(179 days)
Not Found
No
The device description and intended use are purely mechanical, describing metal pins and wires for bone fixation. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes.
The device is intended to perform as a fixation and stabilization unit for bone fractures, which is a therapeutic purpose.
No
Explanation: The device, orthopaedic fixation pins and wires, is intended for fixation, stabilization, and guidance during implant insertion, not for diagnosing medical conditions.
No
The device description clearly states it is comprised of "metal pins" and describes physical characteristics like diameter, length, tips, and surface, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "fixation and stabilization unit of bone fractures or as guidance at insertion of implants into the skeletal system." This describes a surgical or procedural use within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details physical characteristics of metal pins and wires used for bone fixation and guidance. This aligns with a surgical implant or instrument, not a diagnostic reagent or instrument used to analyze biological samples.
- Anatomical Site: The anatomical site is the "Skeletal system, bone fractures," which is a part of the body where surgical procedures are performed.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Orthopaedic fixation pins and wires are intended to perform as fixation and stabilization unit of bone fractures or as guidance at insertion of implants into the skeletal system.
Product codes (comma separated list FDA assigned to the subject device)
87 HTY, 87 JDW
Device Description
Orthopaedic fixation pins and wires are metal pins for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implantation through the skin so that traction may be applied to the skeleton system.
To ensure the multi-use of these devices, many different models are available. The differences can be as follows:
- Diameter: from 0.6 up to 6.35mm (0.020 up to 0.250 inch)
- Length: from 60 up to 500 mm (2.36 up to 19.69 inch)
- Tips: diamond or trocar Point, round, flat, with or without 3- or 4- shank ends, with or without spherical shape.
- Surface: complete or partial smooth and / or threaded, with or without threading cutter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeleton system (bone fractures)
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)
Not Found
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
Image /page/0/Picture/1 description: The image shows a logo for SMT Schilling GmbH Metalltechnik. The logo is black and white and features the letters "SMT" in a bold, stylized font. The word "SCHILLING" is written in a smaller font above the words "GmbH Metalltechnik". The logo is simple and modern, and it is likely used to represent the company's brand.
K100736
SEP 1 0 2010
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS IN AC-CORDANCE WITH SMDA OF 1990
Date of Application: 2010-07-16
APPLICANT: . SMT Schilling Metalltechnik GmbH Griesweg 33 78570 Mühlheim an der Donau Germany Tel.: (07463) 99309-0 Fax: (07463) 99309-59
CONTACT PERSON: Mr. Erik Schilling Managing Director Tel.: (07463) 99309-0 Fax: (07463) 99309-59
1. Device Name
Orthopaedic Fixation Pins and Wires / Kirschner / Guide Wires Trade Name: Kirschner Wire (K-Wire) Common Name:
Classification Product Code / Subsequent Code 2.
Our implant system can be classified according following device names and product codes:
| Device: | Pin, Fixation Smooth | Pin, Fixation, Threaded |
|---|---|---|
| Medical Specialty: | Part 888, Orthopedic | Part 888, Orthopedic |
| Product Code: | 87 HTY | 87 JDW |
| Device Class: | 2 | 2 |
| Regulation Number: | 888.3040 | 888.3040 |
1
Image /page/1/Picture/2 description: The image shows the logo for SMT Schilling GmbH Metatechnik. The logo is black and white and features the letters SMT in large, bold font. Below the letters are the words GmbH and Metatechnik. There is also the text P-2 in the upper right corner of the image.
3. Substantial Equivalence
Orthopaedic fixation pins and wires are substantial equivalent based upon design, dimensional and materials characterization to the Störk Kirschner Wires (K-Wires) and Steinmann Pins (#K030665) of Stork Instrumente GmbH, 78576 Emmingen-Liptingen, Germany and Teleflex KMedic Internal/External Fixation Devices (#K070561) of Teleflex Medical, Bannockburn, IL.
Description of the Device ব
Orthopaedic fixation pins and wires are metal pins for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implantation through the skin so that traction may be applied to the skeleton system.
To ensure the multi-use of these devices, many different models are available. The differences can be as follows:
- Diameter: from 0.6 up to 6.35mm (0.020 up to 0.250 inch) 이
- Length: from 60 up to 500 mm (2.36 up to 19.69 inch) ■
- Tips: diamond or trocar Point, round, flat, with or without 3- or 4- shank ends, with or without spherical . shape.
- Surface: complete or partial smooth and / or threaded, with or without threading cutter. .
Intended Use 5.
SMT Schilling's orthopaedic fixation pins and wires are intended to perform as fixation and stabilization unit of bone fractures or as guidance at insertion of implants into the skeletal system.
Conclusion 6.
Based on the available 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that SMT Schilling's Kirschner Wires and Pins are substantially equivalent to the existing legally marketed devices under Federal Food, Drug and Cosmetic Act.
2
Image /page/2/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 a stylized image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
SMT Schilling Metalltechnik GmbH % Medagent GmbH & Co. KG Mr. Erik Schilling Regulatory Affairs Manager Griesweg 47 Müehlheim, Baden-Württemberg Germany 78570
SEP 1 0 2010
Re: K100736
Trade/Device Name: SMT Schilling Kirschner/Guide Wires Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY, JDW Dated: September 2, 2010 Received: September 7, 2010
Dear Mr. Schilling:
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 Amendmouts, 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
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/ReportalProblem/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.
Barbara Buent
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: K100736
Device Name: SMT Schilling Kirschner/Guide Wires SEP 1 0 2010
Indications For Use:
Orthopaedic fixation pins and wires are intended to perform as fixation and stabilization unit of bone fractures or as guidance at insertion of implants into the skeletal system.
Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Omitte for mxn
(Division Sign-off)
Division of Surgical, Orthopedic, and Restorative Devices
.
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510(k) Number K100736