(223 days)
No
The device description and performance studies focus on the mechanical properties and materials of the locking plate system, with no mention of AI or ML.
No
The device is described as a locking plate system intended for the fixation of bone fractures, which is a structural support function rather than a therapeutic one (e.g., drug delivery, disease treatment).
No
Explanation: The device, KangLi® locking plate system, is an implant used for fixation of tibia fractures. It is a treatment device, not a diagnostic one, as it does not identify or detect a medical condition.
No
The device description explicitly states it contains physical components like locking plates, metal bone and locking screws, and surgical instruments, all made of metallic materials.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of fractures of tibia" in adult patients. This describes a surgical implant used directly on the human body to stabilize a bone fracture.
- Device Description: The description details bone plates, screws, and instruments made of titanium and Ti6AI4V ELI. These are all components of a surgical implant system.
- 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. IVDs typically involve reagents, analyzers, or test kits used in a laboratory or point-of-care setting.
Therefore, the KangLi® locking plate system is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
KangLi® locking plate system is intended for adult patients as indicated for fixation of fractures of tibia.
Product codes
HRS, HWC
Device Description
KangLi® locking plate system contains locking plates with various specifications, metal bone and locking screws with various specifications, and various specific instruments. The bone plates are used for fixation of bones. The screws are used for fix the plates on the bones and the instruments are used for completing the surgery.
The bone plates are manufactured from unalloyed titanium that conforms to ASTM F67. The metal bone and locking screws are made of Ti6AI4V ELI that meets to ASTM F136. The materials of titanium and Ti6AI4V ELI are widely used in the industry with well-known biocompatibility. No new materials are used in the development of this implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tibia
Indicated Patient Age Range
adult patients
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
Bench tests were conducted to verify that proposed device meet all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that proposed device complies with the following standards:
ASTM F 382-99 (Reapproved 2008), Standard Specification and Test Method for Metallic Bone Plates, including the following items:
- Static four point bending
- Dynamic four point bending
ASTM F 543-07, Standard Specification and Test Methods for Metallic Medical Bone Screws including the following item:
- Torsional properties
- Driving torque
- Pull out test
Key Metrics
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
Page | 1
Section 5 of Traditional 510(K) Submission:
JUL 2 9 2014
510 (K) Summary
This 510(K) Summary of safety and effectiveness information is being submitted in accordance with requirement of 21 CFR807.92
-
Date of Submission: Dec. 11, 2013
-
Submitter / 510(K) Holder
Suzhou Kangli Orthopaedics Instrument Co., Ltd., Sha Zhou East Road, Zhangjiagang City, Jiangsu Province, China 215625
Contact Person: Miss Jin Hua Huang Tel: (86) 0512-58560562 Fax: (86) 0512-58358951 E-mail: hjh@kang-li.cn
- Proposed Device Name
Trade name: KangLi® Common name: Locking Plate System
Classification Name: Plate, Fixation, Bone Device Class: Class II Classification Panel: Orthopedic Panel Product Code: HRS Regulation Number: 21 CFR 888.3030
Classification Name: Screw, Fixation, Bone Device Class: Class II Classification Panel: Orthopedic Panel Product Code: HWC Regulation Number: 21 CFR 888.3040
- Predicate Devices
510 (k) Number: K130340 Product Name: Locking Bone Plates and Scews Submitter: Weigao Orthopaedic Device Co., Ltd.
- Device Description
1
Pg.2/2
KangLi® locking plate system contains locking plates with various specifications, metal bone and locking screws with various specifications, and various specific instruments. The bone plates are used for fixation of bones. The screws are used for fix the plates on the bones and the instruments are used for completing the surgery.
The bone plates are manufactured from unalloyed titanium that conforms to ASTM F67. The metal bone and locking screws are made of Ti6AI4V ELI that meets to ASTM F136. The materials of titanium and Ti6AI4V ELI are widely used in the industry with well-known biocompatibility. No new materials are used in the development of this implant.
- Indication for Use/Intended Use
KangLi® locking plate system is intended for adult patients as indicated for fixation of fractures of tibia.
- Non-Clinical Testing
Bench tests were conducted to verify that proposed device meet all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that proposed device complies with the following standards:
ASTM F 382-99 (Reapproved 2008), Standard Specification and Test Method for Metallic Bone Plates, including the following items:
-
Static four point bending
-
Dynamic four point bending
ASTM F 543-07, Standard Specification and Test Methods for Metallic Medical Bone Screws including the following item:
-
Torsional properties
-
Driving torque
-
Pull out test
8. Substantially Equivalent Conclusion
The KangLi® locking plate system has less intended use than the predicate device and similar technological characteristics as the predicate device. The proposed device, the KangLi® locking plate system, is determined to be Substantially Equivalent (SE) to the predicate device, K130340 locking bone plates and screws, in respect of safety and effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 29, 2014
Suzhou Kangli Orthopaedics Instrument Co., Ltd. % Ms. Alice Gong Shanghai Yarui Consultant Co., Ltd. 503 Room, 8 Building, 600 Liu Zhou Road Shanghai, Shanghai 200233 China
Re: K133840
Trade/Device Name: KangLi® Locking Plate 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: June 12, 2014 Received: June 26, 2014
Dear Ms. Gong:
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 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
3
Page 2 - Ms. Alice Gong
(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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" (21 CFR 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/Resourcesfor You/Industry/default.htm.
Sincerely yours, Lori A. Wigqins
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
..............................................................................................................................................................................
Section 4 of Traditional 510(K) Submission:
Indications for Use
510(k) Number: K133840
Device Name: KangLi® Locking Plate System
Indications For Use:
KangLi® locking plate system is intended for adult patients as indicated for fixation of fractures of tibia.
Prescription Use______________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use_ ________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Elizabeth L. Frank -S
Division of Orthopedic Devices
KangLi®, Suzhou Kangli Orthopaedics Instrument Co., Ltd.,