(272 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of the metal screws, with no mention of AI or ML.
Yes
The device is a Metal Cannulated Screw used for internal fixation of fractures, fusions, and corrections of bones, which are therapeutic interventions.
No
The device is a Metal Cannulated Screw, explicitly described as an implant for internal fixation of fractures, fusions, and corrections of bones. It functions as a temporary internal support to aid in bone healing, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "Metal Cannulated Screw" made of Ti-6Al-4V ELI, which is a physical implantable hardware device. The performance studies also focus on mechanical testing of the hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a "Metal Cannulated Screw indicated for internal fixation of fracture, fusion and correction of limb bone and metaphysis, hand and foot." This is a surgical implant used in vivo (within the body) to mechanically stabilize bones.
- Device Description: The description reinforces this by stating it "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." This is a description of a mechanical device used for orthopedic surgery.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is used to perform tests on samples such as blood, urine, or tissues, taken from the human body to detect diseases, conditions, or infections. The Metal Cannulated Screw does not perform any such tests on biological samples in vitro (outside the body).
The information provided consistently points to this device being a surgical implant for orthopedic procedures, not an IVD.
N/A
Intended Use / Indications for Use
Metal Cannulated Screw is indicated for internal fixation of fracture, fusion and correction of limb bone and metaphysis, hand and foot:
1)The 2.3mm No Profile Cannulated Screw is indicated for the fixing the elective osteotomies of the mid foot bones and the metatarsal and phalanges of the foot only.
2)The 3.0mm No Profile Cannulated Screw is indicated for internal fixation of bone fractures of ulna, and small bones (metacarpals, metatarsals, and phalanges).
3)The 4.0mm No Profile Cannulated Screw and 4.0mm No Profile Cannulated Screw, Oblique are indicated for fixation of fractures, fusions, osteotomies, non-unions of small bones and small bone fragments.
4)The 5.0mm No Profile Cannulated Screw and 5.0mm No Profile Cannulated Screw, Oblique are indicated for fixation of fractures, fusions, osteotomies, non-unions of long bones and long bone fragments, and the bones of the hand and foot.
5)The 7.0mm No Profile Cannulated Screw and 7.0mm No Profile Cannulated Screw, Oblique are indicated for fixation of fractures, fusions, osteotomies, non-unions of long bones and long bone fragments, pelvis, sacrum, and the bones of the foot. These screws are also indicated for femoral neck fractures, slipped capiplysis, an adjunct to DHS (Dynamic Hip System) in basilar neck fractures, ankle arthrodesis, intercondylar femur fractures, SI joint disruptions and subtalar arthrodesis.
6)The Headless Cannulated Screw (2.5-4.5mm)/Headless Compression Screw (2.5-4.5mm) are indicated for fixation of fractures in large bones of humerus, ulna, radius, tibia and fibula, and small bones of the foot. These screws are also indicated for intra-articular fractures of knee and ankle joint.
7)The Headless Cannulated Screw (5.0-7.0mm)/ Headless Compression Screw (5.2-7.0mm) are indicated for fixation of fractures of femur, tibia and calcaneus, and intra-articular fractures of knee joint.
8)The 3.5mm/4.0mm Headless Compression Screw, Oblique are indicated for fixation of bone fractures or for bone reconstruction of the foot and hand, including calcaneus, talar, navicular, metacarpals, metatarsals and phalanges. 9)The 6.5mm Cannulated Screw are intended for fixation of fractures, non-unions, and malunions of long bones and long bone fragments, pelvis, sacrum, and the bones of the foot. These screws are also indicated for femoral neck fractures, slipped capital femoral epiphysis, an adjunct to DHS (Dynamic Hip System) in basilar neck fractures, tibial plateau fractures, ankle arthrodesis, intercondylar femur fractures, SI joint disruptions and subtalar arthrodesis. 10)The 7.3mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions of long bones and long bone fragments, pelvis, sacrum and the bones of the foot. These screws are also indicated for slipped capital femoral epiphysis, ankle arthrodesis and subtalar arthrodesis.
Product codes
HWC
Device Description
Metal Cannulated Screw 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, Metal Cannulated Screw is used alone, 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. Metal Cannulated Screw are made of Ti-6Al-4V ELI following ASTM F 136. Metal Cannulated Screw is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
limb bone and metaphysis, hand and foot, mid foot bones, metatarsal and phalanges of the foot, ulna, small bones (metacarpals, metatarsals, and phalanges), long bones, long bone fragments, pelvis, sacrum, femoral neck, humerus, radius, tibia, fibula, knee joint, ankle joint, femur, calcaneus, talar, navicular, SI joint
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data:
Biocompatibility testing: The biocompatibility evaluation for the Metal Cannulated Screw 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".
