(103 days)
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The device description is also not available, which would be a key place to find such information.
Yes
The device is described as an external fixation device used for medical purposes such as stabilizing fractures, arthrodesis, leg lengthening, and correcting bone deformities, all of which are therapeutic interventions.
No
The device is described as an external fixation device used for stabilization, lengthening, and correction of bone deformities, which are therapeutic interventions rather than diagnostic processes.
No
The device description is not found, but the intended use clearly describes an external fixation device, which is a hardware device used to stabilize bones.
Based on the provided information, the Vilex X-Fix is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes the device's function as an external fixation system for stabilizing fractures, performing arthrodesis, leg lengthening, and correcting bone deformities. These are all procedures performed on the body, not on samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on sample analysis
- Using reagents or assays
- Anatomical Site: The anatomical sites mentioned (Rear & Mid-foot, Upper & Lower Extremities) are locations on the body where the device is applied, not where samples are collected.
In summary, the Vilex X-Fix is a surgical device used for external fixation, which is a type of medical device used in vivo (on the body), not in vitro (in a lab setting on samples).
N/A
Intended Use / Indications for Use
The Vilex X-Fix is intended for external fixation with the following indications:
- Stabilization of Fractures & Osteotomy
- Rear & Mid-foot Foot Arthrodesis
- Adult and Pediatric Leg Lengthening
- Correction of Bone Deformity in Upper & Lower Extremities.
Product codes (comma separated list FDA assigned to the subject device)
KTT, JDW
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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.
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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K052196 Page 1/1
Image /page/0/Picture/2 description: The image shows the logo for Vilex Inc. The logo consists of the word "VILEX" in a bold, stylized font, with the letters connected and a line underneath. To the right of the logo is the abbreviation "Inc." The text below the logo states that Vilex is a manufacturer of bone implants, power equipment, and surgical instruments.
Phone: (412) 655-7550
FAX: (412) 655-7551 www.vilex.com
345 Old Curry Hollow Road
Pittsburgh, PA 15236 USA
E-mail: info@vilex.com
510(K) SUMMARY SUMMARY
Vilex External Fixation System, X-Fix
| Date of submission | 6/7/05 |
|---|---|
| Type of submission | 510(k) |
| Reason for submission | New device |
| Product Code | KTT, JDW CFR-21 888.3030, CFR-21 888.3040 |
| Device Class | I |
| Classification Panel | Orthopedics |
| Predicate Devices: | |
| K043174 | |
| K955848 | |
| K970290 | R&R Medical, Inc. |
| Orthofix | |
| EBI | |
| Common/Generic | External Ring Fixation |
| Device Trade Name | Vilex External Fixation System, X-Fix |
| Establishment Reg. No. | 2529556 |
| Owner Operator No. | 9004058 |
| Establishment | |
| Operations | Manufacturer |
| Indication for Use | The Vilex X-Fix is intended for external fixation with the following indications: |
- Stabilization of Fractures & Osteotomy
- Rear & Mid-foot Foot Arthrodesis
- Adult and Pediatric Leg Lengthening
- Correction of Bone Deformity in Upper & Lower Extremities. |
| Submitter | A. Lavi |
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features the HHS emblem, which is a stylized representation of a human figure. The emblem is accompanied by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 2 2005
Dr. Abraham Lavi, Ph.D., M.B.A. President Vilex, Inc. 345 Old Curry Hollow Road Pittsburgh, Pennsylvania 15236
Re: K052196
Trade/Device Name: X-Fix Regulation Number: 21 CFR 888.3030 Regulation Name: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Regulatory Class: II Product Codes: KTT, JDW Dated: October 05, 2005 Received: October 27, 2005
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
2
Page 2 - Dr. Abraham Lavi, Ph.D., M.B.A.
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Z
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the logo for VILEX Inc. The logo is in a rectangular box with the word "VILEX" in bold, black letters. The letters are stylized, with the "I" and "E" connected by a horizontal line. To the right of the box, the word "Inc." is written in a smaller, non-bold font.
Manufacturer of Vilex™ bone implants, Power equipment & surgical instruments.
Phone: (412) 655-7550 FAX: (412) 655-7551 www.vilex.com
345 Old Curry Hollow Road Pittsburgh, PA 15236 USA E-mail: info@vilex.com
INDICATIONS FOR USE:
510(K) NUMBER: K052196
DEVICE NAME: VILEX EXTERNAL FIXATION SYSTEM
Indications for Use:
The Vilex X-Fix is intended for external fixation with the following indications:
- Stabilization of Fractures & Osteotomy
-
- Rear & Mid-foot Foot Arthrodesis
-
- Adult and Pediatric Leg Lengthening
-
- Correction of Bone Deformity in Upper & Lower Extremities.
X Prescription Use: (21 CFR 801 Subpart D)
Over-The-Counter Use NONE (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)
ﺨﻴﻠﻮ
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number [C052196