(131 days)
No
The description focuses on the mechanical components and materials of a screw system for fracture fixation, with no mention of AI or ML capabilities.
Yes
The device is used for internal fixation of fractures, fusions, and revisions, which are therapeutic interventions.
No
Explanation: The device is an internal fixation system for fractures, fusions, and revisions, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a system of physical screws and pins made of titanium or stainless steel, along with ancillary instrumentation for implantation and removal. It is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The BioPro Kwick-Wire™ Universal Screw System is an implantable device used for the internal fixation of fractures, fusions, and revisions. It is surgically placed inside the body.
The description clearly indicates a surgical implant used for structural support and fixation within the body, which is the opposite of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The BioPro Kwick-Wire™ Universal Screw System is indicated for use in the internal fixation of fractures, fusions and revisions. The system is intended for but not limited to hand surgery, orthopedic surgery and podiatric surgery - but is not intended for Spinal Use.
Product codes
JDW, HTN, HWC
Device Description
The BioPro Kwick-Wire™ Universal Screw System comes in two diameter pin sizes of 2.5mm and 3.0mm and in a length of 4.0in. and is used for reduction and fixation of fractures appropriate for the size of the device. A mating compression nut of either the 2.5mm or 3.0mm size is mated with the proper pin size. Both the pin and nut are manufactured from either high strength 6-4 Alloyed Titanium to ASTM F136 or high strength 316 LVM Stainless Steel to ASTM F138. Ancillary instrumentation is available for device implantation and removal. The implant is sold in a 'sterile' condition for single-use. The sterilization method used is Ethylene Oxide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical setting.
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
No nonclinical testing was used in the determination of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
DePuy - Rockwood Clavicle Pin (K991649), Onyx Medical - Hagie Pin (K903258), KMI Kinetikos Medical - Kompressor Compression Screw (K040356), Millenium Medical (now OrthoPediatrics) -- PWC Pecutaneous Compression Wire (K031050)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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BioPro, Inc. Kwick-Wire™ Universal Screw System - 510(k) Summary - K130298. 510(k) Summary of Safety and Effectiveness
| SAFE MEDICAL DEVICES ACT OF 1990 |
|---|
| 510(k) Summary |
JUN 1 8 2013
BioPro, Inc. NAME OF FIRM: 2929 Lapeer Road Port Huron, MI 48060 Al Lippincott 510(k) FIRM CONTACT: Engineering Consulting Services, Inc. 3150 E. 200th St. Prior Lake, MN 55372 Tel. No. 952-492-5858 e-mail: allippincott@msn.com February 1, 2013 DATE: TRADE NAME: BioPro Kwick-Wire™ Universal Screw System Pin, Fixation, Threaded; COMMON NAME: Washer, Bolt Nut Smooth or Threaded Metallic Bone Fixation Fastener, Class II (21CFR, CLASSIFICATION: Sec. 888.3040) Single/multiple Component Metallic Bone Fixation Appliances and Accessories, Class II (21CFR, Sec. 888.3030) JDW DEVICE PRODUCT CODE: SUBSEQUENT PRODUCT CODE: HTN, HWC SUBSTANTIALLY DePuy - Rockwood Clavicle Pin (K991649) EQUIVALENT DEVICES Onyx Medical - Hagie Pin (K903258) KMI Kinetikos Medical - Kompressor Compression Screw (K040356) Millenium Medical (now OrthoPediatrics) -- PWC Pecutaneous Compression Wire (K031050) The BioPro Kwick-Wire™ Universal Screw System comes in two DEVICE DESCRIPTION: diameter pin sizes of 2.5mm and 3.0mm and in a length of 4.0in. and is used for reduction and fixation of fractures appropriate for the size of the device. A mating compression nut of either the 2.5mm or 3.0mm size is mated with the proper pin size. Both the pin and nut are manufactured from either high strength 6-4 Alloyed Titanium to ASTM F136 or high strength 316 LVM Stainless Steel to ASTM F138. Ancillary instrumentation is available for device implantation and removal. The implant is sold in a 'sterile' condition for single-use. The sterilization method used is Ethylene Oxide.
Section XII
1
BioPro, Inc. Kwick-Wire™ Universal Screw System - 510(k) Summary - K130298:
INTENDED USE:
The BioPro Kwick-Wire™ Universal Screw System is indicated for use in the internal fixation of fractures, fusions and revisions. The system is intended for but not limited to hand surgery, orthopedic surgery and podiatric surgery - but is not intended for Spinal Use.
EQUIVALENCE:
The BioPro Kwick-Wire™ Universal Screw System is substantially equivalent(SE) to the predicate systems listed. No nonclinical testing was used in the determination of substantial equivalence.
SUMMARY OF TECH-NOLOGICAL CHAR-ACTERISTICS
The BioPro Kwick-Wire™ Universal Screw System is Similar in Material, Geometry Design/Markings, and Indications to other predicate system(s) currently sold in the U.S. market.
SUMMARY OF SAFETY AND EFFECTIVENESS:
The BioPro Kwick-Wire™ Universal Screw System is shown to be safe and effective for use as 'sterile' and for single-use in a surgical setting.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird, with a wavy line below representing the tail.
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
June 18, 2013
BioPro, Incorporated % Engineering Consultant Services, Incorporated Mr. Al Lippincott BioMedical Engineer & Consultant 3150 East 200th Street Prior Lake, Minnesota 55372
Re: K130298
Trade/Device Name: BioPro Kwick-Wire™ Universal Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: JDW, HTN, HWC Dated: March 8, 2013 Received: March 21, 2013
Dear Mr. Lippincott:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
3
Page 2 - Mr. Al Lippincott
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/ResourcesforYou/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Erin DKeith
For
Mark Melkerson Director -Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: K130298
DEVICE NAME: BioPro Kwick-Wire™ Universal Screw System
The BioPro Kwick-Wire™ Universal Screw System is indicated for use in the internal fixation of fractures, fusions and revisions. The system is intended for but not limited to hand surgery, orthopedic surgery and podiatric surgery - but is not intended for Spinal Use.
Prescription-Use= ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Per 21 CFR 801 Subpart D) (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)
Elizabeth L. Frank -S
Division of Orthopedic Devices