(280 days)
Not Found
No
The 510(k) summary describes a system of bone plates and screws for internal fixation. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies focus on mechanical properties and biocompatibility, not algorithmic performance.
Yes
The device is used for internal fixation of fractures and reconstruction of bones, which are therapeutic interventions aimed at restoring function and healing.
No.
The device is an internal fixation system (bone plates and screws) used for the treatment of fractures, osteotomies, and other bone-related conditions, not for diagnosing them.
No
The device description explicitly states that the device is comprised of bone plates and bone screws made of titanium alloy, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is clearly described as "internal fixation" for fractures, osteotomies, arthrodesis, replantations, and reconstructions of bones in the hand, wrist, foot, and ankle. This is a surgical procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as bone plates and screws made of titanium alloy, used as a "temporary internal stent" to stabilize bone fractures. This is a medical device used for treatment, not for diagnosis.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health. This device is an implantable medical device used for surgical repair.
N/A
Intended Use / Indications for Use
The Advanced Bone Plate (AIMIMINI VARIABLE ANGLE LOCKING PLATES SYSTEM, ITVAL Foot & Ankle VAL System, and Distal Fibular VAL Plate) is internal fixation. Specific indications for the plates included in the system as follows:
The AIMIMINI VARIABLE ANGLE LOCKING PLATES SYSTEM is inticated for the internal fixation (fractures, osteotomies, arthrodesis, replantations and reconstructions) of the hand (metacarpals and phalanges) and wrist of adults and adolescents (age 12-21 years) in which growth plates have fused or will not be crossed by fixation.
The ITVAL Foot & Ankle VAL System is internal fixation (fractures, osteotomies, fusions, nonunions, malunions, small fragment replantations) of the foot and ankle in adults and adolescents (age 12-21 years) possessing normal or osteopenic bone where growth plates have fused or will not be crossed by fixation.
The Distal Fibular VAL Plate is indicated for internal fractures, osteotomies, nonunions, malunions, small fragment replantations) of the distal fibula of adults and adolescents (age 12-21 years) where growth plates have fused or will not be crossed by fixation.
Product codes
HRS, HWC
Device Description
Advanced Bone Plate is mainly used for internal fixation of hand, wrist, foot, ankle and distal fibular fractures. According to the anatomical characteristics of human bones, locking plates of different shapes and locking screws of different diameters are designed. In clinical practice, locking bone plate and locking bone screw are used in combination to play the role of temporary internal stent, providing a stable local environment for fracture ends and creating conditions for the healing of fracture ends.
Bone plates in Advanced Bone Plate are made of titanium alloy following ASTM F1472, and bone screws in Advanced Bone Plate are made of titanium alloy following ASTM F136. Advanced Bone Plate is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand (metacarpals and phalanges), wrist, foot, ankle, distal fibula
Indicated Patient Age Range
adults and adolescents (age 12-21 years)
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)
7.1 Biocompatibility testing
The biocompatibility evaluation for the Advanced Bone Plate 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 mechanical tests of bone plates were performed per ASTM F382-17 Standard Specification and Test Methods for Metallic bone plate and Three-point Bending Test Method to demonstrate substantially equivalent of safety and efficacy with the predicate device. According to ASTM F382-17 and Three-point Bending Test Method, test methods are used to determine the Bending Stiffness, Bending Strength and Bending Structural Stiffness.
The mechanical tests of bone screws were performed per ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws to demonstrate substantially equivalent of safety and efficacy with the predicate device. According to ASTM F543-17, test methods are used to determine the Torsion Test, Insertion/removal Test and Pullout Test.
7.3 Sterilization & Reprocessing
The Advanced Bone Plate is provided as non-sterile. It required to be sterilized via Overkill Approach (Half-Cycle method) to reach a SAL of 10-6 by the hospital prior to surgery. The sterilization method is presented in the instruction for use, which was validated per ISO 17665-1: 2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.
Implants and instruments must be carefully cleaned before initial sterilization. The cleaning instructions presented in the instruction for use have been validated per FDA guidance AAMI TIR30:2003 "A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K141527, K103243, K152974, K090692, K171852, K142121, K130108, K141383, K151277, K222194, K132898, K132886
Reference Device(s)
Not Found
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
January 25, 2023
Image /page/0/Picture/11 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 text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font size.
Double Medical Technology Inc. Yan Zuo Deputy International RA Supervisor No.18, Shanbianhong East Road, Haicang District Xiamen, Fujian 361026 China
Re: K221150
Trade/Device Name: Advanced Bone Plate 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 22, 2022 Received: November 29, 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
1
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,
Shumava 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) K221150
Device Name Advanced Bone Plate
Indications for Use (Describe) Indications for use:
The Advanced Bone Plate (AIMIMINI VARIABLE ANGLE LOCKING PLATES SYSTEM, ITVAL Foot & Ankle VAL System, and Distal Fibular VAL Plate) is internal fixation. Specific indications for the plates included in the system as follows:
The AIMIMINI VARIABLE ANGLE LOCKING PLATES SYSTEM is inticated for the internal fixation (fractures, osteotomies, arthrodesis, replantations and reconstructions) of the hand (metacarpals and phalanges) and wrist of adults and adolescents (age 12-21 years) in which growth plates have fused or will not be crossed by fixation.
The ITVAL Foot & Ankle VAL System is internal fixation (fractures, osteotomies, fusions, nonunions, malunions, small fragment replantations) of the foot and ankle in adults and adolescents (age 12-21 years) possessing normal or osteopenic bone where growth plates have fused or will not be crossed by fixation.
