K Number
K141823
Device Name
AAP LOQTEC CLAVICLE PLATES 2.7/3.5
Manufacturer
Date Cleared
2014-08-07

(31 days)

Product Code
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The aap LOQTEQ® Clavicle Shaft Plate and aap LOQTEQ® Superior Lateral Clavicle Plate are intended for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle. The aap LOQTEQ® AcroPlate is intended for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.
Device Description
The aap LOQTEQ® Clavicle Plates 2.7/3.5 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® Clavicle Plates 2.7/3.5 incorporate: • LOQTEQ® Clavicle Shaft Plate (left and right) • LOQTEQ® Superior Lateral Clavicle Plate (left and right) • LOQTEQ® AcroPlate 3.5 (left and right) to be used with • LOQTEQ® Cortical Screw 3.5, small head, T15, self-tapping • LOQTEQ® Cortical Screw 2.7, small head, T8, self-tapping • Cortical Screw 2.5, small head,T8, self-tapping • Cortical Screw 3.5, small head, self tapping • Set of Instruments aap LOQTEQ® Clavicle Plates 2.7/3.5
More Information

Not Found

No
The device description and performance studies focus solely on the mechanical properties and intended use of bone plates and screws for fracture fixation. There is no mention of any software, algorithms, or data processing that would indicate the presence of AI or ML.

Yes
The device is intended for the fixation of fractures, malunions, non-unions, and osteotomies of the clavicle, which are medical conditions that require treatment. Its purpose is to achieve internal fixation of bone fragments, directly contributing to healing and restoring function, thus qualifying it as a therapeutic device.

No

This device is an implantable plate and screw system intended for internal fixation of bone fragments, typically after fractures or osteotomies. It is a treatment device, not one that identifies or characterizes a disease or 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:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
  • Device Description: The provided text clearly describes a device that is implanted into the body to fix bones. It consists of plates and screws used in surgical procedures.
  • Intended Use: The intended use is for the "fixation of fractures, malunions, non-unions, and osteotomies of the clavicle." This is a surgical intervention, not a diagnostic test performed on a specimen.

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

N/A

Intended Use / Indications for Use

The aap LOQTEQ® Clavicle Shaft Plate and aap LOQTEQ® Superior Lateral Clavicle Plate are intended for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle.

The aap LOQTEQ® AcroPlate is intended for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.

Product codes

HRS

Device Description

The aap LOQTEQ® Clavicle Plates 2.7/3.5 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® Clavicle Plates 2.7/3.5 incorporate:
• LOQTEQ® Clavicle Shaft Plate (left and right)
• LOQTEQ® Superior Lateral Clavicle Plate (left and right)
• LOQTEQ® AcroPlate 3.5 (left and right)
to be used with
• LOQTEQ® Cortical Screw 3.5, small head, T15, self-tapping
• LOQTEQ® Cortical Screw 2.7, small head, T8, self-tapping
• Cortical Screw 2.5, small head,T8, self-tapping
• Cortical Screw 3.5, small head, self tapping

• Set of Instruments aap LOQTEQ® Clavicle Plates 2.7/3.5

Material:

Implants are made of Ti6Al4V (ASTM F136 or ISO 5832-3)

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Clavicle

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: Customized 4-point-bending tests of bone plates, based on ASTM F382-99

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.

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

Not Found

Predicate Device(s)

K073186, K061753

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are oriented to the right and are depicted in a simple, line-art style. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

August 7, 2014

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

Re: K141823

Trade/Device Name: aap LOOTEO® Clavicle Plates 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 Dated: June 25, 2014 Received: July 7, 2014

Dear Dr. Christian 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

1

Page 2 – Dr. Christian Zietsch

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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/Resourcesfor You/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

for

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

Enclosure

2

Indications for Use Statement

510(k) Number (if known): K141823

Device Name: aap LOQTEQ® Clavicle Plates 2.7/3.5

Indications for Use:

The aap LOQTEQ® Clavicle Shaft Plate and aap LOQTEQ® Superior Lateral Clavicle Plate are intended for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle.

The aap LOQTEQ® AcroPlate is intended for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.

× Prescription Use Prescription Use

VOR Over-The
(21 CFR

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)

Elizabethīb%rank -S

Division of Orthopedic Devices

3

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 | June/20/ 2014 |
| Trade Name: | aap LOQTEQ® Clavicle Plates 2.7/3.5 |
| Common Name: | Clavicle Plates 2.7/3.5 |
| Classification Name and
Reference: | 21 CFR 888.3030 Single/multiple component metallic
bone fixation appliances and accessories – Class II |
| Device Product Code and
Panel Code: | Orthopedics/87/ HRS |
| Predicate device: | The aap LOQTEQ® Clavicle Plates 2.7/3.5 are substantial-
ly equivalent to Synthes (USA) 3.5 mm LCP Clavicle Plate
System under the premarket notification K073186 (Dec 17,
2007) and Synthes (USA) Clavicle Hook Plate under the
premarket notification K061753 (Aug 04, 2008). |
| Device Description: | The aap LOQTEQ® Clavicle Plates 2.7/3.5 consists of
bone plates and bone screws, to be implanted by a sur-
geon in order to achieve an internal fixation of bone frag-
ments typically after fractures, osteotomies. If the plates
are used in conjunction with locking screws, a so called in-
ternal fixator will be realized (internal fixation).
The aap LOQTEQ® Clavicle Plates 2.7/3.5 incorporate:
• LOQTEQ® Clavicle Shaft Plate (left and right)
• LOQTEQ® Superior Lateral Clavicle Plate (left and
right)
• LOQTEQ® AcroPlate 3.5 (left and right)
to be used with
• LOQTEQ® Cortical Screw 3.5, small head, T15,
self-tapping
• LOQTEQ® Cortical Screw 2.7, small head, T8, self-
tapping
• Cortical Screw 2.5, small head,T8, self-tapping
• Cortical Screw 3.5, small head, self tapping

• Set of Instruments aap LOQTEQ® Clavicle Plates
2.7/3.5 |

Material:

Implants are made of Ti6Al4V (ASTM F136 or ISO 5832-3)

4

Indications:The aap LOQTEQ® Clavicle Shaft Plate and aap LOQTEQ® Superior Lateral Clavicle Plate are intended for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle. The aap LOQTEQ® AcroPlate is intended for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.
Substantial EquivalenceThe 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: Customized 4-point-bending tests of bone plates, based on ASTM F382-99
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.