Versalock Mini and Micro Plating System is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation of the hand and foot. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone.

Device Description

Versalock Mini and Micro Plating System consists of plates and screws in a variety of designs and sizes that are commonly used in trauma and reconstructive surgery. The bone plates are made from commercially pure titanium allov and the bone screws are manufactured from titanium alloy only. The plates range in thickness from 0.6 to 1.7 mm, and the screws range in diameter from 1.3 to 2.7 mm. They are available on different sizes and shapes, according to the implantation site and the extension of the fracture. Versalock Mini and Micro Plating System are for single use. The devices are provided non-sterile and must being properly cleaned and sterilized before use, according to the recommendations provided in the Instructions for Use.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Versalock Mini and Micro Plating System." As such, it describes the device and its intended use, and argues for its substantial equivalence to previously cleared predicate devices. It does not present acceptance criteria for a device's performance, nor a study proving it meets such criteria in terms of clinical or diagnostic efficacy.

Instead, the provided text describes the mechanical performance testing conducted to demonstrate substantial equivalence to predicate devices, which is a different type of evaluation.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study effect size, standalone performance, training set details) are not applicable or available in this document.

Here's a breakdown of what is available based on the given text:

1. A table of acceptance criteria and the reported device performance

This document does not present specific acceptance criteria in terms of clinical or diagnostic performance, nor does it report such performance for the device. Instead, it states that:

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical performance in accordance with ASTM F382 (for plates), ASTM F3437 (for screws), and ASTM F543 (for screws).	"Based on submitted testing data, the subject device is equivalent to the predicate devices." (Page 5)

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not applicable. This document refers to mechanical testing, not a clinical trial or diagnostic study with a "test set" of patient data. The "sample size" would refer to the number of plates and screws tested mechanically. This specific number is not provided in the document.
Data Provenance: Not applicable. The data provenance would be from laboratory mechanical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is for fracture fixation, and the evaluation here is mechanical equivalence, not a diagnostic or clinical efficacy study requiring expert-established ground truth on patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no "adjudication method" described for mechanical testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical bone plating system, not an AI-powered diagnostic device, and therefore no MRMC study would be relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical bone plating system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For the mechanical testing, the "ground truth" would be established by the ASTM standard test methods (e.g., defined load limits, displacement measurements, failure points).

8. The sample size for the training set

Not applicable. This is a physical device, and the evaluation is for mechanical equivalence to predicate devices, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. See above.

Summary

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November 21, 2024

GM Dos Reis Industria e Comercio Ltda Guilherme Esteves Pontes Regulatory Affairs Analyst Avenida Pierre Simon de La Place, 600 Campinas, SP 13069320 Brazil

Re: K242596

Trade/Device Name: Versalock Mini and Micro Plating 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, HWC Dated: September 17, 2024 Received: September 17, 2024

Dear Guilherme Esteves Pontes:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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,

CHRISTOPHER FERREIRA -S

Christopher Ferreira, MS 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

Submission Number (if known)

K242596

Device Name

Versalock Mini and Micro Plating System

Indications for Use (Describe)

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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Premarket Notification 510(k) - FDA

510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92.

l. Submitter:

GM Dos Reis Industria e Comercio Ltda Avenida Pierre Simon de La Place 600 Campinas, São Paulo, Brazil 13069-320 Guilherme Esteves Pontes, Regulatory Affairs Analyst Phone: +55 (19) 3765-9900 Email: qualidade4@gmreis.com.br Date prepared: August 30, 2024

II. Device Name:

Trade Name:	Versalock Mini and Micro Plating System
Common Name:	Plate, fixation, bone; Screw, fixation, bone
Classification Name:	Single/Multiple Component Metallic Bone Fixation Appliances and Accessories
Device Class:	II
Product Codes:	HRS; HWC
Regulation Number:	21 CFR 888.3030; 21 CFR 888.3040

III. Predicate Devices:

Legally marketed devices to which we are claiming "Substantial Equivalence" are the following: Mini and Micro Fragments Reconstruction System - GMReis (K182718) (Primary predicate device); Mini and Micro Fragments Reconstruction System - Neofix (K142419) (Additional predicate device);

IV. Device Description:

Versalock Mini and Micro Plating System consists of plates and screws in a variety of designs and sizes that are commonly used in trauma and reconstructive surgery.

The bone plates are made from commercially pure titanium allov and the bone screws are manufactured from titanium alloy only. The plates range in thickness from 0.6 to 1.7 mm, and the screws

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Premarket Notification 510(k) - FDA

range in diameter from 1.3 to 2.7 mm. They are available on different sizes and shapes, according to the implantation site and the extension of the fracture.

Versalock Mini and Micro Plating System are for single use. The devices are provided non-sterile and must being properly cleaned and sterilized before use, according to the recommendations provided in the Instructions for Use.

V. Statement of Indications for Use of the Device:

VI. Comparison of Technological Characteristics with The Predicate Device:

The subject and predicate devices have the same basic design and intended use. Differences between them include additional models and indication. Both are packed using the same materials and are to be sterilized by the same methods. All of the subject device final finished components are manufactured in the same facilities using identical materials and identical manufacturing processes as used for the previously cleared predicate devices in K182718, and therefore are substantially equivalent to the predicates with regard to materials and biocompatibility.

VII. Performance Data:

The performance of the subject devices are demonstrated through mechanical testing of plates and screws according to ASTM F382, ASTM F3437 and ASTM F543, respectively. Based on submitted testing data, the subject device is equivalent to the predicate devices.

VIII. Conclusions:

The Versalock Mini and Micro Plating System has the basic design features and intended use as the predicates. Any differences between them are considered minor and do not raise questions concerning safety or effectiveness. Based on the information provided, GMReis has determined that the proposed device is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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.