K Number
K140607
Device Name
AAP LOQTEC(R) OLECRANON PLATE
Manufacturer
Date Cleared
2014-05-08

(59 days)

Product Code
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The aap LOQTEQ® Olecranon Plates are indicated for fixation of fractures, osteotomies and nonunions of the olecranon, particularly in osteopenic bone.
Device Description
The aap LOQTEQ® Olecranon Plate 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. If the plates are used in conjunction with locking screws, a so called internal fixator will be realized (internal fixation). The aap LOQTEQ® Olecranon Plate System consists of: • LOQTEQ® Olecranon Plate (left and right) to be used with • LOQTEQ® Cortical Screw 2.7, small head T8, self-tapping • Cortical Screw 2.5, small head T8, self-tapping • LOQTEQ® Cortical Screw 3.5, T15, self-tapping • Cortical Screw 3.5, self-tapping • Set of Instruments aap LOQTEQ® Olecranon Plate
More Information

No
The description focuses on mechanical components (plates and screws) for bone fixation and does not mention any software, algorithms, or data processing capabilities indicative of AI/ML.

Yes
The device is described as an internal fixation system for fractures, osteotomies, and nonunions of the olecranon, which are conditions that impair normal bodily function. The plates and screws are implanted to stabilize bone fragments, directly treating the injury.

No

This device is described as an implantable system of bone plates and screws for the fixation of fractures, osteotomies, and nonunions. Its purpose is to physically stabilize bone fragments, not to diagnose a condition.

No

The device description explicitly states it consists of bone plates and bone screws, which are physical hardware components intended for surgical implantation.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for the "fixation of fractures, osteotomies and nonunions of the olecranon". This describes a surgical procedure to repair bone, not a test performed on a sample taken from the body to diagnose a condition.
  • Device Description: The device consists of "bone plates and bone screws, to be implanted by a surgeon". This is a description of a surgical implant, not a diagnostic test kit or instrument.
  • IVD Definition: In Vitro Diagnostics are tests performed on samples (like blood, urine, tissue) taken from the human body to provide information about a person's health. This device does not perform such tests.

The device described is a surgical implant used for internal fixation of bone fractures.

N/A

Intended Use / Indications for Use

The aap LOQTEQ® Olecranon Plates are indicated for fixation of fractures, osteotomies and nonunions of the olecranon, particularly in osteopenic bone.

Product codes

HRS

Device Description

The aap LOQTEQ® Olecranon Plate 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. If the plates are used in conjunction with locking screws, a so called internal fixator will be realized (internal fixation).

The aap LOQTEQ® Olecranon Plate System consists of:
• LOQTEQ® Olecranon Plate (left and right)
to be used with
• LOQTEQ® Cortical Screw 2.7, small head T8, self-tapping
• Cortical Screw 2.5, small head T8, self-tapping
• LOQTEQ® Cortical Screw 3.5, T15, self-tapping
• Cortical Screw 3.5, self-tapping
• Set of Instruments aap LOQTEQ® Olecranon Plate

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

olecranon

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.

Non-clinical tests: Customized 4-point bending tests of bone plates, based on ASTM F382-99 (static and dynamic).

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 substantial equivalent, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K082807, K000684

Reference Device(s)

Not Found

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

Summary of Safety and Effectiveness

MAY 0 8 2014

| 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 | February 26 / 2013 |
| Trade Name: | aap LOQTEQ® Olecranon Plate |
| Common Name: | Olecranon Plate |
| Classification Name and
Reference: | 21 CFR 888.3030 Single/multiple component metallic
bone fixation appliances and accessories - Class II |
| Product Code | HRS |
| Predicate device: | Synthes (USA) 3.5mm LCP Olecranon Plates, as part of
the 3.5 / 4.5 mm LCP System under the premarket notifica-
tion K082807 (Jan 13, 2009) and Synthes (USA) Small
Fragment Dynamic Compression Locking (DCL) System
under the premarket notification K000684 (Apr 28, 2000) |
| Device Description: | The aap LOQTEQ® Olecranon Plate 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. If the plates are used in conjunction
with locking screws, a so called internal fixator will be real-
ized (internal fixation). |
| | The aap LOQTEQ® Olecranon Plate System consists of:
• LOQTEQ® Olecranon Plate (left and right)
to be used with
• LOQTEQ® Cortical Screw 2.7, small head T8,
self-tapping
• Cortical Screw 2.5, small head T8, self-tapping
• LOQTEQ® Cortical Screw 3.5, T15, self-tapping
• Cortical Screw 3.5, self-tapping
• Set of Instruments aap LOQTEQ® Olecranon Plate |
| Material: | Implants are made of Ti6Al4V (ASTM F136 or ISO 5832-3) |
| Indications: | The aap LOQTEQ® Olecranon Plates are indicated for
fixation of fractures, osteotomies and nonunions of the
olecranon, particularly in osteopenic bone. |
| 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 sub-
mission. |
| Performance Data
(Non-Clinical and /
or Clinical): | Non-clinical tests have been performed and show
the substantial equivalence of the device. |

1

Summary of Non-clinical tests:

Type of test:

Customized 4-point bending tests of bone plates, based on ASTM F382-99 (static and dynamic)

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 substantial equivalent, 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 has been provided with this submission.

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in bold, black font. The text is stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The background of the image is white.

ood and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 8, 2014

aap Implantate AG Dr. Christian Zietsch Manager Regulatory Affairs Lorenzweg 5 12099 Berlin Germany

Re: K140607

Trade/Device Name: aap LOQTEQ® Olecranon Plate 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: February 28, 2014 Received: March 10, 2014

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

3

Page 2 - Dr. Christian Zietsch

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 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/MedicalDeyices/Safety/ReportalProblem/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.hum.

Sincerely yours.

Lori A. Wiggins

  • for
    Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

Page 1 of 1

Indications for Use Statement

510(k) Number (if known): K140607

Device Name: aap LOQTEQ® Olecranon Plate

Indications for Use:

The aap LOQTEQ® Olecranon Plates are indicated for fixation of fractures, osteotomies and nonunions of the olecranon, particularly in osteopenic bone.

Prescription Use × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

Elizabeth=D&Frank -S

Division of Orthopedic Devices