(27 days)
Not Found
No
The summary describes a physical implant (nail plate) for fracture fixation and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for the fixation of fractures and osteotomies, which is a therapeutic intervention for a medical condition.
No
The device is described as a "nail plate" intended for the "fixation of fractures and osteotomies involving the distal Radius," which indicates it is a surgical implant designed for treatment, not for diagnosing conditions.
No
The device description clearly describes a physical implantable device (nail plate) intended for surgical fixation of fractures. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided description clearly states that the Dorsal Nail Plate is a physical implant intended for the fixation of bone fractures. It is a surgical device, not a diagnostic test.
- Intended Use: The intended use is to fix fractures and osteotomies, which is a therapeutic intervention, not a diagnostic process.
The information provided describes a medical device used for surgical treatment, not for testing biological samples.
N/A
Intended Use / Indications for Use
The Dorsal Nail Plate™, Anatomical is intended for the fixation of fractures and osteotomies involving the distal Radius.
Product codes
HRS
Device Description
The Dorsal Nail Plate™, Anatomical is intended to treat fractures in both left and right Radius. The distal segment of the nail plate is intended to be attached to the dorsal surface of the distal Radius. The proximal segment of the nail plate is intended to be inserted into the Radial shaft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal Radius, Radial shaft
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
The equivalence was confirmed through pre-clinical testing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
SEP 1 4 2005
K052248 pi/
510(k) Summary of Safety and Effectiveness
| General
| Provisions | The name of the device is: | |
|---|---|---|
| Proprietary Name | Common or Usual Name | |
| Dorsal Nail Plate™, Anatomical | Plate Fixation Bone | |
| Name of | ||
| Predicate | ||
| Devices | The device is substantially equivalent to: | |
| • Dorsal Nail Plate of the Distal Radius Fracture Repair System (510(k) # | ||
| K023007 - December 5, 2002) - Hand Innovations, Inc. | ||
| Classification | Class II. | |
| Performance | ||
| Standards | Performance standards have not been established by the FDA under section 514 of | |
| the Food, Drug and Cosmetic Act. | ||
| Indications for | ||
| Use | The Dorsal Nail Plate™, Anatomical is intended for the fixation of fractures | |
| and osteotomies involving the distal Radius. | ||
| Device | ||
| Description | The Dorsal Nail Plate™, Anatomical is intended to treat fractures in both left and | |
| right Radius. The distal segment of the nail plate is intended to be attached to the | ||
| dorsal surface of the distal Radius. The proximal segment of the nail plate is | ||
| intended to be inserted into the Radial shaft. | ||
| Biocompati- | ||
| bility | The Dorsal Nail Plate™, Anatomical do not require biocompatibility testing | |
| because the Titanium Alloy used in fabrication meets the requirements of ASTM | ||
| F 136. | ||
| Summary of | ||
| Substantial | ||
| Equivalence | The Dorsal Nail Plate™, Anatomical is substantially equivalent to the predicate | |
| Dorsal Nail Plate in regards to the intended use, materials, biocompatibility, and | ||
| overall performance characteristics. The equivalence was confirmed through pre- | ||
| clinical testing. |
:
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing left and has its wings spread. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
SEP 1 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ernesto Hernandez Vice President RA/QA Hand Innovations, LLC 8905 SW 87th Avenue, Suite 220 Miami, Florida 33176
Re: K052248 Trade/Device Name: Dorsal Nail Plate™, Anatomical Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: August 16, 2005 Received: August 18, 2005
Dear Mr. Hernandez:
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 such 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); 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 100-1.050.
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Page 2-Mr.Ernesto Hernandez
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Metkerson
Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K052348
Device Name: Dorsal Nail Plate™, Anatomical
Indications for Use Statement
The Dorsal Nail Plate™, Anatomical is intended for the fixation of fractures and osteotomies involving the distal Radius.
Prescription Use______________________________________________________________________________________________________________________________________________________________
.
OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Dorsal Nail Plate™, Anatomical 510(k) Premarket Notification
510(k) Number_LOS UZ48 0024