(266 days)
The ActivOrtho Nitinol Compression Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation of small bones and small bone fragments.
The ActivOrtho Nitinol Compression Screw System includes cannulated, partially threaded bone screws having a 4mm diameter in a variety of lengths to accommodate various applications.
This is a 510(k) premarket notification for a medical device, not a study evaluating device performance against acceptance criteria using AI or human readers. Therefore, much of the requested information regarding acceptance criteria, study design, expert ground truth, and AI-related metrics is not applicable to this document.
However, I can extract the relevant information available:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the format of a table with numerical targets. Instead, it describes performance testing conducted to demonstrate substantial equivalence to predicate devices. The "reported device performance" is described qualitatively as meeting the standards.
| Acceptance Criteria (Implied by testing standards) | Reported Device Performance |
|---|---|
| Mechanical Properties: | Torsional properties, driving torque, and axial pullout strength testing were performed. |
| Torsional Properties (per ASTM F543) | Performed on a worst-case device. (Results not explicitly quantified but implied to be acceptable for substantial equivalence). |
| Driving Torque (per ASTM F543) | Performed on a worst-case device. (Results not explicitly quantified but implied to be acceptable for substantial equivalence). |
| Axial Pullout Strength (per ASTM F543) | Performed on a worst-case device. (Results not explicitly quantified but implied to be acceptable for substantial equivalence). |
| Corrosion Susceptibility: | Corrosion susceptibility testing was performed. |
| Corrosion Resistance (per ASTM F2129) | Performed. (Results not explicitly quantified but implied to be acceptable for substantial equivalence). |
| Technological Characteristics: | The ActivOrtho Nitinol Compression Screw System possesses the same technological characteristics as one or more of the predicate devices, including performance, basic design, material, method of stabilization, and sizes (dimensions are comparable). The differences were shown not to raise new questions of safety and effectiveness. |
| Material Composition: (Implied: biocompatibility and conformity to standard) | Implants are made from Nitinol (ASTM F2063). |
The "Acceptance Criteria" here are inferred from the description of the performance data section, which lists the types of testing performed and the ASTM standards followed. The "Reported Device Performance" summarizes the findings as described in the document, without providing specific numerical results, but asserting that the tests demonstrate equivalency.
Study-Specific Information:
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Sample size used for the test set and the data provenance:
- The document states "Torsional properties, driving torque and axial pullout strength testing was performed on a worst case device according to ASTM F543." This implies a very small sample size, potentially N=1, for each mechanical test, focusing on the most challenging configuration. The exact number of devices tested is not specified beyond "a worst case device."
- Data Provenance: Not specified, but generally, such bench testing would be conducted in a laboratory environment, likely within the manufacturer's or a contracted testing facility. No information on country of origin of data or whether it was retrospective or prospective in a clinical sense.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable to this type of regulatory submission. The "ground truth" for mechanical testing is established by the specified ASTM test methods and a pass/fail criterion based on pre-defined engineering specifications or comparison to predicate device performance. It does not involve human expert interpretation of device performance in a clinical context.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable. Mechanical and corrosion testing adheres to predefined standard protocols (ASTM F543, ASTM F2129). The results are quantitative measurements, not subjective interpretations requiring adjudication.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This is not applicable. This document describes the substantial equivalence of a physical medical implant (Nitinol Compression Screw System) through bench testing. It does not involve AI, image analysis, or human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. This device is a physical implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission is based on engineering specifications and established ASTM standards for mechanical and material properties. The device's performance is compared against these standards and the known performance of predicate devices to establish substantial equivalence. It is not based on expert clinical consensus, pathology, or outcomes data, as this is a 510(k) for an implantable device, not a diagnostic or prognostic tool.
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The sample size for the training set:
- This is not applicable. This device submission does not involve machine learning or a "training set."
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How the ground truth for the training set was established:
- This is not applicable. This device submission does not involve machine learning or a "training set."
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Image /page/0/Picture/0 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.
March 12, 2019
ActivOrtho, Inc. % Karen Warden Representative/Consultant BackRoads Consulting, Inc. PO Box 566 Chesterland, Ohio 44026-0566
Re: K181610
Trade/Device Name: ActivOrtho Nitinol Compression Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: January 29, 2019 Received: January 31, 2019
Dear Karen Warden:
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
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K181610
Device Name
ActivOrtho Nitinol Compression Screw System
Indications for Use (Describe)
The ActivOrtho Nitinol Compression Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation of small bones and small bone fragments.
| 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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| Date: | 8 March 2019 |
|---|---|
| Sponsor: | ActivOrtho, Inc.12820 34th Ave NPlymouth, MN 55441Phone: 651-341-3805 |
| Sponsor Contact: | Paul Hindrichs |
| 510(k) Contact: | Karen E. Warden, PhDBackRoads Consulting, Inc.PO Box 566Chesterland, OH 44026Office: 440.729.8457 |
| Trade Names: | ActivOrtho Nitinol Compression Screw System |
| Common Name: | Bone screw |
| Regulatory Class: | Class II |
| Classification Name /Regulation / ProductCode: | Smooth or threaded metallic bone fixation fastener / 888.3040 / HWC |
| Device Description: | The ActivOrtho Nitinol Compression Screw System includes cannulated,partially threaded bone screws having a 4mm diameter in a variety oflengths to accommodate various applications. |
| Indications for Use: | The ActivOrtho Nitinol Compression Screw System is indicated for use inbone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repairand fracture fixation of small bones and small bone fragments. |
| Materials: | The ActivOrtho Nitinol Compression Screw implants are made from Nitinol(ASTM F2063). |
| Primary Predicate: | dynaMXTM Nitinol Compression Screw (MX Orthopedics Corporation --K160427) |
| AdditionalPredicates: | Synthes 4.0 Cannulated Screw (Synthes USA - K963192); VilexCannulated Bone Screw (Vilex Inc. - K973309), Zimmer Cannulated ScrewSystem (Pioneer Surgical Technology - K102903) |
| Performance Data: | Torsional properties, driving torque and axial pullout strength testing wasperformed on a worst case device according to ASTM F543. In addition,corrosion susceptibility testing was performed per ASTM F2129. |
| TechnologicalCharacteristics: | The ActivOrtho Nitinol Compression Screw System possesses the sametechnological characteristics as one or more of the predicate devices.These include, performance, basic design, material, method of stabilizationand sizes (dimensions are comparable to those offered by the predicatesystems).While the ActivOrtho Nitinol Compression Screw System is not identical tothe predicate devices, the differences were shown not to raise newquestions of safety and effectiveness. Therefore the fundamental scientifictechnology of the ActivOrtho Nitinol Compression Screw System is similarto previously cleared devices. |
| Conclusion: | The ActivOrtho Nitinol Compression Screw System possesses indicationsfor use the same as and technological characteristics similar to thepredicate devices. Therefore the ActivOrtho Nitinol Compression ScrewSystem is substantially equivalent to the predicates. |
510(k) Summary
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.