(56 days)
Not Found
No
The device description and performance studies focus solely on the mechanical properties and intended use of bone screws for fracture fixation, with no mention of AI or ML capabilities.
Yes
The device is intended to treat fractures by providing internal fixation of bone fragments, which is a therapeutic function.
No
Explanation: The device is described as a bone screw intended for internal fixation of bone fragments after fractures or osteotomies, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states that the device is a bone screw made of Titanium alloy, which is a physical implantable hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "treat fractures of various bones" by providing "internal fixation of bone fragments." This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is described as "bone screws, to be implanted by a surgeon." This confirms it's an implantable medical device used in surgery.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform any such tests.
The device is clearly an implantable surgical device used for orthopedic fixation.
N/A
Intended Use / Indications for Use
The devices are intended to treat fractures of various bones, including the clavicle, scapula, pelvis, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, and phalanges) according to the standard of the AO Foundation (AO Principles of Fracture Management).
All aap bone screws are for single use only and are not intended for any spinal fixation procedures.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The aap Cortical Screws 3.5, 4.5 are bone screws, to be implanted by a surgeon in order to achieve an internal fixation of bone fragments typically after fractures or osteotomies. The screws can be used as non locking screws along with the aap LOQTEQ® System as well as lag screws, to hold together fragments of bone. The devices are made of Titanium alloy.
Variations of the aap Cortical Screw 3.5, 4.5:
• Cortical Screw 3.5, T15, self-tapping, Titanium
• Cortical Screw 4.5, T25, self-tapping, Titanium
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle, scapula, pelvis, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, and phalanges)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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 substantial equivalence of the device.
Summary of Non-clinical tests:
Type of test: Mechanical properties of metallic bone screws in accordance with ASTM F543
Tests performed: The Torsional Properties of Metallic Bone Screws, here Torsional Yield Strength, Maximum Torque, and Breaking Angle, the Driving Torque Properties, here Insertion and Removal Torque as well as the Axial Pullout strength of the screws have been determined according to ASTM F543 (Annex A1, A2 and A3).
Assessment of test results: Substantial equivalence with respect to the mechanical performance of the aap screws could be stated due to the test results gained. The minimum acceptable values for Maximum Torque and Breaking Angle as given in Annex A5 of ASTM F543 have been reached. The subject device is substantial equivalent, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses.
Documentation regarding the mechanical testing and technological characteristics to show the substantial equivalence 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
Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle are three stylized human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, flowing line style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 12, 2014
aan Implantate AG Dr. Christian Zietsch Manager Regulatory Affairs Lorenzweg 5 Berlin, Berlin D-12099 Germany
Re: K141949
Trade/Device Name: aap Cortical Screws 3.5, 4.5 Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: August 8, 2014 Received: August 11, 2014
Dear Dr. Christian 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
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
510(k) Number (if known): K141949
Device Name: aap Cortical Screws 3.5, 4.5
Indications for Use:
The devices are intended to treat fractures of various bones, including the clavicle, scapula, pelvis, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, and phalanges) according to the standard of the AO Foundation (AO Principles of Fracture Management).
All aap bone screws are for single use only and are not intended for any spinal fixation procedures.
AND/OR
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
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 1_
3
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 | August/08/ 2014 |
| Trade Name: | aap Cortical Screws 3.5, 4.5 |
| Common Name: | Cortical Screws 3.5, 4.5Clavicle |
| 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/ HWC |
| Predicate device: | The aap Cortical Screw 3.5, 4.5 are substantially equiva-
lent to aap Screw Implants (Cortical Screw 3.5, self-
tapping, Titanium and Cortical Screw 4.5, self-tapping, Ti-
tanium) under the premarket notification K072411 (Mar 20,
2008), aap Cortical Screw 3.5, small head , self-tapping, Ti-
tanium under the premarket notification K113652 (Aug 30,
2012) and Cortical Screw 4.5, small head, self-tapping, Ti-
tanium under the premarket notification K113648 (Sep. 6,
2012). |
| Device Description: | The aap Cortical Screws 3.5, 4.5 are bone screws, to be
implanted by a surgeon in order to achieve an internal fixa-
tion of bone fragments typically after fractures or osteoto-
mies. The screws can be used as non locking screws along
with the aap LOQTEQ® System as well as lag screws, to
hold together fragments of bone. The devices are made of
Titanium alloy. |
| | Variations of the aap Cortical Screw 3.5, 4.5: |
| | • Cortical Screw 3.5, T15, self-tapping, Titanium
• Cortical Screw 4.5, T25, self-tapping, Titanium |
| Material: | Implants are made of Ti6Al4V (ASTM F136 or ISO 5832-3) |
4
| Indications: | The devices are intended to treat fractures of various bones, including the clavicle, scapula, pelvis, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, and phalanges) according to the standard of the AO Foundation (AO Principles of Fracture Management). All aap bone screws are for single use only and are not intended for any spinal fixation procedures. |
|---|---|
| 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 and engineering analysis (dimensions and material) to show the substantial equivalence has been provided with this submission. |
| Performance Data (Non-Clinical and / or Clinical): | Non-clinical tests have been performed and show the substantial equivalence of the device. |
| Summary of Non-clinical tests: | |
| Type of test: Mechanical properties of metallic bone screws in accordance with ASTM F543 | |
| Tests performed: The Torsional Properties of Metallic Bone Screws, here Torsional Yield Strength, Maximum Torque, and Breaking Angle, the Driving Torque Properties, here Insertion and Removal Torque as well as the Axial Pullout strength of the screws have been determined according to ASTM F543 (Annex A1, A2 and A3). | |
| Assessment of test results: Substantial equivalence with respect to the mechanical performance of the aap screws could be stated due to the test results gained. The minimum acceptable values for Maximum Torque and Breaking Angle as given in Annex A5 of ASTM F543 have been reached. The subject device is substantial equivalent, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses. | |
| Documentation regarding the mechanical testing and technological characteristics to show the substantial equivalence has been provided with this submission. |