(31 days)
Not Found
No
The summary describes a mechanical implant (plate and screws) for fracture fixation and does not mention any software, algorithms, or data processing capabilities that would indicate AI/ML.
Yes
The device is intended for "volar fixation of fractures and osteotomies involving the distal radius," which is a therapeutic purpose.
No
The device is a surgical plate system used for fixation of fractures and osteotomies, which is a treatment, not a diagnostic procedure.
No
The device description clearly details physical components made of titanium or stainless steel, such as plates, screws, and sheaths, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "volar fixation of fractures and osteotomies involving the distal radius." This describes a surgical implant used to stabilize bone, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a physical plate and screws made of metal, designed to be surgically implanted. This is consistent with a medical device used for treatment, not an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening
This device is clearly a surgical implant used for orthopedic fixation.
N/A
Intended Use / Indications for Use
The DVO TM Volar Plate System is intended for volar fixation of fractures and osteotomies involving the distal radius. This single use device is for cementless use only.
Product codes (comma separated list FDA assigned to the subject device)
87 HRS, 87 HWC
Device Description
This non-sterile volar plate system offers several sizes and styles of volar plates, in either titanium (ASTM F-136) or stainless steel (ASTM F-138 or ASTM 2229). The three versions include a volar T-plate, a volar intramedullary T-plate and a volar T-plate with translating head. The distal head of the plate contains two rows of fixed angle screw holes that accept 2.7 mm screws. Dorsal and ulnar sheaths are secured into the plate recesses to cover the screw heads. The screws vary in length from 16mm to 26mm. K-wires may also be used for stabilization of bone fragments.
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
K052150 "'//
SEP - 8 2005
| Extremity Solutions | 510(k) Summary of Safety and Effectiveness |
|---|---|
| SUMMARY PREPARED: | 5 AUGUST 2005 |
| 510(k) SPONSOR/APPLICANT: | DVO TM Extremity Solutions, LLC |
| 720 E. Winona Ave., Warsaw IN 46580 | |
| 510(k) PREPARER and | |
| CONTACT PERSON: | Dina L. Weissman, J.D. |
| P.O. Box 205, Derby CT 06418 | |
| Tel: (203) 287-0485, Email: DLWeissman@aol.com | |
| TRADE NAME: | Volar Plate System |
| COMMON NAMES: | Plate, Fixation, Bone and Screw, Fixation, Bone |
| CLASSIFICATION: | Class II per 21 CFR § 888.3030 (single/multiple component |
| metallic bone fixation appliances and accessories) and 21 CFR | |
| § 888.3040 (smooth or threaded metallic bone fixation | |
| fastener) | |
| DEVICE PRODUCT CODE: | 87 HRS and 87 HWC |
| PREDICATE DEVICES: | Hand Innovations, Distal Volar Radius Fracture Repair |
| System, K002775, cleared 5 Dec 2000 | |
| Synthes, Distal Radius Plate System, K982732, cleared 8 Oct | |
| 1998 | |
| DEVICE DESCRIPTION: | This non-sterile volar plate system offers several sizes and |
| styles of volar plates, in either titanium (ASTM F-136) or | |
| stainless steel (ASTM F-138 or ASTM 2229). The three | |
| versions include a volar T-plate, a volar intramedullary T- | |
| plate and a volar T-plate with translating head. | |
| The distal head of the plate contains two rows of fixed angle | |
| screw holes that accept 2.7 mm screws. Dorsal and ulnar | |
| sheaths are secured into the plate recesses to cover the screw | |
| heads. | |
| The screws vary in length from 16mm to 26mm. K-wires may | |
| also be used for stabilization of bone fragments. | |
| INTENDED USE: | The DVO TM Volar Plate System is intended for volar fixation |
| of fractures and osteotomies involving the distal radius. This | |
| single use device is for cementless use only. | |
| COMPARISON TO PREDICATES: | The Volar Plate System is similar to the listed predicate |
| devices in intended use, performance characteristics, materials | |
| of construction, manufacturing methods and design. This is | |
| evidenced by comparison of technological characteristics, | |
| dimensional analysis and finite element analysis. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features three parallel lines that curve upwards and to the right. The lines are thicker at the top and taper towards the bottom, resembling a stylized wing or feather. The caduceus is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES" in a circular arrangement.
Public Health Service
SEP - 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DVO Extremity Solutions c/o Ms. Dina L. Weissman, J.D. Weissman Law Firm P.O. Box 205 Derby, Connecticut 06418
Re: K052150 Trade/Device Name: Volar Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: August 5, 2005 Received: August 8, 2005
Dear Ms. Weissman:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(s) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enciosale) to regally management date of the Medical Device American Frank Frank Frank commerce provide to May 20, 1770, the enation as the Federal Food, Drug.
devices that have been reclassified in accordance with the provisions of the Federal Food. devices mat have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require appro the general controls provisions of the Act. The I ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the fiel labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it IT your device is classified (600 (600 roy ols. Existing major regulations affecting your device can Inay be subject to suell 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 I hat FDA has made a determination that your device complies with other requirements of the Act that 1177 has Intel and regulations administered by other Federal agencies. You must or any I cactar statutes and registanceds, including, but not limited to: registration and listing (21 Comply with an the Net STequirements, while works, which as a manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic ford in the quanty Bysteins (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Ms. Dina L. Weissman. J.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) I ins letter will anow you to oegn maneting of substantial equivalence of your device to a legally prematication: The PDF mailing sification 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 If you desire specific advice for your at not the catalog of as a more the regulation entitled, Colliact the Office of Comphanee at (217) = 17 807.97). You may obtain Misoralling by relevelee to premanteriorities.
other general information on your responsibilities under the Act from the Division of Small other general 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,
Milu A. Millican
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Volar Plate
Indications for Use:
The DVO™ Volar Plate System is intended for volar fixation of fractures and osteotomies involving the distal radius.
This single use device is for cementless use only.
Prescription Use XXXXX (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 Defrice Evaluation (ODE)
Mark McMillan
(Division Sign-Off) (Division Sign Off)
Division of General, Restaurative, Division of Neurological Devices
Page 1 of 1
510(k) Number
5