The Distal Fibular VAL Plate is indicated for internal fractures, osteotomies, nonunions, malunions, small fragment replantations) of the distal fibula of adults and adolescents (age 12-21 years) where growth plates have fused or will not be crossed by fixation.
| 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) | ❌ Prescription Use (Part 21 CFR 801 Subpart D) | ▢ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ❌ 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 |
| Contact person | Yan Zuo |
| Date prepared | Jan 20th, 2023 |
| 2. Proposed Device | |
| Trade/proprietary name | Advanced Bone Plate |
| Common or usual name | Plate, Fixation, Bone; |
| Screw, Fixation, Bone | |
| Classification name | Single/multiple component metallic bone fixation appliance |
| and accessories (Primary); | |
| Smooth or threaded metallic bone fixation fastener | |
| Regulation number | 21 CFR 888.3030 (Primary); |
| 21 CFR 888.3040 | |
| Product code | HRS; HWC |
| Regulatory class | II |
| Classification panel | Orthopedic |
| 3. Predicate Device |
K221150 - 510(k) Summary
4
| Primary predicate device: | |
|---|---|
| K141527 DePuy Synthes Variable Angle Locking Hand | |
| System | |
| Additional predicate devices: | |
| K103243 Synthes (USA) 2.4mm VA-LCP Intercarpal Fusion | |
| System | |
| K152974 Wright ORTHOLOC®3Di Foot Reconstruction | |
| System | |
| Legally marketed | |
| device(s) to which | |
| equivalence is claimed | K090692 Wright ORTHOLOC® 2.0/ 2.4 Plate System |
| K171852 Wright DARCOTM Locking Bone Plate System | |
| K142121 Wright ORTHOLOC® Calcaneal Plating System | |
| K130108 Double Engine Bone Plate and Bone Screw System | |
| K141383 Acumed Hand Plating System | |
| K151277 NOVASTEP Airlock® osteosynthesis plate system | |
| K222194 Baby Gorilla®/Gorilla® Plating System | |
| K132898 Biomet A.L.P.S. Calcaneal Plating System | |
| K132886 Smith&Nephew Variable- Angle Locking | |
| Reason for 510(k) | |
| submission |
4. Device Description
Advanced Bone Plate is mainly used for internal fixation of hand, wrist, foot, ankle and distal fibular fractures. According to the anatomical characteristics of human bones, locking plates of different shapes and locking screws of different diameters are designed. In clinical practice, locking bone plate and locking bone screw are used in combination to play the role of temporary internal stent, providing a stable local environment for fracture ends and creating conditions for the healing of fracture ends.
Bone plates in Advanced Bone Plate are made of titanium alloy following ASTM F1472, and bone screws in Advanced Bone Plate are made of titanium alloy following ASTM F136. Advanced Bone Plate is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.
5. Indications for Use
The Advanced Bone Plate (AIMINI VARIABLE ANGLE LOCKING PLATES SYSTEM, ITVAL Foot & Ankle VAL System, and Distal Fibular VAL Plate) is indicated for internal fixation. Specific indications for the plates included in the system as follows:
5
The AIMIMINI VARIABLE ANGLE LOCKING PLATES SYSTEM is indicated for the internal fixation (fractures, osteotomies, arthrodesis, replantations and reconstructions) of the hand (metacarpals and phalanges) and wrist of adults and adolescents (age 12-21 years) in which growth plates have fused or will not be crossed by fixation.
The ITVAL Foot & Ankle VAL System is indicated for internal fixation (fractures, osteotomies, fusions, nonunions, malunions, small fragment replantations) of the foot and ankle in adults and adolescents (age 12-21 years) possessing normal or osteopenic bone where growth plates have fused or will not be crossed by fixation.
The Distal Fibular VAL Plate is indicated for internal fixation (fractures, osteotomies, nonunions, malunions, small fragment replantations) of the distal fibula of adults and adolescents (age 12-21 years) where growth plates have fused or will not be crossed by fixation.
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: Bone plates in Advanced Bone Plate are made of titanium alloy following ASTM F1472, and bone screws in Advanced Bone Plate are made of titanium alloy following ASTM F136. Both of the materials of bone plates and bone screws are substantially equivalent (SE) to the predicate devices.
Design Features: The subject Advanced Bone Plate shares the same fundamental technological characteristics as the predicate systems. The same design features of the subject and predicate systems such as variable angle locking technology, limited contact profiles, anatomic contours, and similar size ranges. Based on the presented comparisons and discussions, the subject Advanced Bone Plate does not raise any new issues of safety and efficacy.
7. Non-Clinical Performance Data
7.1 Biocompatibility testing
The biocompatibility evaluation for the Advanced Bone Plate was conducted in accordance
6
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 mechanical tests of bone plates were performed per ASTM F382-17 Standard Specification and Test Methods for Metallic bone plate and Three-point Bending Test Method to demonstrate substantially equivalent of safety and efficacy with the predicate device. According to ASTM F382-17 and Three-point Bending Test Method, test methods are used to determine the Bending Stiffness, Bending Strength and Bending Structural Stiffness.
The mechanical tests of bone screws were performed per ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws to demonstrate substantially equivalent of safety and efficacy with the predicate device. According to ASTM F543-17, test methods are used to determine the Torsion Test, Insertion/removal Test and Pullout Test.
7.3 Sterilization & Reprocessing
The Advanced Bone Plate is provided as non-sterile. It required to be sterilized via Overkill Approach (Half-Cycle method) to reach a SAL of 10-6 by the hospital prior to surgery. The sterilization method is presented in the instruction for use, which was validated per ISO 17665-1: 2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.
Implants and instruments must be carefully cleaned before initial sterilization. The cleaning instructions presented in the instruction for use have been validated per FDA guidance AAMI TIR30:2003 "A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.
8. Clinical Data
No clinical performance data was provided to demonstrate substantially equivalence.
9. Conclusion
Advanced Bone Plate 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.