(101 days)
The Dyna Locking Ankle Nail™ is used in various indications as follows.
- Post-traumatic and degenerative arthritis involving both ankle and subtalar joints
- Rheumatoid arthritis
- Revision of failed ankle arthrodesis with subtalar involvement of with an insufficient talar body
- Revision of failed total ankle arthroplasty with subtalar intrusion .
- Talar deficiency conditions requiring tibiocalcaneal arthrodesis
- Avascular necrosis of the talus
- Neuroarthropathy or neuropathic ankle deformity
- Severe deformity as a result of talipes equionovarus, cerebral vascular accident, paralysis of other neuromuscular disease
- Severe pilon fractures with trauma to the subtalar joint .
The Dyna Locking Ankle Nail™ consists of Ankle Nail, Locking Screw, Set Screw, and End Cap. The Ankle nails are available in variety of diameters and lengths. And End Cap screws into the threaded end of the nail to prevent bone ingrowth. Locking Screw has the self-tap at the end of the screw. All components of the Dyna Locking Ankle Nail™ are single use device, supplied non-sterile, and manufactured from titanium alloy (Ti-6Al-4V ELI) in accordance with ASTM 136. Specialized instruments made from surgical instrument grade stainless steel are available for the instrumentation and removal of the Dyna Locking Ankle Nail™.
The provided document is a 510(k) summary for the "Dyna Locking Ankle Nail™," which is an intramedullary fixation system. This type of device is a physical implant used in orthopedic surgery, not an AI/ML-based device. Therefore, the questions related to AI/ML performance metrics, such as accuracy, F1 score, expert ground truth, effect size with AI assistance, and training/test set sample sizes for algorithms, are not applicable.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the mechanical performance testing conducted to demonstrate substantial equivalence to predicate devices.
Here's a breakdown of the relevant information from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Type of Test) | Reported Device Performance |
|---|---|
| Static 4-point bend test of rod | Met all acceptance criteria |
| Static Torsion test of rod | Met all acceptance criteria |
| Dynamic 4-point bend test of rod | Met all acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of nails or samples tested for each type of bench test (static 4-point bend, static torsion, dynamic 4-point bend). It only indicates that "The Dyna Locking Ankle Nail™ was tested in a non clinical setting (bench testing)."
- Data Provenance: The testing was "non clinical setting (bench testing)," meaning it was conducted in a laboratory environment, not using human or animal subjects. The location of the testing laboratory is not explicitly stated, but the manufacturer is based in South Korea. The data is prospective in the sense that these tests were performed specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable. For a mechanical device like an intramedullary nail, "ground truth" is established by engineering standards and specifications (e.g., ASTM standards or internal design requirements for bending and torsion strength/fatigue). There is no "expert consensus" on images or clinical data for this type of submission.
4. Adjudication Method (for the test set)
This question is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or for establishing ground truth from multiple expert opinions. For bench testing, results are quantitative and directly measured against pre-defined performance specifications.
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
This question is not applicable, as the device is a physical intramedullary fixation system, not an AI/ML diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable, as the device is a physical intramedullary fixation system, not an AI/ML algorithm.
7. The Type of Ground Truth Used
The "ground truth" here refers to the engineering specifications and performance criteria that the device's mechanical tests needed to meet to demonstrate substantial equivalence to predicate devices. While not explicitly stated as "ground truth," these are the objective standards against which the test results were compared.
8. The Sample Size for the Training Set
This question is not applicable, as there is no "training set" for a mechanical device undergoing bench testing.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the reasons mentioned above.
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K120419(1/3)
MAY 2 1 2012
5. 510(k) Summary
| Manufacturer: | U & I Corporation529-1, Yonghyun-dong, UijungbuKyunggi-Do, Korea 480-050 |
|---|---|
| Sponsor: | U & I Corporation529-1, Yonghyun-dong, UijungbuKyunggi-Do, Korea 480-050 |
| Sponsor Contact: | Gyeong-Je Kwon, Regulatory Affairs Specialist |
| Date Prepared: | February 6, 2012 |
| Device Name: | Trade Name: Dyna Locking Ankle NailTM |
| Common Name: | Intramedullary Fixation System |
| Classification Name: | Intramedullary Fixation Rod (HSB), per 21 CFR 888.3020 |
| Product Code: | HSB |
| Predicate Devices: | Grosse & Kempf Locking Nail System (K860756)T2 Ankle Arthrodesis Nail (K051590)Titanium Ankle Arthrodesis Nail (K021786) |
Description of Device:
The Dyna Locking Ankle Nail™ consists of Ankle Nail, Locking Screw, Set Screw, and End Cap. The Ankle nails are available in variety of diameters and lengths. And End Cap screws into the threaded end of the nail to prevent bone ingrowth. Locking Screw has the self-tap at the end of the screw.
