(109 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and equivalence to a predicate device, with no mention of AI or ML.
Yes
The device is used for fixation of fractures, which means it is intended to treat a medical condition.
No
Explanation: The device is described as a "Locking Compression Bone Plates and Screws System" used for internal fixation of bone fractures. Its function is to fix bones, not to diagnose conditions.
No
The device description explicitly lists physical components: locking compression plates, locking screws, and various specific instruments. These are hardware components, not software.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the device is a "Locking Compression Bone Plates and Screws System" used for the "internal fixation of bones" and "fix the plates on the bones" during surgery.
- Intended Use: The intended use is for "fixation of fractures" in specific bones (ulna, radius, and tibia). This is a surgical procedure performed directly on the patient's body, not a test performed on a sample outside the body.
The information provided describes a surgical implant and associated instruments, which are not IVDs.
N/A
Intended Use / Indications for Use
The Locking Compression Bone Plates and Screws System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius and tibia.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The proposed product, Locking Compression Bone Plates and Screws System, contains (1) locking compression plates (LCPs) with various specifications, (2) locking screws with various specifications and (3) various specific instruments.
The locking compression plates are used for internal fixation of bones, screws are used for fix the plates on the bones, and instruments are used 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 and tibia
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:
A STM 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
Performance:
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): 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.
Not Found
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
Section 3 510 Summary
Section 3 510(k) Summary
This 510(k) Summary of 510(k) information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: _
l . Date of Submission: 11/04/2013
- Sponsor Identification
Changzhou Dean Medical Instrument Co., Ltd. No. 10, Jinshajiang Road, Xinbei District, Changzhou, Jiangsu, 213125, China
Establishment Registration Number: Not yet registered
Contact Person: Xiaoqing Liu Position: Quality System Specialist Tel: +86-519-85195058 Fax: +86-519-85195058 Email: 717181584@qq.com
- 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
1
4. Proposed Device Identification
Common Name: Locking Bone Plates and Locking Bone Screws Proposed Device Name: Locking Compression Bone Plates and Screws System
Plate:
Classification Name: Plate, Fixation, Bone Common Name: Bone Plates Class: Class II Product Code: HRS Regulation Number: 21 CFR 888.3030 Review Panel: Orthopedic
Screw
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:
The Locking Compression Bone Plates and Screws System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius and tibia.
- Predicate Device Identification 5.
510(k) Number: K131759 Product Name: Metallic Locking Compression Bone Plates and Screws System Manufacturer: Tianjin Walkman Biomaterial Co., Ltd
ર. Device Description
The proposed product, Locking Compression Bone Plates and Screws System, contains (1) locking compression plates (LCPs) with various specifications, (2) locking screws with various specifications and (3) various specific instruments.
The locking compression plates are used for internal fixation of bones, screws are used for fix the plates on the bones, and instruments are used for completing the surgery.
2
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:
A STM 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
- Substantially Equivalent (SE) Conclusion 8.
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 |
|---|---|---|
| K131759 | ||
| Product Code | HRS | |
| HWC | HRS | |
| HWC | ||
| Regulation Number | 21 CFR 888.3030 | |
| 21 CFR 888.3040 | 21 CFR 888.3030 | |
| 21 CFR 888.3040 | ||
| Intended Use | Locking Compression Bone Plates | |
| and Screw System is intended for | ||
| adult patients with age above 21 as | ||
| indicated for fixation of fractures, | ||
| including ulna, radius and tibia. | Metallic Locking Compression | |
| Bone Plate and Screw System is | ||
| intended for adult patients with age | ||
| above 21 as indicated for fixation | ||
| of fractures, including ulna, radius, | ||
| humerus, femur and tibia. | ||
| Material | Bone Plate: Titanium | |
| Locking Screw: Titanium alloy | Bone Plate: Titanium | |
| Locking Screw: Titanium alloy | ||
| How supplied | Non-Sterile | Non-Sterile |
| Single Use | Yes | Yes |
| Sterile | 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. |
Table 3-1 Comnarison of Technology Characteristics
3
Differences in physical specification 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 device, in respect of safety and effectiveness.
Page 4 of 4
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 4, 2014
Changzhou Dean Medical Instrument Co., Ltd. % Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China
Re: K133525
Trade/Device Name: Locking Compression Bone Plates and Screws 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: February 7, 2014 Received: February 10, 2014
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 comply with all the Act's requirements, including, but not limited to: registration and listing
5
Page 2 - Ms. Diana Hong
(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 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/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 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.
Sincerely yours,
Vincent同比evlin -S
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Premarket Notification 510(k) Submission Section 2 Indications for Use Project #: M0292013
Section 2 Indications for Use
K133525 510(k) Number: Device Name: Locking Compression Bone Plates and Screws System
Indications for Use:
The Locking Compression Bone Plates and Screws System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius and tibia.
APRESCRIPTION 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)
Elizabeth Warank -S
- (Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K133525
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