(46 days)
Not Found
No
The device description and performance studies focus solely on the mechanical properties and intended use of a physical screw for bone fixation. There is no mention of software, algorithms, or data processing that would indicate the presence of AI/ML.
Yes
The device, "aap Cannulated Screw 2.0", is used for "fracture fixation of small and long bones and of the pelvis," which is a treatment for bone injuries, thus qualifying it as a therapeutic device.
No
Explanation: The device is a cannulated screw system intended for fracture fixation, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (Cannulated Screws, Washer, Set of Instruments) which are hardware, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "fracture fixation of small and long bones and of the pelvis." This describes a surgical procedure to stabilize bone fractures.
- Device Description: The device is a "Cannulated Screw 2.0" used for "fixation of bone fragments." This is a physical implant used in surgery.
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
The description clearly indicates a surgical implant used for mechanical support within the body, not a test performed on a biological sample outside the body.
N/A
Intended Use / Indications for Use
The aap Cannulated Screw 2.0 is intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.
Product codes (comma separated list FDA assigned to the subject device)
HWC, HTN
Device Description
Cannulated Screws are used for fixation of bone fragments, i.e., for treatment of bone fractures and other bone injuries. Cannulated Screws with a diameter of 2.0 mm are manly in use for foot and hand surgery.
The aap Cannulated Screw 2.0 consists of:
• Cannulated Screw 2.0, Long thread
• Cannulated Screw 2.0, Short thread
• Washer
• Set of Instruments Cannulated Screws
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small and long bones and of the pelvis
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 tests have been performed and show the effectiveness and safety of the device.
Summary of Non-clinical tests:
Type of test: Mechanical tests of Screws acc. to ASTM F543-07
Assessment of test results: The Screws fulfil the relevant requirements of ASTM F543-07 and pre-defined acceptance criteria and intended uses.
Documentation regarding the mechanical testing 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): 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
aap Implantate AG aap Cannulated Screw 2.0
K130590 page 1 of 2
SO (K) Summary of Safety and Effectiveness
APR 2 2 2013
| 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 | February/28/ 2013 |
| Trade Name: | aap Cannulated Screw 2.0 |
| Common Name: | Cannulated Screw 2.0 |
| Classification Name and
Reference: | 21 CFR 888.3030 Single/multiple component metallic
bone fixation appliances and accessories - Class II and
21 CFR 888.3040 Smooth or threaded metallic bone fixa-
tion fastener - Class II |
| Device Product Code and
Panel Code: | Orthopedics/87/ HWC: Screw, Fixation, Bone
Orthopedics/87/ HTN: Washer, Bolt Nut |
| Predicate device: | Asnis™ Micro Cannulated Screw System
from Stryker (former Howmedica) under the premarket noti-
fication K071092 (May 11, 2007) |
| Device Description: | Cannulated Screws are used for fixation of bone frag-
ments, i.e., for treatment of bone fractures and other bone
injuries. Cannulated Screws with a diameter of 2.0 mm are
manly in use for foot and hand surgery.
The aap Cannulated Screw 2.0 consists of:
• Cannulated Screw 2.0, Long thread
• Cannulated Screw 2.0, Short thread
• Washer
• Set of Instruments Cannulated Screws |
| Material: | Implants made of Ti6Al4V (ASTM F136 or ISO 5832-3) or
Implants made of stainless steel (ASTM F138
or ISO 5832-1) |
| Indications: | The aap Cannulated Screw 2.0 is intended for fracture fixa-
tion of small and long bones and of the pelvis. The system
is not intended for spinal use. |
| Substantial Equivalence | The Substantial Equivalence of the new device and the
predicate device is based on similar intended use, design,
functionality, components and materials in use.
Documentation including mechanical testing to show the
substantial equivalence and safety and effectiveness has
been provided with this submission. |
1
oop Implantate AG aap Cannulated Screw 2.0
Performance Data (Non-Clinical and / or Clinical):
Non-clinical tests have been performed and show the effectiveness and safety of the device.
Summary of Non-clinical tests:
Type of test: Mechanical tests of Screws acc. to ASTM F543-07
Assessment of test results: The Screws fulfil the relevant requirements of ASTM F543-07 and pre-defined acceptance criteria and intended uses.
Documentation regarding the mechanical testing to show the substantial equivalence and safety and effectiveness has been provided with this submission.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 22, 2013
aap Implantate AG % Dr. Christian Zietsch Manager RA Lorenzweg 5 D-12099 Berlin Germany
Re: K130590
Trade/Device Name: aap Cannulated Screw 2.0 Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, HTN Dated: February 28, 2013 Received: March 14, 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, 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Dr. Christian Zietsch
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/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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Image /page/3/Picture/6 description: The image shows the name "Erin DKeith" in a stylized font. The letters "E", "r", "i", and "n" are in a simple, bold font. The letters "D", "K", "e", "i", "t", and "h" are in a more complex font with lines and shapes.
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
aap Implantate AG aap Cannulated Screw 2.0
Indications for Use Statement
510(k) Number (if known): K130590
Device Name: aap Cannulated Screw 2.0
Indications for Use:
The aap Cannulated Screw 2.0 is intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.
Prescription Use × (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
Elizabeth @ Frank -S
Division of Orthopedic Devices