(205 days)
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No
The summary describes a physical prosthesis for ossicular chain reconstruction and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a "total/partial reconstruction of the ossicular chain that has lost its function due to disease, trauma, or congenital defect," indicating it is used to address a medical condition by restoring function.
No
The device is described as a prosthesis for ossicular chain reconstruction, indicating a therapeutic or reconstructive function, not a diagnostic one.
No
The device description clearly states it is a physical prosthesis made of Hydroxylapatite and Plasti-Pore, intended for surgical implantation. It does not mention any software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "total/partial reconstruction of the ossicular chain," which is a surgical procedure performed in vivo (within the living body) to restore hearing function.
- Device Description: The device is a physical prosthesis (an implant) made of materials like Hydroxylapatite and Plasti-Pore, designed to be surgically implanted in the middle ear.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the living body) to analyze samples and provide diagnostic information. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
total/partial reconstruction of the ossicular chain that has lost its function due to disease, trauma, or congenital defect.
Product codes
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Device Description
The Richards Total/Partial Prosthesis and the predicate devices both have trimmable shafts made of Plasti-Pore and heads that may be tilted for proper angulation against the tympanic membrane. The Richards Total/Partial Prosthesis is made from Hydroxylapatite, a widely accepted material for middle ear reconstruction.
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
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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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
JAN 2 2 1997
Food and Drug Administration
510(k) Notification - Richards Total/Partial Prosthesis June 28, 1996
Smith & Nephew ENT
Smith & Nephew Richards Inc.
2925 Appling Rd., Bartlett, TN 38133
Telephone: 901-373-0200
Toll Free: 800-262-3540
Fax: 901-373-0220
510(k) Summary of Safety and Effectiveness
| Trade Name: | Richards Total/Partial Prosthesis |
|---|---|
| Common Name: | Partial Ossicular Replacement Prosthesis |
| Total Ossicular Replacement Prosthesis | |
| Classification Name: | Partial Ossicular Replacement Prosthesis (§ 874.3450) |
| Total Ossicular Replacement Prosthesis (§ 874.3495) | |
| Official Contact: | Ronald K. Smith |
| Senior Regulatory Affairs Specialist | |
| Smith & Nephew ENT | |
| a division of Smith & Nephew Richards, Inc. | |
| 2925 Appling Road | |
| Bartlett, TN 38133 | |
| Telephone: | (901) 373-0200 |
| Telefax: | (901) 373-0276 |
| Date Prepared: | June 28, 1996 |
The Richards Total/Partial Prosthesis is substantially equivalent to the Tilt-Top TORP and PORP marketed by Smith & Nephew ENT. These devices have indications for use, total/partial reconstruction of the ossicular chain that has lost its function due to disease, trauma, or congenital defect. The Richards Total/Partial Prosthesis and the predicate devices both have trimmable shafts made of Plasti-Pore and heads that may be tilted for proper angulation against the tympanic membrane. The Richards Total/Partial Prosthesis is made from Hydroxylapatite, a widely accepted material for middle ear reconstruction.
Differences between the Richards Total/Partial Prosthesis and the predicate device should not affect the safety or effectiveness.
Image /page/0/Picture/11 description: The image shows a partial view of a logo or emblem, predominantly in black and white. A bold, sans-serif letter 'R' is prominently featured, partially enclosed within a square or rectangular border. Below the letter, a portion of the word 'RICHARD' is visible, suggesting that the logo is associated with a name or brand. The overall design appears simple and modern.