The APTUS® K-Wire System is intended for use in fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants.

Device Description

The subject device includes four (4) plate designs to expand the range of Medartis APTUS® Proximal Humerus Fixation devices previously cleared in K120108, and two (2) additional K-wire designs, to expand the range of Medartis APTUS® K-Wires previously cleared in K092038. The subject plates are provided in 10-hole and 14-hole designs, each in anatomic designs for the right and left proximal humerus. The subject plates range in length from approximately 180 mm (10-hole plate) to approximately 230 mm (14-hole plate). The proximal region of the subject plates is identical to the devices previously cleared in K120108. This submission includes a spiral locking blade for use with the subject plates that is similar to the spiral blades cleared in K120108. The subject plates are to be used with previously cleared 3.5 mm diameter locking screws and non-locking (cortical) screws. The subject device plates and spiral blades are made of unalloyed titanium conforming to ASTM F67.

The subject device K-wires have a diameter of 2.0 mm and an overall length of 150 mm, and are provided with a trocar tip or lancet (bayonet) tip. The subject device K-wires are also compatible with the subject plates, and with the proximal humerus plates cleared in K120108. The subject K-wires are made of stainless steel conforming to ASTM F138.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device, the APTUS® Proximal Humerus System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria based on studies involving human subjects or AI performance metrics.

Therefore, many of the requested details, such as acceptance criteria, reported device performance (in terms of sensitivity, specificity, etc.), sample sizes for test sets (for AI), number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, type of ground truth used (for AI), training set sample size, and ground truth establishment for training sets, are not applicable to this type of regulatory submission as presented in the document.

The performance data mentioned in the document are focused on non-clinical mechanical testing to demonstrate the structural integrity and equivalence of the new device components to existing predicate devices.

Here's an breakdown of the available information based on your request:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance or AI metrics. The acceptance is based on demonstrating "substantial equivalence" to predicate devices through mechanical testing and comparison of design, materials, and intended use. The implicit acceptance criterion is that the new components perform at least as well as, or are equivalent to, the predicate devices in terms of mechanical properties.
Reported Device Performance:

Performance Metric	Subject Device Performance (Demonstrated Equivalence)
Biocompatibility	Equivalent to K120108 and K092038 (due to identical materials and processing)
Mechanical Testing	Substantially equivalent to K120108 and K041860 (based on ASTM F382)
Out-of-plane bending moments of inertia	Calculations demonstrated equivalence to predicate devices
Comparative Dynamic Testing (in simulated fracture model)	Substantially equivalent to K120108 and K041860

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This submission focuses on non-clinical mechanical testing, not a clinical trial or AI evaluation with a test set of patient data. Therefore, there's no "test set" in the sense of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth established with experts for clinical or AI performance. The "ground truth" here is the established mechanical performance of the predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method for clinical or AI performance is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI device. No MRMC study was performed or is relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context refers to the established mechanical and material properties of the predicate devices. The subject device's performance was compared against these established properties to demonstrate substantial equivalence.

8. The sample size for the training set

Not applicable. This is not an AI device.

9. How the ground truth for the training set was established

Not applicable. This is not an AI device.

Summary from the document regarding the study:

The study conducted for the APTUS® Proximal Humerus System was a non-clinical evaluation designed to demonstrate substantial equivalence to previously cleared predicate devices. It involved:

Biocompatibility assessment: Referenced from previous K-clearances (K120108 and K092038), stating that the materials (unalloyed titanium and stainless steel) are identical, supporting biocompatibility equivalence.
Mechanical testing: Performed according to ASTM F382, demonstrating substantial equivalence to predicate devices K120108 and K041860. This standard likely involves various tests of mechanical properties relevant to bone fixation devices.
Engineering analysis calculations: Specifically for out-of-plane bending moments of inertia, showing equivalence.
Comparative dynamic testing: In a simulated fracture model, also demonstrating substantial equivalence to K120108 and K041860.

This approach is standard for 510(k) submissions for orthopedic implants, where the focus is on physical and mechanical properties, material equivalence, and design similarity to already validated devices, rather than clinical performance trials or AI specific evaluations.

