(109 days)
No
The summary describes a mechanical fixation device and surgical tools, with no mention of AI or ML capabilities.
Yes
The device is indicated for fixation of osteotomies and reconstruction of lesser toes following hammertoe, claw toe, and mallet toe correction procedures, which are considered therapeutic interventions.
No
The device is described as a "fixation device" for "osteotomies and reconstruction of the lesser toes." It is used after correction procedures, indicating a therapeutic or reconstructive purpose rather than diagnosing a condition.
No
The device description explicitly states it is comprised of a sterile PEEK HA fixation device and includes hardware components like K-wires, drills, taps, and inserters.
Based on the provided information, the Vector Hammertoe Correction System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of osteotomies and reconstruction of the lesser toes following surgical procedures. This is a therapeutic intervention performed on the patient's body, not a test performed on a sample taken from the patient's body to diagnose a condition.
- Device Description: The device is a physical implant (PEEK HA fixation device) and associated surgical tools (K-wires, drill, taps, etc.). These are used in a surgical setting.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Vector Hammertoe Correction System does not fit this description.
N/A
Intended Use / Indications for Use
The Vector Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
Product codes
HWC
Device Description
The VECTOR Hammertoe Correction System is comprised of a sterile PEEK (polyetheretherketone) HA (hydroxyapatite) fixation device. The implants are offered in Ø3.50mm and Ø4.00mm and in 0° angle. The system has K-wires, drill, taps, implant inserters, and sizers manufactured from medical grade stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lesser toes
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)
The following tests were performed to demonstrate safety based on recognized consensus standards and current industry practice:
- Torsion, driving torque, and axial pullout (per ASTM F543), as well as static and dynamic bending
- . The device has been tested (LAL testing) to meet recommended Bacterial Endotoxins limits of 20 EU/device.
The results of these tests, as well as engineering analysis of device characteristics, indicate that the VECTOR Hammertoe Correction System is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
February 19, 2019
Nvision Biomedical Technologies, LLC % Jeffrey Brittan Consultant Watershed Ideas Foundry 1815 Aston Avenue, Suite 106 Carlsbad, California 92008
Re: K183055
Trade/Device Name: VECTOR Hammertoe Correction System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: January 17, 2019 Received: January 18, 2019
Dear Mr. Brittan:
We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurence D. Coyne -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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name VECTOR Hammertoe Correction System
Indications for Use (Describe)
The Vector Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
| 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) |
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) Summary
DATE PREPARED
February 7, 2019
MANUFACTURER AND 510(k) OWNER
Nvision Biomedical Technologies, LLC 4754 Shavano Oak, Suite 101 San Antonio, TX 78249, USA Telephone: (210) 545-3713 (866) 764-1139 Fax: Official Contact: Diana Langham, Director of Regulatory and Corporate Compliance
REPRESENTATIVE/CONSULTANT
Jeffrey Brittan Watershed Ideas Foundry Telephone: (714) 287-6780 Email: jeffbrittan@watershedideas.com
PROPRIETARY NAME OF SUBJECT DEVICE
VECTOR™ Hammertoe Correction System
COMMON NAME Bone Fixation Screw
DEVICE CLASSIFICATION
Smooth or Threaded Metallic Bone Fixation Fastener (Classification Regulations: 21 CFR 888.3040, Product Codes: HWC, Class: II)
PREMARKET REVIEW
ODE/DOD/Joint and Fixation Devices (JFDB2) Orthopedic Panel
INDICATIONS FOR USE
The Vector Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
DEVICE DESCRIPTION
The VECTOR Hammertoe Correction System is comprised of a sterile PEEK (polyetheretherketone) HA (hydroxyapatite) fixation device. The implants are offered in Ø3.50mm and Ø4.00mm and in 0° angle. The system has K-wires, drill, taps, implant inserters, and sizers manufactured from medical grade stainless steel.
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PREDICATE DEVICE IDENTIFICATION
The Vector Hammertoe Correction System is substantially equivalent to the following predicates:
| 510(k) Number | Predicate Device Name / Manufacturer |
|---|---|
| K133636 | Extremity Medical HammerFIX Device* (primary) |
| K112675 | Arrowhead Medical Arrow-Lok Digital System** (secondary) |
- Additional HammerFIX clearances include K152710
** Additional Arrow-Lok clearances include K100926
The following reference devices are also cited:
| 510(k) Number | Reference Device Name / Manufacturer |
|---|---|
| K151785 | Innovasis Px HA PEEK IBF System |
| K162426 | Nvision Nva, Nvp, and Nvt Systems |
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for the Vector Hammertoe Correction System. The following tests were performed to demonstrate safety based on recognized consensus standards and current industry practice:
- Torsion, driving torque, and axial pullout (per ASTM F543), as well as static and dynamic bending
- . The device has been tested (LAL testing) to meet recommended Bacterial Endotoxins limits of 20 EU/device.
The results of these tests, as well as engineering analysis of device characteristics, indicate that the VECTOR Hammertoe Correction System is substantially equivalent to the predicate devices.
EQUIVALENCE TO PREDICATE DEVICES
Nvision believes that the Vector Hammertoe Correction System is substantially equivalent to the predicate devices based on the information summarized here.
The subject device system has a similar design, similar dimensions, and uses similar or identical materials as the devices cleared K133636, K112675, K151785, and K162426. The subject device also has the same intended use, as well as similar technological characteristics as these predicates (orthopedic fixation implants in a range of sizes). The Indications for Use for the predicates are equivalent and these technological characteristics have undergone testing and engineering analysis to ensure the subject system is as safe and effective as the predicates.
Bone fixation is the technological principle for both the subject and predicate devices. It is based on use of an implant for the fixation of osteotomies and reconstruction of the lesser toe following correction procedures for hammertoe, claw toe, and mallet toe. At a high level, subject and primary predicate device equivalence is based on the following same technical elements:
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- Screw and barbed segments for fixation to bone
- Cannulation that accommodates use over a k-wire ●
- Use of an insertion instrument for delivery ●
The following technological differences exist between the subject and primary predicate device:
- Inclusion of a marker for radiographic visualization
- The subject device is manufactured from PEEK HA, whereas the predicate device is PEEK
CONCLUSION
Based on the testing performed, including torsion, driving torque, pullout, and static and dynamic bending, as well as engineering analysis of device characteristics, it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed Vector Hammertoe Correction System are assessed to be substantially equivalent to the predicate devices.