VILEX BONE PLATE SYSTEM

• K Number: K041287
• Device Name: VILEX BONE PLATE SYSTEM
• Manufacturer: VILEX, INC.
• Date Cleared: 2004-08-05 ( 84 days)
• Product Code: HWC
• Regulation Number: 888.3040
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: N/A
• Predicate For: K200108 , K210534 , K212348 , K221342

Intended Use

Small-Bone Fracture and Osteotomy in Upper & Lower Extremities, primarily hand, foot, and digits.

Device Description

The material used to manufacture the bone plates is implant-quality 316L Stainless (ASTM Fric material used to manufacture (ASTM F-136). The plates are to be used with accompanying bone screws of the same material.

AI/ML Overview

I am sorry, but the provided text from the FDA letter regarding the Vilex Bone Plate Systems does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) clearance letter, which states that the device is substantially equivalent to a legally marketed predicate device. This type of clearance focuses on equivalence rather than performance against specific acceptance criteria from a clinical study.

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and reported device performance.
2. Sample sized used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a stylized bird-like figure at the top. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 5 2004

Abraham Lavi, Ph.D., MBA President Vilex, Inc. 345 Old Curry Hollow Road Pittsburgh, Pennsylvania 15236

Re: K041287

Trade/Device Name: Vilex Bone Plate Systems Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: May 10, 2004 Received: May 24, 2004

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 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.

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Page 2 -- Abraham Lavi, Ph.D., MBA

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Mark H. Milliken

Celia M. Witten, Ph.D., M.D. 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/2/Picture/0 description: The image shows the word "VILEX" in a stylized, bold font, with the letters connected and slightly slanted. Below the word "VILEX" is the word "Inc.", which is an abbreviation for Incorporated. The text is black and is set against a white background.

Manufacturer of Vilex™ bone implants, Power equipment & surgical instruments. Phone: [phone] FAX: [phone] www.vilex.com

345 Old Curry Hollow Road Pittsburgh, PA 15236 USA E-mail: [e-mail]

510 (K) NUMBER K 041687

DEVICE NAME: Vilex Bone Plate Systems

INDICATIONS FOR USE:

The Vilex Bone Plates have the following Indications for Use:

Small-Bone Fracture and Osteotomy in Upper & Lower Extremities, primarily hand, foot, and digits.

Contra Indications: Elbow, Shoulder, Knee, Hip, Spine, Neck, & Skull

The material used to manufacture the bone plates is implant-quality 316L Stainless (ASTM Fric material used to manufacture (ASTM F-136). The plates are to be used with accompanying bone screws of the same material.

Prescription Use _x (Per 21 CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE

f Device Evaluation (ODE)

Mark N Mulkern

Page __ 1 __ of ______________________________________________________________________________________________________________________________________________________________ 1

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510(k) Number K041287

Regulation Number and Section

§ 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.