(291 days)
No
The device description focuses solely on the mechanical components and assembly of an external fixator. There is no mention of software, algorithms, or any capabilities that would suggest the use of AI or ML.
Yes
The device is used for external fixation in the treatment of long- and short-bone trauma and reconstruction, which are therapeutic interventions.
No
Explanation: The device is an external fixator used for the treatment of bone trauma and reconstruction, which is a therapeutic purpose, not a diagnostic one. It physically stabilizes bones rather than providing information for diagnosis.
No
The device description explicitly lists multiple hardware components made of titanium and stainless steel, such as rods, pins, clamps, and screws, which are physically implanted or attached to the patient.
Based on the provided information, the Vectrix External Fixator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "external fixation... for the treatment of long- and short-bone trauma and reconstruction." This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details mechanical components (rods, pins, clamps, screws) used to physically stabilize bones.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Vectrix External Fixator does not interact with or analyze such specimens.
Therefore, the Vectrix External Fixator is a surgical device used for external fixation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Vectrix External Fixator is indicated for use in which external fixation is necessary for the treatment of long- and shortbone trauma and reconstruction in adult and pediatic patients, including limb lengthening, pseudarthroses, infected fractures, distraction, arthrodesis, and severe open fractures.
Product codes
NDK
Device Description
The Vectrix External Fixator is a comprehensive and modular external fixator, the design of which is based on a ball collet pin clamp system and consists of:
- 6AL-4V titanium and/or 304SS stainless steel spline . rod (0.125, 0.25, and 0.375 inches in diameter)
- . 6AL-4V titanium and/or 316L stainless steel selftapping, threaded fixation pins (5.0 mm and 4.0 mm thread diameter pins with thread lengths from 25 mm to 75 mm, varying in 5 mm increments; and 3.5 mm thread diameter pins with thread lengths of 15 mm)
- Titanium pin clamps
- Titanium ball collets ●
- Titanium collet caps
- Titanium drive knob ●
- Titanium drive screw ●
Fixation pins are percutaneously inserted into the bone segments and secured with pin clamps to the external spline rod. The choice of thread diameter and length is made by the surgeon on a case-by-case basis. The ball and collet design allows extensive pin rotation and, thus, pin placement freedom.
The system can be assembled in three sizes, determined by the spline rod size. Furthermore, elements of the system may be combined in a wide range of configurations as needed to achieve the external fixation structure best suited for each patient. The drive screw and drive knob can also be added to the spline rod constructs of each size to mediate bone compression and distraction for limb reconstruction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long- and short-bone
Indicated Patient Age Range
adult and pediatric patients
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)
Non-clinical interconnection testing per ASTM 1541-02, Standard Specification and Test Methods for External Skeletal Fixation Devices (A2.8.4 Pin/Clamp Eccentric Loading), was conducted to confirm that the connection mechanisms of the Vectrix External Fixator are equivalent to those of the Torus External Fixation System (K925635).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted 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/1 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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 29, 2014
3D Medical Concepts, LLC Ms. Beverly Laird 1061 Morgan Park Road Pelham, Alabama 35242
Re: K140649
Trade/Device Name: Vectrix External Fixator Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: NDK Dated: October 20, 2014 Received: October 27, 2014
Dear Ms. Laird:
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 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.
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/Resourcesfor You/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 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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known)
K140649
Device Name Vectrix External Fixator
Indications for Use (Describe)
The Vectrix External Fixator is indicated for use in which external fixation is necessary for the treatment of long- and shortbone trauma and reconstruction in adult and pediatic patients, including limb lengthening, pseudarthroses, infected fractures, distraction, arthrodesis, and severe open fractures.
Type of Use (Select one or both, as applicable)
|× Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
Company Name:
3D Medical Concepts, LLC 1061 Morgan Park Rd. Pelham, AL 35124 Phone: (205) 987-0935 Fax: (205) 987-0936
Contact Name: Date Prepared: Trade Name: Common Name: Classification:
Product Code: Predicate Device: Device Description: Dr. Beverly Laird October 20, 2014 Vectrix External Fixator External Fixation Device Class II (21 CFR 888.3040) Smooth or Threaded Metallic Bone Fixation Fastener NDK Torus External Fixation System (K925635) The Vectrix External Fixator is a comprehensive and modular external fixator, the design of which is based on a ball collet pin clamp system and consists of:
- 6AL-4V titanium and/or 304SS stainless steel spline . rod (0.125, 0.25, and 0.375 inches in diameter)
- . 6AL-4V titanium and/or 316L stainless steel selftapping, threaded fixation pins (5.0 mm and 4.0 mm thread diameter pins with thread lengths from 25 mm to 75 mm, varying in 5 mm increments; and 3.5 mm thread diameter pins with thread lengths of 15 mm)
- Titanium pin clamps
- Titanium ball collets ●
- Titanium collet caps
- Titanium drive knob ●
- Titanium drive screw ●
Fixation pins are percutaneously inserted into the bone segments and secured with pin clamps to the external spline rod. The choice of thread diameter and length is made by the surgeon on a case-by-case basis. The ball and collet design allows extensive pin rotation and, thus, pin placement freedom.
The system can be assembled in three sizes, determined by the spline rod size. Furthermore, elements of the system may be combined in a wide range of configurations as needed to achieve the external fixation structure best suited for each
4
| patient. The drive screw and drive knob can also be added to the spline rod constructs of each size to mediate bone compression and distraction for limb reconstruction. | |
|---|---|
| Indications for Use: | The Vectrix External Fixator is indicated for use in cases in which external fixation is necessary for the treatment of long- and short-bone trauma and reconstruction in adult and pediatric patients, including limb lengthening, pseudarthroses, infected fractures, distraction, arthrodesis, and severe open fractures. |
| Substantial Equivalence: | The design, indications, materials, and characteristics of the Vectrix External Fixator are substantially equivalent to the Torus External Fixation System (K925635). |
| Technological | |
| Characteristics | |
| Comparison: | The Vectrix External Fixator was designed in conformance with ASTM F136 (Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI Alloy for Surgical Implant Applications), ASTM F138 (Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673), and ASTM F86 (Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants). All requirements were met for these standards. |
| Performance Data: | Non-clinical interconnection testing per ASTM 1541-02, Standard Specification and Test Methods for External Skeletal Fixation Devices (A2.8.4 Pin/Clamp Eccentric Loading), was conducted to confirm that the connection mechanisms of the Vectrix External Fixator are equivalent to those of the Torus External Fixation System (K925635). |