(377 days)
Not Found
No
The summary describes a physical implantable device made of Nitinol for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a "bone fixation appliance intended to be permanently implanted" for "osteotomy fixation and joint arthrodesis" in hand and foot bone fragments, which indicates it restores or replaces a physiological function.
No
Explanation: The Vilex eZ-Staple is described as a "bone fixation appliance intended to be permanently implanted" for "osteotomy fixation and joint arthrodesis." Its function is structural support and fixation, not diagnosis. The performance studies listed are biocompatibility and mechanical tests, not diagnostic accuracy validations.
No
The device description clearly states it is a "single-use bone fixation appliance intended to be permanently implanted" and is made of "shape memory nickel titanium alloy, Nitinol." This describes a physical, implantable hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "hand and foot bone fragments osteotomy fixation and joint arthrodesis." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "single-use bone fixation appliance intended to be permanently implanted." This is a physical implant used in surgery.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
This device is clearly an implantable surgical device, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Vilex eZ-Staple (Superelastic Bone Fixation Staple) is indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.
Product codes
JDR
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand and 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)
Samples of the Vilex eZ-Staple have been tested according to ISO 10993 and applicable FDA regulations for:
• Cytotoxicity (MEM Elution)
• Genotoxicity (Ames Assay)
• Intracutaneous Reactivity
• Acute Systemic Toxicity
• Material-Mediated Pyrogenicity
Additionally, samples of the Vilex eZ-Staple have also been tested to relevant ASTM standards versus samples of the predicate device for:
• Corrosion Susceptibility
• Auger Electron Spectroscopy of Oxide Layer
• Pullout Strength
• Static Bending Stiffness
• Dynamic Bending Fatigue Life
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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OCT 9 2012
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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 and
accessories
Product Code: JDR
Regulatory Class: II |
| Predicate Devices | Memometal Technologies' Memometal Memory Staples - K070031 - (Trade name: MM
EasyClip® SI) |
| Description of
Device | 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. |
| Material | Titanium-Nickel alloy, Nitinol, for human implanting. ASTM F2063-05 Standard
Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices
and Surgical Implants |
| Indications for Use | The Vilex eZ-Staple (Superelastic Bone Fixation Staple) is indicated for hand and foot
bone fragments osteotomy fixation and joint arthrodesis. |
| Non-Clinical Test
Data | Samples of the Vilex eZ-Staple have been tested according to ISO 10993 and applicable
FDA regulations for:
• Cytotoxicity (MEM Elution)
• Genotoxicity (Ames Assay)
• Intracutaneous Reactivity
• Acute Systemic Toxicity
• Material-Mediated Pyrogenicity
Additionally, samples of the Vilex eZ-Staple have also been tested to relevant ASTM
standards versus samples of the predicate device for:
• Corrosion Susceptibility
• Auger Electron Spectroscopy of Oxide Layer
• Pullout Strength
• Static Bending Stiffness
• Dynamic Bending Fatigue Life |
| Substantial
Equivalence | Documentation is provided which demonstrates that the Vilex eZ-Staple is substantially
equivalent to other legally marketed devices in terms of intended use and indications
for use, material, design and function. Any minor differences between these two
devices do not raise new questions of safety and effectiveness. |
| Establishment
Reg. 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
2
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
3
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
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