(58 days)
No
The device description and performance studies focus on the mechanical properties and design of bone plates and screws, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a bone plate system intended for internal fixation of fractures and osteotomies, which is a structural support rather than a therapeutic treatment.
No
This device is an implantable medical device (bone plates) used for fixation of fractures and osteotomies, not for diagnosing conditions.
No
The device description clearly details physical bone plates made of titanium, which are hardware components, not software.
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 management of fractures and osteotomies of the radius and ulna shaft, hand, and forearm. This describes a surgical implant used to fix bones.
- Device Description: The description details bone plates made of titanium, designed to be implanted in the body to stabilize bones.
- Lack of IVD characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze samples. This device is an in vivo (inside the body) implant.
N/A
Intended Use / Indications for Use
APTUS® Forearm Shaft Plates are intended for management of fractures and osteotomies of the radius and ulna shaft.
APTUS® Wrist 2.5 System is intended for use in hand and forearm fractures, osteotomies and arthrodeses.
Product codes
HRS
Device Description
The subject device includes a total of 10 bone plates for internal fixation of the radius and ulna, and hook plates for fixation of avulsed fragments of the distal radius or ulna. All plates have anatomical designs that are appropriate for either the left or right forearm.
The plates for the shaft of the radius and ulna have similar designs, are provided in designs with 10, 14, 18, or 22 holes, with overall lengths ranging from 80 mm to 160 mm. All plates for the radius and ulna have a maximum width of 10 mm, a maximum thickness of 3.4 mm, and the width and thickness taper at the ends of the plates. The radius shaft plates have a slight curvature to match the anatomy of the radius; the ulna shaft plates are straight.
The subject device hook plates are provided in two designs: a design with two curved hooks and six (6) holes, and a design with four (4) curved hooks and twelve (12) holes. The hook plates have approximate overall dimensions of 8.5 mm width by 17.5 mm length, or 18.5 mm width by 17.5 mm length; both plates are 0.6 mm thick.
The subject device plates include screw holes designed to accommodate appropriately sized bone screws and K-wires presently marketed as part of the APTUS® System. The compatible screws are 2.8 mm in diameter (shaft plates) and 1.5 mm in diameter (hook plates) and were previously cleared in K091479, K103332, and K142906. The subject device plates also are compatible with 1.6 mm diameter Medartis APTUS® K-Wires previously cleared in K092038.
All subject device plates are manufactured from unalloyed titanium conforming to ASTM F67.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
radius and ulna shaft, hand and forearm
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 included: biocompatibility and sterilization referenced from K142906 and K103332; engineering analysis; and mechanical testing according to ASTM F382. Clinical data were not provided in this submission.
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
February 16, 2020
Image /page/0/Picture/1 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
Medartis AG % Kevin A. Thomas Vice President and Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K193554
Trade/Device Name: APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 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: December 19, 2019 Received: December 20, 2019
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. 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.
1
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 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.
Shumaya Ali, M.P.H. 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)
K193554
Device Name
APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System
Indications for Use (Describe)
APTUS® Forearm Shaft Plates are intended for management of fractures and osteotomies of the radius and ulna shaft.
APTUS® Wrist 2.5 System is intended for use in hand and forearm fractures, osteotomies and arthrodeses.
| 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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510(k) Summary
K193554
Medartis AG
APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System
February 10, 2020
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Medartis AG
Hochbergerstrasse 60E
CH-4057 Basel, Switzerland
Telephone: +41 61 633 34 34
Fax: +41 61 633 34 00 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Andrea Kiefer-Schweizer
Head of Quality Management and Regulatory Affairs |
| 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 |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System |
|---|---|
| Common Name | Plate, fixation, bone |
| Classification Name | Single/multiple component metallic bone fixation appliances |
| and accessories | |
| Classification Regulation | 21 CFR 888.3030 |
| Product Code | HRS |
| Classification Panel | Orthopedic |
| Reviewing Office | Office of Health Technology 6 (Orthopedic Devices) |
| Reviewing Division | Division of Health Technology 6 C |
| (Restorative, Repair and Trauma Devices) |
PREDICATE DEVICE INFORMATION
Primary Predicate Device K142906, APTUS® Wrist 2.5 System, Medartis AG.
Reference Devices K000684, Small Fragment Dynamic Compression Locking (DCL) System, Synthes (USA), K103332, APTUS® Ulna Plates, Medartis AG, and K151468, ARIX Wrist System, Jeil Medical Corporation.
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INDICATIONS FOR USE STATEMENT
APTUS® Forearm Shaft Plates are intended for management of fractures and osteotomies of the radius and ulna shaft.
