(112 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and materials of a metallic bone plate and screw system, with no mention of AI or ML capabilities.
No
This device is a bone plate and screw system intended for stabilizing fractures, nonunions, and malunions in the femur. Its primary function is mechanical support for healing, not directly treating a disease or condition therapeutically.
No
Explanation: The device is described as a "Bone Plate and Screw System" intended for buttressing fractures, nonunions, malunions, and osteotomies of the femuri. This indicates it is a surgical implant used for structural support and repair, not for diagnosing medical conditions.
No
The device description explicitly states that the product contains metallic bone plates, bone screws, and instruments, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the surgical treatment of bone fractures in the femur. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The description details metallic bone plates and screws, which are implants used to stabilize bone.
- Lack of IVD Characteristics: An IVD is a medical device used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The information provided consistently points to a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
WASTON Metallic Bone Plate and Screw Systems are intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, nonunions and malunions, and osteotomies of the femuri
WASTON Metallic Bone Plate and Screw Systems are intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, nonunions, and osteotomies of the femur.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The proposed products, WASTON Metallic Bone Plate and Screw Systems, contain (1) Distal lateral femoral (condylar) LOC plate, (2) Bone 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 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-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
distal femur, femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 proposed device complies with the following standards:
- 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.
The proposed bone plate and predicate bone plate were tested together per the following standard, to evaluate the performance of the proposed bone plate and predicate bone plate. The test results demonstrated that the mechanical performance of proposed device is similar or better as the predicate, and supported a determination of substantial equivalence between the proposed device and predicate device.
- ASTM F382-99 (Reapproved 2008), Standard Specification and Test Method for Metallic Bone Plates, including the following items: Static four-point bending test Dynamic four-point bending test
The proposed bones screw and predicate screws were tested together per the following standard, to evaluate the performance of the proposed bone screws and predicate bone screws. The test results demonstrated that the mechanical performance of proposed device is similar or better as the predicate, and supported a determination of substantial equivalence between the proposed device and predicate device.
- ASTM F543-13, Standard Specification and Test Methods for Metallic Medical Bone Screws, including the following items: Torsional properties Driving torque Pull-out test Self-tapping test
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 and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized human figure with three faces in profile, representing the department's focus on health and human well-being. The logo is simple, using only black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Changzhou Waston Medical Appliance Company Limited % Ms. Diana Hong Mid-link Consulting Company, Limited P.O. Box 120-119 Shanghai, 200120 CHINA
August 10, 2015
Re: K151057 Trade/Device Name: WASTON Metallic Bone Plate and Screw Systems 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 23, 2015 Received: July 6, 2015
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
1
(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 (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" (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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Pg.1/1
510(k) Number (if known) K151057
Device Name
WASTON Metallic Bone Plate and Screw Systems
Indications for Use (Describe)
W ASTON Metallic Bone Plate and Screw Systems are intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, nonunions and malunions, and osteotomies of the femuri
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
3
Exhibit 2 # 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:__K151057
- Date of Preparation: 06/17/2015 1.
-
- Sponsor Identification
CHANGZHOU WASTON MEDICAL APPLIANCE CO., LTD
9 Xihu Road, Wujin Hi-tech Industry Zone, Changzhou, Jiangsu, 213168, China
Establishment Registration Number: Not yet registered
Contact Person: Mr. Jack Lu Position: International Department Director Tel: +86-519-86522226 Fax: +86-519-86221108 Email: Waston18@gmail.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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Identification of Proposed Device 4.
Trade Name: WASTON Metallic Bone Plate and Screw Systems 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
Intended Use Statement:
WASTON Metallic Bone Plate and Screw Systems are intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, nonunions, and osteotomies of the femur.
Device Description
The proposed products, WASTON Metallic Bone Plate and Screw Systems, contain (1) Distal lateral femoral (condylar) LOC plate, (2) Bone 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 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-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
5
Assurance Level of 10-6 by hospital prior to use.
6
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- Identification of Predicate Devices
Predicate device 1 510(k) Number: K062564 Product Name: Synthes LCP Distal Femur Plates Manufacturer: Synthes (USA)
- Identification of Predicate Devices
Predicate device 2 510(k) Number: K000682 Product Name: Synthes Large Fragment Dynamic Compression Locking System (DCL) (5.0 Locking Screws) Manufacturer: Synthes (USA)
Predicate device 3 510(k) Number: K112583 Product Name: Synthes Cortical Screws (4.5 Cortex Screws) Manufacturer: Synthes (USA)
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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 proposed device complies with the following standards:
- Non-Clinical Test Conclusion
-
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).
-
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.
The proposed bone plate and predicate bone plate were tested together per the following standard, to evaluate the performance of the proposed bone plate and predicate bone plate. The test results demonstrated that the mechanical performance of proposed device is similar or better as the predicate, and supported a determination of substantial equivalence between the proposed device and predicate device.
7
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ASTM F382-99 (Reapproved 2008), Standard Specification and Test Method for Metallic Bone Plates, including the following items: Static four-point bending test Dynamic four-point bending test
The proposed bones screw and predicate screws were tested together per the following standard, to evaluate the performance of the proposed bone screws and predicate bone screws. The test results demonstrated that the mechanical performance of proposed device is similar or better as the predicate, and supported a determination of substantial equivalence between the proposed device and predicate device. -
A ASTM F543-13, Standard Specification and Test Methods for Metallic Medical Bone Screws, including the following items: Torsional properties Driving torque Pull-out test Self-tapping test
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Clinical Test Conclusion 7.
No clinical study is included in this submission.