(77 days)
The Bone Screw Line Addition is intended to be used for the following indications:
- · Bone fractures
- o Jones fractures
- o Acute fractures
- o Avulsion fractures
- o Repetitive stress fractures
- o Malleolar fractures
- o Talus fractures
- o Greater tuberosity fractures
· Fixation of malunions and non-unions
- · Osteotomies
- · Arthrodesis
The Vilex Bone Screw Line Addition includes an implantable device system intended for fixation of bone fractures and osteotomies of the upper and lower extremities. The Bone Screw Line Addition (BSLA) system consists of cannulated and solid screws. The implants are offered fully or partially threaded and in 4.5, 5.5, and 6.0 mm thread diameters. The BSLA implants are fabricated from either titanium or stainless steel.
Based on the provided text, the device is a medical implant (Bone Screw Line Addition) intended for bone fixation, and the document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance criteria through clinical or analytical studies as one might find for an AI/Software as a Medical Device (SaMD).
Therefore, the provided document DOES NOT contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria in the context of an AI/SaMD. This document describes a physical medical device and its mechanical equivalence to existing devices.
The sections for AI/SaMD performance (e.g., sample sizes, expert ground truth, MRMC studies, training set details) are not applicable to this type of device and submission.
However, I can extract the information that is present and explain why the other requested information is not available in this document.
Acceptance Criteria and Device Performance (for a physical Bone Screw Line Addition)
Since this is a physical medical device (bone screw) and not AI/SaMD, the "acceptance criteria" are related to its mechanical performance and substantial equivalence to legally marketed predicate devices, as assessed through engineering analyses.
- Acceptance Criteria: The device must demonstrate mechanical equivalence (e.g., torsional strength, shear strength, bending strength, pull-out strength) to the cleared predicate devices and not introduce any new questions of safety or effectiveness due to differences in technological characteristics (e.g., thread form, screw head geometry).
- Reported Device Performance: "Engineering analyses demonstrated that the BSLA does not introduce an added risk when compared to the cleared predicate devices. Analysis was used to demonstrate substantially equivalent mechanical strength (i.e., torsional strength, shear strength, bending strength, and pull out strength)."
Why the requested AI/SaMD information is not in this document:
This document is a 510(k) summary for a physical medical device, not a software or AI-driven diagnostic/therapeutic device. The FDA's requirements for demonstrating substantial equivalence for a physical device like a bone screw typically involve:
- Comparison of technological characteristics: Material, design, mechanical performance, intended use.
- Performance data: Often bench testing (mechanical strength, durability) and sometimes biocompatibility testing.
- No clinical trials are usually required if substantial equivalence can be demonstrated through non-clinical means.
Therefore, the specific quantitative details about "acceptance criteria" and "study that proves the device meets acceptance criteria" as defined for AI/SaMD (e.g., sensitivity, specificity, AUC, human reader improvement) are not relevant to this submission type and are not present in the provided text.
Absence of Requested Information (Specific to AI/SaMD):
- A table of acceptance criteria and the reported device performance: As explained above, for this physical device, the "acceptance criteria" are related to mechanical equivalence to predicates, not specific numerical diagnostic performance metrics. The performance is stated as "substantially equivalent mechanical strength."
- Sample sizes used for the test set and the data provenance: Not applicable. No test set of patient data (e.g., images) was used for performance validation in the AI/SaMD sense. This involves mechanical testing or analyses, not patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy is not relevant for a bone screw.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This is not an AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable. No training set for an AI model.
- How the ground truth for the training set was established: Not applicable.
In conclusion, the document describes the FDA 510(k) clearance process for a physical medical device (bone screw) based on substantial equivalence principles, which are fundamentally different from the performance evaluation requirements for AI/SaMD.
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Image /page/0/Picture/0 description: The image shows the date July 29, 2019. The text is written in a clear, sans-serif font. The date is likely extracted from a document or image, indicating a specific date of relevance.
