RECONSTRUCTION LOCKING PLATE AND 3.5MM LOCKING SCREW

• K Number: K112819
• Device Name: RECONSTRUCTION LOCKING PLATE AND 3.5MM LOCKING SCREW
• Manufacturer: XIAMEN DOUBLE ENGLINE MEDICAL MATERIAL CO., LTD
• Date Cleared: 2011-12-16 ( 79 days)
• Product Code: HRS , HWC
• Regulation Number: 888.3030
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: k092889
• Predicate For: K151508

Intended 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.

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.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called "Reconstruction Locking Plate and 3.5mm Locking Screw." This summary focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving the device meets those criteria from an AI/algorithm performance perspective.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance (as inferable from the document):

Acceptance Criteria	Reported Device Performance
Material Compliance: Meets ASTM F136 (Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications)	The proposed devices are made of Titanium Alloy (Ti-6AL-4V), which meets ASTM F136.
Biocompatibility: Demonstrated for surgical implants.	Titanium Alloy (Ti-6AL-4V) is widely used for surgical implants with well-known biocompatibility.
Sterilization: Achieves a Sterility Assurance Level (SAL) of $10^{-6}$ via autoclave method.	Sterilization method is presented in the user manual and validated per ISO 17665-1:2006.
Bench Test Performance: Meets design specifications and is Substantially Equivalent (SE) to the predicate device.	Bench tests were conducted to verify that the proposed device met all design specifications and was SE to the predicate device.
Standard Compliance (Metallic Bone Plates): Conforms to ASTM F382-99.	Test results demonstrated compliance with ASTM F382-99.
Standard Compliance (Metallic Medical Bone Screws): Conforms to ASTM F543-07.	Test results demonstrated compliance with ASTM F543-07.

Study Information (Based on the document):

The document describes non-clinical (bench) testing, not a clinical study involving human subjects or AI performance. Therefore, many of your requested points are not applicable to this type of submission.

1. Sample size used for the test set and the data provenance: Not applicable. The "test set" in this context refers to the physical devices undergoing bench tests. The document doesn't specify the number of plates/screws tested for each bench test, nor does it refer to data provenance in the sense of patient data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material and mechanical properties is typically established by laboratory measurements and adherence to engineering standards, not expert consensus in the medical image interpretation sense.
3. Adjudication method for the test set: Not applicable. Bench tests follow standardized protocols.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/algorithm device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm device.
6. The type of ground truth used: For the bench tests, the ground truth is the specified mechanical properties, material composition, and sterilization efficacy as defined by the referenced ASTM and ISO standards. These are objectively measurable physical properties.
7. The sample size for the training set: Not applicable. This is not an AI/algorithm device.
8. How the ground truth for the training set was established: Not applicable. This is not an AI/algorithm device.

Summary of the Study described in the document:

The study was a series of non-clinical bench tests conducted to demonstrate that the "Reconstruction Locking Plate and 3.5mm Locking Screw" met its design specifications and was substantially equivalent to a predicate device (Syntec Osteo - plate and screw Fixation).

• Tests Performed: The document explicitly mentions tests verifying compliance with:
  • ASTM F382-99 (Standard Specification and Test Method for Metallic Bone Plates)
  • ASTM F543-07 (Standard Specification and Test Methods for Metallic Medical Bone Screws)
• Material Verification: The device's material (Ti-6AL-4V) was confirmed to meet ASTM F136, indicating biocompatibility.
• Sterilization Validation: The sterilization method (autoclave) was validated per ISO 17665-1:2006 to ensure a SAL of $10^{-6}$.

The purpose of these tests was to show that the new device performs similarly and safely to a legally marketed predicate device, thereby supporting the 510(k) clearance process based on "Substantial Equivalence." There is no mention of AI, human readers, or clinical data in this submission summary.

Summary

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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:

• 1. Date of Submission: September 23, 2011
• 2. 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: [phone] Fax: [phone] Email: [e-mail]

• 3. Submission Correspondent Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd . P.O. Box 237-023, Shanghai, 200237, China Tel: [phone] Fax: [phone] Email: [e-mail]
• 4. 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.

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K112814 Page 2/2

Additional Information I K112819 - Attachment IV 510(k) Summary

• 5. Predicate Device Identification
     510(k) Number: K092889 Product Name: Syntec Osteo - plate and screw Fixation Manufacturer: Syntec Scientific Corporation

• 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.

• 7. 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:

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.

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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.

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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 [phone] or [phone] 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

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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)

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Hyllett Burr

-(Division Sign-Off)
(Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number K112819

Regulation Number and Section

§ 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.