Locking Screw,CoCrMo is indicated for the fixation of clavicle, scapula, pelvis, humerus, ulna, radius, femur, tibia, fibula, metacarpals, metatarsals and phalanges fractures.

Device Description

Locking Screw, CoCrMo is used to fasten plates onto bones, or, as lag screws, to hold bone fragments together. The screws are differentiated by the manner in which they are inserted into bone, their function, their size, and the type of bone they are intended for. Locking Screw, CoCrMo consists of a series of screws with different sizes and structures, which is designed according to the anatomical characteristics of human bones. In clinical practice, the bone screw shall be used in combination with the bone plate, which acts as a temporary internal support, provides a stable local environment for the fractured end, and creates conditions for the healing of the fractured end. Locking Screw,CoCrMo is made of CoCrMo following ASTM F1537. Locking Screw,CoCrMo is provided as sterile and non-sterile. The implants are intended for single-use only.

AI/ML Overview

This submission describes a medical device, the "Locking Screw, CoCrMo," and its substantial equivalence to predicate devices, not an AI/ML powered device. Therefore, the information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not applicable here.

The document provides details for a traditional medical device submission, focusing on material, design, and mechanical performance. Here's a breakdown of the relevant information provided:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with explicit acceptance criteria and reported device performance in the manner expected for an AI/ML device. Instead, it states that the device was tested to demonstrate substantial equivalence to the predicate device based on specific mechanical tests. The acceptance is implied by the FDA's substantial equivalence determination.

Acceptance Criteria Category	Specific Test/Type of Evaluation	Reported Device Performance/Conclusion
Biocompatibility	Evaluation per FDA Guidance "Use of International Standard ISO 10993-1"	The biocompatibility evaluation was conducted successfully, implying the device meets relevant safety standards for biological interaction. (Specific results like cytotoxicity scores are not provided in this summary but would be in the full submission).
Mechanical Performance	Torsion Test (per ASTM F543-17)	Performed to demonstrate safety and efficacy substantially equivalent to the predicate device. (Specific torque values, failure modes, or comparison data are not provided in this summary but would be in the full submission for comparison against the predicate/standards).
	Insertion/Removal Test (per ASTM F543-17)	Performed to demonstrate safety and efficacy substantially equivalent to the predicate device. (Specific forces, cycles, or comparison data are not provided in this summary but would be in the full submission).
	Pullout Test (per ASTM F543-17)	Performed to demonstrate safety and efficacy substantially equivalent to the predicate device. (Specific forces, displacement, or comparison data are not provided in this summary but would be in the full submission).
Material Composition	CoCrMo following ASTM F1537	The device is made from CoCrMo following ASTM F1537, which is a recognized standard for medical implant materials. This implicitly means it meets the material specifications for this type of implant.
Sterility	Provided as sterile and non-sterile	Not a performance metric in this context, but a manufacturing and packaging standard. The manufacturer provides both options, implying compliance with sterilization standards as needed.
Single-Use	Intended for single-use only	Not a performance metric, but a critical design/usage specification to prevent reuse and associated risks.
Substantial Equivalence	Comparison of Regulatory Classification, Indications for Use, Materials, Design Features with predicate devices.	The device is determined to be substantially equivalent (SE) to the predicate devices in terms of safety and effectiveness, based on the non-clinical performance data and comparison of characteristics. This is the overarching "acceptance criterion" met for 510(k) clearance. Full details of the comparison would be in the complete 510(k) submission.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "non-clinical performance data" and mechanical tests (Torsion, Insertion/removal, Pullout). It does not specify the sample sizes used for these tests. Data provenance (country of origin, retrospective/prospective) is not applicable as these are laboratory mechanical tests, not clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as this is a submission for a physical medical device (locking screw), not an AI/ML diagnostic or predictive tool. Ground truth in this context typically refers to objective measurements and compliance with established ASTM standards for mechanical properties and biocompatibility, not expert consensus on interpretations of medical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not an AI/ML device undergoing a diagnostic performance study requiring adjudication of expert interpretations.