Vilex in Tennessee, Inc Victor Lavi Executive Vice President 111 Moffitt Street McMinnville, Tennessee 37110
Re: K191289
Trade/Device Name: Bone Screw Line Addition Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, HTN Dated: May 8, 2019 Received: May 13, 2019
Dear Victor Lavi:
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
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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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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,
Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma 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
510(k) Number (if known) K191289
Device Name
Bone Screw Line Addition
Indications for Use (Describe)
The Bone Screw Line Addition is intended to be used for the following indications:
- · Bone fractures
- o Jones fractures
- o Acute fractures
- o Avulsion fractures
- o Repetitive stress fractures
- o Malleolar fractures
- o Talus fractures
- o Greater tuberosity fractures
· Fixation of malunions and non-unions
- · Osteotomies
- · Arthrodesis
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Bone Screw Line Addition
l. Submitter:
Vilex in Tennessee, Inc. 111 Moffitt Street McMinnville, TN 37110
Contact Person: Victor Lavi Executive VP Email: info@vilex.com Phone: 931-474-7550
Date of Summary: July 2, 2019
II: Device
| Proprietary Name: | Bone Screw Line Addition (BSLA) |
|---|---|
| Common Name: | Screw, Fixation, Bone |
| Regulatory Class: | Class II |
| Regulation: | 21 CFR 888.3040 Smooth or Threaded Metallic BoneFixation Fastener |
| Device Product Codes: | HWC, HTN |
| Panel: | Orthopedic |
III. Predicate Devices
| Device | Manufacturer | 510(k) No. | Clearance Date |
|---|---|---|---|
| Primary predicate | |||
| Vilex/Orthex/Duval Cannulated BoneScrew | Vilex, Inc. | K991197 | 04/26/1999 |
| Predicates | |||
| Charlotte Carolina Jones FractureSystem Screw | Wright MedicalTechnology, Inc. | K140952 | 05/15/2014 |
| Asnis JFX System | Stryker TraumaAG | K153154 | 12/28/2015 |
IV. Device Description
The Vilex Bone Screw Line Addition includes an implantable device system intended for fixation of bone fractures and osteotomies of the upper and lower extremities. The Bone
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510(k) Summary
Bone Screw Line Addition
Screw Line Addition (BSLA) system consists of cannulated and solid screws. The implants are offered fully or partially threaded and in 4.5, 5.5, and 6.0 mm thread diameters. The BSLA implants are fabricated from either titanium or stainless steel.
V. Intended Use
The Bone Screw Line Addition is intended to be used for the following indications:
- . Bone fractures
- o Jones fractures
- o Acute fractures
- o Avulsion fractures
- Repetitive stress fractures o
- Malleolar fractures o
- o Talus fractures
- o Greater tuberosity fractures
- Fixation of malunions and non-unions ●
- Osteotomies
- Arthrodesis
VI. Comparison of Technological Characteristics with the Predicate Devices
The BSLA is technologically substantially equivalent to predicate devices in terms of intended use, material, design, mechanical performance and safety. The BSLA is manufactured from the same materials as the listed predicate devices. Screws have similar lengths and similar diameters. Washers have similar inner and outer diameters. The Vilex BSLA devices differ slightly in thread form and screw head geometry from the predicate devices. Analyses confirmed that the BSLA is substantially equivalent when compared to the predicate devices. The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness.
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Bone Screw Line Addition
VII. Performance Data
Engineering analyses demonstrated that the BSLA does not introduce an added risk when compared to the cleared predicate devices. Analysis was used to demonstrate substantially equivalent mechanical strength (i.e., torsional strength, shear strength, bending strength, and pull out strength).
Analyses and evaluation concluded that the subject BSLA is substantially equivalent to the predicate devices.
VIII. Conclusions
A review of the device indications, material composition, bone screw and washer design, and technological characteristics confirmed that the BSLA are substantially equivalent to the predicate devices. While the BSLA are not identical to the predicate devices, comparisons of the subject and predicate devices confirmed that any differences in technological characteristics do not raise different questions of safety and effectiveness than the predicate device. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate devices. Therefore, it is concluded that the Bone Screw Line Addition is substantially equivalent to the predicate devices.
§ 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.