Mechanical testing: The following tests were performed (per ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws.) on Metal Cannulated Screw to demonstrate substantially equivalent of safety and efficacy with the predicate device:
- Torsion Test
- Insertion/removal Test
- Pullout Test
Clinical Data: No clinical performance data was provided to demonstrate substantially equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K130108, K143229, K161616, K182361, K170382, K162353
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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 10, 2023
Double Medical Technology Inc. Yan Zuo Deputy International RA Supervisor No.18, Shanbianhong East Road, Haicang District Xiamen, Fujian 361026 China
Re: K221090
Trade/Device Name: Metal Cannulated Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: October 14, 2022 Received: October 18, 2022
Dear Yan 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 (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 located 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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221090
Device Name Metal Cannulated Screw
Indications for Use (Describe)
Metal Cannulated Screw is indicated for internal fixation of fracture, fusion and correction of limb bone and metaphysis, hand and foot:
1)The 2.3mm No Profile Cannulated Screw is indicated for the fixing the elective osteotomies of the mid foot bones and the metatarsal and phalanges of the foot only.
2)The 3.0mm No Profile Cannulated Screw is indicated for internal fixation of bone fractures of ulna, and small bones (metacarpals, metatarsals, and phalanges).
3)The 4.0mm No Profile Cannulated Screw and 4.0mm No Profile Cannulated Screw, Oblique are indicated for fixation of fractures, fusions, osteotomies, non-unions of small bones and small bone fragments.
4)The 5.0mm No Profile Cannulated Screw and 5.0mm No Profile Cannulated Screw, Oblique are indicated for fixation of fractures, fusions, osteotomies, non-unions of long bones and long bone fragments, and the bones of the hand and foot.
5)The 7.0mm No Profile Cannulated Screw and 7.0mm No Profile Cannulated Screw, Oblique are indicated for fixation of fractures, fusions, osteotomies, non-unions of long bones and long bone fragments, pelvis, sacrum, and the bones of the foot. These screws are also indicated for femoral neck fractures, slipped capiplysis, an adjunct to DHS (Dynamic Hip System) in basilar neck fractures, ankle arthrodesis, intercondylar femur fractures, SI joint disruptions and subtalar arthrodesis.
6)The Headless Cannulated Screw (2.5-4.5mm)/Headless Compression Screw (2.5-4.5mm) are indicated for fixation of fractures in large bones of humerus, ulna, radius, tibia and fibula, and small bones of the foot. These screws are also indicated for intra-articular fractures of knee and ankle joint.
7)The Headless Cannulated Screw (5.0-7.0mm)/ Headless Compression Screw (5.2-7.0mm) are indicated for fixation of fractures of femur, tibia and calcaneus, and intra-articular fractures of knee joint.
8)The 3.5mm/4.0mm Headless Compression Screw, Oblique are indicated for fixation of bone fractures or for bone reconstruction of the foot and hand, including calcaneus, talar, navicular, metacarpals, metatarsals and phalanges. 9)The 6.5mm Cannulated Screw are intended for fixation of fractures, non-unions, and malunions of long bones and long bone fragments, pelvis, sacrum, and the bones of the foot. These screws are also indicated for femoral neck fractures, slipped capital femoral epiphysis, an adjunct to DHS (Dynamic Hip System) in basilar neck fractures, tibial plateau fractures, ankle arthrodesis, intercondylar femur fractures, SI joint disruptions and subtalar arthrodesis. 10)The 7.3mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions of long bones and long bone fragments, pelvis, sacrum and the bones of the foot. These screws are also indicated for slipped capital femoral epiphysis, ankle arthrodesis and subtalar arthrodesis.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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."