5. 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/ML device. No MRMC study was performed. The product is a physical implant, not a software tool assisting human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this type of device, the "ground truth" for non-clinical testing refers to:

Established ASTM Standards: The mechanical tests (Torsion, Insertion/removal, Pullout) are performed according to ASTM F543-17. The acceptance criteria for these tests are derived from these industry standards, often with comparative data to the predicate device to show equivalence.
Biocompatibility Standards: The biocompatibility evaluation follows ISO 10993-1, with acceptance based on meeting the requirements of this international standard.
Material Specifications: The material (CoCrMo) must conform to ASTM F1537.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device.

Summary

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December 4, 2024

Double Medical Technology Inc. Joy Zuo International RA Supervisor No.18, Shanbianhong East Road, Haicang District Xiamen. 361026 China

Re: K242348

Trade/Device Name: Locking Screw,CoCrMo Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC. HRS Dated: November 8, 2024 Received: November 8, 2024

Dear Joy Zuo:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE

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by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali -S

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K242348

Device Name

Locking Screw, CoCrMo

Indications for Use (Describe)

Locking Screw, CoCrMo is indicated for the fixation of clavicle, scapula, pelvis, humerus, ulna, radius, femur, tibia, fibula, metacarpals, metatarsals and phalanges fractures.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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1. Submitter
Name	Double Medical Technology Inc.
Address	No. 18, Shanbianhong East Road, Haicang District, Xiamen,361026, P. R. China
Phone	+86 592 6885079
Contact person	Yan Zuo
Date prepared	Agu. 1st, 2024
2. Proposed Device
Trade/proprietary name	Locking Screw, CoCrMo
Common or usual name	Smooth or threaded metallic bone fixation fastenerSingle/multiple component metallic bone fixation applianceand accessories
Classification name	Bone, Fixation, Screw; Bone, Fixation, Plate
Regulation number	21 CFR 888.3040 (primary), 21 CFR 888.3030
Product code	HWC (primary), HRS
Regulatory class	II
Classification panel	Orthopedic
3. Predicate Device
Legally marketeddevice(s) to whichequivalence is claimed	Primary predicate device:K220921 Double Medical Metal Bone Screw
	Additional predicate device:K221088 Double Medical Anatomic Bone Plate
	K130108 Double Engine Bone Plate and Bone Screw Systems
	K221150 Advanced Bone Plate
Reason for 510(k)submission	New device(Implant)

510(k) Summary

4. Device Description

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the healing of the fractured end. Locking Screw,CoCrMo is made of CoCrMo following ASTM F1537. Locking Screw,CoCrMo is provided as sterile and non-sterile. The implants are intended for single-use only.

5. Indication for Use

Locking Screw,CoCrMo is indicated for the fixation of clavicle, scapula, pelvis, humerus, ulna, radius, femur, tibia, fibula, metacarpals, metatarsals and phalanges fractures.

6. Comparison of Technological Characteristics with the Predicate Device

The rationale for substantial equivalence is based on consideration of the following characteristics:

Regulatory Classification: Same as the predicate devices Indications for Use: Substantially equivalent (SE) to the predicate devices Materials: Substantially equivalent (SE) to the predicate devices Design Features: Substantially equivalent (SE) to the predicate devices

7. Non-Clinical Performance Data

7.1 Biocompatibility testing

The biocompatibility evaluation for the Locking Screw,CoCrMo was conducted in accordance with the FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".

7.2 Mechanical testing

The following tests were performed (per ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws.) on Locking Screw,CoCrMo to demonstrate substantially equivalent of safety and efficacy with the predicate device:

Torsion Test
Insertion/removal Test
Pullout Test

8. Clinical Data

No clinical performance data was provided to demonstrate substantially equivalence.

9. Conclusion

Locking Screw,CoCrMo is compared to the predicate devices in respect of safety and

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effectiveness. The information provided within this premarket notification demonstrates that proposed device is determined to be substantially equivalent (SE) to the predicate device.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.