(259 days)
Not Found
No
The summary does not mention AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The software validation follows general software guidance, not specific AI/ML guidance.
Yes
The device is described as an "External Fixation System" intended for "Stabilization of Fractures & Osteotomy," "Adult and Pediatric Leg Lengthening," and "Correction of Bone Deformity." These are therapeutic interventions designed to treat medical conditions or symptoms.
No
The device is described as an external fixation system used for stabilization of fractures, leg lengthening, and correction of bone deformity. Its purpose is mechanical support and correction, not to diagnose a condition.
No
The device description explicitly includes hardware components (External Fixation Rings and Footplates, External Fixation Struts, External Fixation Assembly Accessories) made from stainless steel and aluminum, in addition to the P&C Software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "external fixation" for "Stabilization of Fractures & Osteotomy," "Adult and Pediatric Leg Lengthening," and "Correction of Bone Deformity in Upper & Lower Extremities." These are all procedures performed on the body, not in vitro (outside the body) for diagnostic purposes.
- Device Description: The description details physical components like "External Fixation Rings and Footplates," "External Fixation Struts," and "External Fixation Assembly Accessories." While it mentions "P&C Software," this software is described as a "component of multilateral external fixation system" and is intended for use with the physical fixation system.
- Lack of IVD Indicators: There is no mention of analyzing samples from the human body (like blood, urine, tissue), detecting diseases or conditions, or providing diagnostic information.
In summary, the Vilex X-Fix is an external fixation system used for orthopedic procedures, which falls under the category of medical devices used in vivo (within the body) for treatment or structural support, not in vitro for diagnosis.
N/A
Intended Use / Indications for Use
The Vilex X-Fix is intended for external fixation with the following indications:
-
- Stabilization of Fractures & Osteotomy
-
- Adult and Pediatric Leg Lengthening
-
- Correction of Bone Deformity in Upper & Lower Extremities
The P&C Software is intended to be used as a component of multilateral external fixation system for the indications listed above.
- Correction of Bone Deformity in Upper & Lower Extremities
Product codes (comma separated list FDA assigned to the subject device)
KTT, OSN
Device Description
The X-Fix Line Additions, subject of this 510(k) submission, include External Fixation Rings and Footplates, External Fixation Struts, External Fixation Assembly Accessories, and P&C Software. The line additions are manufactured from stainless steel and aluminum materials in various sizes to accommodate patient needs. The X-Fix Line Additions are used with the X-Fix system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper & Lower Extremities
Indicated Patient Age Range
Adult and Pediatric
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 X-Fix Line Additions were evaluated according to FDA's "Reviewers Guidance Checklist for Orthopedic External Fixation Devices" dated February 21, 1997. Applicable mechanical testing was conducted per ASTM F1541-02 (Sections A6 and A7). All testing confirmed that the device is capable of withstanding expected in vivo loading.
Software verification and validation documentation and testing was completed in conformance with FDA guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff" dated January 11, 2002. The results of software V&V testing indicate that the software performed as intended.
A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the X-Fix Line Additions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Smith & Nephew’s Taylor Spatial Frame (K110069, K093047, and K970748), Smith & Nephew’s Ilizarov External Fixator (K870961), Orthofix’s TL-HEX Truelok Hexapod System (K141078), Vilex’s X-Fix (K052196)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are oriented to the right. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the image of the faces.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 24, 2016
Vilex in Tennessee, Incorporated % Abraham Lavi, Ph.D. Consultant Vilex, Incorporated 8374 Market Street, #167 Lakewood Ranch, Florida 34202
Re: K151881
Trade/Device Name: X-Fix Line Additions Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT. OSN Dated: February 19, 2016 Received: February 22, 2016
Dear Dr. 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. 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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K151881 - Page 1 of 1
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INDICATIONS FOR USE
510(k) NUMBER: K151881
DEVICE NAME: X-Fix Line Additions
INDICATIONS FOR USE:
The Vilex X-Fix is intended for external fixation with the following indications:
-
- Stabilization of Fractures & Osteotomy
-
- Adult and Pediatric Leg Lengthening
-
- Correction of Bone Deformity in Upper & Lower Extremities
The P&C Software is intended to be used as a component of multilateral external fixation system for the indications listed above.
× Prescription Use __ (Per 21 CFR 801.109)
Concurrence of CDRH, Office of Device Evaluation (DOE)
Page 1 of 1
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| 510(k) Summary | K151881 |
|---|---|
| Sponsor: | Vilex in Tennessee, Inc. |
| 111 Moffitt Street | |
| McMinnville, TN 37110 | |
| Phone: (931) 474-7550 | |
| Fax: (931) 474-7551 | |
| Contact: | Abraham Lavi |
| Date Prepared: | March 17, 2016 |
| Trade Name: | X-Fix Line Additions |
| Common Name: | External Fixation System |
| Classification: | 888.3030 Single/multiple component metallic bone fixation |
| appliances and accessories | |
| Product Code: | KTT/OSN/Orthopedics, Class II |
| Predicate Devices: | Smith & Nephew's Taylor Spatial Frame (K110069, K093047, and K970748) |
| Smith & Nephew's Ilizarov External Fixator (K870961) | |
| Orthofix's TL-HEX Truelok Hexapod System (K141078) | |
| Vilex's X-Fix (K052196) |
Description of Device:
The X-Fix Line Additions, subject of this 510(k) submission, include External Fixation Rings and Footplates, External Fixation Struts, External Fixation Assembly Accessories, and P&C Software. The line additions are manufactured from stainless steel and aluminum materials in various sizes to accommodate patient needs. The X-Fix Line Additions are used with the X-Fix system.
Indications for Use:
The Vilex X-Fix is intended for external fixation with the following indications:
-
- Stabilization of Fractures & Osteotomy
-
- Adult and Pediatric Leg Lengthening
-
- Correction of Bone Deformity in Upper & Lower Extremities
The P&C Software is intended to be used as a component of multilateral external fixation system for the indications listed above.
4
Technological Characteristics:
The technological characteristics for the X-Fix Line Additions are the same as the characteristics of the predicate devices. The line additions are manufactured in similar sizes and designs as the predicate devices. In addition, the line additions are manufactured from the same materials as the predicate devices.
Performance Data:
The X-Fix Line Additions were evaluated according to FDA's "Reviewers Guidance Checklist for Orthopedic External Fixation Devices" dated February 21, 1997. Applicable mechanical testing was conducted per ASTM F1541-02 (Sections A6 and A7). All testing confirmed that the device is capable of withstanding expected in vivo loading.
Software verification and validation documentation and testing was completed in conformance with FDA guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff" dated January 11, 2002. The results of software V&V testing indicate that the software performed as intended.
A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the X-Fix Line Additions.
Clinical data was not needed to support the safety and effectiveness of the X-Fix Line Additions.
Substantial Equivalence
The design features of the X-Fix Line Additions are substantially equivalent to the design features of other predicate devices previously cleared for market. The methods used to establish equivalence are based on the comparison of the intended use, product technical characteristics, performance characteristics, and mechanical testing. The safety and effectiveness of the X-Fix Line Additions are adequately supported by the substantial equivalence information, material information, analysis data, and testing provided within this Premarket Notification. Therefore, it is concluded that the X-Fix Line Additions are substantially equivalent to the noted predicate devices.
Conclusions
While the X-Fix Line Additions are not identical to the predicate devices, any differences that may exist do not significantly affect device safety and effectiveness. In addition, the differences do not add new or increased risks and complications. Therefore, it is concluded that the X-Fix Line Additions are substantially equivalent to the predicate devices as outlined previously and should not render the subject device NSE.