(163 days)
The VERTEX Nitinol Staple System is indicated for bone fragments and osteotomy fixation and joint arthrodesis of the hand or foot.
The VERTEX Nitinol Staple System consists of a series of nickel titanium alloy staple implants and the instruments necessary for the treatment of pathologies of the foot and ankle. The VERTEX bone staples are made from superelastic nitinol that does not require cold storage or heating.
This document is a 510(k) summary for the VERTEX Nitinol Staple System. It describes non-clinical testing performed to establish substantial equivalence to predicate devices. This type of document refers to the regulatory clearance process for medical devices and does not typically include information about clinical studies or AI-related performance.
Here's a breakdown based on your request, highlighting what's not available in this specific document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (as described in the document) |
|---|---|
| Static Bending, Bending Fatigue, and Pullout (per ASTM F564) | Tested to demonstrate safety. Results indicate substantial equivalence to predicate devices. (Specific quantitative results or pass/fail criteria are not provided in this summary) |
| Cyclic Potentiodynamic Polarization Testing (per ASTM F2129) | Tested to demonstrate safety. Results indicate substantial equivalence to predicate devices. (Specific quantitative results or pass/fail criteria are not provided in this summary) |
| Bend and Free Recovery (BFR) Testing (per ASTM F2082) | Tested to demonstrate safety. Results indicate substantial equivalence to predicate devices. (Specific quantitative results or pass/fail criteria are not provided in this summary) |
Note: The document states, "No FDA performance standards have been established for the VERTEX Nitinol Staple System." Therefore, the acceptance criteria are based on recognized consensus standards and current industry practice for demonstrating safety and substantial equivalence to predicate devices. The document only states that the device "meets" these criteria in a general sense, not providing specific pass/fail thresholds or quantitative results of the tests.
2. Sample Size Used for the Test Set and Data Provenance
This document describes non-clinical bench testing rather than a clinical study with a "test set" of patients.
- Sample size for test set: Not applicable (non-clinical bench testing). The sample size would refer to the number of physical staples tested for each benchmark. This specific detail is not provided in the summary.
- Data provenance: Not applicable. The data is generated from laboratory bench tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. Ground truth, in the context of clinical or AI studies, typically refers to expert labels or diagnoses. This document concerns a physical medical device and its mechanical/material properties, evaluated through non-clinical testing.
4. Adjudication method for the test set
Not applicable, as this is non-clinical bench testing of a physical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This document does not mention any MRMC comparative effectiveness study. This type of study is for evaluating human performance, often with and without AI assistance, which is not relevant to the non-clinical testing described for this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is for a physical medical device (nitinol staples), not an algorithm or AI system.
7. The type of ground truth used
For the non-clinical testing described, the "ground truth" would be established by:
- Physical measurements and material properties: Conforming to the specifications outlined in the respective ASTM standards (F564, F2129, F2082).
- Engineering analysis: Comparing the design, dimensions, and materials to the predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/algorithm study that involves a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Nvision Biomedical Technologies, LLC % Jeffrey Brittan Consultant Watershed Ideas Foundry 1815 Aston Ave., Suite 106 Carlsbad, California 92008
Re: K182943
Trade/Device Name: VERTEX Nitinol Staple System 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 22, 2018 Received: October 23, 2018
Dear Jeffrey Brittan:
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
April 4, 2019
{1}------------------------------------------------
requirements, including, but not limited to: registration and listing (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 (OS) 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 medical devices and radiation-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.
Daniel S. Ramsey -S 2019.04.04 14:34:48 -04'00'
FOR Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K182943
Device Name VERTEX™ Nitinol Staple System
Indications for Use (Describe)
The VERTEX Nitinol Staple System is indicated for bone fragments and osteotomy fixation and joint arthrodesis of the hand or foot.
| 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 NECESSARY
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}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for Nvision Biomedical Technologies. The logo features a stylized "N" with horizontal lines emanating from the left side, followed by the word "VISION" in a bold, sans-serif font. Below the main logo, the words "biomedical technologies" are written in a smaller, italicized font, suggesting the company's focus on the biomedical field.
510(k) Summary
DATE PREPARED
April 2, 2019
MANUFACTURER AND 510(k) OWNER
Nvision Biomedical Technologies, Inc. 4754 Shavano Oak, Suite 101 San Antonio, TX 78249, USA Telephone: (210) 545-3713 Fax: (866) 764-1139 Official Contact: Diana Langham, Director of Regulatory and Corporate Compliance
REPRESENTATIVE/CONSULTANT
Jeffrey Brittan Watershed Idea Foundry Telephone: (714) 287-6780 Email: jeffbrittan(@watershedideas.com
PROPRIETARY NAME OF SUBJECT DEVICE
VERTEXTM Nitinol Staple System
COMMON NAME Bone Staple
DEVICE CLASSIFICATION Staple, Fixation, Bone
(Classification Regulations: 21 CFR 888.3030, Product Codes: JDR, Class: II)
PREMARKET REVIEW
ODE/DOD/Joint and Fixation Devices (JFDB2) Orthopedic Panel
INDICATIONS FOR USE
The VERTEX Nitinol Staple System is indicated for bone fragments and osteotomy fixation and joint arthrodesis of the hand or foot.
DEVICE DESCRIPTION
The VERTEX Nitinol Staple System consists of a series of nickel titanium alloy staple implants and the instruments necessary for the treatment of pathologies of the foot and ankle. The VERTEX bone staples are made from superelastic nitinol that does not require cold storage or heating.
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image contains the logo for Nvision biomedical technologies. The logo has a stylized "N" with a series of short, parallel lines extending from the left side of the "N", giving the impression of movement or technology. Below the main logo, the words "biomedical technologies" are written in a smaller, sans-serif font.
PREDICATE DEVICE IDENTIFICATION
| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---|---|---|
| K142111 | Novastep Arcad Compressive Osteosynthesis Staple | ✓ |
| K011716 | New Deal (Integra) Uni-Clip Staple* | |
| K142292 | BioMedical Enterprises, Inc Speed Staple |
The VERTEX Nitinol Staple System is substantially equivalent to the following predicates:
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for the VERTEX Nitinol Staple System. The following tests were performed to demonstrate safety based on recognized consensus standards and current industry practice:
- Static bending, bending fatigue, and pullout (per ASTM F564)
- . Cyclic potentiodynamic polarization testing (per ASTM F2129)
- . Bend and free recovery (BFR) testing (per ASTM F2082)
The results of these tests, as well as engineering analysis of device characteristics, indicate that the VERTEX Nitinol Staple System is substantially equivalent to the predicate devices.
EQUIVALENCE TO PREDICATE DEVICES
Nvision believes that the VERTEX Nitinol Staple System is substantially equivalent to the predicate devices based on the information summarized here:
The subject device has a similar design, similar dimensions, and uses similar or identical materials as the devices cleared in K142111, K011716, and K142292. The subject device also has the same intended use, as well as similar technological characteristics (low profile bone staples with toothed legs in a range of sizes) as these predicates. The Indications for Use are equivalent and these technological characteristics have undergone testing and engineering analysis to ensure the device is as safe and effective as the predicates.
CONCLUSION
Based on the testing performed, including static bending fatigue, and pullout, cvclic potentiodynamic polarization, bend and free recovery as well as engineering analysis of device characteristics. it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed VERTEX Nitinol Staple System are assessed to be substantially equivalent to the predicate devices.
§ 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.