter | Length |
|---|---|---|
| Ilizarov Drill Tip Wire, 1.8mm x 400mm | 1.8mm | 400mm |
| Ilizarov Drill Tip Wire with Stopper, | ||
| 1.8mm x 400mm | 1.8mm | 400mm |
Intended Use:
Ilizarov Drill Tip Wires are intended to be used for the following indications:
Post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; open and closed fracture fixation; pseudoarthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; and infected fractures or nonunions.
Ilizarov Drill Tip Wires are for single use only.
Technological Characteristics:
Ilizarov Drill Tip Wires are very similar to legally marketed predicate devices listed below in that they share identical or very similar indications for use, are manufactured from stainless steel material and incorporate identical or very similar technological design characteristics.
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Substantial Equivalence Information:
When compared to the predicate devices listed below, substantial equivalence is based on identical or very similar design features, overall indications for use, and raw material composition.
- . Smith & Nephew Smooth and Olive Wires - K994143
- Ilizarov Drill Tip Wires K093047 .
- . Richards Transfixation Wires - K870961
- Smith & Nephew Drill Tip Kirschner Wires (K-wires) K090675 .
- . llizarov External Fixation System – Titanium Wires and Washers – K962808
Preclinical Testing:
To further support a determination of substantial equivalence, pre-clinical bench testing was conducted on the subject Ilizarov Drill Tip Wires. Mechanical test results were compared against predicate devices. The specific type of pre-clinical testing conducted is described as:
- . Cutting performance of the wire including: number of start/stops prior until failure, time to insertion and insertion temperature
Conclusion:
Based on similarities in design and on the results of mechanical testing, the subject device is substantially equivalent to predicates.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes that resemble a human figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
Letter dated: May 14, 2013
Smith and Nephew, Incorporated % Mr. David Henley Regulatory Affairs Project Manager 1450 Brooks Road Memphis, Tennessee 38116
Re: K130479
Trade/Device Name: Ilizarov Drill Tip Wires Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: March 15, 2013 Received: March 18, 2013
Dear Mr. Henley:
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. David Henley
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 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 yours,
Mark Nigeljierson -S
Mark N. Melkerson Director Division of Orthonedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Premarket Notification Indications for Use Statement
510(k) Number (if known): K130479
Device Name: Ilizarov Drill Tip Wires
Indications for Use:
llizarov Drill Tip Wires are intended to be used for the following indications:
- Post-traumatic joint contracture which has resulted in loss of range of motion .
- Fractures and disease which generally may result in joint contractures or loss of . range of motion and fractures requiring distraction
- . Open and closed fracture fixation
- . Pseudoarthrosis of long bones
- Limb lengthening by epiphyseal or metaphyseal distraction �
- Correction of bony or soft tissue deformities �
- Correction of bony or soft tissue defects
- Joint arthrodesis
- Infected fractures or nonunions
Ilizarov Drill Tip Wires are for single use only.
Prescription Use AND/OR Over-the-Counter Use י (Part 21 CFR 801 Subpart D) י (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D.
Division of Orthopedic:Devices
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