(251 days)
Not Found
No
The summary describes a mechanical implant system (plates and screws) and instruments, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is described as a "Locking Plate System" and is indicated for the "fixation of fractures." Its components (plates and screws) are made of biocompatible materials (titanium) and are designed to be implanted in the body for therapeutic purposes. This aligns with the definition of a therapeutic device as something intended to treat or alleviate a medical condition.
No
The device, a "Locking Plate System," is indicated for the fixation of fractures, which is a therapeutic purpose, not a diagnostic one. It consists of plates, screws, and instruments used for surgical implantation.
No
The device description explicitly states that the product contains physical components: Locking Plates, Locking screws, and various specific instruments, made of titanium and titanium alloy. This indicates it is a hardware medical device, not software-only.
No, 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 physical implants (plates and screws) and instruments used in surgery.
- 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 clearly an implantable surgical device used for orthopedic procedures, not for testing biological samples.
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 (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The proposed product, Locking Plate System, contains (1) Locking Plates, (2) Locking screws and (3) various specific instruments.
The raw material of the plate, titanium, conforms to ASTM F67-13, Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNSR50550, UNS R50700). The bone screws are made of titanium alloy (TI-6AL-4V ELI), which complies with ASTM F136-13, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
The devices are provided un-sterilized, but shall be sterilized via autoclave method to achieve Sterility Assurance Level of 10-6 by hospital prior to use.
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
- ASTM F67-13, Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNSR50550, UNS R50700).
- ASTM F136-13: Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNSR56401).
- ASTM F138-13, Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673).
- ISO 17665-1:2006, Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.
Key results:
Plate: Static and Dynamic Performance were tested per ASTM F 382
Locking screw: Torsional, Driving Torque and Pull- out Strength performance were 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
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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Beijing Keyi Medical Device Technology Co., Ltd. % Diana Hong General Manager Mid-link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CN
May 2, 2017
Re: K162380 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: April 1, 2017 Received: April 3, 2017
Dear Ms. Diana 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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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/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/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162380
Device Name Locking Plate System
Indications for Use (Describe)
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.
| 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)
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3
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K162380
-
- Date of Preparation: 04/25/2017
-
- Sponsor Identification
Beijing KeYi Medical Device Technology Co., Ltd.
Building 1, No. 11, 3rd Jinghai Street, Economic and Technological Development Area, Beijing, 100176, China
Establishment Registration Number: Not yet registered
Contact Person: Hongxin Nie Position: Vice President Tel: +86-10-67853877 Fax: +86-10-67853877 ext 817 Email: gm(@keyibangen.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Jing Cheng (Alternative Contact Person)
- Designated Submission Correspondent
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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4. Identification of Proposed Device
Trade Name: Locking Plate System Common Name: Metallic Bone Plates and Bone Screws
Regulatory Information Plate Classification Name: Plate, Fixation, Bone Classification: II Product Code: HRS Regulation Number: 21 CFR part 888.3030 Review Panel: Orthopedic
Screw Classification Name: Screw, Fixation, Bone Classification: II Product Code: HWC Regulation Number: 21 CFR part 888.3040 Review Panel: Orthopedic
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.
Device Description
The proposed product, Locking Plate System, contains (1) Locking Plates, (2) Locking screws and (3) various specific instruments.
The raw material of the plate, titanium, conforms to ASTM F67-13, Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNSR50550, UNS R50700). The bone screws are made of titanium alloy (TI-6AL-4V ELI), which complies with ASTM F136-13, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
The devices are provided un-sterilized, but shall be sterilized via autoclave method to achieve Sterility Assurance Level of 10-6 by hospital prior to use.
5
- ર : Identification of Predicate Devices
Primary Predicate 510(k) Number: K101400 Product Name: Locking Compression Plate Manufacturer: Changzhou Orthmed Medical Instrument Co., Ltd.
Additional Predicate 510(k) Number: K100721 Product Name: Locking Bone Screw Manufacturer: Changzhou Orthmed Medical Instrument Co., Ltd.
Additional Predicate 510(k) Number: K130340 Product Name: Locking Bone Plates and Screws Manufacturer: Weigao Orthopaedic Device Co., Ltd.
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- 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:
- Non-Clinical Test Conclusion
-
A ASTM F382-99 (Reapproved 2008), Standard Specification and Test Method for Metallic Bone Plates
-
A ASTM F543-07, Standard Specification and Test Methods for Metallic Medical Bone Screws
-
ASTM F67-13, Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNSR50550, UNS R50700).
-
ASTM F136-13: Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNSR56401).
-
A ASTM F138-13, Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673).
-
A ISO 17665-1:2006, Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
6
Substantially Equivalent (SE) Comparison 8.
| ITEM | Proposed Device | Primary Predicate,K101400 | |
|---|---|---|---|
| Locking Plate System | Locking Compression Plate | ||
| Product Code | Plate: HRS | Plate: HRS | |
| Screw: HWC | N.A. | ||
| Regulation No. | Plate: 21 CFR 888.3030 | Plate: 21 CFR 888.3030 | |
| Screw: 21 CFR 888.3040 | N.A. | ||
| Class | Class II | Class II | |
| Intended Use | Locking Plate System can be used for adult patients | Locking Compression Plate can be used for adult | |
| with age above 21 as indicated for fixation of | patients with age above 21 as indicated for fixation | ||
| fractures, including ulna, radius, humerus, femur, | of features, including ulna,radius, humerus, femur | ||
| tibia and fibula. | and tibia. | ||
| Features of | Slots-Limited Contact Area | Slots-Limited Contact Area | |
| Locking Plates | Combi-Holes | Combi-Holes | |
| Features of | Self-tapping locking screws and Self-tapping-drilling | N.A. | |
| Locking Screws | locking screws | ||
| Material | Locking Plates: Titanium | Locking Plate: Titanium alloy | |
| Locking Screws: Titanium alloy | N.A. | ||
| How supplied | Non-Sterile, | Non-Sterile, | |
| Subject to steam sterilized prior to use. | Subject to steam sterilized prior to use. | ||
| Perfor | |||
| mance | Plate | Static and Dynamic Performance were tested per | Static and Dynamic Performance were tested per |
| ASTM F 382 | ASTM F 382 | ||
| Locking screw | Torsional, Driving Torque and Pull- out Strength | Torsional, Driving Torque, Pull- out strength | |
| performance were tested per | performance was evaluated per | ||
| ASTM F543 | ASTM F543 for screws cleared in K100721 |
Table 1 Comparison of Technology Characteristics
9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.