(38 days)
Not Found
No
The summary describes a mechanical orthopedic implant system (plates, screws, and instruments) and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a Locking Plate System designed for internal fixation of fractures, which is a therapeutic intervention.
No
Explanation: The device is a Locking Plate System used for fixating fractures, not for diagnosing conditions.
No
The device description explicitly lists physical components made of titanium (plates and screws) and various instruments, indicating it is a hardware-based medical device.
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 in bones (ulna, radius, humerus, femur, tibia, and fibula). This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of plates, screws, and instruments used for bone fixation. These are physical implants and tools used during surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of this device does not involve any such testing of biological samples.
Therefore, the Locking Plate System is a surgical implant and instrument system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Locking Plate System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur tibia and fibula.
Product codes
HRS, HWC
Device Description
The proposed products, Locking Plate System, contain (1) locking plates (LPs) with various specifications, (2) locking screws with various specifications and (3) various specific instruments. Locking Plates are the plates that made of Titanium. The limited-contact design of LPs reduces plate-to-bone contact, thus limiting vascular trauma. The screws are available in three kinds, which are 3.5mm Hexagonal Locking Screws with hexagonal interface, 3.5mm Stardrive Locking Screws with Torx interface, and 5.0mm Locking Screws with hexagonal interface. There are various instruments specific to the proposed device intend for completing the surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ulna, radius, humerus, femur tibia and fibula
Indicated Patient Age Range
adult patients with 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ASTM F382-99 (Reapproved 2008), Standard Specification and Test Method for Metallic Bone Plates.
- ASTM F543-07. Standard Specification and Test Methods for Metallic Medical Bone Screws.
- IS O 17665-1:2006 Sterilization of health care products- Moist heat, Part 1: Requirements for the development. validation and routing control of a sterilization process for medical devices.
Static and Dynamic Performance tested per ASTM F382
Torsional, Driving Torque and Pull out strength tested per ASTM F543.
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.
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K132642 page 1 0f 5
Section 3 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21. CFR Section 807.92.
K132642 The assigned 510(k) Number:
3.1 Date of Submission
08/23/2013
OCT 0 3 2013
3.2 Sponsor Identification
Beijing Libeier Bio-Engineering Institute Co. Ltd. 100, 6th Kechuang Street. Economic And Technological Development Area East, Beijing, 100176. China.
Establishment Registration Number: Not yet registered
Contact Person: Jenny Jiang Position: Overseas Specialist Tel: +86 10 67895577 ext. 8226 Fax: +86 10 67857129 Email: jenny@libeier.com
3.3 Submission Correspondent
Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co.. Ltd P.O. Box 120-119 Shanghai. 200120. China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
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3.4 Proposed Devices Identification
K132642 page 2 of 5
Proposed Device Name: Locking Plate System Proposed Device Common Name: Bone Plates and Bone Screws
Regulatory Information of Plates: Classification Name: Plate, Fixation, Bone Common Name: Bone Plates Class: Class II Product Code: HRS Regulation Number: 21 CFR 888.3030 Review Panel: Orthopedic
Regulatory Information of Screws: Classification Name: Screw, Fixation, Bone Common Name: Bone Screws Class: Class II Product Code: HWC Regulation Number: 21 CFR 888.3040 Review Panel: Orthopedic
Intended Use Statement:
I.ocking Plate System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus. femur tibia and fibula.
3.5 Device Description
The proposed products, Locking Plate System, contain (1) locking plates (1.Ps) with various specifications. (2) locking screws with various specifications and (3) various specific instruments. Locking Plates are the plates that made of Titanium. The limited-contact design of LPs reduces plate-to-bone contact, thus limiting vascular trauma. The screws are available in three kinds, which are 3.5mm Hexagonal Locking Screws with hexagonal interface, 3.5mm Stardrive Locking Screws with Torx interface, and 5.0mm Locking Screws with hexagonal interface. There are various instruments specific to the proposed device intend for completing the surgery.
3-2
2
3.6 Predicate Device Identification
Predicate Device 1
510(k) Number K 101400
Predicate Device Name Locking Compression Plate
Manufacturer Changzhou Orthmed Medical Instrument Co., Ltd
Predicate Device 2
510(k) Number K100721
Predicate Device Name Locking Bone Screw
Manufacturer
Changzhou Orthmed Medical Instrument Co., Ltd
3
3.7 Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ASTM F382-99 (Reapproved 2008), Standard Specification and Test Method for Metallic Bone a) Plates.
