(118 days)
No
The device description and performance studies focus on the mechanical properties and surgical placement of a bone screw, with no mention of AI or ML capabilities. The use of radiological images is for surgeon guidance, not automated analysis.
Yes
The device is a percutaneous compression screw used for fixing and stabilizing bones, which is a therapeutic intervention.
No
Explanation: The device is a percutaneous compression screw used for fixing and stabilizing bones. Its function is to provide anatomical reduction and stable fixation, not to diagnose medical conditions, and it does not interpret any medical images or patient data to provide a diagnosis. The mentions of "radiological image" and "guide wire" are for guiding the placement of the screw during surgery, not for diagnostic purposes.
No
The device description clearly describes a physical implantable screw made of Titanium Alloy, not a software product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided description clearly states that the "Cut Screw - Percutaneous Compression Screw" is a device used for fixing and stabilizing bones within the foot. It is an implantable medical device used directly on the patient's anatomy during surgery.
- Intended Use: The intended use is for surgical fixation of bones, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological specimens.
Therefore, based on the provided information, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Cut Screw - Percutaneous Compression Screw are single use devices indicated for fixing and stabilizing the bones of the mid foot, metatarsal and phalanges of the foot using an appropriate relation bone-screw size.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Cut Screw - Percutaneous Compression Screw for bone synthesis, with a hole in the center in order to allow the passage of the guide wire, thus facilitating its placement, as the surgeon is able to verify the positioning of the screw through the radiological image of the guide wire before its placement. In addition, the Cut Screw -Percutaneous Compression Screw, provides anatomical reduction, stable fixation, and preservation of blood supply by using a percutaneous incision.
The screws have a hexagonal connection for a wrench. They are found in a variety of diameters to meet the range of anatomies of the patients, are presented in Titanium Alloy according to the standard ASTM F136, it could be provided in sterile condition sterilized by Ethylene Oxide or non-sterile condition to end user and must be cleaned, and steam sterilized before use.
The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in orthopedic surgeries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiological image
Anatomical Site
bones of the mid foot, metatarsal and phalanges of the foot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified surgeons mastering the surgical technique, having been trained and qualified in orthopedic surgeries.
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 Non-clinical tests performed and the Recognized Consensus Standards to which the Cut Screw - Percutaneous Compression Screw have been tested are specifically the following:
- Torsional Properties of Metallic Bone Screws per ASTM F543 .
- Driving Torque of Medical Bone Screws per ASTM F543 .
- Axial Pullout Strength of Medical Bone Screws per ASTM F543 .
The test results demonstrate that the subject device presents safety and efficacy in terms of mechanical properties.
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.
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.
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
§ 888.3040 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.
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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: K230397
Trade/Device Name: Cut Screw - Percutaneous Compression Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: May 11, 2023 Received: May 11, 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 (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.
Tejen D. Soni -S 2023.06.12 16:49:16 -04'00'
For Shumaya Ali, MPH 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) K230397
Device Name
Cut Screw - Percutaneous Compression Screw
Indications for Use (Describe)
Cut Screw - Percutaneous Compression Screw are single use devices indicated for fixing and stabilizing the bones of the mid foot, metatarsal and phalanges of the foot using an appropriate relation bone-screw size.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
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: February 06, 2023
II. Device Name:
| Trade Name: | Cut Screw - Percutaneous Compression Screw |
|---|---|
| Common Name: | Screw, Fixation, Bone |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
| Device Class: | II |
| Product Codes: | HWC |
| Regulation Number: | 21 CFR 888.3040 |
III. Predicate Devices:
Legally marketed devices to which we are claiming "Substantial Equivalence" are the following:
Nexis® osteosynthesis compressive screws (K143229) (Primary predicate device).
Mini and Micro Fragments Reconstruction System - GMReis (GMReis, K182718) (Reference device).
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EXPERT - Joint Fixation System - GMReis (GMReis, K200332) (Reference Device).
IV. Device Description:
The purpose of this submission is to obtain marketing clearance for the Cut Screw -Percutaneous Compression Screw.
The Cut Screw - Percutaneous Compression Screw for bone synthesis, with a hole in the center in order to allow the passage of the guide wire, thus facilitating its placement, as the surgeon is able to verify the positioning of the screw through the radiological image of the guide wire before its placement. In addition, the Cut Screw -Percutaneous Compression Screw, provides anatomical reduction, stable fixation, and preservation of blood supply by using a percutaneous incision.
The screws have a hexagonal connection for a wrench. They are found in a variety of diameters to meet the range of anatomies of the patients, are presented in Titanium Alloy according to the standard ASTM F136, it could be provided in sterile condition sterilized by Ethylene Oxide or non-sterile condition to end user and must be cleaned, and steam sterilized before use.
The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in orthopedic surgeries.
V. Statement of Indications for Use of the Device:
Cut Screw - Percutaneous Compression Screw are single use devices indicated for fixing and stabilizing the bones of the mid foot, metatarsal and phalanges of the foot using an appropriate relation bone-screw size.
VI. Comparison of Technological Characteristics with The Predicate Device:
The subject device is substantially equivalent in indications and design principles to the following predicate device:
K143229 - Nexis® osteosynthesis compressive screws - Novastep
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The subject and predicate devices have equivalent intended use and equivalent technological characteristics. The subject and predicate devices are all manufactured from identical materials and share equivalent design characteristics. The subject and predicate devices encompass equivalent physical dimensions. Any difference in the technological characteristics do not raise new issues of safety or efficacy.
Biocompatibility of the subject devices are supported by the reference device K182718. The performance of the subject device screws was compared with the specific guidance "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway" and are demonstrated through mechanical testing according to ASTM F543. No clinical data were included in this submission. The subject devices could be provided sterile by Ethylene Oxide method or could be provided non-sterile to be sterilized at the end-user and have no expiration date defined. Both sterilization method was validated according to the applicable standards. Pyrogenicity monitoring according to AAMI/ANSI ST72 meeting pyrogen limit specifications.
VII. Performance Data:
The Non-clinical tests performed and the Recognized Consensus Standards to which the Cut Screw - Percutaneous Compression Screw have been tested are specifically the following:
- Torsional Properties of Metallic Bone Screws per ASTM F543 .
- Driving Torque of Medical Bone Screws per ASTM F543 .
- Axial Pullout Strength of Medical Bone Screws per ASTM F543 .
The test results demonstrate that the subject device presents safety and efficacy in terms of mechanical properties.
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Image /page/6/Picture/0 description: The image shows the logo for GMREIS. The logo consists of a circular graphic on the left and the text "GMREIS" on the right. Below the text is the phrase "Qualidade para Vida". The circular graphic is made up of blue, red, and gray shapes.
VIII. Conclusions:
As was established in this submission, the subject Cut Screw - Percutaneous Compression Screw are substantially equivalent to the predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics, intended use, indications for use, material composition, anatomical region, multiple sizes, and basic design features compared to its predicate devices. Any differences between the Cut Screw - Percutaneous Compression Screw and the predicate devices are considered minor and do not raise different questions of safety or effectiveness.