(150 days)
Not Found
No
The device description and performance studies focus on the physical properties and equivalence to predicate devices, with no mention of AI or ML.
No.
The devices are described as implants for fixation, guide pins, and accessories for external fixation, which are structural and mechanical functions to aid healing or surgery, rather than directly providing a therapeutic effect on a disease or condition.
No
The device description indicates that the wires are used as implants for fixation of bone fractures, fusion of joints, or bone reconstructions, or as guide pins for insertion of other implants. These are therapeutic and surgical functions, not diagnostic.
No
The device description clearly states the device is a portfolio of physical wires (K-Wires, Steinmann Pins, Cerclage Wires) made of Titanium alloy or implant stainless steel, intended for use as implants. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that these devices are implants used for the fixation of bone fractures, fusion of joints, bone reconstructions, or as guide pins for inserting other implants. They are physically inserted into the body.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient.
Therefore, the function and application of these wire devices fall under the category of surgical implants and instruments, not in vitro diagnostics.
N/A
Intended Use / 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
Product codes
JDW, HTY
Device Description
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 .
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)
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.
Documentation with respect to performance data to show the substantial equivalence and safety and effectiveness has been provided with this submission.
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 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
・
aap Implantate AG
aap Wire Bone
ﺔ
:
Summary of Safety and Effectiveness
| Sponsor: | aap Implantate AG
Lorenzweg 5
D-12099 Berlin Germany |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Dr. Christian Zietsch
Phone:+49-30-750-19-193
Fax: +49-30-750-19-111 |
| Date | October/17/2013
OCT 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 and
Reference: | 21 CFR 888.3040 Smooth or threaded metallic bone
fixation fastener - Class II |
| Device Product Code and
Panel Code: | Orthopedics/87/ JDW: Pin, Fixation, Threaded
Orthopedics/87/ HTY: Pin, Fixation Smooth |
| Predicate device: | Bone Wire from Störk Instrumente GmbH, Germany under
the premarket notification K030665 (Mar 25, 2003) and
Kirschner / Guide Wires from SMT Schilling Metalltechnik
GmbH, Germany under the premarket notification K100736
(Sep 10, 2010) |
| Device Description: | The aap Wire Bone Portfolio consists of K-Wires, Steinmann
Pin and Cerclage Wire. The devices have to be used as im-
plants 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 devic-
es 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 .
Page 1 of 2
1
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 implants | |
| accessories 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: |
.
·
.
.
Documentation with respect to performance data to show the substantial equivalence and safety and effectiveness has been provided with this submission.
· ·
・
,
. .
・
:
:
:
,
:
2
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
3
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
4
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