(228 days)
No reference devices were used in this submission.
No
The summary describes a mechanical bone plate and screw system and its bench testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is used for the "fixation of fractures" and "internal fixation of bone fracture," which are treatments for a pathological condition.
No
Explanation: The device is a Metallic Locking Bone Plate and Screw System used for fixation of fractures. Its function is to support bone healing, not to diagnose a condition or disease.
No
The device description explicitly states it consists of "bone plate and screw" made of metallic materials, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The provided description clearly states that the device is a "Metallic Locking Bone Plate and Screw System" intended for "internal fixation of bone fracture". This device is implanted inside the body to stabilize bones.
- Intended Use: The intended use is for "fixation of fractures", which is a surgical procedure performed on the body, not a diagnostic test performed on a sample.
The device described is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Metallic Locking Bone Plate and Screw System are intents with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The proposed device, Metallic Locking Bone Plate and Screw System consists of bone plate and screw. The bone plates are used for internal fixation of bone fracture, including ulna, radius, humerus, femur and tibia. Implant is made of Ti6Al4V Eli and titanium which conforms to ASTM F 136 and ASTM F67.
The proposed devices are provided un-sterilized. They shall be sterilized prior to use by healthcare provider. The proposed devices shall never be reused.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ulna, radius, humerus, femur and tibia
Indicated Patient Age Range
age above 21
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
Bench tests were conducted to verify that proposed device meets all design specifications as was substantially equivalence to the predicate device. The following bench testing was performed to support a determination of substantial equivalence:
ASTM F382 standard specification and test method for metallic bone plates, including the following items:
- . Static four point bending
- . Dynamic four point bending
ASTM F543 standard specification and test methods for metallic medical bone screw including the following item:
- Torsional properties
- Driving torque
- Pullout test
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data were provided in support of the substantial equivalence determination.
No clinical performance testing:
Bench tests were conducted to verify that proposed device meets all design specifications as was substantially equivalence to the predicate device.
The non-clinical data support the safety of the device and the performance testing report demonstrate that the metallic locking bone plate system should perform as intended in the specified use conditions. Changzhou Dingjian Medical Appliance Co., Ltd., Inc considers the metallic locking bone plate system does not raise any new issues of safety or effectiveness.
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.
No reference devices were used in this submission.
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
§ 888.3030 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, representing the department's focus on people and health.
June 5, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Changzhou Dingjian Medical Appliance Company, Ltd % Mr. Mike Gu OSMUNDA Medical Device Consulting Company, Ltd 7th Floor Jingui Business Buildng No. 982 Cogyuan Road, Baiyun District Guangzhou, 510420 Guangdong China
Re: K143002/S003 Trade/Device Name: Metallic Locking Bone Plate and Screw System 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 25, 2015 Received: May 28, 2015
Dear Mr. Mike Gu:
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. 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
1
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Metallic Locking Bone Plate and Screw System
Indications for Use (Describe)
The Metallic Locking Bone Plate and Screws System are intents with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image contains the logo for D&J medical. The logo consists of a stylized graphic of three concentric arcs with circles at the ends, colored in shades of green and teal. To the right of the graphic, the text "D&J medical" is written in green. Below the text, there are three Chinese characters in gray.
Premarket Notification Submission_ Metallic Locking Bone Plate and Screw System
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided: SUBMITTER l.
Changzhou Dingjian Medical Appliance Co., Ltd.
No. 19 Juxiang Road
Wujin Economic Development Zone
Changzhou, Jiangsu Province, 213149, China
Mike Gu Primary Contact Person:
Regulatory Affairs Manager
OSMUNDA Medical Device Consulting Co., Ltd
Tel: (+86) 20-6232 1333
Fax: (+86) 20-8633 0253
Secondary Contact Person: Li Qingsong
Changzhou Dingjian Medical Appliance Co., Ltd.
Tel: 0086-13584330156
Fax: 0086-519-89603573
| Date Prepared: | April 13, 2015 | |
|---|---|---|
| DEVICE | ||
| II. | ||
| Name of Device: | Metallic Locking Bone Plate and Screw System | |
| Common/Usual Name: | Bone Fixation Plate and Bone Fixation Screw | |
| Classification Names: | Plate, Fixation, Bone (21 CFR 888.3030) | |
| Screw, Fixation, Bone (21 CFR 888.3040) | ||
| Regulation Class: | ============================================================================================================================================================================== |
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Image /page/4/Picture/0 description: The image shows the logo for D&J medical. The logo consists of a teal and light green graphic on the left, followed by the text "D&J medical" in teal and light green. Below the text are four Chinese characters in gray.
market Notification Submission_ Metallic Locking Bone Plate and Screw System
Product Code: HRS and HWC
lll. PREDICATE DEVICE
Locking Bone Plates and Screws K130340;
Spacer K123918;
These predicates have not been subject to a design-related recall.
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
The proposed device, Metallic Locking Bone Plate and Screw System consists of bone plate and screw. The bone plates are used for internal fixation of bone fracture, including ulna, radius, humerus, femur and tibia. Implant is made of Ti6Al4V Eli and titanium which conforms to ASTM F 136 and ASTM F67.
The proposed devices are provided un-sterilized. They shall be sterilized prior to use by healthcare provider. The proposed devices shall never be reused.
V. INDICATIONS FOR USE
The Metallic Locking Bone Plate and Screw System are intended for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Metallic Locking Bone Plate and Screw System employs the same technology as its predicate devices K130340 and K123918.
