(387 days)
No
The device description focuses on mechanical properties, materials, and a compression mechanism using a Nitinol element and external frame. There is no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are based on mechanical testing standards.
Yes
The device is intended for tibio-talo-calcaneal fusions to treat various medical conditions like arthritis, arthrosis, non-union, and deformities, which are therapeutic interventions.
No
The device is described as an Intramedullary Fixation Rod intended for tibio-talo-calcaneal fusions, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a sterile, single-use titanium Intramedullary Fixation Rod, which is a physical hardware device.
Based on the provided information, the DynaNail™ Ankle Nail is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- DynaNail™ Function: The DynaNail™ is described as a "sterile, single use titanium Intramedullary Fixation Rod" intended for surgical implantation to fuse bones in the ankle and heel. It is a physical implant used within the body for structural support and fixation.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic purposes related to analyzing bodily fluids or tissues.
Therefore, the DynaNail™ is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DynaNail™ Ankle Nail is intended for tibio-talo-calcaneal fusions:
- Post-traumatic and degenerative arthritis.
- Post-traumatic or primary arthrosis involving both ankle and subtalar joints.
- Revision after failed ankle arthrodesis with subtalar involvement.
- Failed total ankle arthroplasty.
- Non-union ankle arthrodesis.
- Rheumatoid hindfoot.
- Absent Talus (requiring tibiocalcaneal arthrodesis).
- Avascular necrosis of the talus.
- Neuroarthropathy or neuropathic ankle deformity.
- Neuromuscular disease and severe deformity.
- Osteoarthritis.
- Charcot Foot.
- Previously infected arthrosis, second degree.
Product codes
HSB
Device Description
The proposed DynaNail™ is a sterile, single use titanium Intramedullary Fixation Rod for use in tibiotalocalcaneal fusions. The DynaNail is implanted with a proprietary deployment frame and various lengths of fixation screws. Similar to existing IMFR's, the DynaNail™ provides rigid fixation across the arthrodesis site, and also provides a method of in-line compression through the nail. The nail incorporates a method of compression that is applied during implantation in the same manner as existing nails.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ankle, subtalar joints, tibiotalocalcaneal
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)
Functional performance testing and analysis of the DynaNail™ and VersaNail™ were conducted per ASTM F 1264-03, Standard Specification and Test Methods for Intramedullary Fixation Devices. Four point bend testing was performed on the DynaNail™ and VersaNail™ devices and fixation screws. Fatigue testing was performed on the DynaNail™ and VersaNail™ fixation screws. Nickel release testing and corrosion testing were also performed on the DynaNail™. Analysis of the results demonstrates that the proposed device performs in a substantially equivalent manner to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
DePuy Ace VersaNail™ Intramedullary Fixation Rod, K023115
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.
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MFDSHAP SOLUTIONS
AUG - 3 2011
510(k) Summary
510(k) Number: K101934
Date Prepared: July 9, 2010
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
- A. Submitter: MedShape Solutions, Inc. 1575 Northside Drive, Suite 440 Atlanta, Georgia 30318
- B. Company Contact: Don Griffin Director of Operations (678) 235-3317(direct) (404) 249-9158 (fax) Don.Griffin@MedShapeSolutions.com
- ். Device Information: Trade Name: DynaNail Ankle Nail Common Name: Ankle Nail
- D. Classification Name: Intramedullary Fixation Rod HSB 21 CFR 888.3020
- E. Predicate Device(s): DePuy Ace VersaNail™ Intramedullary Fixation Rod, K023115
- F. Physical Description:
The proposed DynaNail™ is a sterile, single use titanium Intramedullary Fixation Rod for use in tibiotalocalcaneal fusions. The DynaNail is implanted with a proprietary deployment frame and various lengths of fixation screws. Similar to existing IMFR's, the DynaNail™ provides rigid fixation across the arthrodesis site, and also provides a method of in-line compression through the nail. The nail incorporates a method of compression that is applied during implantation in the same manner as existing nails.
