(238 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of the intramedullary nail system, with no mention of AI or ML capabilities.
Yes
The device is described as "intended to be implanted into the medullary canal of limbs for alignment, stabilization, fixation of fractures caused by trauma or diseases," which directly indicates a therapeutic purpose.
No
The device is an intramedullary nail system intended for the physical fixation of fractures and osteotomies, not for diagnosing conditions.
No
The device description explicitly states it is an "Advanced Intramedullary Nail System" made of Ti-6Al-4V ELI, which is a physical implantable device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to be implanted into the medullary canal of limbs for alignment, stabilization, and fixation of fractures. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is an intramedullary nail made of Ti-6Al-4V ELI, designed for internal fixation of bones.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not interact with biological samples for diagnostic purposes.
The device described is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
Advanced Intramedullary Nail System is intended to be implanted into the medullary canal of limbs for alignment, stabilization, fixation of fractures caused by trauma or diseases.
Indications:
-
Ulna Nail: Indicated for the fixation of fractures and osteotomies of the ulna.
-
Fibular Nail: Indicated for fixation of fractures and osteotomies of the fibula.
-
Ankle Fusion Nail: Indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot: tibiocalcaneal arthrodesis; combined arthrodesis of the ankle and subtalar joints; avascular necrosis of the ankle and subtalar joints; failed total ankle replacement with subtalar intrusion; failed ankle arthrodesis with insufficient talar body; rheumatoid arthritis; severe deformity secondary to untreated talipes equinovarus or neuromuscular disease; and severe pilon fractures with trauma to the subtalar joints.
Product codes
HSB
Device Description
The method of intramedullary nail fixation is symmetrical central splint fixation; central fixation is theoretically superior to cortical external fixation, which can reduce the moment arm, reduce the incidence of varus and valgus angulation and internal fixation failure. Intramedullary nail fixation of fractures is stress-distributed fixation rather than stress-shielded fixation, which is beneficial to the plasticity of callus. Advanced Intramedullary Nail System are made of Ti-6Al-4V ELI following ASTM F136. Advanced Intramedullary Nail System 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
ulna, fibula, tibiotalar and talocalcaneal articulations in the hindfoot, ankle and subtalar joints
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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:
7.1 Biocompatibility testing: The biocompatibility evaluation for the Advanced Intramedullary Nail System 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 and ASTM F1264-16 Standard Specification and Test Methods for Intramedullary Fixation Devices) on Advanced Intramedullary Nail System to demonstrate substantially equivalent of safety and efficacy with the predicate device:
Locking Screw:
- Torsion Test
- Insertion/removal Test
- Self-tapping Test
- Pullout Test
- Bending Test
Intramedullary Nail:
- Four-Point Bend Test
- Static Torsion Test
Clinical Data: No clinical performance data was provided to demonstrate substantially equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 21, 2022
Double Medical Technology Inc. Yan Zuo Deputy International RA Supervisor No.18, Shanbianhong East Road, Haicang District Xiamen, Fujian 361026 China
Re: K221221
Trade/Device Name: Advanced Intramedullary Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: December 9, 2022 Received: December 19, 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/cfpm/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 mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continumg-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,
Victoria A.
Lilling -S
Digitally signed by Victoria A. Lilling -S
Date: 2022.12.21 15:47:49 -05'00"
Victoria Lilling, M.D. Assistant Director DHT6A: Division of Joint Arthroplasty 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) K221221
Device Name Advanced Intramedullary Nail System
Indications for Use (Describe)
Advanced Intramedullary Nail System is intended to be implanted into the medullary canal of limbs for alignment. stabilization, fixation of fractures caused by trauma or diseases.
Indications:
- Ulna Nail: Indicated for the fixation of fractures and osteotomies of the ulna.
2.Fibular Nail: Indicated for fixation of fractures and osteotomies of the fibula.
- Ankle Fusion Nail: Indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot: tibiocalcaneal arthrodesis; combined arthrodesis of the ankle and subtalar joints; avascular necrosis of the ankle and subtalar joints; failed total ankle replacement with subtalar intrusion;failed ankle arthrodesis with insufficient talar body; rheumatoid arthritis; severe deformity secondary to untreated talipes equinovarus or neuromuscular disease; and severe pilon fractures with trauma to the subtalar joints.
| 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)
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3
| 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 | December 21th, 2022 | |
| 2. Proposed Device | ||
| Trade/proprietary name | Advanced Intramedullary Nail System | |
| Common or usual name | Advanced Intramedullary Nail System | |
| Classification name | Intramedullary fixation rod | |
| Regulation number | 21 CFR 888.3020 | |
| Product code | HSB | |
| Regulatory class | II | |
| Classification panel | Orthopedic | |
| 3. Predicate Device | ||
| Legally marketed | ||
| device(s) to which | ||
| equivalence is claimed | Primary predicate device: | |
| K143276 Acumed Small Bone IM Nail System | ||
| Additional predicate devices: | ||
| K043052 TriGen Hindfoot Fusion Nail | ||
| Reason for 510(k) | ||
| submission | New device (Implant) |
K221221- 510(k) Summary
4. Device Description
The method of intramedullary nail fixation is symmetrical central splint fixation; central fixati on is theoretically superior to cortical external fixation, which can reduce the moment arm, re duce the incidence of varus and valgus angulation and internal fixation failure. Intramedullary nail fixation of fractures is stress-distributed fixation rather than stress-shielded fixation, whi ch is beneficial to the plasticity of callus. Advanced Intramedullary Nail System are made of Ti-6Al-4V ELI following ASTM F136. Advanced Intramedullary Nail System is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.
4
5. Indication for Use
Advanced Intramedullary Nail System is intended to be implanted into the medullary canal of limbs for alignment, stabilization, fixation of fractures caused by trauma or diseases. Indications:
- (1) Ulna Nail: Indicated for the fixation of fractures and osteotomies of the ulna.
- (2) Fibular Nail: Indicated for fixation of fractures and osteotomies of the fibula.
- (3) Ankle Fusion Nail: Indicated for degeneration,deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot;tibiocalcaneal arthrodesis; combined arthrodesis of the ankle and subtalar joints; avascular necrosis of the ankle and subtalar joints; failed total ankle replacement with subtalar intrusion;failed ankle arthrodesis with insufficient talar body; rheumatoid arthritis; severe deformity secondary to untreated talipes equinovarus or neuromuscular disease; and severe pilon fractures with trauma to the subtalar joints.
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 Advanced Intramedullary Nail System 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 and ASTM F1264-16 Standard Specification and Test Methods for Intramedullary Fixation Devices) on Advanced Intramedullary Nail System to demonstrate substantially equivalent of safety and efficacy with the predicate device:
Locking Screw:
- Torsion Test
5
- Insertion/removal Test
- Self-tapping Test
- Pullout Test ●
- Bending Test
Intramedullary Nail:
- Four-Point Bend Test
- Static Torsion Test
8. Clinical Data
No clinical performance data was provided to demonstrate substantially equivalence.
9. Conclusion
Advanced Intramedullary Nail System does not raise different questions of safety and effectiveness when compared to the predicate device. The information provided within this premarket notification demonstrates that proposed device is determined to be substantially equivalent (SE) to the predicate device.