(853 days)
No
The summary does not mention AI, ML, image processing, or any data-driven algorithms. The device description focuses on the material and mechanical properties of the implant.
Yes
The device is used for the fixation of fractures of the distal radius, which is a therapeutic intervention aimed at treating a medical condition.
No
Explanation: The device description states its intended use is for the "fixation of fractures of the distal radius," which is a treatment function, not a diagnostic one.
No
The device description clearly states it is an "intramedullary device" made from titanium alloy and Nitinol, indicating it is a physical implant, not software.
Based on the provided information, the Conventus DRS™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "in the fixation of fractures of the distal radius." This describes a surgical implant used to treat a physical injury.
- Device Description: The description details an "intramedullary device" made of titanium alloy and Nitinol, designed to be implanted within the bone. This is characteristic of a medical device used for structural support and fixation.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any interaction with biological specimens or diagnostic purposes.
Therefore, the Conventus DRS™ is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Conventus DRSTM is intended for use in the fixation of fractures of the distal radius.
Product codes
HRS, HSB
Device Description
The Conventus DRSTM is an intramedullary device intended to treat distal radius fractures. The device remains flexible during placement, but is made rigid at the completion of the surgical implant procedure. The implant is made from titanium alloy (Ti-6Al-4V) and Nitinol.
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
Clinical evaluation of the Conventus DRSTM was conducted outside the United States in Tier 1 countries for clinical subjects that experienced distal radius fracture due to high impact conditions (falls, sports, etc.). The clinical evaluation included collection of radiographic outcomes, functional outcomes (DASH), and adverse event information. Radiographic success of 95% was demonstrated for study subjects 12 weeks post-operatively. The DRSTM performs substantially equivalently to the predicates at 12 weeks, 6 months, and 1 year post-operatively as assessed by DASH score. Adverse events included surgical instrument failure (4), nerve irritation and pain not requiring intervention (4), and one revision due to a fragment that was not properly secured at time of implantation.
Key Metrics
Radiographic success of 95% was demonstrated for study subjects 12 weeks post-operatively.
Predicate Device(s)
Synthes T-Plate (Pre-amendment device), Sonoma Orthopedic Products EnsplintRxTM Intramedullary Distal Radius Fixation Device (K071809), Wright Radial Nail System (MICRONAIL®) (K040938)
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
K102689 Page 1 of 2
510(k) Summary
.
JAN 1 7 2013
.
| Company: | Conventus Orthopaedics, Inc.
10200 73rd Avenue North, Suite 122
Maple Grove, MN 55369 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | Conventus DRSTM |
| Contact: | Kent R. Lind
Vice President, Quality and Regulatory
Phone: (763) 515-5000
Fax: (763) 315-4980 |
| Prepared By: | Musculoskeletal Clinical Regulatory Advisers, LLC
1331 H Street, NW, 12th Floor
Washington, DC 20005
Phone: (202) 552-5800
Fax: (202) 552-5798 |
| Date Prepared: | December 7, 2012 |
| Classification: | 21 CFR 888.3030, Single/multiple component metallic bone
fixation appliances and accessories |
| Class: | II |
| Product Codes: | HRS and HSB |
| Indications for Use: | The Conventus DRSTM is intended for use in the fixation of
fractures of the distal radius. |
| Device Description: | The Conventus DRSTM is an intramedullary device intended
to treat distal radius fractures. The device remains flexible
during placement, but is made rigid at the completion of the
surgical implant procedure. The implant is made from
titanium alloy (Ti-6Al-4V) and Nitinol. |
1
Substantial Equivalence:
This 510(k) supports the substantial equivalence of the Conventus DRS™ to legally marketed devices with respect to indications for use, design, materials, and function. Specifically, this 510(k) demonstrates substantial equivalence of the Conventus DRS™ to the following predicate devices: Synthes T-Plate (Pre-amendment device), Sonoma Orthopedic Products EnsplintRxTM Intramedullary Distal Radius Fixation Device (K071809), Wright Radial Nail System (MICRONAIL®) (K040938). Like the identified predicates, the Conventus DRS™M can capture distal radius bone fragments at various angles.
Clinical evaluation, animal testing, analysis of the static and fatigue axial and bending characteristics of the device in a fracture model, biocompatibility testing, nickel release testing, and corrosion testing performed by the company demonstrate that the Conventus DRS™ is substantially equivalent to legally marketed predicate devices.
Clinical evaluation of the Conventus DRS™ was conducted outside the United States in Tier 1 countries for clinical subjects that experienced distal radius fracture due to high impact conditions (falls, sports, etc.). The clinical evaluation included collection of radiographic outcomes, functional outcomes (DASH), and adverse event information.
Radiographic success of 95% was demonstrated for study subjects 12 weeks post-operatively. The DRSTM performs substantially equivalently to the predicates at 12 weeks, 6 months, and 1 year post-operatively as assessed by DASH score. Adverse events included surgical instrument failure (4), nerve irritation and pain not requiring intervention (4), and one revision due to a fragment that was not properly secured at time of implantation.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure with three lines forming the body and wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 17, 2013
Conventus Orthopaedics, Incorporated % Mr. Kent Lind Vice President, Quality and Regulatory 10200 73td Avenue North, Suite 122 Maple Grove, Minnesota 55369
Re: K102689
Trade/Device Name: Conventus DRSTM Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories . . Regulatory Class: Class II Product Code: HRS, HSB Dated: December 17, 2012 Received: December 17, 2012
Dear Mr. Lind:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
3
Page 2 - Mr. Kent Lind
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/3/Picture/6 description: The image shows the name "Erin Keith" in a stylized font. The letters "E", "r", "i", "n", "i", "t", and "h" are in a simple, bold font. The letters "K", "e" are in a more complex, geometric font, with lines and shapes filling the interior of the letters.
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: K102689
Device Name: Conventus DRSTM
The Conventus DRS™ is intended for the fixation of distal radius fractures.
Prescription Use V (Part 29 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (29 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices / 205'00' 11
2013.01.17 14:05:41