(257 days)
Metal Bone Screw is indicated for the fixation of clavicle, scapula, pelvis, humerus, ulna, radius, femur, tibia, fibula, metacarpals, metatarsals and phalanges fractures.
Metal Bone Screw are used to fasten plates onto bones, or, as lag screws, to hold bone fragments together. The screws are differentiated by the manner in which they are inserted into bone, their function, their size, and the type of bone they are intended for. Metal Bone Screw consists of a series of screws with different sizes and structures, which is designed according to the anatomical characteristics of human bones. In clinical practice, the bone screw can be used alone or in combination with the bone plate, which acts as a temporary internal support, provides a stable local environment for the fractured end, and creates conditions for the healing of the fractured end. Metal Bone Screw are made of Ti-6A1-4V ELI following ASTM F136. Metal Bone Screw is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.
This document is a 510(k) premarket notification for a medical device called "Metal Bone Screw." It is a regulatory filing with the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not a study evaluating AI or software performance. Therefore, most of the requested information regarding acceptance criteria, AI study design, human-in-the-loop performance, and training/test set details is not applicable to this document.
However, I can extract the relevant information from this document:
Device Description and Purpose:
The "Metal Bone Screw" is a medical device used for the fixation of various bone fractures. It is made of Ti-6A1-4V ELI (a titanium alloy).
Acceptance Criteria and Device Performance (Based on this document, these refer to mechanical and biocompatibility testing for a hardware device, not AI performance):
This document describes the regulatory process for a physical medical device (Metal Bone Screw), not a software or AI-driven device. Therefore, the "acceptance criteria" and "device performance" are established through non-clinical performance data (mechanical testing and biocompatibility testing) to demonstrate substantial equivalence to a legally marketed predicate device.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the document for a medical hardware device):
| Acceptance Criteria Category | Specific Tests Performed (as per FDA Guidance and ASTM Standards) | Reported Device Performance (Conclusion) |
|---|---|---|
| Biocompatibility | In accordance with FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". | Biocompatibility evaluation was conducted. (Implied acceptability based on filing, though specific results are not detailed here). |
| Mechanical Performance | - Torsion Test (per ASTM F543-17) - Insertion/removal Test (per ASTM F543-17) - Pullout Test (per ASTM F543-17) | Tests performed "to demonstrate substantially equivalent of safety and efficacy with the predicate device". (Implied successful performance to meet substantial equivalence, specific numerical results are not detailed here). |
Details Not Applicable to This Document (as it's a hardware device 510(k) not an AI study):
- Sample size used for the test set and the data provenance: Not applicable. This refers to mechanical and biocompatibility testing of the physical device, not an AI test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a study involving expert-established ground truth for a test set in the context of an AI device.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 for AI-assisted diagnostic devices.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithm performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of an AI test set. For this hardware device, the "ground truth" for demonstrating substantial equivalence is established through adherence to recognized standards (ASTM) and a comparison of performance characteristics to a predicate device.
- The sample size for the training set: Not applicable, as this is a hardware device, not an AI model.
- How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/0 description: The image shows the date December 12, 2022. The text is written in a clear, sans-serif font. The date is written in the format of month, day, and year. The text is centered and takes up most of the image.
Double Medical Technology Inc. Yan Zuo Deputy International RA Supervisor No.18, Shanbianhong East Road, Haicang District Xiamen, Fujian 361026 China
Re: K220921
Trade/Device Name: Metal Bone Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: November 9, 2022 Received: November 14, 2022
Dear Yan Zuo:
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.
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
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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 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
Enclosure
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Indications for Use
510(k) Number (if known) K220921
Device Name Metal Bone Screw
Indications for Use (Describe)
Metal Bone Screw is indicated for the fixation of clavicle, scapula, pelvis, humerus, ulna, radius, femur, tibia, fibula, metacarpals, metatarsals and phalanges fractures.
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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| 1. Submitter | |
|---|---|
| Name | Double Medical Technology Inc. |
| Address | No. 18, Shanbianhong East Road, Haicang District, Xiamen,361026, P. R. China |
| Phone | +86 592 6885079 |
| Fax | +86 592 6587078 |
| Contact person | Yan Zuo |
| Date prepared | December 8th, 2022 |
| 2. Proposed Device | |
| Trade/proprietary name | Metal Bone Screw |
| Common or usual name | Metal Bone Screw |
| Classification name | Smooth or threaded metallic bone fixation fastener. |
| Regulation number | 21 CFR 888.3040 |
| Product code | HWC |
| Regulatory class | II |
| Classification panel | Orthopedic |
| 3. Predicate Device | |
| Legally marketeddevice(s) to whichequivalence is claimed | Primary predicate device:K130108 Double Engine Bone Plate and Bone Screw SystemAdditional predicate device:K143146 Nexis® osteosynthesis snap-off screws |
| Reason for 510(k)submission | New device(Implant) |
K220921 - 510(k) Summary
4. Device Description
Metal Bone Screw are used to fasten plates onto bones, or, as lag screws, to hold bone fragments together. The screws are differentiated by the manner in which they are inserted into bone, their function, their size, and the type of bone they are intended for. Metal Bone Screw consists of a series of screws with different sizes and structures, which is designed according to the anatomical characteristics of human bones. In clinical practice, the bone screw can be used alone or in combination with the bone plate, which acts as a temporary internal support, provides a stable local environment for the fractured end, and creates conditions for the healing of the fractured end. Metal Bone Screw are made of Ti-6A1-4V ELI following ASTM F136. Metal Bone Screw is provided as non-sterile. The implants are
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intended for single-use only, while the instruments are reusable.
5. Indication for Use
Metal Bone Screw is indicated for the fixation of clavicle, scapula, pelvis, humerus, ulna, radius, femur, tibia, fibula, metacarpals, metatarsals and phalanges fractures.
6. Comparison of Technological Characteristics with the Predicate Device
The rationale for substantial equivalence is based on consideration of the following characteristics:
Regulatory Classification: Same as the predicate devices Indications for Use: Substantially equivalent (SE) to the predicate devices Materials: Substantially equivalent (SE) to the predicate devices Design Features: Substantially equivalent (SE) to the predicate devices
7. Non-Clinical Performance Data
7.1 Biocompatibility testing
The biocompatibility evaluation for the Metal Bone Screw was conducted in accordance with the FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
7.2 Mechanical testing
The following tests were performed (per ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws.) on Metal Bone Screw to demonstrate substantially equivalent of safety and efficacy with the predicate device:
- Torsion Test ●
- Insertion/removal Test ●
- Pullout Test
8. Clinical Data
No clinical performance data was provided to demonstrate substantially equivalence.
9. Conclusion
Metal Bone Screw is compared to the predicate devices in respect of safety and effectiveness. The information provided within this premarket notification demonstrates that proposed device is determined to be substantially equivalent (SE) to the predicate device.
§ 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.