(150 days)
Wire devices (K-Wire, Cerclage Wires, Steinmann Pins)
- guide wire for osteosynthesis implants .
- accessories for external fixation (Steinmann Pin) .
- application as implant according to the AO/ASIF principles of fracture . management
The aap Wire Bone Portfolio consists of K-Wires, Steinmann Pin and Cerclage Wire. The devices have to be used as implants for the fixation of bone fractures, fusion of joints or bone reconstructions or as guide pins for insertion of other implants and are offered in a variety of lengths, diameters, tip styles, and threading. The devices are made of either Titanium alloy or implant stainless steel. The devices are delivered non-sterile and have to be sterilized before use. After fracture healing the implants have to be removed.
The aap Wire Bone Portfolio consists of:
• K-wire with trocar point, ø0.8 mm - ø3.0 mm, 60 mm - 430 mm
• K-wire with thread and trocar point, ø0.8 mm - ø3.0 mm; 45 mm - 380 mm
• K-wire with 2 trocar points, ø0.8 mm - ø3.0 mm; 70 mm - 310 mm
• Steinmann pin trocar, 3-flat end ø2.5 mm - ø6.0 mm; 120 mm - 350 mm
• Cerclage wire with eye, soft, ø0.8 mm - ø1.2 mm; 280 mm - 600 mm
Cerclage wire soft, coil, ø0.8 mm - ø1.5 mm, 10 m .
This document, a 510(k) premarket notification for the "aap Wire Bone" device, describes the device's characteristics and its substantial equivalence to predicate devices, rather than a study demonstrating its performance against specific acceptance criteria.
The core assertion for the aap Wire Bone is substantial equivalence to existing legally marketed predicate devices, not direct performance against new, explicitly defined acceptance criteria through a dedicated study.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, MRMC study, training set details) are not applicable because the submission relies on demonstrating equivalence rather than novel performance testing.
Here's a breakdown of the available information:
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Reported Device Performance General Safety and Effectiveness (Demonstrated via Substantial Equivalence) The aap Wire Bone (K-Wire, Cerclage Wire, Steinmann Pin) is claimed to be substantially equivalent to the predicate devices: Bone Wire from Störk Instrumente GmbH (K030665) and Kirschner/Guide Wires from SMT Schilling Metalltechnik GmbH (K100736). Conformity in Materials of Construction Met: The aap Wire Bone is made of Ti6Al4V (ASTM F136 or ISO 5832-3) or Stainless Steel (ASTM F138 or ISO 5832-1). These materials are consistent with those typically used in predicate bone fixation devices. The submission explicitly states: "The proposed devices are substantially equivalent to the identified predicate device in materials of construction..." and "The aap Wire Bone are equivalent in physical dimensions and materials to the identified predicate devices." Conformity in Physical Characteristics (Dimensions, Tip Styles, Threading) Met: The aap Wire Bone portfolio offers various lengths, diameters, tip styles (trocar, 2 trocar), and threading (with or without thread). The submission explicitly states: "The proposed devices are substantially equivalent to the identified predicate device in... physical characteristics..." and "The aap Wire Bone are equivalent in physical dimensions and materials to the identified predicate devices." Implicitly, these dimensions and styles align with the predicates. Conformity in Intended Use and Indications for Use Met: The device is intended for use as implants for fixation of bone fractures, fusion of joints, bone reconstructions, or as guide pins for insertion of other implants. Specifically, indications for use include: guide wire for osteosynthesis implants, accessories for external fixation (Steinmann Pin), and application as implant according to AO/ASIF principles of fracture management. These indications are stated to be substantially equivalent to the predicate devices: "The proposed devices are substantially equivalent to the identified predicate device in... intended use." Performance Data (Non-Clinical and/or Clinical Testing) Met (via equivalence): The submission states: "The non-clinical testing to be conducted on the aap Wire Bone will include material and dimensional verification. The aap Wire Bone are equivalent in physical dimensions and materials to the identified predicate devices. Testing, therefore, is not needed to demonstrate that the subject devices are substantially equivalent to the legally marketed predicate devices." It further states, "Documentation with respect to performance data to show the substantial equivalence and safety and effectiveness has been provided with this submission." This implies that the performance data for the predicate devices, combined with verification of material and dimensional similarity for the new device, is considered sufficient. No new specific performance study data (e.g., mechanical strength, biocompatibility testing results) for the new device is presented in this summary beyond the claim of equivalence. Sterilization requirements (prior to use) Met: The devices are delivered non-sterile and must be sterilized before use. This is a characteristic of the device design and common practice for such implants. Removal requirements (after fracture healing) Met: The implants have to be removed after fracture healing. This is a characteristic of the device's intended lifecycle and use. The study/justification that proves the device meets the acceptance criteria is the 510(k) submission itself, by demonstrating substantial equivalence to predicate devices which have already been deemed safe and effective.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This submission does not describe a performance study with a test set of data in the manner typically associated with AI/software devices. The "testing" mentioned is material and dimensional verification of the new device to establish its similarity to predicate devices. The data provenance for the predicate devices is not detailed in this summary.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. This is not an AI/software device and does not involve ground truth established by experts for a test set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Not applicable for this type of submission.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- N/A. This is a physical medical device (bone fixation wires/pins), not an AI/software device, so MRMC studies are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. Not applicable for this type of submission, as it focuses on direct material and dimensional equivalence to existing devices rather than a diagnostic or predictive task. The "ground truth" here is essentially the established safety and effectiveness of the FDA-cleared predicate devices.
