(377 days)
The Vilex eZ-Staple (Superelastic Bone Fixation Staple) is indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.
The Vilex memory bone fixation staples (eZ-Staple) are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.
The Vilex eZ-Staple Superelastic Bone Fixation Staple is a single-use bone fixation appliance intended to be permanently implanted. Super Elastic staples are compression staples made of shape memory nickel titanium alloy, Nitinol. Vilex will offer Monocortical Staples ranging in width from 10mm to 20mm with leg lengths ranging from 10mm to 20mm and Biocortical Staples ranging in width from 10mm to 18mm with leg lengths from 15x13 to 19x17.
The provided text describes a 510(k) summary for the Vilex eZ-Staple Superelastic Bone Fixation Staple. This document outlines the device's characteristics, intended use, and the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device. It does not contain information about clinical studies, acceptance criteria for device performance based on human reader studies, or details about ground truth establishment with expert consensus.
Therefore, I cannot provide a table of acceptance criteria and device performance as no such criteria or clinical performance data are presented in the document.
Based on the provided text, here's what can be inferred and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Non-Clinical Test Data: • Cytotoxicity (MEM Elution) - No specific performance metrics provided, but expected to be within acceptable limits for biocompatibility. • Genotoxicity (Ames Assay) - No specific performance metrics provided, but expected to be within acceptable limits for biocompatibility. • Intracutaneous Reactivity - No specific performance metrics provided, but expected to be within acceptable limits for biocompatibility. • Acute Systemic Toxicity - No specific performance metrics provided, but expected to be within acceptable limits for biocompatibility. • Material-Mediated Pyrogenicity - No specific performance metrics provided, but expected to be within acceptable limits for biocompatibility. • Corrosion Susceptibility - Tested against predicate device, implied comparable performance. • Auger Electron Spectroscopy of Oxide Layer - Tested against predicate device, implied comparable characteristics. • Pullout Strength - Tested against predicate device, implied comparable performance. • Static Bending Stiffness - Tested against predicate device, implied comparable performance. • Dynamic Bending Fatigue Life - Tested against predicate device, implied comparable performance. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable. The provided document details non-clinical laboratory testing, not clinical trials with "test sets" in the context of diagnostic or AI performance.
- Data Provenance: Not applicable for clinical data. The non-clinical tests were performed on "samples of the Vilex eZ-Staple." The country of origin of the data is not specified beyond being part of a U.S. FDA 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. This device is a bone fixation staple, not a diagnostic or AI device requiring expert-established ground truth for performance evaluation in the context of clinical images or data.
4. Adjudication Method for the Test Set:
- Not applicable. There is no mention of a test set requiring adjudication in the context of clinical evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. The document describes non-clinical testing of a bone fixation staple, not an AI or diagnostic device that would typically undergo an MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Not applicable. This is a medical implant, not an algorithm or AI device.
7. The Type of Ground Truth Used:
- Not applicable in the context of clinical ground truth. For the physical and material properties, the "ground truth" would be established by validated ASTM and ISO standards for material properties and predicate device performance for comparative testing.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI or machine learning device.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. This is not an AI or machine learning device.
In summary, the provided document details a 510(k) submission for a medical implant (bone fixation staple), which primarily relies on non-clinical engineering and material compatibility testing to demonstrate substantial equivalence to a predicate device. It does not involve AI, diagnostic imaging, or human reader studies, and therefore, most of the requested information regarding acceptance criteria and studies in that context is not present.
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510(k) Summary, K112837
| Sponsor | Vilex in Tennessee, Inc., 111 Moffitt St., McMinnville, TN 37110,Phone: 931-474-7550, Fax: 931-474-7551, Email: sylvias@vilex.com |
|---|---|
| Contact | Sylvia Southard |
| Date | September 27, 2012 |
| Device Name | Vilex eZ-Staple Superelastic Bone Fixation Staple |
| Classification | 21 CFR 888.3030 - Single/multiple component metallic bone fixation appliances andaccessoriesProduct Code: JDRRegulatory Class: II |
| Predicate Devices | Memometal Technologies' Memometal Memory Staples - K070031 - (Trade name: MMEasyClip® SI) |
| Description ofDevice | The Vilex eZ-Staple Superelastic Bone Fixation Staple is a single-use bone fixationappliance intended to be permanently implanted. Super Elastic staples arecompression staples made of shape memory nickel titanium alloy, Nitinol. Vilex willoffer Monocortical Staples ranging in width from 10mm to 20mm with leg lengthsranging from 10mm to 20mm and Biocortical Staples ranging in width from 10mm to18mm with leg lengths from 15x13 to 19x17. |
| Material | Titanium-Nickel alloy, Nitinol, for human implanting. ASTM F2063-05 StandardSpecification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devicesand Surgical Implants |
| Indications for Use | The Vilex eZ-Staple (Superelastic Bone Fixation Staple) is indicated for hand and footbone fragments osteotomy fixation and joint arthrodesis. |
| Non-Clinical TestData | Samples of the Vilex eZ-Staple have been tested according to ISO 10993 and applicableFDA regulations for:• Cytotoxicity (MEM Elution)• Genotoxicity (Ames Assay)• Intracutaneous Reactivity• Acute Systemic Toxicity• Material-Mediated PyrogenicityAdditionally, samples of the Vilex eZ-Staple have also been tested to relevant ASTMstandards versus samples of the predicate device for:• Corrosion Susceptibility• Auger Electron Spectroscopy of Oxide Layer• Pullout Strength• Static Bending Stiffness• Dynamic Bending Fatigue Life |
| SubstantialEquivalence | Documentation is provided which demonstrates that the Vilex eZ-Staple is substantiallyequivalent to other legally marketed devices in terms of intended use and indicationsfor use, material, design and function. Any minor differences between these twodevices do not raise new questions of safety and effectiveness. |
| EstablishmentReg. No. | 1051526 |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
OCT
9
2012
Vilex, Inc. % Ms. Sylvia Southard 111 Moffitt Street McMinnville, Tennessee 37110
Re: K112837 Trade/Device Name: Vilex eZ-Staple (Memory Bone Fixation Staple) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories ・ Regulatory Class: II Product Code: JDR Dated: September 27, 2012 Received: September 28, 2012
Dear Ms. Southard:
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. 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 801); medical device reporting (reporting of medical
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Page 2 - Ms. Sylvia Southard
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Mellekerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number: K12837
Device Name: Vilex eZ-Staple (memory bone fixation staple).
Indications for Use:
The Vilex memory bone fixation staples (eZ-Staple) are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K. Asahi.
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112837
Page 1 of 1
§ 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.