(258 days)
The Conventus DRSTM is intended for the fixation of distal radius fractures.
The Conventus DRSTM is an intramedullary device intended to treat distal radius fractures. The DRS is comprised of an Expandable Scaffold, Fragment Screws, and a Proximal Plate. 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 (Ti6Al4V) and Nitinol.
The provided text is a 510(k) summary for the Conventus DRS™ (Distal Radius System) device, which is a fracture fixation device. The document describes the device, its intended use, and its substantial equivalence to a previously cleared device. However, it does not contain information about acceptance criteria, device performance metrics, or any studies with AI involvement.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (K102689) based primarily on the device's design, materials (titanium alloy and Nitinol), and intended use for distal radius fractures. The only "testing" mentioned is for "MR Conditional" labeling, which assesses safety in a magnetic resonance environment, not clinical performance for fracture fixation.
Therefore, I cannot populate the table or answer the questions as the required information (acceptance criteria, performance data, details of a study proving criteria, sample sizes, ground truth establishment, AI involvement, etc.) is not present in the provided document.
The document is a regulatory submission for a traditional medical device (fracture fixation) and does not appear to involve any AI/ML components for diagnosis, prediction, or intervention that would require performance studies against specific acceptance criteria in the manner described in your request.
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5. 510(k) Summary
·
FEB 1 2 2014
| Company: | Conventus Orthopaedics, Inc.10200 73rd Avenue North, Suite 122Maple Grove, MN 55369 |
|---|---|
| Device Trade Name: | Conventus DRSTM |
| Common Name: | Fracture Fixation Device |
| Contact: | Kent R. LindVice President, Quality and RegulatoryPhone: (763) 515-5000Fax: (763) 315-4980 |
| Date Prepared: | May 30, 2013 |
| Classification: | 21 CFR 888.3030, Single/multiple component metallic bonefixation appliances and accessories21 CFR 888.3020: Intramedullary fixation rod |
| Class: | II |
| Product Codes: | HRS and HSB |
| Indications for Use: | The Conventus DRSTM is intended for the fixation of distalradius fractures. |
| Device Description: | The Conventus DRSTM is an intramedullary device intendedto treat distal radius fractures. The DRS is comprised of anExpandable Scaffold, Fragment Screws, and a ProximalPlate. The device remains flexible during placement, but ismade rigid at the completion of the surgical implantprocedure. The implant is made from titanium alloy(Ti6Al4V) and Nitinol. |
| Substantial Equivalence: | The Conventus DRSTM is substantially equivalent to thepreviously cleared Conventus DRSTM device (K102689).Testing in accordance with FDA's Guidance Document"Establishing Safety and Compatibility of Passive Implantsin the Magnetic Resonance (MR) Environment" wasperformed and supports "MR Conditional" labeling for theConventus DRSTM device. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2014
Conventus Orthopaedics, Incorporated Mr. Kent Lind Vice President, Quality, Regulatory, Clinical 10200 73td Avenue North, Suite 122 Maple Grove, Minnesota 55369
Re: K131552
Trade/Device Name: Conventus DRS™ 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: January 13, 2014 Received: January 14, 2014
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
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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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,
Lori A. Wiggins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use 4.
11/2
.
:
2017-02-05
510(k) Number (if known): _K131552
Device Name: Conventus DRSTM
The Conventus DRS™ is intended for the fixation of distal radius fractures.
V Prescription Use __ (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)
Elizabeth に腕時nk -S
Division of Orthopedic Devices
17
§ 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.