Who is the manufacturer of POLY/PLATINUM WIRE PISTON?

Micromed Development Corp. submitted the Traditional clearance for POLY/PLATINUM WIRE PISTON (K945105).

What is the FDA product code for POLY/PLATINUM WIRE PISTON?

ETB. It is classified under 21 CFR 874.3450 as a Class 2 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for POLY/PLATINUM WIRE PISTON?

510(k) clearance (submission type: Traditional).

What are the predicate devices for POLY/PLATINUM WIRE PISTON?

Plasti-Pore pistons (Smith-Nephew Richards); Fluoroplastic shaft Platinum pistons (Xomed, Inc.).

POLY/PLATINUM WIRE PISTON

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

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.

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.

Predicate Devices

Plasti-Pore pistons (Smith-Nephew Richards)
Fluoroplastic shaft Platinum pistons (Xomed, Inc.)

Related Devices

K993234 — MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS · Micromedics, Inc. · Nov 10, 1999
K083780 — SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2 · Audio Technologies S.R.L. · Mar 23, 2009
K030492 — TITANIUM OSSICULAR REPLACMENT SYSTEM · Invotec International, Inc. · Mar 3, 2003
K091187 — GRACE DYNAMIC TORP · Grace Medical, Inc. · Sep 14, 2009
K060518 — PARTIAL OSSICULAR REPLACEMENT PROSTHESES · Grace Medical, Inc. · Jun 28, 2006

Submission Summary (Full Text)

{0} 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