- ASTM F543-07. Standard Specification and Test Methods for Metallic Medical Bone Screws. b)
- 1SO 17665-1:2006 Sterilization of health care products- Moist heat, Part 1: Requirements for the c) development. validation and routing control of a sterilization process for medical devices.
- 3.8 Clinical Testing Conclusion
No clinical study is included in this submission.
- 3.9 Substantially Equivalent (SE) Conclusion
The following table compares the DEVICE to the predicate device with respect to intended use. technological characteristics and principles of operation, etc.
| Item | Proposed Device | Predicate Device 1 | Predicate Device 2 |
|---|---|---|---|
| Product Code | HRS | HRS | / |
| HWC | / | HWC | |
| Regulation | 21 CFR 888.3030 | 21 CFR 888.3030 | / |
| Number | 21 CFR 888.3040 | / | 21 CFR 888.3040 |
| Class | Class 2 | Class 2 | Class 2 |
| Intended Use | Locking Plate System | ||
| can be used for adult | |||
| patients with age above | |||
| 21 as indicated for | |||
| fixation of fractures. | |||
| including ulna, radius, | |||
| humerus, femur tibia and | |||
| fibula. | Locking Compression | ||
| Plate can be used for | |||
| adult patients with age | |||
| above 21 as indicated for | |||
| fixation of fractures. | |||
| including ulna, radius. | |||
| humerus, femur and | |||
| tibia. | Locking Bone Screw is | ||
| indicated for bone | |||
| reconstruction, | |||
| osteotomy, arthrodesis. | |||
| joint fusion, fracture | |||
| repair, and fracture | |||
| fixation of bones | |||
| appropriate for the size | |||
| of the device. | |||
| Material | Plate: Titanium | ||
| Locking Screw: | |||
| Titanium alloy | Plate: Titanium | / | |
| Locking Screw: | |||
| Titanium alloy |
Table 3-1 Comparison of Technology Characteristics
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K132642 page 5 of 5
Premarket Notification 510(k) Submission
Section 3 510k Summary
Project #: M0572013
| How supplied | Non-Sterile | Non-Sterile | Non-Sterile |
|---|---|---|---|
| Single Use | Yes | Yes | Yes |
| Sterile | Subject | ||
| to steam | |||
| sterilized prior to use. | Subject | ||
| to steam | |||
| sterilized prior to use. | Subject | ||
| to steam | |||
| sterilized prior to use. | |||
| Performance | Static and Dynamic | ||
| Performance tested per | |||
| ASTM F382 | |||
| Torsional, Driving | |||
| Torque and Pull out | |||
| strength tested per | |||
| ASTM F543. | Static and Dynamic | ||
| Performance tested per | |||
| ASTM F382 | Torsional, Driving | ||
| Torque and Pull out | |||
| strength tested per | |||
| ASTM F543. |
Differences in intended use. material and performance between the proposed and predicate device have been discussed and address. The proposed device is determined to be Substantially Equivalent (SE) to the predicate devices, in respect of safety and effectiveness.
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Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the logo is a symbol that resembles three stylized human figures.
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
October 3, 2013
Beijing Libeier Bio-Engineering Institute Company, Limited % Ms. Diana Hong General Manager Mid-Link Consulting Company, Limited P.O. Box 120-119 Shanghai, 200120 CHINA
Re: K132642
Trade/Device Name: 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: August 23, 2013 Received: August 26, 2013
Dear Ms. Hong:
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
6
Page 2 - Ms. Diana Hong
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/MedicalDcvices/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 Small Manufacturers, International and Consumer Assistance 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.
Sincercly yours,
Image /page/6/Picture/6 description: The image shows the name "Erin Keith" in a simple, bold font. The letters are black against a white background, making the text easily readable. The font appears to be a sans-serif style, giving it a clean and modern look. The name is presented in a straightforward manner without any additional design elements.
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 2 Indications for Use
K132642 510(k) Number: Device Name: Locking Plate System
Indications for Use:
Locking Plate System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur tibia and fibula.
OPRESCRIPTION USE (Part 21 CFR 801 Subpart D)
OR
OVER-THE-COUNTER USE (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Elizabeth L. Frank -S
Division of Orthopedic Devices