(84 days)
Not Found
No
The device description and intended use are for physical orthopedic fixation devices (wires, pins, screws) and do not mention any software, image processing, or AI/ML capabilities. The substantial equivalence is based on physical characteristics and materials.
No
The device is indicated for fixation of bone fractures, bone reconstructions, and as guide pins, which are surgical interventions rather than therapeutic treatments.
No
This device is used for the fixation of bone fractures and reconstruction, and as guide pins for other implants or traction. Its function is to provide structural support or guidance during medical procedures, rather than to diagnose medical conditions or diseases.
No
The device description clearly indicates physical components (wires, pins, screws) made of materials with specific dimensions and geometries, which are hardware, not software.
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 Intended Use: The intended use of the Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and Screws is for the fixation of bone fractures, bone reconstructions, and as guide pins for implant insertion or traction. This is a direct surgical intervention on the body, not a test performed on a specimen outside the body.
- Device Description: The description details physical characteristics of the pins and wires, not components for analyzing biological samples.
Therefore, based on the provided information, this device is a surgical implant/instrument, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and Screws are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.
Product codes (comma separated list FDA assigned to the subject device)
HWC, HTY and IDW
Device Description
Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and Screws are available in several diameters and lengths, in both threaded and non-threaded designs with a variety of point geometries.
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
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)
Preclinical Testing: The Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and Screws have similar physical dimensions, materials and technological characteristics as the identified predicate devices, and the substantial equivalence rationale is based on comparisons of these parameters.
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
§ 888.3040 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
5. 510(k) Summary
| Device Trade Name: | Komet Medical Kirschner Wires, Steinmann Pins and
Guide Pins |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Gebr. Brasseler GmbH & Co. KG |
| Contact: | Gebr. Brasseler GmbH & Co. KG
Trophagener Weg 25 • 32657 Lemgo
Postfach 160 • 32631 Lemgo
Germany
Phone: +49 5261 701 467
Fax: +49 5261 701 96467 |
| 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: | April 30, 2013 |
| Classifications: | 21 CFR 888.3040, Smooth or threaded metallic bone
fixation fasteners. |
| Common Name: | Screw, Fixation Bone
Pin, Fixation, Smooth or Threaded |
| Class: | II |
| Product Codes: | HWC, HTY and IDW |
Indications For Use:
The Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and Screws are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.
Device Description:
Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and Screws are available in several diameters and lengths, in both threaded and non-threaded designs with a variety of point geometries.
Substantial Equivalence
The Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and Screws are substantially equivalent to the following devices: SMT Schilling Metalltechnik GmbH Orthopaedic Fixation Pins and Wires, Kirschner, Guide Wires (K100736); DePuy Inc.
JUL 2 6 2013
1
Preclinical Testing:
The Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and Screws have similar physical dimensions, materials and technological characteristics as the identified predicate devices, and the substantial equivalence rationale is based on comparisons of these parameters.
2
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 26, 2013
Gebr. Brasseler GmbH & Company KG % Musculoskeletal Clinical Regulatory Advisers, LLC Ms. Erela Dana Associate, Regulatory Affairs 1331 H Street Northwest 12th Floor Washington, District of Columbia 20005
DEPARTMENT OF HEALTH & HUMAN SERVICES
Re: K131264
Trade/Device Name: Komet Medical Kirschner Wires, Steinmann Pins and Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, HTY, JDW Dated: July 3, 2013 Received: July 5, 2013
Dear Ms. Dana:
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 - Ms. Erela Dana
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 clectronic 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. plcase 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.fdagov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Erin I. Keith
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use 4.
510(k) Number (if known): K131264
Device Name: Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and Screws
.
The Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and Screws are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.
ﮯ Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
の 2007年07月17日 08:00 PM 10:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM 1
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lori A. Wiggins
Division of Orthopedic Devices