(59 days)
The DynaNail Mini™ Fusion System is indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of large bones in the foot and ankle.
The proposed DynaNail Mini Hybrid™ is part of the DynaNail Mini™ Fusion System. The proposed implant is sterile, single use titanium device with an additional internal Nitinol compressive element for use in midfoot and hindfoot reconstruction. A titanium outer body provides bending and torsional rigidity to the arthrodesis construct, while the internal Nitinol compressive element sustains compression across the joints post-operatively. The DynaNail Mini Hybrid™ is available in multiple diameters and lengths to accommodate variations in patient anatomy. The DynaNail Mini Hybrid™ is implanted with a driver/ deployment frame and fixation screws. The fixation screws are single use titanium headless screws. These are available in various lengths to accommodate the anatomical fixation required. The system includes instruments for implantation.
The provided text describes a medical device, the DynaNail Mini HybridTM, and its 510(k) premarket notification to the FDA. The information focuses on the device's characteristics, intended use, and comparison to a predicate device to establish substantial equivalence.
Based on the provided text, the device is a Smooth or threaded metallic bone fixation fastener / Orthopedic Nail. The acceptance criteria and the study that proves the device meets them are described in the context of establishing substantial equivalence to a predicate device, not in the typical sense of AI/algorithm performance.
Here's a breakdown of the requested information based on the provided document:
- A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance Tests) | Reported Device Performance |
|---|---|
| Static Torsion test per ASTM F543 | Test results and analysis demonstrate substantial equivalent performance to the predicate device. |
| Static Axial Strain test per ASTM F2516 | Test results and analysis demonstrate substantial equivalent performance to the predicate device. |
| Fatigue Strain test per ASTM E606 | Test results and analysis demonstrate substantial equivalent performance to the predicate device. |
| Pyrogenicity testing per ANSI/AAMI ST72 (worst-case largest DynaNail™ system) | Confirms the most loaded device scenario meets the limit of 20EU. |
| Bacterial endotoxin testing (BET) per ANSI/AAMI ST-72:2011 (R2016) | Confirms the most loaded device scenario meets the limit of 20EU. |
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes for the mechanical tests (Static Torsion, Static Axial Strain, Fatigue Strain, Pyrogenicity, BET). These tests are typically performed on a limited number of device samples, not patient data. The provenance of this data is from engineering analysis and laboratory testing, not patient-derived data from specific countries or study designs (retrospective/prospective). -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable (N/A). The evaluation is based on engineering and material performance specifications of the device itself, not on expert interpretations of medical images or patient outcomes. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. This concept is for clinical trials or diagnostic performance studies involving human interpretation. The reported studies are mechanical and biocompatibility tests. -
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
N/A. This is a medical device (bone fixation fastener), not an AI diagnostic or assistance tool. Therefore, MRMC studies are not relevant. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is a hardware medical device, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is established by validated engineering standards (ASTM F543, ASTM F2516, ASTM E606) and biocompatibility standards (ANSI/AAMI ST72). The ground truth for performance is the ability of the device to meet the specified performance criteria set by these standards, demonstrating substantial equivalence to the predicate device. -
The sample size for the training set
N/A. This medical device does not involve a "training set" in the context of machine learning or AI. -
How the ground truth for the training set was established
N/A. As there is no training set, this question is not applicable.
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January 15, 2021
MedShape Inc Akhilesh Gokhale Product Manager 1575 Northside Drive. Suite 440 Atlanta, Georgia 30318
Re: K203381
Trade/Device Name: DynaNail Mini HybridTM Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, JDS Dated: October 21, 2020 Received: November 17, 2020
Dear Akhilesh Gokhale:
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.
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542 of the Act); 21 CFR 1000-1050.
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 (OS) 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-
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, 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
510(k) Number (if known) K203381
Device Name DynaNail Mini Hybrid™
Indications for Use (Describe)
The DynaNail Mini™ Fusion System is indicated for fracture fixation, osteotomies, reconstruction procedures, nonunions, and fusions of large bones in the foot and ankle.
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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510(k) Summary
510(k) Number: K203381
Date Submitted: October 21, 2020
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
-
A. Submitter:
MedShape, Inc. 1575 Northside Drive, Suite 440 Atlanta, Georgia 30318 -
B. Company Contact:
Akhilesh Gokhale Product Manager, Research & Development (678) 235-3322 (direct) (404) 249-9158 (fax) akhilesh.gokhale@medshape.com -
C. Device Information:
| Trade Name: | DynaNail Mini Hybrid ™ | |
|---|---|---|
| Common Name: | Smooth or threaded metallic bone fixation fastenerOrthopedic Nail | |
| D. | Classification Name: | Smooth or threaded metallic bone fixation fastenerSingle/multiple component metallic bone fixation appliancesand accessories |
| Regulatory Class: | Class II, Panel Code: 87 | |
| Product Code: | HWC, Screw, Fixation Bone, 888.3040JDS, Nail, Fixation, Bone, 888.3030 |
- E. Predicate Device(s):
DynaNail Mini™, Orthopedic Nail, K182677
This statement is based on the similarity of the subject device to the predicate devices in one or more of intended use, materials, design and principles of operation.
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F. Physical Description:
The proposed DynaNail Mini Hybrid™ is part of the DynaNail Mini™ Fusion System. The proposed implant is sterile, single use titanium device with an additional internal Nitinol compressive element for use in midfoot and hindfoot reconstruction. A titanium outer body provides bending and torsional rigidity to the arthrodesis construct, while the internal Nitinol compressive element sustains compression across the joints post-operatively.
The DynaNail Mini Hybrid™ is available in multiple diameters and lengths to accommodate variations in patient anatomy. The DynaNail Mini Hybrid™ is implanted with a driver/ deployment frame and fixation screws. The fixation screws are single use titanium headless screws. These are available in various lengths to accommodate the anatomical fixation required. The system includes instruments for implantation.
G. Indications for Use:
The DynaNail Mini™ Fusion System is indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of large bones in the foot and ankle.
H. Comparison of Technological Characteristics:
The DynaNail Mini Hybrid™ is substantially equivalent in Intended Use, design, function, material, diameter and length to the following predicate devices:
DynaNail Mini™, Orthopedic Nail, K182677
The proposed and predicate devices are comprised of implant grade Titanium alloy and Nickel Titanium Alloy. All implants are sold sterile. In addition to engineering analysis, the device was subjected to following performance tests to support the assertion of substantial equivalence:
- Static Torsion test per ASTM F543
- Static Axial Strain test per ASTM F2516
- Fatigue Strain test per ASTM E606
The test results and analysis demonstrate substantial equivalent performance to the predicate device.
The manufacture and processing of all patient contacting materials are identical to the predicate DynaNail Mini™ K182677.
Pyrogenicity testing was conducted per ANSI/AAMI ST72 for the worst case largest DynaNail™ system, confirming the most loaded device scenario meets the limit of 20EU. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011 (R2016).
Analysis substantiates the statement that the proposed device performs equivalently to the predicate device.
§ 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.