(30 days)
No
The summary describes a mechanical fixation system and does not mention any AI or ML components or functionalities.
No
This device is a surgical implant used for fixation of osteotomies and reconstruction of lesser toes, not a therapeutic device in the sense of providing treatment or therapy directly.
No
The device is described as a "fixation device" for "osteotomies and reconstruction of the lesser toes." It is used for correction procedures, not for diagnosing conditions.
No
The device description explicitly states it is comprised of a sterile PEEK HA fixation device and includes K-wires, drill, taps, implant inserters, and sizers, all of which are hardware components.
Based on the provided information, this device 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 correction procedures for hammertoe, claw toe, and mallet toe." This describes a surgical implant used in vivo (within the body) for structural support and repair.
- Device Description: The device is a "sterile PEEK (polyetheretherketone) HA (hydroxyapatite) fixation device" with associated surgical tools. This is consistent with a surgical implant and its delivery system.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any such use or interaction with biological specimens for diagnostic purposes.
Therefore, the Vector Hammertoe Correction System is a surgical implant, not an IVD.
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 Ø3.00mm, 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
Prescription Use (Part 21 CFR 801 Subpart D)
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
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for the Vector Hammertoe Correction System. The following was performed to demonstrate safety per methods of the previous submission:
- . Engineering analysis comparing device characteristics including materials, intended use and processes (cleaning and sterilization methods)
The results of this comparison indicate that the Vector Hammertoe Correction System is substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K201850 Nvision Biomedical's Vector Hammertoe, K183055 Correction System
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
November 19, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Nvision Biomedical Technologies. Inc Analaura Villarreal-Berain Extremity Project Engineer 4590 Lockhill Selma San Antonio, Texas 78249
Re: K213421
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: October 11, 2021 Received: October 20, 2021
Dear Analaura Villarreal-Berain:
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. 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/cdrh/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.
1
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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K213421
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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
DATE PREPARED
November 18, 2021
MANUFACTURER AND 510(k) OWNER
Nvision Biomedical Technologies, Inc. 4590 Lockhill Selma San Antonio, TX 78249, USA Telephone: (210) 545-3713 Fax: (866) 764-1139 Official Contact: Diana Langham, Director of Regulatory and Corporate Compliance
REPRESENTATIVE
Analaura Villarreal-Berain, Extremity Project Engineer Nvision Biomedical Technologies Telephone: (210) 545-3713 ext. 109 Email: analauravillarreal(@nvisionbiomed.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
Orthopedic Devices
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 Ø3.00mm, 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.
PREDICATE DEVICE IDENTIFICATION
The subject Vector Hammertoe Correction System is substantially equivalent to the following predicates:
4
| 510(k) Number | Predicate Device Name / Manufacturer | Predicate |
|---|---|---|
| K201850 | Nvision Biomedical's Vector Hammertoe | Primary |
| K183055 | Correction System | Additional Predicate |
Nvision Biomedical's nva, nvt (K193645) is also cited in this submission as a reference predicate device.
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for the Vector Hammertoe Correction System. The following was performed to demonstrate safety per methods of the previous submission:
- . Engineering analysis comparing device characteristics including materials, intended use and processes (cleaning and sterilization methods)
The results of this comparison 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 modification is substantially equivalent to the predicate devices. The subject implants maintain the same features as the previously cleared devices, but steam sterilization is being added as an alternative sterilization method, which is commonly used for medical devices such as the predicates. This modification does not change the intended use or performance of the device and does not raise additional questions of substantial equivalence. These technological characteristics have undergone a comparison of characteristics to ensure the device is as safe and effective as the predicates.
CONCLUSION
Based on the comparison 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 options are assessed to be substantially equivalent to the predicate devices.