Summary

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August 5, 2018

Medartis AG % Kevin Thomas Vice President and Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

Re: K181425

Trade/Device Name: APTUS® Proximal Humerus 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. HWC. HTY Dated: May 29, 2018 Received: May 31, 2018

Dear Kevin Thomas:

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

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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); 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.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Vesa

Vuniqi - S

Digitally signed
by Vesa Vuniqi -S
Date: 2018.08.05
23:38:47 -04'00'

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

Enclosure

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Indications for Use

510(k) Number (if known) K181425

Device Name

APTUS® Proximal Humerus System

Indications for Use (Describe)

APTUS® Proximal Humerus System is indicated for fractures, osteotomies and non-unions of the proximal humerus.

The APTUS® K-Wire System is intended for use in fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants.

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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K181425 Page 1/4 APTUS® Proximal Humerus System

510(k) Summary

Medartis AG

APTUS® Proximal Humerus System

July 20, 2018

ADMINISTRATIVE INFORMATION

Manufacturer Name	Medartis AGHochbergerstrasse 60ECH-4057 Basel, SwitzerlandTelephone: +41 61 633 34 34Fax: +41 61 633 34 00
Official Contact	Andrea SchweizerHead of Quality Management

Representative/Consultant	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: kthomas@paxmed.com flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	APTUS® Proximal Humerus System
Common Name	Plate, fixation, bone
	Pin, fixation, smooth
	Screw, fixation, bone
Classification Name	Single/multiple component metallic bone fixation appliancesand accessories
Classification Regulations	21 CFR 888.3030
	21 CFR 888.3040
Product Codes	HRS, HTY, HWC
Classification Panel	Orthopedic Products Panel

PREDICATE DEVICE INFORMATION

The primary predicate device is K120108. Additional predicate devices are K041860, K092038, and K960385.

INDICATIONS FOR USE STATEMENT

APTUS® Proximal Humerus System is indicated for fractures, osteotomies and non-unions of the proximal humerus.

The APTUS® K-Wire System is intended for use in fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants.

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SUBJECT DEVICE DESCRIPTION

PERFORMANCE DATA

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility (referenced from K120108 and K092038), mechanical testing to ASTM F382), engineering analysis calculations of out-of-plane bending moments of inertia, and comparative dynamic testing in a simulated fracture model. Clinical data were not provided in this submission.

EQUIVALENCE TO MARKETED DEVICE

Medartis AG submits the information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the subject device is substantially equivalent in indications and design principles to the following legally marketed predicate devices:

K120108, APTUS® Proximal Humerus System, Medartis AG;

K041860, Synthes (USA) LCP® Proximal Humerus Plates, Long, Synthes (USA);

K092038, APTUS® K-Wire System, Medartis AG; and

K960385. Sterile Kirschner Wires and Steinmann Pins. DePuy. Inc.

A comparison of the technological characteristics of the subject device and the primary predicate device K120108 is provided in the following table.

	Subject Device	Primary Predicate Device
Comparison	APTUS® Proximal Humerus SystemMedartis AG	K120108APTUS® Proximal Humerus SystemMedartis AG
Indications for UseStatement	APTUS® Proximal Humerus System is indicated forfractures, osteotomies and non-unions of the proximalhumerus.The APTUS® K-Wire System is intended for use infixation of bone fractures, for bone reconstruction, and asguide pins for insertion of other implants.	APTUS® Proximal Humerus System is indicated forfractures, osteotomies and non-unions of the proximalhumerus.
Device Characteristics
Plate Designs	Anatomic plate designMultiple sizes:10 and 14 shaft screw hole plates;Specific plates for right and left proximal humerus;	Anatomic plate designMultiple sizes:3, 5, and 7 shaft screw hole plates;Specific plates for right and left proximal humerus;

