K Number
K211650
Device Name
The Radian MIS Bunion System
Date Cleared
2021-11-24

(180 days)

Product Code
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Radian MS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.
Device Description
The Radian MIS Bunion System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the first metatarsal in the correction of a bunion. The plate has 4 screw-receiving holes. It is designed to allow for intramedullary insertion of the 2 proximal screws and medial insertion of the 2 distal screws. The plate is provided in 1 size and 1 configuration that can be used across all patient anatomy. The locking 3.0mm diameter titanium screws are designed in lengths of 14mm to 30mm in increments of 2mm. The system is provided non-sterile.
More Information

No
The device description and performance studies focus on the mechanical properties of a bone fixation system (plate and screws) and do not mention any software, algorithms, or data processing that would indicate the use of AI/ML.

No

This device is an implant for bone fixation, specifically for bunion correction, and is not designed to provide therapeutic treatment itself.

No
The device is a bone fixation system for surgical correction of bunions, not a diagnostic tool.

No

The device description clearly states it is a "single-use bone fixation device intended to be permanently implanted" and consists of "a titanium alloy plate and screws." This indicates a physical hardware device, not software.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states it's for "fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus." This describes a surgical procedure performed directly on the patient's body.
  • Device Description: The device is described as a "single-use bone fixation device intended to be permanently implanted." This is a physical implant used in surgery.
  • IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.

The Radian MS Bunion System is a surgical implant, not a device used for testing samples outside the body.

N/A

Intended Use / Indications for Use

The Radian MS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.

Product codes

HRS

Device Description

The Radian MIS Bunion System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the first metatarsal in the correction of a bunion. The plate has 4 screw-receiving holes. It is designed to allow for intramedullary insertion of the 2 proximal screws and medial insertion of the 2 distal screws. The plate is provided in 1 size and 1 configuration that can be used across all patient anatomy. The locking 3.0mm diameter titanium screws are designed in lengths of 14mm to 30mm in increments of 2mm. The system is provided non-sterile.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hallux

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)

No FDA performance standards have been established for the Radian MIS Bunion System. The following testing was performed:

  • Static and dynamic bending (per ASTM F382) ●
  • Engineering analysis to evaluate screw mechanical strength
    The results of these tests indicate that the Radian MIS Bunion System is substantially equivalent to the predicate devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K212487, K172178, K181872

Reference Device(s)

K202657

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

November 24, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

Nvision Biomedical Technologies, Inc % Analaura Villarreal-Berain Extremity Project Engineer Nvision Biomedical Technologies 4590 Lockhill Selma San Antonio, Texas 78249

Re: K211650

Trade/Device Name: The Radian MIS Bunion 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 Dated: October 27, 2021 Received: October 28, 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.

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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 -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K211650

Device Name Radian MIS Bunion System

Indications for Use (Describe)

The Radian MS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K211650

Image /page/3/Picture/2 description: The image shows the logo for Nvision Biomedical Technologies. The logo features a stylized letter N with horizontal lines on the left side, followed by the word "VISION" in bold, sans-serif font. Below the main text, the words "biomedical technologies" are written in a smaller, italicized font, with a gold color scheme.

510(k) Summary

DATE PREPARED

November 23, 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

Radian MIS Bunion System

COMMON NAME Bone Plate

DEVICE CLASSIFICATION

Single/multiple component metallic bone fixation appliances and accessories (Classification Regulations: 21 CFR 888.3030, Product Codes: HRS, Class: II)

PREMARKET REVIEW

Orthopedic Device Panel

INDICATIONS FOR USE

The Radian MIS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.

DEVICE DESCRIPTION

The Radian MIS Bunion System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the first metatarsal in the correction of a bunion. The plate has 4 screw-receiving holes. It is designed to allow for intramedullary insertion of the 2 proximal screws and medial insertion of the 2 distal screws. The plate is provided in 1 size and 1 configuration that can be used across all patient anatomy. The locking 3.0mm diameter titanium screws are designed in lengths of 14mm to 30mm in increments of 2mm. The system is provided non-sterile.

PREDICATE DEVICE IDENTIFICATION

The Radian MIS Bunion System is substantially equivalent to the following predicates:

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Image /page/4/Picture/2 description: The image is a logo for NVision biomedical technologies. The logo features the letter N with a series of lines to the left of it. To the right of the N is the word VISION in a bold, sans-serif font. Below the logo is the phrase "biomedical technologies" in a smaller, italicized font.

510(k) NumberPredicate Device Name / ManufacturerPredicate
K212487In2Bones USA CoLink Vallux Plating SystemPrimary
K172178Trilliant Surgical LTD– Minimally Invasive Bunion
Plating SystemAdditional
K181872CrossRoads Extremity Systems, LLC - MIS Bunion
SystemAdditional
K202657Nvision Biomedical's Javelin Tailor's Bunion Fixation
SystemReference

SUMMARY OF NON-CLINICAL TESTING

No FDA performance standards have been established for the Radian MIS Bunion System. The following testing was performed:

  • Static and dynamic bending (per ASTM F382) ●
  • Engineering analysis to evaluate screw mechanical strength

The results of these tests indicate that the Radian MIS Bunion System is substantially equivalent to the predicate devices.

EQUIVALENCE TO PREDICATE DEVICES

Nvision believes that the Radian MIS Bunion System is substantially equivalent to the predicate devices. The subject plates are similar to the predicates in that the geometry, thicknesses and lengths are similar, they are intended for use with ancillary screws, and they incorporate the similar number of ancillary screws. Furthermore, the ancillary screws are similar in size. The implants from the Radian MIS Bunion System are manufactured using Titanium and the instruments using medical grade Stainless Steel, identical to Javelin Tailor's Bunion Fixation System (K202657).

CONCLUSION

Based on the testing performed, including static and dynamic bending, and engineering analysis, 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 Radian MIS Bunion System are assessed to be substantially equivalent to the predicate devices.