(94 days)
Not Found
No
The summary describes a mechanical bone plate and screw system for fracture fixation. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on mechanical testing.
Yes
The device is described as an internal fixation system for complex fractures and osteotomies of the distal radius and ulna, which are therapeutic interventions.
No
The device, consisting of bone plates and screws, is intended for mechanical fixation of bone fragments after fractures or osteotomies, rather than for diagnosing medical conditions.
No
The device description explicitly states that the device consists of bone plates and bone screws, which are physical hardware components intended for surgical implantation.
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 bone fractures and osteotomies. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of bone plates and screws, which are implanted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support and fixation.
N/A
Intended Use / Indications for Use
LOQTEQ® VA Volar Distal Radius Plate 2.5, LOQTEQ® VA Distal Radius Straight Plate 2.5, LOQTEQ® VA Distal Radius L-Plate 2.5
· Fixation of complex intra-articular and extra-articular fractures and osteotomies of the distal radius
LOQTEQ® VA Distal Ulna Plate 2.5, LOQTEQ® VA Distal Ulna Hook Plate 2.5
• Fractures and osteotomies of the distal ulna
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The aap LOQTEQ® VA Radius Set 2.5 consists of bone plates and bone screws, to be implanted by a surgeon in order to achieve an internal fixation of bone fragments typically after fractures, osteotomies. If the plates are used in conjunction with locking screws, a so called internal fixator will be realized (internal fixation).
The aap LOQTEQ® VA Radius Set 2.5 incorporates:
- LOQTEQ® VA Volar Distal Radius Plate 2.5, narrow/broad, right/left
- LOQTEQ® VA Volar Distal Radius Plate 2.5, narrow, XL, right/left
- LOQTEQ® VA Distal Radius Straight Plate 2.5
- LOQTEQ® VA Distal Radius L-Plate 2.5, right/left
- LOQTEQ® VA Distal Ulna Plate 2.5
- LOQTEQ® VA Distal Ulna Hook Plate 2.5
- LOQTEQ® VA Cortical Screw 2.5, T8
- Cortical Screw 2.5, small head, T8, self-tapping
- Set of Instruments LOQTEQ® VA Distal Radius Set 2.5
Material: Ti6Al4V (ASTM F136 or ISO 5832-3) unalloyed Titanium (ASTM F67 or ISO 5832-2)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius, distal ulna
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: Static and dynamic system tests, representing worst case scenario with respect to clinical use. Screw tests according to ASTM F543 – 13.
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 screws fulfil the relevant demands of ASTM F543-13. The subject device is safe and effective, and whose performance meets the requirements of its 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.
K102694, K070946, K083694, K103332
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
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 21, 2016
aap Implantate Ag Dr. Christian Zietsch Director Quality Assurance and Regulatory Affairs Lorenzweg 5 Berlin, D-12099 GERMANY
Re: K153034 Trade/Device Name: aap LOQTEQ® VA 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: October 20, 2015 Received: October 23, 2015
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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/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 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 yours,
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K153034
Device Name aap LOOTEO® VA Radius Set 2.5
Indications for Use (Describe)
LOQTEQ® VA Volar Distal Radius Plate 2.5, LOQTEQ® VA Distal Radius Straight Plate 2.5,
LOQTEQ® VA Distal Radius L-Plate 2.5
· Fixation of complex intra-articular and extra-articular fractures and osteotomies of the distal radius
LOQTEQ® VA Distal Ulna Plate 2.5,
LOQTEQ® VA Distal Ulna Hook Plate 2.5
• Fractures and osteotomies of the distal ulna
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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5. 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 | Jan/21/2016 |
| Trade Name: | aap LOQTEQ® VA Radius Set 2.5 |
| Common Name: | Variable Angle Distal Radius/Ulna Plates and Screws 2.5 |
| Classification Name and
Reference: | 21 CFR 888.3030 Single/multiple component metallic bone
fixation appliances and accessories - Class II
21 CFR 888.3040 Smooth or threaded metallic bone fixa-
tion fastener - Class II |
| Device Product
Code
and Panel Code: | Orthopedics/87/HRS
Orthopedics/87/HWC |
| Predicate devices | Synthes (USA) Variable Angle LCP Dorsal Distal Radius
System under the premarket notification K102694 (Dec 09,
2010)
Synthes (USA) LCP Diaphyeal-Metaphyseal (Dia-Meta)
Volar Distal Radius Plate under the premarket notification
K070946 (Jun 06, 2007)
Synthes (USA) VA LCP Two-Column Volar Distal Radius
Plates under the premarket notification K083694 (MAR 06,
2009)
Medartis AG APTUS Ulna Plates under the premarket noti-
fication K103332 (Jan 24, 2011). |
| Device Description: | The aap LOQTEQ® VA Radius Set 2.5 consists of bone
plates and bone screws, to be implanted by a surgeon in
order to achieve an internal fixation of bone fragments typi-
cally after fractures, osteotomies. If the plates are used in
conjunction with locking screws, a so called internal fixator
will be realized (internal fixation). |
4
The aap LOQTEQ® VA Radius Set 2.5 incorporates:
| LOQTEQ® VA Volar Distal Radius Plate 2.5, narrow/broad, right/leftLOQTEQ® VA Volar Distal Radius Plate 2.5, narrow, XL, right/leftLOQTEQ® VA Distal Radius Straight Plate 2.5LOQTEQ® VA Distal Radius L-Plate 2.5, right/leftLOQTEQ® VA Distal Ulna Plate 2.5LOQTEQ® VA Distal Ulna Hook Plate 2.5LOQTEQ® VA Cortical Screw 2.5, T8Cortical Screw 2.5, small head, T8, self-tappingSet of Instruments LOQTEQ® VA Distal Radius Set 2.5 | |
|---|---|
| Material: | Ti6Al4V (ASTM F136 or ISO 5832-3) unalloyed Titanium (ASTM F67 or ISO 5832-2) |
| Indications: | The aap LOQTEQ® VA Volar Distal Radius Plate 2.5, LO- QTEQ® VA Distal Radius Straight Plate 2.5, LOQTEQ® VA Distal Radius L-Plate 2.5 are intended for fixation of complex intra-articular and extra-articular fractures and osteotomies of the distal radius . The aap LOQTEQ® VA Distal Ulna Plate 2.5, LOQTEQ® VA Distal Ulna Hook Plate 2.5 are intended for fractures and osteotomies of the distal ulna . |
| 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 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 : Static and dynamic system tests, representing worst case scenario with respect to clinical use. Screw tests according to ASTM F543 – 13. 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 screws fulfil the relevant demands of ASTM F543-13. The subject device is safe and effective, and whose performance meets the requirements of its 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. |