4
| 1. Submitter | |
|---|---|
| Name | Double Medical Technology Inc. |
| Address | No. 18, Shanbianhong East Road, Haicang District, Xiamen, |
| 361026, P. R. China | |
| Phone | +86 592 6885079 |
| Fax | +86 592 6587078 |
| Contact person | Yan Zuo |
| Date prepared | January 10th, 2023 |
| 2. Proposed Device | |
| Trade/proprietary name | Metal Cannulated Screw |
| Common or usual name | Metal Cannulated Screw |
| Classification name | Smooth or threaded metallic bone fixation fastener. |
| Regulation number | 21 CFR 888.3040 |
| Product code | HWC |
| Regulatory class | II |
| Classification panel | Orthopedic |
| 3. Predicate Device | |
| Legally marketed | |
| device(s) to which | |
| equivalence is claimed | Primary Predicate Device: |
| K130108 Double Engine Bone Plate and Bone Screw Systems | |
| Additional Predicate Devices: | |
| K143229 Nexis® osteosynthesis compressive screws | |
| K161616 DePuy Synthes 4.0 mm/4.5 mm/6.5 mm/7.3 mm Cannulated Screws | |
| K182361 Arthrex Compression FT Screws | |
| K170382 Arthrex Compression Screws | |
| K162353 MICATM Screw System | |
| Reason for 510(k) | |
| submission | New device (Implant) |
K221090- 510(k) Summary
4. Device Description
Metal Cannulated Screw 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, Metal Cannulated Screw is used alone, 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. Metal Cannulated Screw are made of Ti-6Al-4V ELI following
5
ASTM F 136. Metal Cannulated Screw is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.
5. Indication for Use
Metal Cannulated Screw is indicated for internal fixation of fracture, fusion and correction of limb bone and metaphysis, hand and foot:
1)The 2.3mm No Profile Cannulated Screw is indicated for the fixing and stabilizing the elective osteotomies of the mid foot bones and the metatarsal and phalanges of the foot only.
2)The 3.0mm No Profile Cannulated Screw is indicated for internal fixation of bone fractures of ulna, radius, fibula, and small bones (metacarpals, metatarsals, and phalanges).
3)The 4.0mm No Profile Cannulated Screw and 4.0mm No Profile Cannulated Screw, Oblique are indicated for fixation of fractures, fusions, osteotomies, and malunions of small bones and small bone fragments.
4)The 5.0mm No Profile Cannulated Screw and 5.0mm No Profile Cannulated Screw, Oblique are indicated for fixation of fractures, fusions, osteotomies, and malunions of long bones and long bone fragments, and the bones of the hand and foot.
5)The 7.0mm No Profile Cannulated Screw and 7.0mm No Profile Cannulated Screw, Oblique are indicated for fixation of fractures, fusions, osteotomies, and malunions of long bones and long bone fragments, pelvis, sacrum, and the bones of the foot. These screws are also indicated for femoral neck fractures, slipped capital femoral epiphysis, an adjunct to DHS (Dynamic Hip System) in basilar neck fractures, tibial plateau fractures, ankle arthrodesis, intercondylar femur fractures, SI joint disruptions and subtalar arthrodesis.
6)The Headless Cannulated Screw (2.5-4.5mm) /Headless Compression Screw (2.5-4.5mm) are indicated for fixation of fractures in large bones of humerus, ulna, radius, tibia and fibula, and small bones of the foot. These screws are also indicated for intra-articular fractures of knee and ankle joint.
7)The Headless Cannulated Screw (5.0-7.0mm)/ Headless Compression Screw (5.2-7.0mm) are indicated for fixation of fractures of femur, tibia and calcaneus, and intra-articular fractures of knee joint.
8)The 3.5mm/4.0mm Headless Compression Screw, Oblique are indicated for fixation of bone fractures or for bone reconstruction of the foot and hand, including calcaneus, talar, navicular, metacarpals, metatarsals and phalanges.
9)The 6.5mm Cannulated Screw are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments, pelvis, sacrum, and the bones of the foot. These screws are also indicated for femoral neck fractures, slipped capital femoral
6
epiphysis, an adjunct to DHS (Dynamic Hip System) in basilar neck fractures, tibial plateau fractures, ankle arthrodesis, intercondylar femur fractures, SI joint disruptions and subtalar arthrodesis.
10)The 7.3mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments, pelvis, sacrum and the bones of the foot. These screws are also indicated for slipped capital femoral epiphysis, ankle arthrodesis and subtalar arthrodesis.
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 Metal Cannulated Screw 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 Metal Cannulated Screw 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
Metal Cannulated Screw is compared to the predicate devices in respect of safety and
7
effectiveness. The information provided within this premarket notification demonstrates that proposed device is determined to be substantially equivalent (SE) to the predicate device.