(22 days)
Not Found
No
The summary describes a sterile plating system for bone fixation and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
Yes
The device is intended for fixation of fractures and osteotomies, which is a therapeutic intervention.
No
The device is described as a "Plating System" intended for "fixation of fractures and osteotomies." This indicates it is a surgical implant used for treatment, not for diagnosing conditions.
No
The device description explicitly states it is a "plating system 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: The intended use is for the "fixation of fractures and osteotomies of the distal radius." This describes a surgical procedure performed directly on a patient's bone.
- Device Description: The device is a "plating system of plates and screws." 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, tissue, or urine) in vitro (outside the body) to provide information about a patient's health status.
IVDs are typically used for diagnosis, monitoring, or screening by analyzing samples taken from the body. This device is a surgical implant used for structural support.
N/A
Intended Use / Indications for Use
The Sterile DVR Anatomic Plating System is intended for fixation of fractures and osteotomies of the distal radius.
Product codes (comma separated list FDA assigned to the subject device)
LXT
Device Description
The Sterile DVR Anatomic Plating System offers the DVR plating system of plates and screws in a sterile configuration.
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)
Equivalence was confirmed through bench testing.
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
MAR 1 1 2009
.
510(k) Summary
| Submitted by: | DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, IN 46581
Phone: (305) 269-6386
Fax: (305) 269-6441 | |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Contact Person: | Suzana Otaño, Project Manager, Regulatory Affairs | |
| Date Prepared: | February 16, 2009 | |
| General
Provisions | The name of the device is: | |
| | Proprietary Name | Common or Usual Name |
| | DVR Anatomic Plating System | Plate, Fixation, Bone |
| Name of
Predicate
Devices | The device is substantially equivalent to the currently marketed DePuy
DVR Anatomic Plating System, K050932. | |
| Classification | Class II, 21 CFR 888.3030 | |
| Performance
Standards | Performance standards have not been established by the FDA under
section 514 of the Food, Drug and Cosmetic Act for these devices. | |
| Indications for
Use | The Sterile DVR Anatomic Plating System is intended for fixation of
fractures and osteotomies of the distal radius. | |
| Device
Description | The Sterile DVR Anatomic Plating System offers the DVR plating system
of plates and screws in a sterile configuration. | |
| Biocompatibility | The Sterile DVR Anatomic Plating System does not require
biocompatibility testing. | |
| Summary of
Substantial
Equivalence | The Sterile DVR Anatomic Plating System is substantially equivalent to
the predicate device. Equivalence was confirmed through bench testing. | |
ﺴﮧ
1
Image /page/1/Picture/13 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 1 2009
Depuy Orthopaedics, Inc. % Ms. Suzana Otaño Project Manager, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46581
Re: K090374
Trade/Device Names: DePuy Sterile DVR Anatomic Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: LXT
Dated: February 16, 2009 Received: February 17, 2009
Dear Ms. Otaño:
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 1000-1050.
2
Page 2 - Ms. Suzana Otaño
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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:
K090374
DePuy Sterile DVR Anatomic Plating System Device Name:
Indications For Use:
The DePuy Sterile DVR Anatomic Plating System is intended for fixation of fractures and osteotomies of the distal radius.
Prescription Use (Per 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
Bivision Sign-Off) Division of General, Restorative, and Neurological Devices
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