(156 days)
No
The device description focuses on the mechanical design and surgical application of a bone plate and screws, with no mention of AI or ML capabilities.
Yes
The device is described as a plate and screw system intended for internal fixation of bone after fractures, osteotomies, or non-unions, which are therapeutic interventions.
No
The device description clearly states it is an implantable plate and screw system used for internal fixation of bone after fractures, osteotomies, or non-unions. It is a treatment device, not one used for diagnosis.
No
The device description clearly states it is a bone plate and associated screws, which are physical hardware components intended for surgical implantation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for the treatment of bone fractures, osteotomies, and non-unions of the distal humerus through surgical implantation. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The description details a surgical implant (plate and screws) used for internal fixation of bone. This is a medical device used within the body, not a device used to examine specimens from the body.
- No mention of in vitro testing: The text does not mention any analysis of biological samples (blood, urine, tissue, etc.) outside of the body, which is the defining characteristic of an IVD.
Therefore, this device is a surgical implant for orthopedic use, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intra-articular fractures, supracondylar fractures, osteotomies and non-unions of the distal humerus
Product codes
HRS, HWC
Device Description
The aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 is part of the LOQTEQ® Elbow System (K132787 and K140607), to be implanted by a surgeon in order to achieve a repositioning of fragments and an internal fixation of the bone after fractures, osteotomies or non-unions. By using locking screws the plate-screw system guarantees an additional mechanical fixation and enables the application for osteopenic bones.
aap already offers a system of two plates for treatment of distal Humerus fractures: these are the anatomical shaped Plates LOQTEQ® Distal Dorsolateral Humerus Plate and LOQTEQ® Distal Medial Humerus Plate. Typically these devices are used together for one fracture and are placed under 90° orientation. The devices are already registered under the premarket notification K132787.
Depending on the surgeons education some doctors prefer to use a different placement of the two plates.
Therefore aap wants to add a further plate for the use in the identical intended use: this is the LOQTEQ® Distal Lateral Humerus Plate which is also used together with the LOQTEQ® Distal Medial Humerus Plate (see surgical approach above). In some rare indications this new device might be used as a standalone
The anatomically performed plates are available as right and left version and in different lengths and with several shaft holes. The tapered end of the plate enables tissue-conserving, submuscular insertion. The tip of the shaft is tapered to allow a minimally invasive surgical technique. The bottom of shaft area is structured and tunnelled by cross grooves to minimize bone contact.
All shaft holes, with the exception of the elongated hole are compatible with unidirectional locking screws as well as cortical screws. The use of locking screws is state of the art and is particularly important in osteoporotic bones or for stabilizing comminuted fractures. The elongated hole can be used to adjust the height as well as the initial fixation of the plate.
The round locking holes are suitable for locking screws as well as cortical screws. The locking screws allow evening catching very small fragments.
The design of the so-called glide holes allows angle stable fixation and proximal compression of bone fragments at the same time if LOQTEQ® Cortical Screws are used. The use of standard cortical bone screws leads to a non-angle stable fixation.
A compression of the bone fragments can be realised, if the screws are positioned eccentric inside the glide hole. If the screws are placed directly in the locking part of the gliding hole, no compression occurs.
The aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 consists of:
LOQTEQ® Distal Lateral Humerus Plate, right/left, 2/3/5/7/11 holes
LOQTEQ® Cortical Screw 2.7, small head, T8, self-tapping
LOQTEQ® Cortical Screw 3.5, T15, self-tapping
Cortical Screw 2.5, small head, T8, self-tapping
Cortical Screw 3.5, self-tapping
Set of Instruments aap LOQTEQ® Distal Lateral Humerus Plate
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal humerus
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)
An engineering analysis was used to show substantial equivalence of the subject device to the predicate device in terms mechanical performance, including bending strength, bending stiffness, bending structural stiffness, and fatigue strength.