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The sample size for the training set
- N/A. This is not an AI/software device.
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How the ground truth for the training set was established
- N/A. This is not an AI/software device.
In summary, the "study" proving the device meets the acceptance criteria is the documentation provided in the 510(k) premarket notification, which argues for substantial equivalence based on material composition, physical dimensions, and intended use matching previously cleared predicate devices. No new clinical trials or extensive non-clinical performance studies beyond verification of similarity to predicates were deemed necessary or conducted for this specific submission, according to the provided text.
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aap Implantate AG
aap Wire Bone
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:
Summary of Safety and Effectiveness
| Sponsor: | aap Implantate AGLorenzweg 5D-12099 Berlin Germany |
|---|---|
| Company Contact: | Dr. Christian ZietschPhone:+49-30-750-19-193Fax: +49-30-750-19-111 |
| Date | October/17/2013OCT 17 2013 |
| Trade Name: | aap Wire Bone / K-Wire; Cerclage Wire, Steinmann Pin |
| Common Name: | Wire Bone / K-Wire; Cerclage Wire, Steinmann Pin |
| Classification Name andReference: | 21 CFR 888.3040 Smooth or threaded metallic bonefixation fastener - Class II |
| Device Product Code andPanel Code: | Orthopedics/87/ JDW: Pin, Fixation, ThreadedOrthopedics/87/ HTY: Pin, Fixation Smooth |
| Predicate device: | Bone Wire from Störk Instrumente GmbH, Germany underthe premarket notification K030665 (Mar 25, 2003) andKirschner / Guide Wires from SMT Schilling MetalltechnikGmbH, Germany under the premarket notification K100736(Sep 10, 2010) |
| Device Description: | The aap Wire Bone Portfolio consists of K-Wires, SteinmannPin and Cerclage Wire. The devices have to be used as im-plants for the fixation of bone fractures, fusion of joints orbone reconstructions or as guide pins for insertion of otherimplants and are offered in a variety of lengths,diameters, tip styles, and threading. The devices are madeof either Titanium alloy or implant stainless steel. The devic-es are delivered non-sterile and have to be sterilized beforeuse. After fracture healing the implants have to be removed. |
| The aap Wire Bone Portfolio consists of: | |
| • K-wire with trocar point,ø0.8 mm - ø3.0 mm, 60 mm - 430 mm | |
| • K-wire with thread and trocar point,ø0.8 mm - ø3.0 mm; 45 mm - 380 mm | |
| • K-wire with 2 trocar points,ø0.8 mm - ø3.0 mm; 70 mm - 310 mm | |
| • Steinmann pin trocar, 3-flat endø2.5 mm - ø6.0 mm; 120 mm - 350 mm | |
| • Cerclage wire with eye, soft,ø0.8 mm - ø1.2 mm; 280 mm - 600 mm |
Cerclage wire soft, coil, ø0.8 mm - ø1.5 mm, 10 m .
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aap Implantate AG aap Wire Bone
| Material: | Ti6Al4V (ASTM F136 or ISO 5832-3) or Stainless Steel (ASTM F138 or ISO 5832-1) |
|---|---|
| Indications: | Wire devices (K-Wire, Cerclage Wires, Steinmann Pins)guide wire for osteosynthesis implantsaccessories for external fixation (Steinmann Pin)application as implant according to the AO/ASIF princi-ples of fracture management |
| Substantial Equivalence | The proposed devices are substantially equivalent to the identified predicate device in materials of construction, phys- ical characteristics, and intended use. |
| Documentation to show the substantial equivalence and has been provided with this submission. | |
| Performance Data(Non-Clinical and /or Clinical): | The non-clinical testing to be conducted on the aap Wire Bone will include material and dimensional verification.The aap Wire Bone are equivalent in physical dimensions and materials to the identified predicate devices. Testing, therefore, is not needed to demonstrate that the subject devices are substantially equivalent to the legally marketed predicate devices. |
| Summary of performance data: |
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Documentation with respect to performance data to show the substantial equivalence and safety and effectiveness has been provided with this submission.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 17, 2013
aap Implantate AG Dr. Christian Zietsch Manager, Regulatory Affairs Lorenzweg 5 12099 Berlin GERMANY
Re: K131459
Trade/Device Name: aap Wire Bone Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: JDW, HTY Dated: July 17, 2013 Received: July 19, 2013
Dear Dr. Zietsch:
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. Isting 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
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Page 2 - Dr. Christian Zietsch
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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.
Casey Hanley-S
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 Statement
510(k) Number (if known): K131459
Device Name: aap Wire Bone
Indications for Use:
Wire devices (K-Wire, Cerclage Wires, Steinmann Pins)
- guide wire for osteosynthesis implants .
- accessories for external fixation (Steinmann Pin) .
- application as implant according to the AO/ASIF principles of fracture . management
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
Over-The-Counter Use AND/OR (21 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)
Page 1 of 1
Elizabeth L. Frank -S
Division of Orthopedic Devices
§ 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.