(107 days)
No
The device description and performance studies focus on the mechanical properties and design of bone plates for fracture fixation, with no mention of AI or ML technologies.
Yes
The device is a plate intended for fracture fixation, which is a therapeutic intervention.
No
Explanation: The device is an orthopedic implant (plates and screws) used for fracture fixation and osteotomies, not for diagnosing medical conditions. Its purpose is treatment, not diagnosis.
No
The device description clearly states the device is a physical plate made of titanium alloy, intended for surgical implantation. It also describes mechanical testing performed on the physical plates.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fractures and osteotomies, in particular for the ulna." This describes a surgical implant used to fix bones, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The device is a "Dorsal Olecranon Plate," which is a physical implant made of titanium alloy. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any reagents, calibrators, controls, or procedures for analyzing biological samples, which are typical components and functions of IVD devices.
- Performance Studies: The performance studies described are mechanical tests (ASTM F382) to assess the structural integrity of the plate, not studies evaluating the accuracy or reliability of a diagnostic test.
Therefore, the APTUS Elbow Dorsal Olecranon Plates are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The APTUS Elbow Dorsal Olecranon Plates are indicated for fractures and osteotomies, in particular for the ulna.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The purpose of this submission is to obtain marketing clearance for new APTUS Elbow Dorsal Olecranon Plates.
The subject device APTUS Elbow Dorsal Olecranon Plates are available in three (3) designs: Standard, Medium and Extended. The designs differ in the shape of the proximal ends of the Standard Plates are available in 6 lengths; The Medium Plates are available in 2 lenghts and the Extended Plates are available in 3 lenghts, each for left and right. All plates have appropriate for the olecranon. The subject device plates are compatible with screws and k-wires previously cleared in K051567, K09332, K112560, K232144 (for screws) and K092038 (for k-wires).
The subject device plates are manufactured from titanium alloy, conforming to ASTM F136. All plates are provided sterile and selected plates are provided non-sterile aswell.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ulna, olecranon, proximal ulna
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)
The safety and performance of the plates were established by performing to ASTM F382 and comparing the results to the minimum requirements pointed out in the relative FDA guidance for Industry and Food and Drug Administration Staff, Orthopedic Fracture Fixation Plates – Performance Criteria for Safety and Performance Based Pathway (2022). Clinical data were not provided in this submission.
The mechanical test results show that the bending structural stiffness of the Dorsal Olecranon Medartis APTUS Elbow Plates are higher than the acceptance values indicated in the relative FDA guidance for Industry and Food and Drug Administration Staff, Orthopedic Fracture Fixation Plates – Performance Criteria for Safety and Performance Based Pathway (2022)). Clinical data were not provided in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K051567, K09332, K112560, K232144, K092038, K193554, K091479, K10332144
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
June 20, 2024
Medartis AG Claudia De Santis Head Global Regulatory Affairs Hochbergerstrasse 60E Basel, BS 4057 Switzerland
Re: K240613
Trade/Device Name: APTUS Elbow Dorsal Olecranon Plates 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: March 5, 2024 Received: May 21, 2024
Dear Claudia De Santis:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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, Thomas Mcnamara -S
Digitally signed by Thomas Mcnamara -S Date: 2024.06.20 16:21:01 -04'00
For 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
APTUS Elbow Dorsal Olecranon Plates
Indications for Use (Describe)
The APTUS Elbow Dorsal Olecranon Plates are indicated for fractures and osteotomies, in particular for the ulna.
