(54 days)
Not Found
No
The 510(k) summary describes a standard mechanical orthopedic implant system (plates and screws) and mentions only bench testing for mechanical properties. There is no mention of AI/ML terms, image processing, or data sets for training/testing.
No
This device is a locking plate system used for the fixation of bones, specifically the tibia, which is a mechanical support and not a therapeutic treatment.
No
The device is a locking plate system intended for the fixation of tibia. It is a surgical implant used for mechanical support, not for diagnosing medical conditions.
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. This indicates it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "fixation of tibia" in adult patients. This describes a surgical implant used to stabilize bone fractures.
- Device Description: The description details bone plates, screws, and instruments used in surgery. These are physical devices implanted into the body.
- 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.
This device is a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
BaiDe® locking plate system is intended for adult patients as indicated for fixation of tibia.
Product codes
HRS, HWC
Device Description
BaiDe" 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 Ti6A14V ELI that meets to ASTM F136. The materials of titanium and Ti6A14V 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 (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
Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Jiangsu BaiDe Medical Instrument Co., Ltd. % Ms. Alice Gong Shanghai Yarui Consultant Co., Ltd. 503 Room, 8 Building, 600 Liu Zhou Road Shanghai, Shanghai 200233 China
February 25, 2015
Re: K150009 Trade/Device Name: Baide® 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 18, 2014 Received: January 2, 2015
Dear Ms. Alice 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
1
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 (OS) 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/Resourcesfor You/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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Trade name: BaiDe®
Common name: Locking Plate System
Indications for Use (Describe)
BaiDe® locking plate system is intended for adult patients as indicated for fixation of tibia.
Type of Use (Select one or both, as applicable)
2 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)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Section 5 of Traditional 510(K) Submission:
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: Nov. 18, 2014
-
- Submitter / 510(K) Holder
Jiangsu BaiDe Medical Instrument Co.,Ltd. South Side of Dongqi Road, Donglai Village, YangShe Town Zhangjiagang City Jiangsu Province China
Contact Person: Mr. Kang Shui Tel: (86) 0512-56987731 Fax: (86) 0512-56987279 E-mail: yvigmm@126.com
3. Proposed Device Namet
Trade name: BaiDe® 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
4. Predicate Devices
Predicate Devices #1:
4
Predicate Devices #2:
510 (k) Number: K130340 Product Name: Locking Bone Plates and Scews Submitter: Weigao Orthopaedic Device Co., Ltd.
5. Device Description
BaiDe" 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 Ti6A14V ELI that meets to ASTM F136. The materials of titanium and Ti6A14V ELI are widely used in the industry with well-known biocompatibility. No new materials are used in the development of this implant.
6. Indication for Use/Intended Use
BaiDe® locking plate system is intended for adult patients as indicated for fixation of fractures of tibia.
7. 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
5
The BaiDe® locking plate system has same intended use as the predicate device and similar technological characteristics as the predicate device. The proposed device, the BaiDe® locking plate system, is determined to be Substantially Equivalent (SE) to the predicate device, K133840 Kangli® locking plate system and K130340 locking bone plates and screws, in respect of safety and effectiveness.