APTUS® Wrist 2.5 System is intended for use in hand and forearm fractures, osteotomies and arthrodeses.
SUBJECT DEVICE DESCRIPTION
The subject device includes a total of 10 bone plates for internal fixation of the radius and ulna, and hook plates for fixation of avulsed fragments of the distal radius or ulna. All plates have anatomical designs that are appropriate for either the left or right forearm.
The plates for the shaft of the radius and ulna have similar designs, are provided in designs with 10, 14, 18, or 22 holes, with overall lengths ranging from 80 mm to 160 mm. All plates for the radius and ulna have a maximum width of 10 mm, a maximum thickness of 3.4 mm, and the width and thickness taper at the ends of the plates. The radius shaft plates have a slight curvature to match the anatomy of the radius; the ulna shaft plates are straight.
The subject device hook plates are provided in two designs: a design with two curved hooks and six (6) holes, and a design with four (4) curved hooks and twelve (12) holes. The hook plates have approximate overall dimensions of 8.5 mm width by 17.5 mm length, or 18.5 mm width by 17.5 mm length; both plates are 0.6 mm thick.
The subject device plates include screw holes designed to accommodate appropriately sized bone screws and K-wires presently marketed as part of the APTUS® System. The compatible screws are 2.8 mm in diameter (shaft plates) and 1.5 mm in diameter (hook plates) and were previously cleared in K091479, K103332, and K142906. The subject device plates also are compatible with 1.6 mm diameter Medartis APTUS® K-Wires previously cleared in K092038.
All subject device plates are manufactured from unalloyed titanium conforming to ASTM F67.
PERFORMANCE DATA
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: biocompatibility and sterilization referenced from K142906 and K103332; engineering analysis; and mechanical testing according to ASTM F382. Clinical data were not provided in this submission.
EQUIVALENCE TO MARKETED DEVICES
The subject device is substantially equivalent in indications and design principles to the primary predicate device and the reference devices listed above.
The subject device, the primary predicate device, and reference devices have the same intended use for internal fixation of the bones of the upper extremity. The IFUS for the subject device includes a statement for the shaft plates and a statement for the hook plates. The statement for the hook plates is identical to the IFUS for the primary predicate device K142906.
The differences in the IFUS for the subject device shaft plates compared to that of the primary predicate device and the reference devices include: the specific language in the subject device IFUS referring to the radius and ulna shaft that is not in the other IFUS statements; language referring to fixation of additional bones in the IFUS for K000684; and the language referring to osteopenic bone in the IFUS for K000684.
5
These minor differences do not impact substantial equivalence because all IFUS express equivalent intended use for internal fixation of the bones of the upper extremity.
The plates from the subject device, the primary predicate device K142906, and the reference devices K000684 and K103332 have the same technological characteristics, have similar design characteristics. and include screw holes to accommodate locking and non-locking screws.
The plates from the subject device, the primary predicate device K142906, and the reference devices K000684 and K103332 encompass a similar range of physical dimensions (overall width, overall length, and thickness). The subject device and K000684 include plates for the radius and ulna shaft with similar designs and dimensions. Similarly, the subject device and K142906 both include plates with similar designs for hook plates. The plates from the subject device, K142906, and K103332 are manufactured from identical unalloyed titanium material. The plates from the subject device, K142906, and K103332 also are compatible exclusively with previously cleared Medartis APTUS® screws, and also are compatible with previously cleared Medartis APTUS® K-Wires.
All of the subject device final finished components are manufactured in the same facilities using identical materials and identical manufacturing processes as used for the previously cleared Medartis device components (K142906 and K10332) and, therefore, are substantially equivalent to these devices regarding biocompatibility.
The subject device components and the Medartis device components cleared in K142906 and K103332 are packaged using the same materials, and are to be sterilized by the same methods. Any minor differences in the technological characteristics among the subject device and the devices in K142906 and K103332 do not impact safety or effectiveness.
The differences among the plates from the subject device, K142906, K000684, and K103332 are variations in the designs of the plates (number of designs, overall dimensions, placement of screw holes), and variations in the sizes of the compatible screws. The plates and screws from the reference device K000684 are made of different material (titanium alloy) compared to the subject device. These slight differences among the subject device and the predicate and reference devices do not impact safety or effectiveness.
CONCLUSION
The subject device, the primary predicate device, and the reference devices have the same intended use, have similar technological characteristics, and encompass a similar range of physical dimensions appropriate to the anatomy. The data included in this submission demonstrate substantial equivalence to the primary predicate device and the reference devices listed above.