(574 days)
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No
The summary describes a passive, mechanical implant for ossicular chain reconstruction and contains no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is intended for the elective reconstruction of the ossicular chain to facilitate the conduction of sound energy, which is a therapeutic purpose.
No
This device is an implantable prosthesis used for the elective reconstruction of the ossicular chain, meaning it helps to restore hearing by physically conducting sound. It does not diagnose conditions but rather treats them.
No
The device description clearly states it is an "implant for middle ear reconstruction" and is a physical "single patient use only implant," indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of the Poly/Platinum Pistons is for the reconstruction of the ossicular chain within the middle ear to facilitate sound conduction. This is a surgical implant, not a device used to test or analyze biological samples.
- The device description clearly states it is an implant. Implants are surgically placed within the body, which is fundamentally different from the function of an IVD.
The information provided describes a surgical implant used for middle ear reconstruction, not a diagnostic test performed on a specimen.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
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Device 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
middle ear
Indicated Patient Age Range
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Intended User / Care Setting
qualified health care professional
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 874.3450 Partial ossicular replacement prosthesis.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for TreBay Medical Corporation. The logo consists of a geometric shape to the left of the company name. The geometric shape is a hexagon with a dot in the center and lines radiating outward. The company name is in bold, black letters, with the word "Medical Corporation" in smaller letters below.
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