(84 days)
Not Found
No
The device description and performance studies focus on mechanical properties and traditional surgical implants, with no mention of AI/ML terms or functionalities.
Yes.
The device is used for the fixation of fractures and osteotomies of the distal radius, which directly treats and alleviates a medical condition.
No
Explanation: The device description and intended use clearly state that it is a set of bone plates and screws for the fixation of bone fragments in fractures and osteotomies. This is a therapeutic function, not a diagnostic one.
No
The device description explicitly lists physical components such as bone plates, screws, and a set of instruments, which are hardware implants and surgical tools.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of intra- and extra-articular fractures and osteotomies of the distal radius." This is a surgical procedure to repair bone, not a diagnostic test performed on biological samples.
- Device Description: The device consists of "Bone plates and screws" which are described as "implants" used for "fixation of bone fragments." This is consistent with surgical implants, not diagnostic tools.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health status.
In summary, the aap Radius Set 2.5 is a surgical implant used for bone repair, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The aap Radius Set 2.5 is indicated for the fixation of intra- and extra-articular fractures and osteotomies of the distal radius.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
Bone plates and screws are used for fixation of bone fragments, i.e., for treatment of bone fractures and other bone injuries. Bone plates are fixed by the use of bone screws. Bone plates and bone screws are implants. If the plates are used in conjunction with locking screws, a so called internal fixator will be realized (internal fixation).
The aap Radius Set 2.5 consists of:
- Extra-art. Radius Plate WSP 2.5, (left and right version)
- Juxta-art. Radius Plate WSP 2.5, (left and right version)
- L-Plate WSP 2.5, (left and right version)
- Straight Plate WSP 2.5
- T-Plate WSP 2.5
- Cortical Screw WS 2.5, self-tapping (locking bone screw)
- Cortical Screw 2.5, self-tapping
- Set of Instruments, Radius Set 2.5
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius
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:
Fatigue implant tests with progressive loadings, representing worst case scenario with respect to clinical use. Mechanical tests of Screws acc. to ASTM F543-07
Assessment of test results:
Substantial equivalence with respect to the mechanical performance of the aap system could be stated due to the test results gained. The subject device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses.
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
oop Implantate AG aap Radius Set 2.5
K123875 Page 1 of 2
:
Summary of Safety and Effectiveness
MAR 1 1 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 | December/13/2012 |
| Trade Name: | aap Radius Set 2.5 |
| Common Name: | Radius Set 2.5 |
| 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 fixation fas-
tener - Class II |
| Device Product Code and
Panel Code: | Orthopedics/87/ HRS: Plate, Fixation, Bone
Orthopedics/87/ HWC: Screw, Fixation, Bone |
| Predicate device: | Synthes Locking Distal Radius Plating System, Synthes (USA)
with premarket notification no. K012114 (SEP 28, 2001). |
| Device Description: | Bone plates and screws are used for fixation of bone fragments,
i.e., for treatment of bone fractures and other bone injuries.
Bone plates are fixed by the use of bone screws. Bone plates
and bone screws are implants. If the plates are used in conjunc-
tion with locking screws, a so called internal fixator will be real-
ized (internal fixation).
The aap Radius Set 2.5 consists of: Extra-art. Radius Plate WSP 2.5, (left and right version)Juxta-art. Radius Plate WSP 2.5, (left and right version)L-Plate WSP 2.5, (left and right version)Straight Plate WSP 2.5T-Plate WSP 2.5Cortical Screw WS 2.5, self-tapping (locking bone screw)Cortical Screw 2.5, self-tappingSet of Instruments, Radius Set 2.5 |
| Material: | Plates are made of cp Titanium (ASTM F67 or ISO 5832-2).
Screws are made of Ti6Al4V (ASTM F136 or ISO 5832-3) |
| Indications: | The aap Radius Set 2.5 is indicated for the fixation of intra- and
extra-articular fractures and osteotomies of the distal radius. |
-- ·
1
aap Implantate AG aop LOQTEQ® Distal Lateral Femur Plate 4.5 System
Page 2 of 2
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.
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:
Fatigue implant tests with progressive loadings, representing worst case scenario with respect to clinical use. Mechanical tests of Screws acc. to ASTM F543-07
Assessment of test results:
Substantial equivalence with respect to the mechanical performance of the aap system could be stated due to the test results gained. The subject device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses.
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
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 11, 2013
aap Implantate AG % Dr. Christian Zietsch Manager Regulatory Affairs Lorenzweg 5 Berlin Germany 12099
Re: K123875
Trade/Device Name: aap Radius Set 2.5 Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and
accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: December 13, 2012 Received: December 17, 2012
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. Iisting 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
3
Page 2 - Dr. Christian Zietsch
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 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/Safetv/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/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 "Erin" and "eith" are in a solid black font. The letters "D" and "K" are in a more decorative font with multiple lines.
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
aap Implantate AG aap Radius Set 2.5
Indications for Use Statement
K123875 510(k) Number (if known):
Device Name: aap Radius Set 2.5
Indications for Use:
The aap Radius Set 2.5 is indicated for the fixation of intra- and extra-articular fractures and osteotomies of the distal radius.
. ..
Prescription Use x (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 1
Elizabeth L. Frank -S
Divison of Orthopedic Devices