(51 days)
No
The device description and performance studies focus on the material properties and mechanical performance of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
Explanation: The device is a bone fixation implant used for fracture and osteotomy fixation and joint arthrodesis, which are therapeutic procedures aimed at treating medical conditions.
No
Explanation: This device is a bone fixation device (surgical implant) used for fracture and osteotomy fixation and joint arthrodesis. It is designed to physically stabilize bone fragments, not to gather information about a patient's medical condition or diagnose a disease.
No
The device description clearly states it is a physical, permanently implanted bone fixation device made of Nickel Titanium (Nitinol).
Based on the provided information, the Arthrex DynaNite Nitinol Staples are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "Fracture and osteotomy fixation and joint arthrodesis of the hand and foot," "Fixation of proximal tibial metaphysis osteotomy," and "Fixation of small bone fragments." These are all procedures performed in vivo (within the living body) to fix bones.
- Device Description: The device is described as a "bone fixation device intended to be permanently implanted." Implantation is an in vivo procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The description of the Arthrex DynaNite Nitinol Staples does not involve any such testing of bodily specimens.
Therefore, the Arthrex DynaNite Nitinol Staples are a surgical implant used for bone fixation, not an IVD device.
N/A
Intended Use / Indications for Use
The Arthrex DynaNite Nitinol Staples are indicated for:
- . Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
- . Fixation of proximal tibial metaphysis osteotomy.
- . Hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
- . Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extend to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.
Product codes
JDR
Device Description
The Arthrex DynaNite Nitinol Staples are Nickel Titanium (Nitinol) bone fixation devices intended to be permanently implanted. The implant is formed with two legs connected by a bridge and is offered in multiple combinations of bridge widths, leg lengths, and cross sections to accommodate various anatomies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand, foot, proximal tibial metaphysis, small bone fragments in long bones (femur, fibula, tibia, humerus, ulna, radius, clavicle, ribs), flat bones (pelvis, scapula, sternum).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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: Bench testing including Pull-out (ASTM F564), Static Four-Point Bend (ASTM F564), Four-Point Bend Fatigue (ASTM F564), Cyclic Potentiodynamic Polarization Corrosion (ASTM F2129), Transformation Temperature (ASTM F2082/F2082M), MRI compatibility testing (ASTM F2052, ASTM F2119, ASTM F2182, ASTM F2213), Bacterial Endotoxins Test (BET) (ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14), Biocompatibility testing (Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, Subchronic/Subacute Toxicity, Implantation, Material Characterization) (ISO 10993-1:2018).
Sample Size: Not specified.
AUC: Not applicable.
MRMC: Not applicable.
Standalone Performance: Not applicable.
Key results:
- Pull-out, Static Four-Point Bend, and Four-Point Bend Fatigue testing demonstrated statistical equivalence to predicate devices (K142292, K993714, K172052).
- MRI force, torque, and image artifact testing were conducted in accordance with FDA guidance and ASTM standards.
- Bacterial Endotoxins Test demonstrated that the staples meet pyrogen limit specifications.
- Biocompatibility testing conducted in accordance with ISO 10993-1:2018.
- Assessment of physical product attributes, design, size, materials, manufacturing, and packaging determined no additional risks or concerns regarding sterilization and shelf-life.
Key Metrics
Not Found
Predicate Device(s)
K142292: BME, Inc. Speed, Speed Shift, Speed Titan, Speed Arc
Reference Device(s)
K172052: Arthrex DynaNite Nitinol Staple, K993714: BME, Inc. Memograph Staple System (OSStaple)
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
December 16, 2020
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 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.
Arthrex Inc. Rebecca Homan Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K203180
Trade/Device Name: Arthrex DynaNite Nitinol Staples Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDR Dated: October 26, 2020 Received: October 27, 2020
Dear Rebecca Homan:
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 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
1
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 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,
Vesa Vuniqi Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
Indications for Use
510(k) Number (if known)
K203180
Device Name Arthrex DynaNite Nitinol Staples
Indications for Use (Describe)
The Arthrex DynaNite Nitinol Staples are indicated for:
- . Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
- . Fixation of proximal tibial metaphysis osteotomy.
- . Hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
- . Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extend to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| Date Prepared | October 20, 2020 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Rebecca R. Homan |
| Regulatory Affairs Specialist | |
| 1-239-643-5553, ext. 73429 | |
| rebecca.homan@arthrex.com | |
| Name of Device | Arthrex DynaNite Nitinol Staples |
| Common Name | Staple, Fixation, Bone |
| Product Code | JDR |
| Classification Name | 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances |
| and accessories | |
| Regulatory Class | II |
| Predicate Device | K142292: BME, Inc. Speed, Speed Shift, Speed Titan, Speed Arc |
| Reference Device | K172052: Arthrex DynaNite Nitinol Staple |
| K993714: BME, Inc. Memograph Staple System (OSStaple) | |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain expanded |
| indications for use for the Arthrex DynaNite Nitinol Staples. | |
| Device Description | The Arthrex DynaNite Nitinol Staples are Nickel Titanium (Nitinol) bone fixation |
| devices intended to be permanently implanted. The implant is formed with two | |
| legs connected by a bridge and is offered in multiple combinations of bridge | |
| widths, leg lengths, and cross sections to accommodate various anatomies. | |
| Indications for Use | The Arthrex DynaNite Nitinol Staples are indicated for: |
| • Fracture and osteotomy fixation and joint arthrodesis of the hand and | |
| foot. | |
| • Fixation of proximal tibial metaphysis osteotomy. | |
| • Hand and foot bone fragment and osteotomy fixation and joint | |
| arthrodesis. | |
| • Fixation of small bone fragments (i.e. small fragments of bone which are | |
| not comminuted to the extend to preclude staple placement). These | |
| fragments may be located in long bones such as the femur, fibula and | |
| tibia in the lower extremities; the humerus, ulna or radius in the upper | |
| extremities; the clavicle and ribs; and in flat bone such as the pelvis, | |
| scapula and sternum. | |
| Performance Data | Pull-out (ASTM F564), Static Four-Point Bend (ASTM F564), Four-Point Bend |
| Fatigue (ASTM F564), Cyclic Potentiodynamic Polarization Corrosion (ASTM | |
| F2129) and Transformation Temperature (ASTM F2082/F2082M) testing was | |
| conducted to demonstrate that the Arthrex DynaNite Nitinol Staples perform | |
| statistically equivalent to the devices cleared under K142292, K993714 and | |
| K172052. |
MRI force, torque, and image artifact testing were conducted in accordance with
FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic
Resonance (MR) Environment, ASTM F2052 Standard Test Method for
Measurement of Magnetically Induced Displacement Force on Medical Devices in
the Magnetic Resonance Environment, ASTM F2119 Standard Test Method for
Evaluation of MR Image Artifacts from Passive Implants, ASTM F2182 Standard
Test Method for Measurement of Measurement of Radio Frequency Induced |
| Heating Near Passive Implants During Magnetic Resonance Imaging and ASTM
F2213 Standard Test Method for Measurement of Magnetically Induced Torque
on Medical Devices in the Magnetic Resonance Environment. | |
| Bacterial Endotoxins Test (BET) was performed on the Arthrex DynaNite Nitinol
Staples utilizing the Kinetic Chromogenic Method in accordance with ANSI/AAMI
ST72:2011/(R)2016, USP , USP , EP 2.6.14. The testing conducted
demonstrates that the Arthrex DynaNite Nitinol Staples meet pyrogen limit
specifications. | |
| Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity,
Subchronic/Subacute Toxicity, Implantation and Material Characterization testing
was conducted on the Arthrex DynaNite Nitinol Staples in accordance with ISO
10993-1:2018. | |
| Assessment of physical product attributes including product, design, size, and
materials as well as the conditions of manufacture and packaging has determined
that the Arthrex DynaNite Nitinol Staples do not introduce additional risks or
concerns regarding sterilization and shelf-life. | |
| Conclusion
The Arthrex DynaNite Nitinol Staples are substantially equivalent to the predicate
devices in which the basic design features and intended uses are the same. Any
differences between the proposed device and the predicate devices are
considered minor and do not raise different questions concerning safety or
effectiveness. | |
| The submitted mechanical testing data demonstrates that the Pull-out, Static
Four-Point Bend, and Four-Point Bend Fatigue strength of the proposed device is
substantially equivalent to that of the predicate devices for the desired
indications. | |
| Based on the indications for use, technological characteristics, and the summary
of data submitted, Arthrex Inc. has determined that the proposed device is
substantially equivalent to the currently marketed predicate devices. | |
4