(58 days)
ANSI AAMI ISO 17665-1
No
The device description and intended use clearly define it as a set of trauma implants (bone plates and screws) for internal fixation of bone fractures. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML. The performance studies focus on biocompatibility, sterilization, and mechanical testing, not algorithmic performance.
No.
The device is a trauma implant (bone plates and screws) used for internal fixation of bone fragments after fractures or injuries, rather than for therapeutic treatment.
No
The device is described as trauma implants (bone plates and screws) used for internal fixation of bone fragments after fractures or other bone injuries, which is a therapeutic function rather than a diagnostic one.
No
The device description explicitly states that the components are "trauma implants, bone plates and screws, which are implanted into the human body". This indicates a physical hardware device, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is intended for the internal fixation of bone fragments after fractures, osteotomies, and non-unions of the distal humerus and olecranon. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as "trauma implants, bone plates and screws, which are implanted into the human body". This clearly indicates an implantable medical device used for structural support and fixation within the body.
- IVD Definition: In vitro diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on samples.
The information provided consistently describes a surgical implant, not a device used for in vitro testing.
N/A
Intended Use / Indications for Use
The LOQTEQ® VA Elbow Plates 2.7/3.5 includes the LOQTEQ® VA Distal Medial Humerus Plate 2.7/3.5, LOQTEQ® VA Distal Dorsolateral Humerus Plate 2.7/3.5, LOQTEQ® VA Distal Lateral Humerus Plate 2.7/3.5 and LOQTEQ® VA Olecranon Plate 2.7/3.5.
LOQTEQ® VA Distal Medial Humerus Plate 2.7/3.5, LOQTEQ® VA Distal Dorsolateral Humerus Plate 2.7/3.5, LOQTEQ® VA Distal Lateral Humerus Plate 2.7/3.5 are indicated for:
- Intra-articular fractures of the distal humerus
- Supracondylar fractures of the distal humerus
- Osteotomies, and non-unions of the distal humerus
LOQTEQ® VA Olecranon Plate 2.7/3.5 is indicated for:
- Fixation of fractures, osteotomies and non-unions of the olecranon, particularly in osteopenic bone
Product codes
HRS
Device Description
The components of the LOQTEQ VA Elbow Plates 2.7/3.5 are trauma implants, bone plates and screws, which are implanted into the human body to achieve an internal fixation of bone fragments, typically after fractures or other bone injuries (e.g., joint reconstruction). LOQTEQ plates function according to the fixateur interne principle, i.e., they incorporate an angular stable plate-screw connection as a result of screwing threaded screw heads into threaded plate holes. Conventional bone screws can be used in all plate holes and allow for off-axis angulation up to 15° inside threaded plate holes. After fracture healing, the implants (plates and screws) are to be removed.
The shape of the bone plates is adapted to the anatomy of and the biomechanical stress on the distal humerus and the olecranon (ulna), respectively.
The LOQTEQ VA Elbow Plates 2.7/3.5 consists of the LOQTEQ VA Distal Dorsolateral Humerus Plate, LOQTEQ VA Distal Lateral Humerus Plate, LOQTEQ VA Distal Medial Humerus Plate and the LOQTEQ VA Olecranon Plate 2.7/3.5.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal humerus and the olecranon (ulna)
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 testing data submitted, referenced, or relied upon to demonstrate substantial equivalence to from predicate devices K132787, K140607, and K161696 included biocompatibility and validation of the recommended end-user moist heat sterilization cycle according to ANSI AAMI ISO 17665-1 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices. Mechanical testing against the predicate device K120717 was completed. Clinical data were not submitted in this premarket notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K132787, K140607, K161696, K120717
Reference Device(s)
ANSI AAMI ISO 17665-1
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
March 17, 2023
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aap Implantate AG % Melissa Burbage Senior Regulatory Specialist PaxMed International. LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K230141
Trade/Device Name: LOQTEQ® VA Elbow Plates 2.7/3.5 System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS Dated: November 18, 2022 Received: January 18, 2023
Dear Melissa Burbage:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows the name "Shumaya Ali-S" in a large, clear font. The text is horizontally oriented and appears to be the main subject of the image. The background is plain and does not distract from the text.
Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230141
Device Name
LOQTEO® VA Elbow Plates 2.7/3.5
Indications for Use (Describe)
The LOQTEQ® VA Elbow Plates 2.7/3.5 includes the LOQTEQ® VA Distal Medial Humerus Plate 2.7/3.5, LOQTEO® VA Distal Dorsolateral Humerus Plate 2.7/3.5, LOQTEQ® VA Distal Lateral Humerus Plate 2.7/3.5 and LOQTEQ® VA Olecranon Plate 2.7/3.5.
