(44 days)
Not Found
No
The device description and intended use are purely mechanical, and there is no mention of AI, ML, or any software-driven analytical capabilities.
No
The device is intended for the fixation of fractures, osteotomies, and non-unions, which falls under the category of orthopedic surgery, a form of treatment, making it a therapeutic device.
No
Explanation: The device is a Diaphyseal Plate used for the fixation of fractures, osteotomies, and non-unions. Its intended use is mechanical support and stabilization, not the diagnosis of a medical condition.
No
The device description explicitly states the device is fabricated from 316L Stainless Steel and is available in various physical configurations (plates with different numbers of holes), indicating it is a physical implantable device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of fractures, osteotomies and non-unions" of various bones. This is a surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a physical implant (a plate made of stainless steel) used to stabilize bone. This is characteristic of a surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The proposed Diaphyseal Plate is intended for the fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, pelvis, distal tibia, and fibula, particularly in osteopenic bone.
Product codes
HRS
Device Description
The proposed Diaphyseal Plate is fabricated from 316L Stainless Steel and is available in five configurations - 6, 8, 10, 12, and 14 hole plate configuration. The proposed Diaphyseal Plate has both slotted holes, for accommodating the Multi-Directional Screws, and round holes for accommodating either Multi-Directional or 90° Lock Screws. 90° Set Screws are used to secure the 90° Lock Screws within the plate to prevent backout.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle, scapula, olecranon, humerus, radius, pelvis, distal tibia, and fibula
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)
The equivalence was confirmed through pre-clinical testing. See Section 8 Performance Testing for a summary of tests used to demonstrate safety and effectiveness of the proposed device. Attachment 9 Engineering Test Protocol and Report presents the detailed test results demonstrating safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
MAR 2 2 2006
20 March 2006
Amendments to K060294 – Hand Innovations Diaphyseal Plate 510(k) Summary of Safety and Effectiveness
| General Provisions | The name of the device is: |
|---|---|
| -------------------- | ---------------------------- |
| Proprietary Name | Common or Usual Name | |
|---|---|---|
| Hand Innovations Diaphyseal Plate | Plate Fixation Bone |
| Name of Predicate Devices | The proposed Diaphyseal Plate is substantially equivalent to the following predicate device:
3.5mm LCP® Plate - SYNTHES (USA) (510(k) No. K000684- April 28, 2000). |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 proposed Diaphyseal Plate is intended for the fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, pelvis, distal tibia, and fibula, particularly in osteopenic bone. |
| Device Description | The proposed Diaphyseal Plate is fabricated from 316L Stainless Steel and is available in five configurations - 6, 8, 10, 12, and 14 hole plate configuration. The proposed Diaphyseal Plate has both slotted holes, for accommodating the Multi-Directional Screws, and round holes for accommodating either Multi-Directional or 90° Lock Screws. 90° Set Screws are used to secure the 90° Lock Screws within the plate to prevent backout. |
| Biocompatibility | The proposed Diaphyseal Plate do not require biocompatibility testing because 316L stainless steel is used in all fabrications per the requirements of ASTM F 138-03. 316L is universally regarded as biocompatible and suitable for surgical implant per the requirements of ISO 10993-1. |
| Summary of Substantial Equivalence | The proposed Diaphyseal Plate is substantially equivalent to the predicate competitive 3.5mm LCP® Plate SYNTHES (USA) with regards to the intended use, materials, biocompatibility, and overall performance characteristics. The equivalence was confirmed through pre-clinical testing. See Section 8 Performance Testing for a summary of tests used to demonstrate safety and effectiveness of the proposed device. Attachment 9 Engineering Test Protocol and Report presents the detailed test results demonstrating safety and effectiveness. |
(original page 19)
ﺴ ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
1
Image /page/1/Picture/1 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 wings and body. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 2 2006
Hand Innovations, LLC c/o Mr. Richard Jones QA Manager 8905 SW 87th Avenue Suite 220 Miami, Florida 33176
Re: K060294
Trade/Device Name: Hand Innovations Diaphyseal Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: February 1, 2006 Received: February 7, 2006
Dear Mr. Jones:
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
2
Page 2 - Mr. Richard Jones
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 1000-1050. 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/dsma/dsmamain.html
Sincerely yours.
Harlan Lenner co
Mark N. Melkerson 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): ____________________________________________________________________________________________________________________________________________________
Device Name: Diaphyseal Plate
Indications for Use Statement
The Diaphyseal Plate is intended for the fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, pelvis, distal tibia, and fibula, particularly in osteopenic bone.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | √ | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------ | --- | ---- | ---------------------- |
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K060294 |
|---|---|
| --------------- | --------- |
Diaphyseal Plates Traditional 510(k)