(79 days)
Not Found
No
The summary describes a mechanical plating system for fracture fixation and does not mention any AI/ML components or functionalities.
Yes
The device is a plating system intended for the fixation of fractures and osteotomies, which is a therapeutic intervention.
No
The device is described as a plating system for fracture fixation, not for diagnosing medical conditions.
No
The device description explicitly states the system is comprised of "an array of plates and screws," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is indicated for the fixation of fractures and osteotomies involving the distal radius. This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is comprised of plates and screws used for fixation. These are physical implants used in surgery.
- Lack of IVD characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not to directly treat or repair the body itself.
N/A
Intended Use / Indications for Use
The EBI® Distal Radius Plating System is indicated for the fixation of fractures and osteotomies involving the distal radius.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The EBI® Distal Radius Plating System is intended to provide fixation of fractures and osteotomies involving the distal radius. The System is comprised of an array of plates and screws, which will provide fixation of the distal radius.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius
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)
Not Found
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
§ 888.3030 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
'JUN 2 5 2004
K040908
page 1 of 2
510(k) Summary
This 510(k) Summary for the EBI® Distal Radius Plating System is provided as required per Section 513(3) of the Food, Drug and Cosmetic Act.
| 1. Submitter: | EBI, L.P.
100 Interpace Parkway
Parsippany, NJ 07054 |
|-----------------|------------------------------------------------------------|
| Contact Person: | Frederic Testa |
| Phone: | (973)299-9300, ext. 2208 |
| Date prepared: | April 6, 2004 |
| 2. Proprietary Name: | EBI® Distal Radius Plating System |
|---|---|
| Common Name: | Internal Fixation Device |
| Classification Names: | Smooth or Threaded Metallic Bone |
| Fixation Fastener, 21 CFR 888.3040 | |
| Single/Multiple Component Metallic Bone Fixation | |
| Appliances and Accessories, 21 CFR 888.3030 |
3. Predicate or legally marketed devices that are substantially equivalent:
- Stryker Trauma Plating System (K000636) .
- Hand Innovations Distal Volar Radius Fracture Repair System (K002775) .
- Description of the device: The EBI® Distal Radius Plating System is intended to 4. provide fixation of fractures and osteotomies involving the distal radius. The System is comprised of an array of plates and screws, which will provide fixation of the distal radius.
-
- Intended Use: The EBI® Distal Radius Plating System is indicated for the fixation of fractures and osteotomies involving the distal radius.
1
K040908
page 2 of 2
-
- Materials: The components of the System may be manufactured from stainless steel as per ASTM F138 and ASTM F139.
7. Comparison of the technological characteristics of the device to predicate
devices: There are no significant differences between the EBI® Distal Radius Plating
System and other currently marketed internal fixation systems. It is substantially
equivalent* to the predicate device in regards to intended use, materials, and function.
- Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any * Any statement made in conjunction with this submission regarding a celeminated without pre-market approval or other product is intended to be interpreted as an admission or any other type of evidence in patent infringement litigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]
2
Image /page/2/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem of an eagle with three stylized wings or feathers. The seal is black and white and appears to be of official government origin.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 5 2004
Frederic Testa, RAC Senior Regulatory Affairs Specialist EBI. L.P. 100 Interpace Parkway Parsippany, New Jersey 07054
Re: K040908
Trade/Device Name: EBI® Distal Radius Plating System Regulation Numbers: 21 CFR 888.3030, 21 CFR 888.3040 Regulation Names: 21 OF CF 0001e component metallic bone fixation appliances and accessories, Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Codes: HRS, HWC Dated: April 6, 2004 Received: April 7, 2004
Dear Mr. Testa:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bected by the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the enorosale) to regard) the Medical Device Amendments, or to commerce price to May 20, 1976, the excordance with the provisions of the Federal Food, Drug. devices mat have been roomsomed in assee approval of a premarket approval application (PMA). alla Cosmetic Act (110c) market the device, subject to the general controls provisions of the Act. The 1 ou may, merelore, market are as rees, and include requirements for annual registration, listing of general controls provisions of ractice, 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 II your device is classified (socrated in the existing major regulations affecting your device can may be subject to subli additions, 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 r lease oe advised that 1 Dri s issuation of a budevice complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any it catal statutes and regaranents, including, but not limited to: registration and listing (21 comply with an the Act 31equirements,01); good manufacturing practice requirements as set CI IN I at 607), adomig (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Frederic Testa, RAC
This letter will allow you to begin marketing your device as described in your becise to Jacqu I his letter will anow you to begin manieting of substantial equivalence of your device to a legally premarket notheadon: "The PDF mising of ication 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 (1 CFR Part 801), please of If you desire specific advice for your as (301) 594-4659. Also, please note the regulation entitled, Colliact the Office of Comphalled as (so t notification" (21CFR Part 807.97). You may obtain Misbianuning by icierchee to premantee notificas under the Act from the Division of Small other gelleral information on your responses and its toll-free number (800) 638-2041 or Manufacturers, International and Octess http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark A. Milburn
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
STATEMENT OF INDICATIONS FOR USE
Page _ 1 _ of _ 1
510(k) Number (if known): K040908
Device Name: EBI® Distal Radius Plating System
Indications For Use:
The EBI® Distal Radius Plating System is indicated for the fixation of fractures and osteotomies involving the distal radius.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off) (Division of General, Restorative, and Neurological Devices
510(k) Number.