(217 days)
No
The 510(k) summary describes a standard surgical implant and instrument kit for fracture fixation, with no mention of AI or ML capabilities in its intended use, device description, or performance studies.
No
Explanation: This device is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation, which are structural and mechanical interventions, not therapeutic in the sense of treating disease or illness.
No
This device is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation, which are treatment procedures, not diagnostic ones.
No
The device description clearly states it is a "plate and instruments kit" made of Titanium Alloy and Stainless Steel, which are hardware components.
Based on the provided text, 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 describes a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of "plate and instruments kit, for osteosynthesis procedures of the distal radius." These are physical implants and tools used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body, while this device is used for surgical intervention and repair within the body.
N/A
Intended Use / Indications for Use
Quick - Radius Disposable Set is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation of the hand and wrist. The use of locking plate and screw systems is suited for treatment of fractures in osteopenic bone.
Product codes
HRS, HWC
Device Description
Quick - Radius Disposable Set are plate and instruments kit, for osteosynthesis procedures of the distal radius, in sterile condition, single use and disposable instruments after use. This sterile set must be used with 2.4mm screws, also sterile and individually packaged. The surgeon selects the best combination of plate size, left or right and screw designs and quantities, as needed. Single use and sterile templates are available, individually packed, for determining the size of the plate to be used. Also, as an option, individually packed plates, instruments only kit, and instruments with plates and screws kit, are available in sterile condition. The plates and screws are produced with Titanium Alloy, according with standard ASTM F136, and the instruments are made of Stainless Steel, according with standard ASTM F899.
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
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 subject Quick - Radius Disposable Set components possess the same technological characteristics as the predicate devices. These include: . performance: shape and dimensions; ● material and manufacturing; . . sizes: . biocompatibility and . device usage. The sterilization method is ethylene oxide exposure. The EO sterilization has been validated to a sterility assurance level (SAL) of 106, according to ISO 11135 -Sterilization of health care products - Ethylene oxide - Requirements for the development, validation, and routine control of a sterilization process for medical 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
§ 888.3030 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
Indications for Use
510(k) Number (if known) K231684
Device Name Quick - Radius Disposable Set
Indications for Use (Describe)
Quick - Radius Disposable Set is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation of the hand and wrist. The use of locking plate and screw systems is suited for treatment of fractures in osteopenic bone.
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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510(k) Summary K231684
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92.
I. 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 Telephone: +55 (19) 3765-9900 Email: guilherme.qualidade@gmreis.com.br Date prepared: January 11, 2024
II. Device Name:
| Trade/Device Name: | Quick - Radius Disposable Set |
|---|---|
| Common Name: | Plate, Fixation, Bone |
| Screw, Fixation, Bone | |
| Regulation Number: | 21 CFR 888.3030 (Primary) |
| 21 CFR 888.3040 | |
| Regulation Name: | Single/multiple component metallic bone fixation |
| appliances and accessories. (Primary) | |
| Smooth or threaded metallic bone fixation fastener. | |
| Regulatory Class: | II |
| Product Codes: | HRS (Primary) |
| HWC |
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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).
Synthes (USA) 2.4mim VA-LCP Two-Column Narrow Volar Distal Radius Plates -Synthes (USA) (K092556) (Reference device).
EXPERT - Joint Fixation System - GMReis (K200332) (Reference device).
IV. Device Description:
Quick - Radius Disposable Set are plate and instruments kit, for osteosynthesis procedures of the distal radius, in sterile condition, single use and disposable instruments after use. This sterile set must be used with 2.4mm screws, also sterile and individually packaged. The surgeon selects the best combination of plate size, left or right and screw designs and quantities, as needed. Single use and sterile templates are available, individually packed, for determining the size of the plate to be used. Also, as an option, individually packed plates, instruments only kit, and instruments with plates and screws kit, are available in sterile condition.
The plates and screws are produced with Titanium Alloy, according with standard ASTM F136, and the instruments are made of Stainless Steel, according with standard ASTM F899.
V. Statement of Indications for Use of the Device:
Quick - Radius Disposable Set is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation of the hand and wrist. The use of locking plate and screw systems is suited for treatment of fractures in osteopenic bone.
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VI. Comparison of Technological Characteristics with The Predicate Device:
The proposed device is a line extension to the predicate device with new presentation forms. The proposed and predicate devices have the same basic design, intended use and biocompatibility profile. Difference between the proposed device and the predicate includes addition of a presentation form in a sterile condition. The proposed Quick -Radius Disposable Set is substantially equivalent to the predicate device in which the basic design features and intended uses are the same. Any differences between the proposed device and the predicate device are considered minor and do not raise new or different questions concerning safety or effectiveness.
VII. Performance Data:
The subject Quick - Radius Disposable Set components possess the same technological characteristics as the predicate devices. These include:
- . performance:
- shape and dimensions; ●
- material and manufacturing; .
- . sizes:
- . biocompatibility and
- . device usage.
The sterilization method is ethylene oxide exposure. The EO sterilization has been validated to a sterility assurance level (SAL) of 106, according to ISO 11135 -Sterilization of health care products - Ethylene oxide - Requirements for the development, validation, and routine control of a sterilization process for medical devices.
VIII. Conclusions:
The Quick - Radius Disposable Set is substantially equivalent to the predicate device in which the basic design features and intended use are the same. Any differences between the proposed device and the predicate device are considered minor and do not raise and
4
different questions concerning safety or effectiveness. Based on the indications for use, technological characteristics, and the summary of data submitted, GMReis has determined that the proposed device is substantially equivalent to the currently marketed predicate device.
5
January 12, 2024
Image /page/5/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" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
GM Dos Reis Industria e Comercio Ltda Guilherme Esteves Pontes Regulatory Affairs Analyst Avenida Pierre Simon de La Place 600 Campinas, SP 13069-320 Brazil
Re: K231684
Trade/Device Name: Ouick - Radius Disposable Set 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: May 18, 2023 Received: June 9, 2023
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.
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).
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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 (OS) 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.
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 mediation-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