The LOQTEQ®Distal Humerus Plate has passed all defined criteria, has performed as well or better than the predicate device and therefore considered substantially equivalent to the cleared predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected and appear to be flowing or merging together. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 23, 2016
aap Implantate AG Reni Schaller Manager Regulatory Affairs Lorenzweg 5 Berlin, D-12099 Germany
Re: K161696 Trade/Device Name: aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 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 16, 2016 Received: October 18, 2016
Dear Ms. Schaller:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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" (21 CFR 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5
Indications for Use (Describe)
Intra-articular fractures, supracondylar fractures, osteotomies and non-unions of the distal humerus
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(K) Traditional Premarket Notification, K161696
aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5
Section 5 510(k) Summary
5. 510(K) Summary
(as required by section 807.92)
| (as required by section 807.92) | |
|---|---|
| (1) | |
| Sponsor | aap Implantate AG |
| Lorenzweg 5 | |
| D-12099 Berlin, Germany | |
| Company Contact | Reni Schaller |
| Phone: +49-30-750-19 - 193 | |
| Fax: +49-30-750-19 – 111 | |
| Email: r.schaller@aap.de | |
| Date | November/22/2016 |
| (2) | |
| Trade Name | aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 |
| Common Name | LOQTEQ® Distal Lateral Humerus Plate |
| 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 fixation | |
| fastener – Class II | |
| Device Product Code and | |
| Panel Code | Orthopedics/87/HRS |
| Orthopedics/87/HWC | |
| (3) | |
| Predicate devices | Company Synthes (USA): |
| 3.5 MM LCP Distal Humerus System under the premarket | |
| notification K033995 | |
| (4) | |
| Device Description | The aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 is part of the |
| LOQTEQ® Elbow System (K132787 and K140607), to be implanted by | |
| a surgeon in order to achieve a repositioning of fragments and an | |
| internal fixation of the bone after fractures, osteotomies or non- | |
| unions. By using locking screws the plate-screw system guarantees | |
| an additional mechanical fixation and enables the application for | |
| osteopenic bones. | |
| aap already offers a system of two plates for treatment of distal | |
| Humerus fractures: these are the anatomical shaped Plates | |
| LOQTEQ® Distal Dorsolateral Humerus Plate and LOQTEQ® Distal | |
| Medial Humerus Plate. Typically these devices are used together for | |
| one fracture and are placed under 90° orientation. The devices are | |
| already registered under the premarket notification K132787. | |
| Depending on the surgeons education some doctors prefer to use a | |
| different placement of the two plates. | |
| Therefore aap wants to add a further plate for the use in the | |
| identical intended use: this is the LOQTEQ® Distal Lateral Humerus | |
| Plate which is also used together with the LOQTEQ® Distal Medial | |
| Humerus Plate (see surgical approach above). In some rare | |
| indications this new device might be used as a standalone | |
| The anatomically performed plates are available as right and left | |
| version and in different lengths and with several shaft holes. The | |
| tapered end of the plate enables tissue-conserving, submuscular | |
| insertion. The tip of the shaft is tapered to allow a minimally invasive | |
| surgical technique. The bottom of shaft area is structured and | |
| tunnelled by cross grooves to minimize bone contact. | |
| All shaft holes, with the exception of the elongated hole are | |
| compatible with unidirectional locking screws as well as cortical | |
| screws. The use of locking screws is state of the art and is | |
| particularly important in osteoporotic bones or for stabilizing | |
| comminuted fractures. The elongated hole can be used to adjust the | |
| height as well as the initial fixation of the plate. | |
| The round locking holes are suitable for locking screws as well as | |
| cortical screws. The locking screws allow evening catching very small | |
| fragments. | |
| The design of the so-called glide holes allows angle stable fixation | |
| and proximal compression of bone fragments at the same time if | |
| LOQTEQ® Cortical Screws are used. The use of standard cortical | |
| bone screws leads to a non-angle stable fixation. | |
| A compression of the bone fragments can be realised, if the screws | |
| are positioned eccentric inside the glide hole. If the screws are | |
| placed directly in the locking part of the gliding hole, no compression | |
| occurs. | |
| The aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 consists of: | |
| LOQTEQ® Distal Lateral Humerus Plate, right/left, 2/3/5/7/11 holes | |
| LOQTEQ® Cortical Screw 2.7, small head, T8, self-tapping | |
| LOQTEQ® Cortical Screw 3.5, T15, self-tapping | |
| Cortical Screw 2.5, small head, T8, self-tapping | |
| Cortical Screw 3.5, self-tapping | |
| Set of Instruments aap LOQTEQ® Distal Lateral Humerus Plate | |
| Material | All implants are made of Ti6Al4V |
| (according ISO 5832-3 or ASTM F136) | |
| Surface | The surface of the plates is generated by an automatic slide |
| finishing, the so-called “KeramoFinish”. Those surfaces correspond | |
| to polished surfaces. The surface of the LOQTEQ® Cortical Screws | |
| are slightly polished and anodised. The surface of the Cortical Screws | |
| are fine blasted and anodised as well. | |
| (5) | |
| Indications | aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5: |
| Intra-articular fractures, supracondylar fractures, osteotomies and | |
| non-unions of the distal humerus | |
| (6a) | |
| Technological | |
| characteristics | The LOQTEQ® Distal Lateral Humerus Plate and the legally marketed |
| predicated devices have similar indications, dimensions, geometry | |
| and materials. | |
| Comparison | The LOQTEQ® Distal Lateral Humerus Plate is technologically |
| substantially equivalent to the predicate devices according to the | |
| Decision-Making Process for 510(k)s: | |
| Predicate device is legally marketed |
4
5
(6b)
-
- The devices have the identical intended use
-
- The devices have similar technological characteristics
All characteristics which are known and are relevant for the safety for both devices are described and assessed mainly:
- 1.Indication for use statement: identical
-
- Functionality: identical
-
- Components, Materials, Dimensions of components: comparable
-
- Mechanical properties (ensured by benchmark tests) at least comparable
Documentation including mechanical testing to show the substantial equivalence has been provided with this submission.
Performance Data An engineering analysis was used to show substantial equivalence of the subject device to the predicate device in terms mechanical performance, including bending strength, bending stiffness, bending structural stiffness, and fatigue strength.
The LOQTEQ®Distal Humerus Plate has passed all defined criteria, has performed as well or better than the predicate device and therefore considered substantially equivalent to the cleared predicate device.