(80 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and material (nitinol) of the staple, with no mention of AI or ML technologies.
Yes
The device is described as a bone fixation appliance intended to facilitate osteotomy fixation and joint arthrodesis, which are therapeutic medical procedures.
No
Explanation: The device is a bone fixation appliance intended for surgical use to fix bone fragments and facilitate joint arthrodesis, not to diagnose a condition.
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.
Based on the provided information, the NITINEX Memory Compression Staple is not an IVD (In Vitro Diagnostic) device.
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 described as a "single-use bone fixation appliance intended to be permanently implanted." This is a medical device used for structural support within the body.
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. The NITINEX staple does not perform this function.
The NITINEX Memory Compression Staple is a surgical implant, not a diagnostic tool used outside the body.
N/A
Intended Use / Indications for Use
The NITINEX Memory Compression Staple is intended for hand and foot bone fragments osteotomy fixation and joint arthrodesis.
Product codes
JDR
Device Description
The NITINEX Memory Compression Staple is a single-use bone fixation appliance intended to be permanently implanted. The implantation of the NITINEX Memory Compression Staple facilitates hand and foot bone fragment osteotomy fixation and joint arthrodesis. NITINEX Staples are compression staples made of shape memory nickel titanium alloy, nitinol. Vilex LLC will offer NITINEX Staples ranging in width from 8-mm to 30-mm with leg lengths ranging from 8-mm to 30-mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand and foot
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)
The following nonclinical tests were performed to demonstrate the substantial equivalence of the subject device to the predicate device:
- Static Pullout Testing per ASTM F564-17
- Bend Testing per ASTM F564-17
- Cyclic Polarization Corrosion Testing per ASTM F2129-19a
The mechanical tests evaluated samples from the NITINEX Memory Compression Staple against the predicate device. All tests demonstrated that the subject device performs equivalently to the predicate device. Therefore, the NITINEX Memory Compression Staple is substantially equivalent to the predicate device with respect mechanical strength and performance.
The corrosion testing demonstrated the corrosion resistance of the subject device. The NITINEX Memory Compression Staple was shown to meet equivalent corrosion resistance criteria as the predicate device.
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.
0
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, 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.
August 11, 2023
Vilex, LLC Brock Johnson President 111 Moffitt Street McMinnville, Tennessee 37110
Re: K231493
Trade/Device Name: NITINEX Memory Compression Staple 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: August 9, 2023 Received: August 10, 2023
Dear Brock Johnson:
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
1
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/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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/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).
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
Submission Number (if known)
Device Name
NITINEX Memory Compression Staple
Indications for Use (Describe)
The NITINEX Memory Compression Staple is intended for hand and 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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Traditional 510(k)
510(k) SUMMARY
| Device Trade Name | NITINEX Memory Compression Staple |
|---|---|
| Date | August 9, 2023 |
| Sponsor | Vilex, LLC |
| 111 Moffitt Street | |
| McMinnville, TN 37110 | |
| Contact Person | Brock Johnson |
| President | |
| (801)916-4157 | |
| brock.johnson@vilex.com | |
| Device Common Name | NITINEX Memory Compression Staple |
| Regulatory Class | Class II |
| Product Code | JDR |
| Classification Name | Staple, Fixation, Bone |
| Regulation | 21 CFR 888.3030 |
| Regulation Name | Single/multiple component metallic bone fixation |
| appliances and accessories | |
| Device Regulation Panel | Orthopedic |
| Predicate Device | K112837, Vilex eZ-Staple Superelastic Bone Fixation |
| Staple |
Device Description:
The NITINEX Memory Compression Staple is a single-use bone fixation appliance intended to be permanently implanted. The implantation of the NITINEX Memory Compression Staple facilitates hand and foot bone fragment osteotomy fixation and joint arthrodesis. NITINEX Staples are compression staples made of shape memory nickel titanium alloy, nitinol. Vilex LLC will offer NITINEX Staples ranging in width from 8-mm to 30-mm with leg lengths ranging from 8-mm to 30-mm.
Indications for Use:
The NITINEX Memory Compression Staple is intended for hand and foot bone fragments osteotomy fixation and joint arthrodesis.
The indications for use of the NITINEX Memory Compression Staple are identical to those of the predicate device (K112837).
Technological Characteristics:
The NITINEX Memory Compression Staple is substantially equivalent to the predicate devices cleared under K112837. The NITINEX Memory Compression Staple has identical indications for use, basic designs, fundamental scientific principles of operation, and implant materials as the predicate device.
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NITINEX Memory Compression Staple
Traditional 510(k)
The NITINEX Memory Compression Staple has a thicker staple bridge and different teeth size and spacing than the predicate device.
The NITINEX Memory Compression Staple System contains a sizer instrument to aid the surgeon in determining the appropriate size implant to use on the patient. The NITINEX Memory Compression Staple System also contains long drills and short drills to form snowmanshaped holes to aid in insertion. The predicate devices do not contain a sizer or long drills.
The NITINEX Memory Compression Staple System uses instruments that are composed of a nylon material and stainless steel. The predicate devices use instruments composed of stainless steel.
The NITINEX Memory Compression Staple is provided sterile to the end user and is intended for single use only. The predicate devices require end user sterilization prior to use and are intended for single use only.
The differences between the NITINEX Memory Compression Staple and the predicate devices are considered minor and raise no questions of safety or effectiveness. Therefore, the NITINEX Memory Compression Staple is substantially equivalent to the predicate device.
Assessment of performance data:
The following nonclinical tests were performed to demonstrate the substantial equivalence of the subject device to the predicate device:
- Static Pullout Testing per ASTM F564-17
- Bend Testing per ASTM F564-17
- Cyclic Polarization Corrosion Testing per ASTM F2129-19a
The mechanical tests evaluated samples from the NITINEX Memory Compression Staple against the predicate device. All tests demonstrated that the subject device performs equivalently to the predicate device. Therefore, the NITINEX Memory Compression Staple is substantially equivalent to the predicate device with respect mechanical strength and performance.
The corrosion testing demonstrated the corrosion resistance of the subject device. The NITINEX Memory Compression Staple was shown to meet equivalent corrosion resistance criteria as the predicate device.
Conclusion:
Based upon the similarities between the subject and the predicate devices, the NITINEX Memory Compression Staple is substantially equivalent to the predicate device. The technological differences between the subject and predicate devices are considered minor. The similarities in technological characteristics and the performance data demonstrate substantial equivalence.