(49 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of the wires and pins, with no mention of AI or ML.
No
Explanation: The device is used for fixation of bone reconstruction, as guide pins, or for applying traction, which are mechanical support or positioning functions, not therapeutic treatments.
No
The device description and intended use state that it is used for "fixation of bone reconstruction" and "fracture stabilization during the healing process," which are therapeutic rather than diagnostic functions.
No
The device description clearly states it is composed of Kirschner wires and Steinmann pins, which are physical hardware components used for bone fixation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided text clearly describes Kirschner wires and Steinmann pins as devices used for mechanical fixation and stabilization of bone. They are implanted into the skeletal system.
- Lack of Biological Sample Analysis: There is no mention of analyzing biological samples or performing any diagnostic tests on bodily fluids or tissues.
The device is a surgical implant used for structural support, not for diagnostic testing.
N/A
Intended Use / Indications for Use
Kirschner wires (K-Wires) and Steinmann pins are used for fixation of bone reconstruction, as guide pins for insertion of other implants, or to be implanted through the skin so that traction may be applied to the skeletal system. The pins and wires may be used in the threaded form depending upon the desired application.
Product codes
HTY, JDW
Device Description
Zimmer Kirschner Wires and Steinmann Pins are used for fracture stabilization during the healing process. These wires are available in multiple diameters and lengths and threaded/unthreaded (smooth) versions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
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)
Non-Clinical Performance and Conclusions: Biocompatibility - Biocompatibility testing on the Pins and Wires materials was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed. The Zimmer subject devices were considered for conformance to dimensional and material mechanical property standards ASTM F366 -10 and ISO 5838-1. All items in the scope were in conformance with those standards and are therefore substantially equivalent to the predicate devices.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for these devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
0
Image /page/0/Picture/1 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 resembling a stylized human figure with three faces in profile, stacked on top of each other.
February 6, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Zimmer, Incorporated Mr. Stephen H. McKelvey Senior Project Manager, Trauma Regulatory Affairs P.O. BOX 708 Warsaw, Indiana 46581
Re: K143618
Trade/Device Name: Zimmer Kirschner wires and Steinmann pins Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY, JDW Dated: December 18, 2014 Received: December 19, 2014
Dear Mr. Stephen McKelvey:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Mr. Stephen H. McKelvey
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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Zimmer Kirschner wires and Steinmann pins
Indications for Use (Describe)
Kirschner wires (K-Wires) and Steinmann pins are used for fixation of bone reconstruction, as guide pins for insertion of other implants, or to be implanted through the skin so that traction may be applied to the skeletal system. The pins and wires may be used in the threaded form depending upon the desired application.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Sponsor: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stephen H. McKelvey
Senior Project Manager, Trauma Regulatory Affairs
Telephone: (574) 372-4944
Fax: (574) 371-8760 |
| Date: | 12/18/2014 |
| Trade Name: | Zimmer Kirschner Wires and Steinmann Pins, |
| Common Name: | Kirschner Wires and Steinmann Pins |
| Classification Names
and References: | Pin, Fixation, Smooth (HTY) and Pin, Fixation, Threaded
(JDW) - both per 21 § CFR 888.3040, Smooth or threaded
metallic bone fixation faster |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | Kirschner Medical Corp., Kirschner Wire and Steinman
Pins (K831005 - cleared 05/18/1983) |
| Purpose and Device Description: | Zimmer Kirschner Wires and Steinmann Pins are used for
fracture stabilization during the healing process. These
wires are available in multiple diameters and lengths and
threaded/unthreaded (smooth) versions. |
| Intended Use: | Kirschner wires (K-Wires) and Steinmann pins are used
for fixation of bone fractures, bone reconstruction, as
guide pins for insertion of other implants, or to be
implanted through the skin so that traction may be applied
to the skeletal system. The pins and wires may be used in
the threaded or unthreaded form depending upon the
desired application. |
4
| Comparison to Predicate Device: | The Zimmer Kirschner Wires and Steinmann Pins are
identical in intended use and similar in basic shape,
materials and performance characteristics to the predicate
devices. The subject devices are provided sterile or non-
sterile. |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data (Nonclinical
and/or Clinical): | Non-Clinical Performance and Conclusions: |
| | Biocompatibility - Biocompatibility testing on the
Pins and Wires materials was conducted per
ISO 10993-1 and Good Laboratory Practices
(21 CFR § 58). All testing passed. The Zimmer subject devices were considered for
conformance to dimensional and material mechanical
property standards ASTM F366 -10 and
ISO 5838-1. All items in the scope were in
conformance with those standards and are therefore |
Conclusions: The data presented in this submission demonstrates that the subject device is substantially equivalent to the predicate devices.
substantially equivalent to the predicate devices.
Clinical Performance and Conclusions:
- . Clinical data and conclusions were not needed for these devices.