K945105 · Micromed Development Corp. · ETB · May 14, 1996 · Ear, Nose, Throat
Device Facts
Record ID
K945105
Device Name
POLY/PLATINUM WIRE PISTON
Applicant
Micromed Development Corp.
Product Code
ETB · Ear, Nose, Throat
Decision Date
May 14, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 874.3450
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Poly/Platinum Pistons are intended for the elective reconstruction of the ossicular chain to facilitate conduction of sound energy from the ear drum to the inner ear. The prosthesis is implanted into the middle ear during a tympanoplasty procedure and is retained in the middle ear by the design configuration of the device.
Device Story
Middle ear implant; used for ossicular chain reconstruction; facilitates sound conduction from eardrum to inner ear. Device consists of shaft with loop for ossicular attachment. Implanted during tympanoplasty by qualified healthcare professional. Single-patient use; sterile packaged. Solid ultra-high molecular weight polyethylene (UHMWPe) shaft; platinum component. Retained in middle ear via design configuration.
Clinical Evidence
No clinical data; bench testing only.
Technological Characteristics
Middle ear prosthesis; materials: solid ultra-high molecular weight polyethylene (UHMWPe) and platinum. Design: shaft with loop for ossicular attachment. Sterile packaged; single-patient use.
Indications for Use
Indicated for patients requiring elective ossicular chain reconstruction during tympanoplasty to facilitate sound conduction from the eardrum to the inner ear.
Regulatory Classification
Identification
A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. The device is made of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.
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TreBay Medical Corporation
K945105
MAY 14 1996
K 945105
510(k) Summary of Safety and Effectiveness
Submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
TreBay Medical Corporation
Poly/Platinum Pistons
1. Description
Poly/Platinum Pistons are implants for middle ear reconstruction. Available in a range of shaft diameters and lengths with loops for ossicular attachment. The device is a single patient use only implant, labeled as a restricted device for use only by a qualified health care professional and is individually sterile packaged, contained in a carton provided with an Important Product Information insert for the physician.
2. Identification of the Predicate Device
The Poly/Platinum Pistons are substantially equivalent in material, size, and design with the Plast-Pore pistons of Smith-Nephew Richards, Memphis, TN, differing in the ultra high molecular weight polyethylene material is solid, not porous as with the Plasti-Pore pistons, and are substantially equivalent to the fluoroplastic shaft Platinum pistons of Xomed, Inc., Jacksonville, FL.
3. Intended Use
The Poly/Platinum Pistons are intended for the elective reconstruction of the ossicular chain to facilitate conduction of sound energy from the ear drum to the inner ear. The prosthesis is implanted into the middle ear during a tympanoplasty procedure and is retained in the middle ear by the design configuration of the device.
4. Information Bearing on the Safety and Effectiveness
The Poly/Platinum Pistons have the same intended use and similar materials as the predicate devices. The use of solid UHMWPe (polyethylene) in the shaft of the piston is the difference in the material as the predicate devices use solid fluoroplastic or porous high density polyethylene. There are no additional characteristics known that should adversely affect the safety and effectiveness. The package insert provided with each device should be referred to for indications and patient information regarding the use of these implants.
Signature ___________________________ Date October 16, 1995
Dan H. Treace, Vice-President
4911 Creekside Drive ♦ Clearwater, Florida 34620 ♦ Phone: 813-572-5555 ♦ Fax: 813-572-5444
