(82 days)
No
The device description and performance studies focus on mechanical properties and sterilization, with no mention of AI or ML.
Yes
The device is a medical plate intended for use in forearm fractures, which is a therapeutic intervention.
No.
The device description indicates that APTUS® Wrist Spanning Plates 2.5 are intended for use in forearm fractures and are specifically described as plates made from titanium alloy to be applied using a dorsal approach. This describes a surgical implant used for fixation, not a device that diagnoses conditions.
No
The device description explicitly states it includes "plates" made from "titanium alloy," which are physical hardware components. The performance studies also focus on non-clinical testing of these physical components (sterilization, shelf life, biocompatibility, mechanical testing).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "forearm fractures," which is a structural issue within the body.
- Device Description: The device is a physical plate made of titanium, designed to be surgically implanted to stabilize bone fractures.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform any such tests.
The description clearly indicates a surgical implant used for orthopedic fixation, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
APTUS® Wrist Spanning Plates 2.5 are intended for use in forearm fractures.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The subject device includes plates to be applied using a dorsal approach: two (2) plates with an anatomical pre-bent design specifically for the left and right wrist; and an additional plate design appropriate for either the left or right wrist. The plates have an overall length of 196 mm, a maximum width of 10 mm, and a maximum thickness of 3.4 mm tapering to 1.6 mm. The plates are made from titanium allov conforming to ASTM F136. The plates are designed to accommodate appropriately sized bone screws presently marketed as part of the APTUS® System and previously cleared in K103332 (cortical screws) and K051567 (TriLock locking screws). The subject device plates also are compatible with Medartis APTUS® K-Wires previously cleared in K092038.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forearm fractures / wrist
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: sterilization validation according to ISO 11137-1, and ISO 11137-3; bacterial endotoxin testing according to ANSI AAMI ST72; sterile barrier shelf life testing according to ISO 11607-1, ISO 11607-2, ASTM F1980, ASTM D4332, ASTM D4169, ASTM F2096, DIN EN 868-5, and ASTM F88/F88M; biocompatibility testing according to ISO 10993-12, ISO 10993-15, and ISO 10993-18; and comparative 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): 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.
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
September 30, 2019
Image /page/0/Picture/1 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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
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: K191848
Trade/Device Name: APTUS Wrist Spanning Plates 2.5 Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: August 1, 2019 Received: August 2, 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.
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
1
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191848
Device Name
APTUS® Wrist 2.5 System
Indications for Use (Describe)
APTUS® Wrist Spanning Plates 2.5 are intended for use in forearm fractures.
Type of Use (Select one or both, as applicable)
| ---------------------------------------------- |
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510(k) Summary
Medartis AG
APTUS® Wrist 2.5 System
July 9, 2019
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 Schweizer
Head 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/Device Name | APTUS® Wrist 2.5 System |
|---|---|
| Common Name | Plate, Fixation, Bone |
| Regulation Number | 21 CFR 888.3030 |
| Regulation Name | Single/multiple component metallic bone fixation appliances |
| and accessories | |
| Regulatory Class | Class II |
| Product Code | HRS |
| Classification Panel | Orthopedic Products Panel |
| 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 Device K131764, Acumed Wrist Spanning Plate, Acumed, LLC
INDICATIONS FOR USE STATEMENT APTUS® Wrist Spanning Plates 2.5 are intended for use in forearm fractures.
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SUBJECT DEVICE DESCRIPTION
The subject device includes plates to be applied using a dorsal approach: two (2) plates with an anatomical pre-bent design specifically for the left and right wrist; and an additional plate design appropriate for either the left or right wrist. The plates have an overall length of 196 mm, a maximum width of 10 mm, and a maximum thickness of 3.4 mm tapering to 1.6 mm. The plates are made from titanium allov conforming to ASTM F136. The plates are designed to accommodate appropriately sized bone screws presently marketed as part of the APTUS® System and previously cleared in K103332 (cortical screws) and K051567 (TriLock locking screws). The subject device plates also are compatible with Medartis APTUS® K-Wires previously cleared in K092038.
PERFORMANCE DATA
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: sterilization validation according to ISO 11137-1, and ISO 11137-3; bacterial endotoxin testing according to ANSI AAMI ST72; sterile barrier shelf life testing according to ISO 11607-1, ISO 11607-2, ASTM F1980, ASTM D4332, ASTM D4169, ASTM F2096, DIN EN 868-5, and ASTM F88/F88M; biocompatibility testing according to ISO 10993-12, ISO 10993-15, and ISO 10993-18; and comparative mechanical testing according to ASTM F382. Clinical data were not provided in this submission.
EQUIVALENCE TO MARKETED DEVICE
The subject device is substantially equivalent in indications and design principles to the primary predicate device and the reference device listed above. Provided at the end of this summary is a table comparing the Indications for Use Statements and the technological characteristics of the subject device, the primary predicate device, and the reference device.
The primary predicate device K142906 is for support of substantial equivalence based upon a similar Indications for Use Statement (IFUS), similar device designs, and identical materials. The reference device K131764 is for support of substantial equivalence based upon a similar IFUS, similar device designs, similar materials, and performance in side-by-side mechanical testing.
The subject device, the primary predicate device, and reference device have the same intended use for internal fixation of the wrist. The IFUS is similar for the subject device, the primary predicate device K142906, and the reference device K131764. The IFUS for K142906 includes language for use in the hand and for osteotomies and arthrodeses. The IFUS for K131764 includes language concerning osteotomies, non-unions, and the radius. These slight differences in language do not impact substantial equivalence because the subject devices cleared in K142906 and K131764 are intended for similar fixation (fusions) of the upper extremity.
The subject device and the primary predicate device K142906 have the same technological characteristics and are fabricated from identical titanium alloy conforming to ASTM F136. The subject device and the primary predicate device K142906 also are compatible with the same previously-cleared screws and K-Wires. The reference device K131764 also is fabricated from titanium alloy conforming to ASTM F136, and has similar design features. The subject device, the primary predicate device K142906, and the reference device K131764 all include plates that are to be placed by a dorsal surgical approach, and are to be fixed with locking and non-locking bone screws.
The titanium alloy material of the subject device in its final finished form is identical to the titanium alloy used in the primary predicate K142906 in formulation and processing. The subject device is manufactured
5
in the same facilities using the same manufacturing processes as used for the components previously cleared in K142906.
The subject device and the reference device K131764 are provided sterile to the end user; the sterilization method is not stated in the 510(k) Summary for K131764.
The subject device plates are slightly longer than the reference device K131764; this difference does not impact safety or effectiveness because the plates are to be used in an anatomic location that can safely accommodate a slightly longer plate design.
The subject device plates are to be used with a smaller number of fixation screws, and smaller size (diameter) screws than the reference device K131764. These differences are mitigated by the mechanical testing according to ASTM F382 that demonstrated the subject device plates to be substantially equivalent to the reference device plates cleared in K131764.
CONCLUSION
The subject device, the primary predicate device, and the reference device have the same intended use, have similar technological characteristics, and encompass a similar range of physical dimensions appropriate to the anatomy. The subject device and the primary predicate device are made of the identical material. The data included in this submission demonstrate substantial equivalence to the primary predicate device K142906 and the reference device K131764.