LOQTEQ® VA Distal Medial Humerus Plate 2.7/3.5, LOQTEQ® VA Distal Dorsolateral Humerus Plate 2.7/3.5, LOQTEQ® VA Distal Lateral Humerus Plate 2.7/3.5 are indicated for:
- Intra-articular fractures of the distal humerus
· Supracondylar fractures of the distal humerus
· Osteotomies, and non-unions of the distal humerus
LOQTEQ® VA Olecranon Plate 2.7/3.5 is indicated for:
· Fixation of fractures, osteotomies and non-unions of the olecranon, particularly in osteopenic bone
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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FORM FDA 3881 (6/20)
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510(k) Summary
K230141
LOQTEQ® VA Elbow Plates 2.7/3.5
aap Implantate AG
March 17, 2022
ADMINISTRATIVE INFORMATION
| Manufacturer Name | aap Implantate AG | |
|---|---|---|
| Lorenzweg 5 | ||
| 12099 Berlin Germany | ||
| Telephone: | +49 30 750 19 129 | |
| Fax: | +49 30 750 19 111 | |
| Official Contact | Agnieszka Mierzejewska, Chief Operating Officer | |
| Representative/Consultant | Melissa Burbage | |
| Kevin A. Thomas, PhD; Floyd G. Larson, MS, MBA | ||
| PaxMed International, LLC | ||
| 12264 El Camino Real, Suite 400 | ||
| San Diego, CA 92130 | ||
| Telephone: | +1 858-792-1235 | |
| Fax: | +1 858-792-1236 | |
| Email: | mburbage@paxmed.com | |
| kthomas@paxmed.com; flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Device Name | LOQTEQ® VA Elbow Plates 2.7/3.5 |
|---|---|
| Common Name | Plate, Fixation, Bone |
| Regulation Number | 21 CFR 888.3030 |
| Regulation Name | Single/multiple component metallic bone fixation appliances and accessories |
| Regulatory Class | Class II |
| Product Code | HRS |
| Classification Panel | Orthopedic |
| Reviewing Division | Office of Orthopedic Devices (OHT6), Division of Restorative, Repair and Trauma Devices (DHT6C) Stereotaxic, Bone Growth Stimulators and Fracture Fixation Devices Team |
PREDICATE DEVICE INFORMATION
Primary Predicate Device K132787, aap LOQTEQ® Elbow System, aap Implantate AG
Additional Predicate Devices K140607, aap LOQTEQ® Olecranon Plate, aap Implantate AG K161696, aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5, aap Implantate AG K120717, Synthes Variable Angle LCP Elbow System, Synthes
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INDICATIONS FOR USE STATEMENT
The LOQTEQ® VA Elbow Plates 2.7/3.5 includes the LOQTEQ® VA Distal Medial Humerus Plate 2.7/3.5, LOQTEQ® VA Distal Dorsolateral Humerus Plate 2.7/3.5, LOQTEQ® VA Distal Lateral Humerus Plate 2.7/3.5 and LOOTEO® VA Olecranon Plate 2.7/3.5.
LOQTEQ® VA Distal Medial Humerus Plate 2.7/3.5, LOQTEQ® VA Distal Dorsolateral Humerus Plate 2.7/3.5, LOQTEQ® VA Distal Lateral Humerus Plate 2.7/3.5 are indicated for:
• Intra-articular fractures of the distal humerus
· Supracondylar fractures of the distal humerus
· Osteotomies, and non-unions of the distal humerus
LOQTEO® VA Olecranon Plate 2.7/3.5 is indicated for:
· Fixation of fractures, osteotomies and non-unions of the olecranon, particularly in osteopenic bone
SUBJECT DEVICE DESCRIPTION
The components of the LOOTEO VA Elbow Plates 2.7/3.5 are trauma implants, bone plates and screws, which are implanted into the human body to achieve an internal fixation of bone fragments, typically after fractures or other bone injuries (e.g., joint reconstruction). LOQTEQ plates function according to the fixateur interne principle, i.e., they incorporate an angular stable plate-screw connection as a result of screwing threaded screw heads into threaded plate holes. Conventional bone screws can be used in all plate holes and allow for off-axis angulation up to 15° inside threaded plate holes. After fracture healing, the implants (plates and screws) are to be removed.
The shape of the bone plates is adapted to the anatomy of and the biomechanical stress on the distal humerus and the olecranon (ulna), respectively.
The LOQTEQ VA Elbow Plates 2.7/3.5 consists of the LOQTEQ VA Distal Dorsolateral Humerus Plate, LOQTEQ VA Distal Lateral Humerus Plate, LOQTEQ VA Distal Medial Humerus Plate and the LOQTEQ VA Olecranon Plate 2.7/3.5.
PERFORMANCE DATA
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence to from predicate devices K132787, K140607, and K161696 included biocompatibility and validation of the recommended end-user moist heat sterilization cycle according to ANSI AAMI ISO 17665-1 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices. Mechanical testing against the predicate device K120717 was completed. Clinical data were not submitted in this premarket notification.
EQUIVALENCE TO MARKETED DEVICES
The subject device, predicate devices K132787, K140607, K161696, and K120717 have the same technological characteristics and use the same operating principles for bone fixation. The plate
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design and dimensions are the same as predicate devices K132787, K140607, and K161696. Slight modifications have been made to the plates to accommodate the variable angle feature that is similar to the predicate device K120717.
The subject devices are compatible with aap locking and non-locking screws previously cleared with predicate devices K132787, K140607, and K161696.
CONCLUSION
The subject devices, the primary predicate device, and the additional predicate device have the same intended use and similar technological characteristics. They encompass a similar range of physical dimensions, are manufactured from the same materials, and are to be sterilized using identical methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.