(59 days)
Not Found
No
The description focuses on the mechanical properties and materials of the device, with no mention of AI or ML.
Yes
The device is indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions, which are all therapeutic interventions.
No
The device is described as an implant used for fracture fixation, osteotomies, reconstruction, non-unions, and fusions, all of which are treatment procedures rather than diagnostic functions.
No
The device description explicitly details a physical implant made of titanium and Nitinol, along with associated instruments and screws for implantation. This is a hardware-based medical 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 "fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of large bones in the foot and ankle." This describes a surgical implant used to treat musculoskeletal conditions.
- Device Description: The device is described as a "sterile, single use titanium device with an additional internal Nitinol compressive element" and is implanted with "a driver/ deployment frame and fixation screws." This is consistent with a surgical implant and its associated instruments.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
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
The DynaNail Mini™ Fusion System is indicated for fracture fixation, osteotomies, reconstruction procedures, nonunions, and fusions of large bones in the foot and ankle.
Product codes (comma separated list FDA assigned to the subject device)
HWC, JDS
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot and ankle
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)
Engineering analysis and performance tests were conducted to support the assertion of substantial equivalence.
Specific tests include:
- 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows the logo for the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".
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.
1
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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3
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 fastener | |
| Orthopedic Nail | ||
| D. | Classification Name: | Smooth or threaded metallic bone fixation fastener |
| Single/multiple component metallic bone fixation appliances | ||
| and accessories | ||
| Regulatory Class: | Class II, Panel Code: 87 | |
| Product Code: | HWC, Screw, Fixation Bone, 888.3040 | |
| JDS, 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.