(90 days)
No
The description focuses on the mechanical properties and design of titanium plates for bone fixation, with no mention of AI or ML.
No.
The device is an orthopedic plate used to treat fractures and non-unions of the scaphoid, which is a structural repair rather than a therapeutic treatment in the sense of actively treating a disease or condition.
No
Explanation: The device, APTUS Hand Scaphoid Plates, is an implant indicated for fractures and non-unions of the scaphoid. It is a surgical plate used for fixation, not for diagnosing conditions.
No
The device description explicitly states the device is a physical plate manufactured from unalloyed titanium, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fractures and non-unions of the scaphoid." This describes a surgical implant used to fix bones, not a test performed on biological samples to diagnose a condition.
- Device Description: The description details a "plate" made of titanium with screw holes, designed to be implanted in the scaphoid bone. This is a physical medical device, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a disease or condition through in vitro testing.
Therefore, the APTUS Hand Scaphoid Plates are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
APTUS Hand Scaphoid Plates are indicated for fractures and non-unions of the scaphoid.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The purpose of this submission is to obtain marketing clearance for an additional device design to expand the range of the Medartis APTUS® Hand Plates, previously cleared under K102537. The subject device APTUS Hand Scaphoid Plates is available in three designs - small, standard, large - all with 6 screw holes. All plates have anatomical designs that are appropriate for the scaphoid. The subject device plates are compatible with screws and k-wires previously cleared in K102537, K051567, K232144 (for srews), K092038, K202589 and K232144 (for k-wires). The subject device plates are manufactured from unalloyed titanium conforming to ASTM F67, and are provided non-sterile and sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
scaphoid, hand, forearm, shoulder and foot
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: Mechanical fatigue and static testing, Based on the testing, the performance of the subject device was judged to be substantially equivalent to the primary previously cleared with K102537. Clinical data were not provided in this submission. The mechanical test results show that the subject device than the predicate device, when subjected to worst case static and fatigue testing. 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.
Not Found
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
March 21, 2024
Image /page/0/Picture/1 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Medartis AG Claudia De Santis Head Regulatory Affairs Hochbergerstrasse 60E Basel, BS 4057 Switzerland
Re: K234062
Trade/Device Name: APTUS Hand Scaphoid 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 Dated: December 7, 2023 Received: December 22, 2023
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"
1
(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).
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 OS 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.
Shumaya Ali -S
Shumaya Ali, MPH 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
2
Indications for Use
Submission Number (if known)
Device Name
APTUS Hand Scaphoid Plates
Indications for Use (Describe)
APTUS Hand Scaphoid Plates are indicated for fractures and non-unions of the scaphoid.
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) Summary
Prepared on: 2023-12-21
Contact Details
| 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 Hand Scaphoid Plates | ||||
| Common Name | Single/multiple component metallic bone fixation appliances and accessories | ||||
| Classification Name | Plate, Fixation, Bone | ||||
| Regulation Number | 888.3030 | ||||
| Product Code | HRS | ||||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | ||||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |||
| K102537 | 1.2/1.5 TriLock Plate 3/5 Hole T, t0.8 | HRS | |||
| K223853 | 2.5 TriLock Distal Ulna Plates | HRS | |||
| Device Description Summary | 21 CFR 807.92(a)(4) | ||||
| The purpose of this submission is to obtain marketing clearance for an additional device design to expand the range of the Medartis | |||||
| APTUS® Hand Plates, previously cleared under K102537. | |||||
| The subject device APTUS Hand Scaphoid Plates is available in three designs - small, standard, large - all with 6 screw holes. All plates | |||||
| have anatomical designs that are appropriate for the scaphoid. The subject device plates are compatible with screws and k-wires | |||||
| previously cleared in K102537, K051567, K232144 (for srews), K092038, K202589 and K232144 (for k-wires). | |||||
| The subject device plates are manufactured from unalloyed titanium conforming to ASTM F67, and are provided non-sterile and sterile. | |||||
| Intended Use/Indications for Use | 21 CFR 807.92(a)(5) | ||||
| APTUS Hand Scaphoid Plates are indicated for fractures and non-unions of the scaphoid. | |||||
| Indications for Use Comparison | |||||
| 21 CFR 807.92(a)(5) |
4
The Indications for Use Statements (JFUS) for the primary predicate device K102537 include language for fractures in hand, in particular transversal fractures, spiral fractures near joints with or without joint involvement, shaft factures, dislocation fractures, avulsion for Use Statements (JFUS) for the subject device include language for fractures and non-unions of the scaphoid, which is covered in the Indications for US for the primary predicate device K102537. The intended use of the subject device and the primary predicate device is identical: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot.
Technological Comparison
21 CFR 807.92(a)(6)
The primary predicate K102537 and the additional predicate K223853 are in support of substantial equivalence in terms of same technological characteristics and similar design characteristics (including screw holes to accommodate locking screws). same principle of operation, same plate material, the same moist heat sterilization process for devices provided non-sterile to the end user and are packaged using the same material. K102537 is also for support of substantial equivalence in terms of comparative mechanical testing (dynamic testing).
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 K223853. Clinical data were not provided in this submission.
The subject device plates are compatible with Medartis screws previously cleared in K102537. K232144 (Cortical). The subject device plates also are compatible with Medartis K-Wires previously cleared in K092038, K202144.
All subject device final finished components (plates) are manufactured using identical materials and same manufacturing steps as used for the primary predicate K102537, and therefore, are substantially equivalent to this previously-cleared device regarding biocompatibility.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: Mechanical fatigue and static testing, Based on the testing, the performance of the subject device was judged to be substantially equivalent to the primary previously cleared with K102537. Clinical data were not provided in this submission.
Not Applicable
The mechanical test results show that the subject device than the predicate device, when subjected to worst case static and fatigue testing. Clinical data were not provided in this submission.