(280 days)
Not Found
No
The device description and intended use focus solely on the mechanical properties and anatomical design of bone plates and screws for fracture fixation. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as an "internal fixation of fractures" and provides a "temporary internal stent" to facilitate "healing of fracture ends," which are actions aimed at treating or alleviating a medical condition, making it a therapeutic device.
No
The device description clearly states it is an "Anatomic Bone Plate" mainly used for internal fixation of fractures, acting as a "temporary internal stent" to provide a stable local environment for fracture healing, which is a therapeutic function, not diagnostic.
No
The device description clearly states that the device is a physical bone plate and screw system made of titanium alloy, intended for internal fixation of fractures. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Anatomic Bone Plates are for the internal fixation of fractures, fracture dislocations, osteotomies, and mal/non-unions of various bones in the body. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device description details the physical characteristics of bone plates and screws used for internal fixation. It describes them as temporary internal stents.
- 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 screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support and fixation.
N/A
Intended Use / Indications for Use
The Anatomic Bone Plates are intended for the internal fixation of fractures (VAL Distal Clavicle, VAL Proximal Humeral, VAL Distal Humeral, Distal Ulnar Locking, Distal Radial Locking, VAL Proximal Tibia, VAL Distal Tibia, VAL Distal Lateral Fibular, VAL Distal Femoral, Pelvic Bone Plate), fracture dislocations (VAL Proximal Humeral), osteotomies, and mal/non-unions (VAL Distal Clavicle, VAL Proximal Humeral) of the clavice, pelvis, and the upper (i.e., humerus, ulna and radius) and lower (i.e., femur, tibia, and fibula) extremities. Additional plates included in the system with specific indications as follows:
VAL (Variable Angle Locking) Distal Clavicle Plate is indicated for fractures of the shaft and lateral clavicle, malunions and non-unions ;
VAL Distal Humeral Plate is indicated for fractures (including supracondylar), and nonunions ;
VAL Distal Femoral Plate is indicated for distal femoral fractures (diaphyseal, supracondy)ar, , and intra-articular);
Pelvic Bone Plate is indicated for pelvic fractures (e.g., acetabular , iliac wing, and symphysis pubis).
Product codes
HRS
Device Description
Anatomic Bone Plate is mainly used for internal fixation of fracture. 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. Anatomic Bone Plate is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.
Anatomic Bone Plate are made of titanium alloy following ASTM F1472 or unalloyed titanium following ASTM F67.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavice, pelvis, and the upper (i.e., humerus, ulna and radius) and lower (i.e., femur, tibia, and fibula) extremities.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Non-Clinical Performance Data:
7.1 Biocompatibility testing: The biocompatibility evaluation for the Anatomic 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 were performed per ASTM F382-17 Standard Specification and Test Methods for Metallic bone plate and three-point bending test method on Anatomic Bone Plate 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.
Clinical Data:
Clinical literature was provided to demonstrate substantially equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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 18, 2023
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Double Medical Technology Inc. Yan Zuo Deputy International RA Supervisor No.18, Shanbianhong East Road, Haicang District Xiamen, Fujian 361026 China
Re: K221088
Trade/Device Name: Anatomic 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 Dated: September 16, 2022 Received: September 23, 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,
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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) K221088
Device Name Anatomic Bone Plate
Indications for Use (Describe)
The Anatomic Bone Plates are intended for the internal fixation of fractures (VAL Distal Clavicle, VAL Proximal Humeral, VAL Distal Humeral, Distal Ulnar Locking, Distal Radial Locking, VAL Proximal Tibia, VAL Distal Tibia, VAL Distal Lateral Fibular, VAL Distal Femoral, Pelvic Bone Plate), fracture dislocations (VAL Proximal Humeral), osteotomies, and mal/non-unions (VAL Distal Clavicle, VAL Proximal Humeral) of the clavice, pelvis, and the upper (i.e., humerus, ulna and radius) and lower (i.e., femur, tibia, and fibula) extremities. Additional plates included in the system with specific indications as follows:
VAL (Variable Angle Locking) Distal Clavicle Plate is indicated for fractures of the shaft and lateral clavicle, malunions and non-unions ;
VAL Distal Humeral Plate is indicated for fractures (including supracondylar), and nonunions ;
VAL Distal Femoral Plate is indicated for distal femoral fractures (diaphyseal, supracondy)ar, , and intra-articular);
Pelvic Bone Plate is indicated for pelvic fractures (e.g., acetabular , iliac wing, and symphysis pubis).
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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| 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 16th, 2023 |
| 2. Proposed Device | |
| Trade/proprietary name | Anatomic Bone Plate |
| Common or usual name | Anatomic Bone Plate |
| Classification name | Single/multiple component metallic bone fixation appliance |
| and accessories | |
| Regulation number | 21 CFR 888.3030 |
| Product code | HRS |
| Regulatory class | II |
| Classification panel | Orthopedic |
| 3. Predicate Device | |
| Legally marketed | |
| device(s) to which | |
| equivalence is claimed | Predicate device: |
| K130108 | |
| Double Engine Bone Plate and Bone Screw System | |
| Reason for 510(k) | |
| submission | New device |
K221088 - 510(k) Summary
Device Description 4.
Anatomic Bone Plate is mainly used for internal fixation of fracture. 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. Anatomic Bone Plate is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.
Anatomic Bone Plate are made of titanium alloy following ASTM F1472 or unalloyed titanium following ASTM F67.
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న. Indications for Use
The Anatomic Bone Plates are intended for the internal fixation of fractures (VAL Distal Clavicle, VAL Proximal Humeral, VAL Distal Humeral, Distal Ulnar Locking, Distal Radial Locking, VAL Proximal Tibia, VAL Distal Tibia, VAL Distal Lateral Fibular, VAL Distal Femoral, Pelvic Bone Plate), fracture dislocations (VAL Proximal Humeral), osteotomies, and mal/non-unions (VAL Distal Clavicle, VAL Proximal Humeral, VAL Distal Humeral) of the clavicle, pelvis, and the upper (i.e., humerus, ulna and radius) and lower (i.e., femur, tibia, and fibula) extremities. Additional plates included in the system with specific indications as follows:
- A VAL (Variable Angle Locking) Distal Clavicle Plate is indicated for fractures of the shaft and lateral clavicle, malunions and non-unions ;
-
VAL Distal Humeral Plate is indicated for fractures (including supracondylar), and nonunions :
- A VAL Distal Femoral Plate is indicated for distal femoral fractures (diaphyseal, supracondylar, and intra-articular);
-
Pelvic Bone Plate is indicated for pelvic fractures (e.g., acetabular , iliac wing, and symphysis pubis).
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 Anatomic 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".
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7.2 Mechanical testing
The mechanical tests were performed per ASTM F382-17 Standard Specification and Test Methods for Metallic bone plate and three-point bending test method on Anatomic Bone Plate 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.
8. Clinical Data
Clinical literature was provided to demonstrate substantially equivalence.
9. Conclusion
The Anatomic Bone Plate is compared to the predicate devices in respect of safety and effectiveness. The information provided within this premarket notification demonstrates that Anatomic Bone Plate is determined to be substantially equivalent (SE) to the predicate device.