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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3
510(k) #: K240613
510(k) Summary
Prepared on: 2024-06-20
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | Medartis AG |
|---|---|
| Applicant Address | Hochbergerstrasse 60E Basel BS 4057 Switzerland |
| Applicant Contact Telephone | +41 798835288 |
| Applicant Contact | Mrs. Claudia De Santis |
| Applicant Contact Email | claudia.desantis@medartis.com |
| Device Name | 21 CFR 807.92(a)(2) |
| Device Trade Name | APTUS Elbow Dorsal Olecranon Plates |
| Common Name | Plate, Fixation, Bone; Screw, Fixation, Bone |
| Classification Name | Single/multiple component metallic bone fixation appliances and accessories (Primary), Smooth or threaded metallic bone fixation fastener |
| Regulation Number | 888.3030 (Primary), 888.3040 |
| Product Code(s) | HRS (Primary), HWC |
| Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) Product Code |
| K120070 | SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM HRS |
| K193633 | APTUS Ankle Trauma System 2.8/3.5 HRS |
| K193639 | APTUS Foot System HRS |
| Device Description Summary 21 CFR 807.92(a)(4) |
The purpose of this submission is to obtain marketing clearance for new APTUS Elbow Dorsal Olecranon Plates.
The subject device APTUS Elbow Dorsal Olecranon Plates are available in three (3) designs: Standard, Medium and Extended. The designs differ in the shape of the proximal ends of the Standard Plates are available in 6 lengths; The Medium Plates are available in 2 lenghts and the Extended Plates are available in 3 lenghts, each for left and right. All plates have appropriate for the olecranon. The subject device plates are compatible with screws and k-wires previously cleared in K051567, K09332, K112560, K232144 (for screws) and K092038 (for k-wires).
The subject device plates are manufactured from titanium alloy, conforming to ASTM F136. All plates are provided sterile and selected plates are provided non-sterile aswell.
Intended Use/Indications for Use
The APTUS Elbow Dorsal Olecranon Plates are indicated for fractures and osteotomies, in particular for the ulna.
Indications for Use Comparison
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
4
The Indications for Use Statements (IFUS) for the primary predicate device K120070 include language for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna. The Indications for Use Statements (IFUS) for the subject device include language for fractures and osteotomies of the ulna, which is covered by the Indications for Use Statements (IFUS) for the primary predicate device K120070.
The subject device is part of the APTUS Elbow system, which in turn is part of the APTUS fixation system. The intended use of the APTUS fixation system includes fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. This covers the intended use of the primary predicate device, which includes the fixation of fractures of the distal humerus, olecranon and ulna.
Technological Comparison
21 CFR 807.92(a)(6)
The primary predicate device K120070 is in support of substantial equivalence in terms of same technological characteristics, similar design characteristics (including screw holes to accommodate locking screws), similar principle of operation and similar plate material.
The additional predicate devices K193554 are in support of substantial equivalence in terms of same design characteristics regarding screw holes to accommodate Trilock locking and non-locking (cortical) screws.
All subject device final finished components (plates) are manufactured using identical material and same manufacturing steps as used for the additional predicate devices K193639, and therefore, are substantially equivalent to these previously-cleared devices regarding biocompatibility.
The additional predicate K193633 is in support of substantial equivalence in terms of same same moist heat sterilization process for subject devices provided non-sterile to the end user and are packaged using the same material.
The subject device components that are provided sterile to the end user are materials, are sterilized by the same method, and have the same sterile barrier shelf life as the additional predicate K193633.
Clinical data were not provided in this submission.
The subject device plates are compatible with Medatis screws previously cleared in K051567, K091479, K10332144. The subject device plates also are compatible with Medartis K-Wires previously cleared in K092038.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The safety and performance of the plates were established by performing to ASTM F382 and comparing the results to the minimum requirements pointed out in the relative FDA guidance for Industry and Food and Drug Administration Staff, Orthopedic Fracture Fixation Plates – Performance Criteria for Safety and Performance Based Pathway (2022). Clinical data were not provided in this submission.
The mechanical test results show that the bending structural stiffness of the Dorsal Olecranon Medartis APTUS Elbow Plates are higher than the acceptance values indicated in the relative FDA guidance for Industry and Food and Drug Administration Staff, Orthopedic Fracture Fixation Plates – Performance Criteria for Safety and Performance Based Pathway (2022)). Clinical data were not provided in this submission.
The subject device, the primary predicate device, and the additional predicate devices have intended use, have similar technological characteristics, and are made of identical or similar materials. The primary predicate, and the additional predicate devices encompass the same range of physical dimensions, are packaged in similar materials, and are similar methods.
The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.