← Product Code [ETB](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETB) · K945105 # POLY/PLATINUM WIRE PISTON (K945105) _Micromed Development Corp. · ETB · May 14, 1996 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETB/K945105 ## Device Facts - **Applicant:** Micromed Development Corp. - **Product Code:** [ETB](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETB.md) - **Decision Date:** May 14, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 874.3450 - **Device Class:** Class 2 - **Review Panel:** Ear, Nose, Throat - **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. ## Regulatory 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.) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETB/K945105](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETB/K945105) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com