The Metallic Locking Bone Plate and Screw System is a structure formed by locking plate (which has at least one taper-thread hole) and locking screw (which has a head of taper-thread). Wherein the metal locking plate is a fracture fixation device with threaded holes, When the screw is revolved tightened in the plate, the plate system becomes an angle-fixed device. Locking plate can have both locking and nonlocking screw holes fitting with various types of screws (also known as locking compression plate). In practice, positioning a plurality of screws in the locking plate maintains fracture anatomical reduction, which restores physiological function after bone healing.
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Image /page/5/Picture/0 description: The image contains a logo for D&J medical. The logo consists of a teal and light green circular design on the left, followed by the text "D&J medical" in teal and light green. Below the text, there are three Chinese characters in gray. The logo appears to be for a medical practice or company.
| Specification | Predicate Device | Proposed Device |
|---|---|---|
| Locking Bone Plates and Screws K | ||
| 130340 | Metallic locking bone plate and | |
| screw system | ||
| Manufacturer | Weigao Orthopaedic Device Co., | |
| Ltd. | Changzhou Dingjian Medical | |
| Appliance Co., Ltd. | ||
| Class | II | II |
| Product Code | Plate: HRS; Screw: HWC | Plate: HRS; Screw: HWC |
| Regulation Number | Plate: 21CFR 888.3030 | Plate: 21CFR 888.3030 |
| Screw: 21CFR 888.3040 | Screw: 21CFR 888.3040 | |
| Intended Use | Locking bone plates and screws are | |
| intended for adult patients with age | ||
| above 21 as indicated for fixation of | ||
| fracture. | Metallic locking bone plate and | |
| screw systemis intended for adult | ||
| patients with age above 21 as | ||
| indicated for fixation of fracture. | ||
| Indications for Use | Bone fracture in ulna, radius, | |
| humerus, femur and tibia | Bone fracture in ulna, radius, | |
| humerus, femur and tibia | ||
| Patient Population | Adult patients of age above 21 | Adult patients of age above 21 |
| Prescription/OTC Use | Prescription use | Prescription use |
| Mechanical | ||
| Performance | FOR PLATES: ASTM F 382-99 | |
| FOR SCREWS: ASTM F543-07 | FOR PLATES: ASTM F 382-99(2008) | |
| FOR SCREWS: ASTM F543-07 | ||
| Materials | PLATES: titanium which conforms | |
| to ASTM F67 | ||
| Screw: Titanium alloy (TiAl4V ELI) | ||
| which conforms to ASTM F136 | PLATES: titanium which conforms | |
| to ASTM F67 | ||
| Screw: Titanium alloy (TiAl4V ELI) | ||
| which conforms to ASTM F136 | ||
| Biocompatibility | PLATES: titanium which conforms | |
| to ASTM F67 | ||
| Screw: Titanium alloy (TiAl4V ELI) | ||
| which conforms to ASTM F136 | PLATES: titanium which conforms | |
| to ASTM F67 | ||
| Screw: Titanium alloy (TiAl4V ELI) | ||
| which conforms to ASTM F136 | ||
| Sterility | Provided as non-sterile, needs | |
| autoclave prior to use | Provided as non-sterile, needs | |
| steam sterilization prior to use | ||
| Test items for bone | ||
| plates | Static four point bending | |
| Dynamic four point bending | Static four point bending | |
| Dynamic four point bending | ||
| Test items for bone | ||
| screws | Torsional properties | |
| Driving torque | ||
| Pull-out test | Torsional properties | |
| Driving torque | ||
| Pull-out test |
510(k) Premarket Notification Submission_ Metallic Locking Bone Plate and Screw System
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Image /page/6/Picture/0 description: The image shows the logo for D&J medical. The logo consists of a stylized teal and light green graphic to the left, resembling three people holding hands in a circle. To the right of the graphic is the text "D&J medical" in teal and light green. Below the text are four gray Chinese characters.
emarket Notification Submission_ Metallic Locking Bone Plate and Screw System
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
No clinical performance testing:
Bench tests were conducted to verify that proposed device meets all design specifications as was substantially equivalence to the predicate device. The following bench testing was performed to support a determination of substantial equivalence:
ASTM F382 standard specification and test method for metallic bone plates, including the following items:
- . Static four point bending
- . Dynamic four point bending
ASTM F543 standard specification and test methods for metallic medical bone screw including the following item:
- Torsional properties
- Driving torque
- Pullout test
Animal and clinical study
The subject of this premarket submission, metallic locking bone plate system, does not require clinical studies to support substantial equivalence.
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Image /page/7/Picture/0 description: The image contains the logo for D&J medical. The logo consists of a stylized graphic of three concentric arcs with circles at the ends, colored in shades of teal and light green. To the right of the graphic, the text "D&J medical" is displayed, with "D&J" in teal and "medical" in light green. Below the text, there are three Chinese characters in gray.
510(k) Premarket Notification Submission_ Metallic Locking Bone Plate and Screw System
VIII. CONCLUSIONS
The non-clinical data support the safety of the device and the performance testing report demonstrate that the metallic locking bone plate system should perform as intended in the specified use conditions. Changzhou Dingjian Medical Appliance Co., Ltd., Inc considers the metallic locking bone plate system does not raise any new issues of safety or effectiveness.