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G. Indications for Use:
The DynaNail™ Ankle Nail is intended for tibio-talo-calcaneal fusions:
Post-traumatic and degenerative arthritis. Post-traumatic or primary arthrosis involving both ankle and subtalar joints. Revision after failed ankle arthrodesis with subtalar involvement. Failed total ankle arthroplasty. Non-union ankle arthrodesis. Rheumatoid hindfoot. Absent Talus (requiring tibiocalcaneal arthrodesis). Avascular necrosis of the talus. Neuroarthropathy or neuropathic ankle deformity. Neuromuscular disease and severe deformity. Osteoarthritis. Charcot Foot. Previously infected arthrosis, second degree
H. Comparison of Technological Characteristics:
The DynaNail is substantially equivalent in design, function and intended use to the following predicate devices:
DePuy Ace VersaNail™Intramedullary Fixation Rod, K023115
The construction of the DynaNail™ body is equivalent to that of the VersaNail™ device. Both devices are made from Ti-6AL-4V Titanium, have a hollow body with flutes and distal and proximal screw attachment points. The DynaNail™ is offered in a 12 mm diameter, as is the VersaNail™. The DynaNail™ is offered in lengths comparable to those of the VersaNail™
The DynaNail™ device has an external frame that aligns the IMFR with the tibia and calcaneous and compresses the fusion site before insertion of the distal fixation screws. The DynaNail™ fusion site compression is a function of the compression applied by the external frame and the DynaNail™ Nitinol element.
Image /page/1/Picture/10 description: The image shows the words "MEDSHAPE" on the top line and "SOLUTIONS" on the bottom line. There is a line separating the two words. The words are in a bold, sans-serif font. The image is in black and white.
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Image /page/2/Picture/0 description: The image shows a handwritten string of characters. The string appears to be a combination of letters and numbers. The string reads 'KIO1934'. The characters are written in black ink on a white background.
Functional performance testing and analysis of the DynaNail™ and VersaNail™ were conducted per ASTM F 1264-03, Standard Specification and Test Methods for Intramedullary Fixation Devices. Four point bend testing was performed on the DynaNail™ and VersaNail™ devices and fixation screws. Fatigue testing was performed on the DynaNail™ and VersaNail™ fixation screws. Nickel release testing and corrosion testing were also performed on the DynaNail™. Analysis of the results demonstrates that the proposed device performs in a substantially equivalent manner to the predicate device.
Don Griffly Director of Operations
Image /page/2/Picture/4 description: The image shows the words "MEDSHAPE SOLUTIONS" in bold, black letters. The word "MEDSHAPE" is on the top line, and the word "SOLUTIONS" is on the bottom line. There is a line separating the two words. The words are centered and the font is sans-serif.
1575 Northside Drive, Suite 440 Allanta, GA 30318 404-249-9156 phone 404-249-9158 fax
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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle or bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird image.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
MedShape Solutions % Mr. Don Griffin 1575 Northside Drive, Suite 440 Atlanta. Georgia 30318
Re: K101934
Trade/Device Name: DynaNail Ankle Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: July 11, 2011 Received: July 15, 2011
AUG - 3 2011
Dear Mr. Griffin:
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. 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.
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
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Page 2 - Mr. Don Griffin
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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.lda.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.
Mark A. Millhusan
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number: K101934
Device Name: DynaNai/™ Ankle Nail
Indications for Use:
The DynaNail™ Ankle Nail is intended for tibio-talo-calcaneal fusions:
- Post-traumatic and degenerative arthritis. .
- Post-traumatic or primary arthrosis involving both ankle and subtalar joints. ●
- Revision after failed ankle arthrodesis with subtalar involvement. ●
- Failed total ankle arthroplasty. .
- Non-union ankle arthrodesis. ●
- Rheumatoid hindfoot. .
- Absent Talus (requiring tibiocalcaneal arthrodesis). �
- Avascular necrosis of the talus. .
- Neuroarthropathy or neuropathic ankle deformity. ●
- Neuromuscular disease and severe deformity. ●
- Osteoarthritis. .
- Charcot Foot. .
- Previously infected arthrosis, second degree .
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Page 1 of 1
for M. melkeron
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101934