(79 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and sterilization of a bone plate and screw system, with no mention of AI or ML.
Yes
The device is intended to treat fractures of bones, which is a therapeutic purpose.
No
The device is a surgical implant (reconstruction locking plate and screws) used to treat fractures, not to diagnose them.
No
The device description explicitly states that the device is made of Titanium Alloy and describes physical components (plates and screws). It also mentions sterilization requirements, which are relevant to physical medical devices. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly states that the Reconstruction Locking Plate and 3.5mm Locking Screw are implants used to treat bone fractures. They are physically placed within the body to stabilize broken bones.
- Intended Use: The intended use is to "treat fractures of various bones," which is a surgical intervention, not a diagnostic test performed on a sample outside the body.
The device is a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Reconstruction Locking Plate and 3.5mm Locking Screw are used together and intended to treat fractures of various bones, including the clavicle and pelvis.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The proposed devices of Reconstruction Locking Plate and 3.5mm Locking Screw are intended to treat fractures of various bones, including the clavicle and pelvis.
They are made of Titanium Alloy (Ti-6AL-4V), which meet ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well known biocompatibility.
The plates vary essentially through different lengths and number of plate holes. The screws are self-tapping with 3.5mm major diameter, which are applied with the reconstruction locking plates together.
The proposed devices are not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10 by the hospital prior to surgery. The sterilization method is presented in the user manual, which was validated per 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones, including the clavicle and pelvis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital
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 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 F 382-99, Standard Specification and Test Method for Metallic Bone Plates
ASTM F 543-07, Standard Specification and Test Methods for Metallic Medical Bone Screws
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
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Additional Information I K 112819 - Attachment IV 510(k) Summary
DEC 1 6 2011
Attachment IV 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 21 CFR 807.92.
The assigned 510(k) Number:
-
- Date of Submission: September 23, 2011
-
- Sponsor
Xiamen Double Engine Medical Material Co., Ltd. No.218, Houxiang Road, Haicang District, Xiamen, 361022, China
Contact Person: Jian Wu Position: General manager assistant Tel: 86-0592-6087671 Fax: 86-0592-6587078 Email: xmde.ltd@gmail.com
-
- Submission Correspondent Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd . P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
-
- Proposed Device Identification
Proposed Device Name: Reconstruction Locking Plate and 3.5mm Locking Screw
Classification: II Product Code: HRS, HWC Regulation Number: 21 CFR 888.3030, 21 CFR 888.3040 Review Panel: Orthopedic
Intended Use Statement:
The Reconstruction Locking Plate and 3.5mm Locking Screw are used together and intended to treat fractures of various bones, including the clavicle and pelvis.
1
K112814 Page 2/2
Additional Information I K112819 - Attachment IV 510(k) Summary
-
- Predicate Device Identification
510(k) Number: K092889 Product Name: Syntec Osteo - plate and screw Fixation Manufacturer: Syntec Scientific Corporation
- Predicate Device Identification
-
Device Description 6.
The proposed devices of Reconstruction Locking Plate and 3.5mm Locking Screw are intended to treat fractures of various bones, including the clavicle and pelvis.
They are made of Titanium Alloy (Ti-6AL-4V), which meet ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well known biocompatibility.
The plates vary essentially through different lengths and number of plate holes. The screws are self-tapping with 3.5mm major diameter, which are applied with the reconstruction locking plates together.
The proposed devices are not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10 by the hospital prior to surgery. The sterilization method is presented in the user manual, which was validated per 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.
-
- Non-Clinical Test Conclusion
Bench 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
ASTM F 382-99, Standard Specification and Test Method for Metallic Bone Plates ASTM F 543-07, Standard Specification and Test Methods for Metallic Medical Bone Screws
- Substantially Equivalent Conclusion 8.
The proposed device, Reconstruction Locking Plate and 3.5mm Locking Screw, is determined to be Substantially Equivalent (SE) to the predicate device, Syntec Osteo - plate and screw Fixation, in respect of safety and effectiveness.
2
Image /page/2/Picture/1 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Mail Center - WO66-G609, Silver Spring, MD 20993-0002. The text is left-aligned and uses a serif font.
DEC 1 6 2011
Xiamen Double Engine Medical Material Co., Ltd. % Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023 Shanghai, 200237, China
Re: K112819
Trade/Device Name: Reconstruction Locking Plate and 3.5mm Locking Screw Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: II Product Code: HRS, HWC Dated: September 23td, 2011 Received: September 28th, 2011
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.
3
Page 2 - Ms. Diana Hong
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Erin Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
//2819
Section II Indications for Use
510(k) Number: Device Name: Reconstruction Locking Plate and 3.5mm Locking Screw
Indications for Use:
The Reconstruction Locking Plate and 3.5mm Locking Screw are used together and intended to treat fractures of various bones, including the clavicle and pelvis.
OPRESCRIPTION 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 ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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Hyllett Burr
-(Division Sign-Off)
(Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number K112819