All components of the Dyna Locking Ankle Nail™ are single use device, supplied non-sterile, and manufactured from titanium alloy (Ti-6Al-4V ELI) in accordance with ASTM 136. Specialized instruments made from surgical instrument grade stainless steel are available for the instrumentation and removal of the Dyna Locking Ankle Nail™.
Dyna Locking Ankle Nail™
CORPORATION
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K120419(2/3)
Intended Use:
The Dyna Locking Ankle Nail™ is used in various indications as follows.
- Post-traumatic and degenerative arthritis involving both ankle and subtalar ● joints
- Rheumatoid arthritis ●
- Revision of failed ankle arthrodesis with subtalar involvement of with an . insufficient talar body
- Revision of failed total ankle arthroplasty with subtalar intrusion
- Talar deficiency conditions requiring tibiocalcaneal arthrodesis
- Avascular necrosis of the talus
- Neuroarthropathy or neuropathic ankle deformity
- Severe deformity as a result of talipes equionovarus, cerebral vascular accident, paralysis of other neuromuscular disease
- Severe pilon fractures with trauma to the subtalar joint ●
Substantial Equivalence:
The Dyna Locking Ankle Nail™ is substantially equivalent to Grosse and Kempf Locking Nail System (K860756), T2 Ankle Arthrodesis Nail (K051590), Titanium Ankle Arthrodesis Nail (K021786) in design, performance, function and intended use.
-
- Comparison Technological Characteristics
The predicate and proposed devices have the similar intended use and basic fundamental scientific technology and share the following similaritiesL:
- Comparison Technological Characteristics
-
. The similar indications for use
-
Similar design features
-
Incorporate the same or similar materials
-
The equivalent mechanical performance
- Performance Testing
The Dyna Locking Ankle Nail™ was tested in a non clinical setting (bench testing) to assess that no new safety and efficiency issues were raised with this device. The testing met all acceptance criteria and verifies that performance of the Dyna Locking Ankle Nail 14 is substantially equivalent to the predicate devices.
The following tests were performed:
- (1) Static test
- · 4-point bend test of rod
- Torsion test of rod
Dyna Locking Ankle Nail™ "
Image /page/1/Picture/27 description: The image shows the logo for U&I Corporation. The logo is black and white. The letters U&I are in a stylized font, with the ampersand (&) connecting the two letters. To the right of the letters is the word "CORPORATION" in a sans-serif font.
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(2) Dynamic test 4-point bend test of rod ●
- Conclusion
The data and information provided in this submission support the conclusion that the Dyna Locking Ankle Nail™ is substantially equivalent to its predicate devices with respect to indications for use and technological characteristics.
1120419(3/3
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle, with three stylized wing feathers.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
U&I Corporation % Mr. Gyeong-Je Kwon Regulatory Affairs Specialist 529-1 Yonghyun-Dong Uijungbu, Kyunggi-do Republic of Korea 480-050
MAY 2 1 2012
Re: K120419
Trade/Device Name: Dyna Locking Ankle Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: February 6, 2012 Received: February 21, 2012
Dear Mr. Kwon:
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.
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.
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.
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Page 2 - Mr. Gyeong-Je Kwon
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/ReportaProblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
sincerely yours,
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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Indications for Use Statement
510(k) Number (if known):
Device Name: Dyna Locking Ankle Nail™
Indications for Use:
The Dyna Locking Ankle Nail™ is used in various indications as follows.
- Post-traumatic and degenerative arthritis involving both ankle and subtalar joints
- Rheumatoid arthritis
- Revision of failed ankle arthrodesis with subtalar involvement of with an insufficient talar body
- Revision of failed total ankle arthroplasty with subtalar intrusion .
- Talar deficiency conditions requiring tibiocalcaneal arthrodesis
- Avascular necrosis of the talus
- Neuroarthropathy or neuropathic ankle deformity
- Severe deformity as a result of talipes equionovarus, cerebral vascular accident, paralysis of other neuromuscular disease
- Severe pilon fractures with trauma to the subtalar joint .
| Prescription Use | X | AND/OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (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)
A.S.S
(Division Sign-Off) Division o Surgical, Orthopedic, and Restorative Devices
510(k) Number K12,0419
Dyna Locking Ankle Nail™
U&j CORPORATION
§ 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.