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	Subject Device	Primary Predicate Device
Comparison	APTUS® Proximal Humerus SystemMedartis AG	K120108APTUS® Proximal Humerus SystemMedartis AG
	Screw holes accommodate conventional and lockingscrews;Locking blades	Screw holes accommodate conventional and lockingscrews;Locking blades
Plate Thickness	Proximal: 3.0 mmShaft: 3.8 mm	Proximal: 3.0 mmShaft: 3.0 mm
Plate Material	Unalloyed titanium, grade 4 (ASTM F67)	Unalloyed titanium, grade 4 (ASTM F67)
Screw Designs	Previously cleared:Locking screws: cortical thread form, double thread,self-tapping, fully threadedNon-locking screws: cortical thread form, singlethread, self-tapping, fully threaded	Locking screws: cortical thread form, double thread,self-tapping, fully threadedNon-locking screws: cortical thread form, singlethread, self-tapping, fully threaded
Screw Diameter	Previously cleared:3.5 mm (locking and non-locking)	3.5 mm
Screw Length	Previously cleared:Locking and non-locking:16 mm to 60 mm	Locking and non-locking:16 mm to 60 mm
Screw Material	Previously cleared:Ti-6Al-4V alloy (ASTM F136)	Ti-6Al-4V alloy (ASTM F136)

The Indications for Use Statement for the subject device (plates) is identical to that that of the primary predicate device K120108. The Indications for Use Statement for the subject device (K-Wires) is identical to that of the additional predicate device K092038.

The plates from the subject device, the primary predicate device K120108, and additional predicate device K041860 have the same intended use for fixation of the proximal humerus, and have the same technological characteristics. The plates from the subject device and the primary predicate device K120108 are fabricated from the identical unalloyed titanium material. The plates from the subject device and the primary predicate device K120108 have the same or similar design characteristics, including the design of the proximal region of the plate, screw holes to accommodate locking and non-locking screws, and the design of the spiral blade components. The plates from the subject device, primary predicate device K120108, and additional predicate device K041860 encompass a similar same range of physical dimensions (overall lengths and thicknesses). The subject device are compatible with screws from the primary predicate device K120108, as well as K110908. The difference between the subject device and primary predicate device K121018 is the longer lengths of the subject device plates. The additional predicate K041860 is for substantial equivalence of the longer plate lengths (extending to the humeral shaft).

The K-wires from the subject device and the additional predicate devices K092038 and K960385 have the same intended use and have the same technological characteristics. The K-wires from the subject device and the additional predicate device K092038 are fabricated from the identical stainless steel material. The K-wires from the subject device and the additional predicate device K092038 have the same characteristics, except for the diameter of the wires. The additional predicate device K960385 is for substantial equivalence of the larger diameter (2 mm) of the subject device K-wires.

Substantial equivalence of the subject device components in terms of biocompatibility is supported by the fact that the unalloyed titanium and stainless steel materials used in the subject devices are identical in formulation, processing, component interactions, and storage conditions to the predicate devices in K120108 and K092038.

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APTUS® Proximal Humerus System

Performance data provided to demonstrate substantial equivalence included mechanical testing (according to ASTM F382), and engineering analysis calculations of out-of-plane bending moments of inertia, and comparative dynamic testing in a simulated fracture model. The data demonstrated substantial equivalence to the primary predicate device K120108 and the additional predicate device K041860.

CONCLUSION

The subject device plates and the primary predicate device (K120108) plates have intended use, have similar technological characteristics, and are material. The subject device plates and primary predicate device (K120108) plates also are provided in pre-contoured anatomic designs for the left and right radius, and encompass a similar range of physical dimensions appropriate to the anatomy. The subject device and primary predicate device K120108 components are packaged in similar materials and are to be sterilized by the end-user using similar methods. The subject device plates and the additional predicate device K041860 include designs in lengths for treatment of the humeral shaft. Performance data demonstrated the subject device plates to be substantially equivalent to the primary predicate device K120108 and to the additional predicate device K041860.

The subject device K-wires have the same intended use, have similar technological characteristics, and are made of the same material as the additional predicate K092038. The subject device and primary predicate device components are packaged in similar materials and are to be sterilized by the end-user using similar methods. The subject device K-wires are substantially equivalent in diameter to the additional predicate device K960385.

The data included in this submission demonstrate substantial equivalence to the predicate devices K120108, K041860, K092038, and K960385.

Regulation Number and Section

§ 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.