(263 days)
Not Found
No
The summary describes a mechanical implant made of nickel-titanium alloy and its associated instruments. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies focus on mechanical properties and material characteristics.
Yes. A therapeutic device is used to treat a disease, injury, or medical condition. These staples are indicated for foot bone fragments osteotomy fixation and joint arthrodesis, which are treatments for bone conditions or injuries.
No
The device is an osteosynthesis compressive staple, which is an implant used for fixation of bone fragments and joint arthrodesis, not for diagnosing medical conditions.
No
The device description clearly states it is an implant manufactured from nickel-titanium alloy and includes instruments for implantation, indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The arcad® 2.0 Duo & Quadro osteosynthesis compressive staples are described as implants made of nickel-titanium alloy, designed to facilitate bone fusion. They are surgically implanted into the foot bone.
- Intended Use: The intended use is for "foot bone fragments osteotomy fixation and joint arthrodesis," which are surgical procedures.
The device is a surgical implant used directly within the body for structural support and bone healing, not for testing specimens outside the body.
N/A
Intended Use / Indications for Use
arcad® 2.0 Duo & Quadro osteosynthesis compressive staples are indicated for foot bone fragments osteotomy fixation and joint arthrodesis.
Product codes (comma separated list FDA assigned to the subject device)
JDR
Device Description
arcad® 2.0 Duo & Quadro osteosynthesis compressive staple implants with two-leg and four-leg configurations with multiple bridge and leg lengths. The implants are manufactured from nickel-titanium alloy (ASTM F2063). The system is provided as a single-use sterile pack comprising of a bone staple implant ready to implant assembled in open legs position on its dedicated disposable insertor forceps and instruments for implantation. The implant is designed to facilitate bone fusion with Nitinol pseudoelastic behavior.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot bone
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)
arcad®2.0 Duo & Quadro osteosynthesis compressive staples have undergone functional testing to provide evidence that its non-clinical properties are substantially equivalent to predicate devices already cleared.
Performance testing and engineering analysis demonstrated substantial equivalence to the predicate device in the following (according to FDA guidance for Nitinol products "Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol"):
- Static bending, bending fatigue, and pullout strength (per ASTM F564-17 "Standard Specification and Test -Methods for Metallic Bone Staples");
- Corrosion resistance (per ASTM F2129-19a "Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices");
- -Thermal analysis by Differential Scanning Calorimetry (per ASTM F2004-17 "Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis".
Clinical studies were not required for 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.
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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" stacked on top of the word "ADMINISTRATION".
December 4, 2023
Novastep Manon Dupleichs Regulatory Affairs Manager 2, Allée Jacques Frimot 35000 Rennes France
Re: K230724
Trade/Device Name: arcad® 2.0 Duo & Quadro osteosynthesis compressive 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: November 6, 2023 Received: November 6, 2023
Dear Manon Dupleichs:
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).
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Sincerely,
Limin Sun -S
Limin Sun, Ph.D. 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
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Indications for Use
K230724 Page 1 of 1 Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
arcad® 2.0 Duo & Quadro osteosynthesis compressive staples
Indications for Use (Describe)
arcad® Duo & Quadro osteosynthesis compressive staples are indicated for foot bone fragments osteotomy fixation and joint arthrodesis.
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
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the arcad® 2.0 Duo & Quadro osteosynthesis compressive staples.
SUBMITTER/510(K) HOLDER
Novastep® S.A.S 2, Allée Jacques Frimot 35000 Rennes France Phone: +33-2-99-33-86-50
Contact: Manon Dupleichs, Regulatory Affairs Manager Contact Phone: +33-2-99-33-86-50 Contact Email: manon.dupleichs@novastep-ortho.com Date Prepared: March 15, 2023
DEVICE NAME
| Device name: | arcad®2.0 Duo & Quadro osteosynthesis compressive staples |
|---|---|
| Device Classification Name: | Staple, Fixation, Bone |
| Regulation Number: | 888.3030 |
| Classification Product Code: | JDR |
| Device Class: | Class II |
PREDICATE DEVICE
| Manufacturer: | Novastep® S.A.S |
|---|---|
| Device name: | ARCAD compressive osteosynthesis staple |
| Device Classification Name: | Staple, Fixation, Bone |
| 510(k) Number: | K142111 |
| Regulation Number: | 888.3030 |
| Classification Product Code: | JDR |
| Device Class: | Class II |
DEVICE DESCRIPTION
arcad® 2.0 Duo & Quadro osteosynthesis compressive staple implants with two-leg and four-leg configurations with multiple bridge and leg lengths. The implants are manufactured from nickel-titanium alloy (ASTM F2063). The system is provided as a single-use sterile pack comprising of a bone staple implant ready to implant assembled in open legs position on its dedicated disposable insertor forceps and instruments for implantation. The implant is designed to facilitate bone fusion with Nitinol pseudoelastic behavior.
5
INTENDED USE/INDICATION FOR USE
The intended use is:
- . Osteosynthesis compressive staple
The indication for use is:
arcad® 2.0 Duo & Quadro osteosynthesis compressive staples are indicated for foot bone fragments osteotomy fixation and joint arthrodesis.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICES
Compared to the legally marketed primary predicate arcad® compressive osteosynthesis staple (K142111, cleared 19-Dec-2014), the subject arcad®2.0 Duo & Quadro osteosynthesis compressive staples has a similar design, intended use (including indication for use), and performance characteristics. The system features the same principles of operation for bone fixation and sterilization method as the predicate system. The subject and predicate are manufactured from the same nitinol material (ASTM F2063) and share similar features such as their legs with teeth. The subject bone staples feature wider bridges while maintaining similar bridge and leg lengths as the predicate devices. The subject system adds sizes with longer bridges, and 4-leg staples when compared to the predicate to further accommodate varying patient anatomy. The system is provided as a single-use sterile pack comprising of a bone staple implant ready to implant assembled in open legs position on its dedicated disposable insertor forceps and instruments for implantation when compared to the predicate.
SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
arcad®2.0 Duo & Quadro osteosynthesis compressive staples have undergone functional testing to provide evidence that its non-clinical properties are substantially equivalent to predicate devices already cleared.
Performance testing and engineering analysis demonstrated substantial equivalence to the predicate device in the following (according to FDA guidance for Nitinol products "Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol"):
- Static bending, bending fatigue, and pullout strength (per ASTM F564-17 "Standard Specification and Test -Methods for Metallic Bone Staples");
- Corrosion resistance (per ASTM F2129-19a "Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices");
- -Thermal analysis by Differential Scanning Calorimetry (per ASTM F2004-17 "Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis".
SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
Not applicable. Clinical studies were not required for this submission.
CONCLUSIONS
arcad®2.0 Duo & Quadro osteosynthesis compressive staples are substantially equivalent to the predicate device, arcad® compressive osteosynthesis staple (K142111, cleared 19-Dec-2014) in terms of intended use, performance, material, manufacturing process and biocompatibility. The design and performance characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices are considered substantially equivalent to the predicate device.