(118 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical bone screw, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a bone screw used for fixation of fractures, which is a supportive and stabilizing function, rather than directly therapeutic in the sense of treating or curing a disease. It aids the body's natural healing process by providing mechanical support.
No
The device description clearly states its purpose is for the fixation of bone fractures and for fastening plates onto bones, acting as temporary internal support. This describes a therapeutic or reconstructive function, not a diagnostic one.
No
The device description clearly states it is a physical implant made of CoCrMo, used to fasten plates onto bones or hold bone fragments together. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of bone fractures in various anatomical locations. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical implant (a screw) made of CoCrMo, designed to be used in combination with bone plates to provide structural support for fractured bones.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications 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.
Product codes
HWC, HRS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Clavicle, scapula, pelvis, humerus, ulna, radius, femur, tibia, fibula, metacarpals, metatarsals and phalanges
Indicated Patient Age Range
Not Found
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
Non-Clinical Performance Data:
- Biocompatibility testing: 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".
- Mechanical testing: Performed per ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws. Tests performed: Torsion Test, Insertion/removal Test, Pullout Test.
Clinical Data:
No clinical performance data was provided to demonstrate substantially equivalence.
Key Metrics
Not Found
Predicate Device(s)
K220921, K221088, K130108, K221150
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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)
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 fastener |
| Single/multiple component metallic bone fixation appliance | |
| and 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 marketed | |
| device(s) to which | |
| equivalence 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
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
5
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
6
effectiveness. The information provided within this premarket notification demonstrates that proposed device is determined to be substantially equivalent (SE) to the predicate device.