(451 days)
No
The device description and intended use are solely focused on mechanical components for fracture fixation. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
This device is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation, which are therapeutic medical interventions.
No
Explanation: The device is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly states it is composed of plates and screws made of titanium alloy, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation of the hand and wrist. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is composed of plates and screws made of titanium alloy, designed to be implanted into bone.
- Function: The function of the device is to provide structural support and stability to fractured or damaged bones.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
This device is an implantable surgical device, not an IVD.
N/A
Intended Use / Indications for Use
Mini and Micro Fragments Reconstruction System - GMReis is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation of the hand and wrist. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
Mini and Micro Fragments Reconstruction System – GMReis is composed of plates and screws. The bone plates are made from commercially pure titanium alloy (Ti-4Al-6V) and the bone screws are manufactured from titanium alloy only. The plates range in thickness from 0.6 to 2.0 mm, and the screws range in diameter from 1.5 to 2.7 mm. They are available on different sizes and shapes, according the implantation site and the extension of the fracture.
Mini and Micro Fragments Reconstruction System – GMReis are for single use. The devices are provided non-sterile and must being properly cleaned and sterilized before use, according the recommendations provided in the Instructions for Use.
In order to promote a correct placement of the plates and screws, GMReis has also available a range of instruments (class I exempt) to serve the surgeon such as drills, drill guides, cutting pliers, reamers, screwdrivers, among others. GMReis recommends the use of these instruments in order to ensure the compatibility with the implants and promote the success of the procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand and wrist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified surgeons mastering the surgical technique, having been trained and qualified in osteosyntheses procedures.
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 performance of the subject devices are demonstrated through mechanical testing of plates and screws according to ASTM F382 and ASTM F543, respectively.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K142419 - NEOORTHO Produtos Ortopédicos S/A - Neoortho Productos Orthopedicos S/A (Primary Predicate), K051567 - APTUS® Titanium Fixation System - Medartis, Inc., K100776 - Synthes 2.4mm12.7 mm Variable Angle LCP forefoot/. Midfoot system - Synthes (USA) LP, K081546 - Small Bone Locking Plating System - DePuy Orthopaedics, Inc., K142906 - APTUS® Wrist 2.5 System - Medartis AG
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K180626 – Pedimax II -Pedicular Screw Spinal System - GM dos Reis Indústria e Comércio Ltda
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
December 23, 2019
Gm Dos Reis Industria E Comerico Ltda. % Paula Oliveira Quality Manager Passarini Regulatory Affairs of America, LLC 201 S. Biscayne Blvd. Suite 1200 Miami, Florida 33131
Re: K182718
Trade/Device Name: Mini and Micro Fragments Reconstruction System - GMReis 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: November 18, 2019 Received: November 21, 2019
Dear Paula Oliveira:
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 Ouality Center for Devices and Radiological Health
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K182718
Device Name
Mini and Micro Fragments Reconstruction System - GMReis
Indications for Use (Describe)
Mini and Micro Fragments Reconstruction System - GMReis is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation of the hand and wrist. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone.
| 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 | |
|---|---|
| ADMINISTRATIVE INFORMATION | |
| Sponsor/Manufacturer Name | GM dos Reis Indústria e Comércio Ltda |
| Avenida Pierre Simon de La Place 600 | |
| Campinas, São Paulo, Brazil 130693-320 | |
| Telephone: +55 (19) 3765-9900 | |
| Contact Person | Paula Oliveira |
| Quality Manager | |
| qualidade@gmreis.com.br | |
| Telephone: +55 (19) 3765-9900 | |
| Date Prepared | 19/Dec/2019 |
| Preparer / Alternate Contact | Janine Treter |
| Regulatory Affairs Specialist | |
| Passarini Regulatory Affairs | |
| janine@rapassarini.com.br | |
| Telephone +55 (47) 3804 0075 | |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/ Proprietary Name | Mini and Micro Fragments Reconstruction System – |
| GMReis | |
| Common Names | Plate, Fixation, Bone |
| Classification Names | Single/multiple component metallic bone fixation |
| appliances and accessories | |
| Product Codes | HRS, HWC |
| Classification Regulations | 21 CFR 888.3030, Class II |
| Review Panel | Orthopedic |
| PREDICATE DEVICE INFORMATION | |
| Predicate Devices | K142419 - NEOORTHO Produtos Ortopédicos S/A - Neoortho |
| Productos Orthopedicos S/A (Primary Predicate) | |
| K051567 - APTUS® Titanium Fixation System - Medartis, Inc. | |
| K100776 - Synthes 2.4mm12.7 mm Variable Angle LCP | |
| forefoot/. Midfoot system - Synthes (USA) LP | |
| K081546 - Small Bone Locking Plating System - DePuy | |
| Orthopaedics, Inc. | |
| K142906 - APTUS® Wrist 2.5 System - Medartis AG | |
| Reference Device | K180626 – Pedimax II -Pedicular Screw Spinal System - GM dos |
| Reis Indústria e Comércio Ltda |
4
INDICATIONS FOR USE
Mini and Micro Fragments Reconstruction System - GMReis is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation of the hand and wrist. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone.
DEVICE DESCRIPTION
Mini and Micro Fragments Reconstruction System – GMReis is composed of plates and screws. The bone plates are made from commercially pure titanium alloy (Ti-4Al-6V) and the bone screws are manufactured from titanium alloy only. The plates range in thickness from 0.6 to 2.0 mm, and the screws range in diameter from 1.5 to 2.7 mm. They are available on different sizes and shapes, according the implantation site and the extension of the fracture.
Mini and Micro Fragments Reconstruction System – GMReis are for single use. The devices are provided non-sterile and must being properly cleaned and sterilized before use, according the recommendations provided in the Instructions for Use.
In order to promote a correct placement of the plates and screws, GMReis has also available a range of instruments (class I exempt) to serve the surgeon such as drills, drill guides, cutting pliers, reamers, screwdrivers, among others. GMReis recommends the use of these instruments in order to ensure the compatibility with the implants and promote the success of the procedure.
The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in osteosyntheses procedures.
EQUIVALENCE TO MARKETED DEVICE
The subject device is substantially equivalent in indications and design principles to the following predicate devices:
K142419 - NEOORTHO Produtos Ortopédicos S/A - Neoortho Productos Orthopedicos S/A K051567 – APTUS® Titanium Fixation System - Medartis, Inc. K100776 - Synthes 2.4mm12.7 mm Variable Angle LCP forefoot/.Midfoot system - Synthes (USA) LP K081546 - Small Bone Locking Plating System - DePuy Orthopaedics, Inc. K142906 - APTUS® Wrist 2.5 System - Medartis AG
The subject device and the predicate devices have intended use and have similar technological characteristics. The subject and predicate devices are all manufactured from the same or similar materials and share similar design characteristics, including plate screw holes to accommodate locking and non-locking screws. The subject and predicate devices encompass the same range of physical dimensions, are packaged using similar materials and are to be sterilized by the same methods. Any difference in the technological characteristics do not raise new issues of safety or efficacy.
5
Biocompatibility of the subject devices were supported by the tests required according to its contact profile as recommended by FDA guidance entitled Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".
The performance of the subject devices are demonstrated through mechanical testing of plates and screws according to ASTM F382 and ASTM F543, respectively.
The subject devices are provided non-sterile and have no expiration date defined. Steam sterilization validation was performed according to ISO 17665-1 and 17665-2.
CONCLUSION
The documentation submitted in this premarket notification demonstrates that the subject devices have comparable features and performance and, therefore, are substantially equivalent to the identified predicate device.