(94 days)
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No
The summary describes a rigid rod lens endoscope with no mention of AI or ML capabilities, image processing, or performance studies related to algorithmic analysis.
No
The device is described as an endoscope intended for surgical imaging, which is a diagnostic tool rather than a therapeutic one. It facilitates visualization for medical procedures but does not actively treat a condition.
No
Explanation: The device is described as an endoscope intended for surgical imaging during procedures, which is primarily for visualization and intervention, not for diagnosing conditions.
No
The device description clearly states it is a series of rigid rod lens endoscopes, which are physical hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "surgical imaging in otolaryngology and Head and Neck procedures." This describes a device used during a surgical procedure to visualize internal structures, not a device used to test samples (like blood, urine, or tissue) outside the body to diagnose a condition.
- Device Description: The description details a rigid rod lens endoscope, which is a tool for direct visualization within the body. This is consistent with a surgical imaging device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, chemical reactions, or diagnostic testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for visualization during surgery.
N/A
Intended Use / Indications for Use
The Xomed SHARPSITE Ac rigid rod lens endoscopes are intended for use in surgical imaging in otolaryngology and Head and Neck procedures, including rhinology, and endoscopic plastic and reconstructive surgery.
Product codes
78GCM, 77EOB
Device Description
The SHARPSITE Ac endoscopes are a series of small diameter, rigid rod lens endoscopes; available in diameters of 2.7mm, 4.0mm and 5.0mm with tip angles o 0, 30 and 70 degrees. The length of the scopes range from 175mm to 188 mm. Each scope is fitted with a removable light port adapter for use with light cables from different manufacturers.
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
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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 (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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
APR -4 1997 K965233
revised 4/9
510(k) Summary
1.0 Date Prepared December 23, 1996
- 2.0 Submitter (Contact) David Timlin Xomed Surgical Products Jacksonville, FL (904) 279-7532
3.0 Device Name
Proprietary Name: SHARPSITE Ac
Common Name(s): Rigid Rod Lens Endoscopes
Classification Name:
Endoscope, rigid Nasopharyngoscope (flexible or rigid)
5.0 Device Classification
| Endoscope, rigid | Procode 78GCM Class II; 21 CFR 876.1500 Tier 2 |
|---|---|
| Nasopharyngoscope (flexible or rigid) | Procode 77EOB Class II; 21 CFR 874.4760 Tier 2 |
6.0 Device Description
The SHARPSITE Ac endoscopes are a series of small diameter, rigid rod lens endoscopes; available in diameters of 2.7mm, 4.0mm and 5.0mm with tip angles o 0, 30 and 70 degrees. The length of the scopes range from 175mm to 188 mm. Each scope is fitted with a removable light port adapter for use with light cables from different manufacturers.
7.0 Intended Use
The Xomed SHARPSITE Ac rigid rod lens endoscopes are intended for use in surgical imaging in otolaryngology and Head and Neck procedures, including rhinology, and endoscopic plastic and reconstructive surgery.
8.0 Substantial Equivalence
Substantial equivalency is based on the fact that the SHARPSITE Ac endoscopes are equivalent to current Xomed endoscopes in their intended use and materials. They are likewise equivalent in design, intended use and performance claims to sinuscopes currently marketed by Smith & Nephew (S&N) ENT.