(58 days)
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No
The description focuses on standard endoscopic video system components and manual instruments, with no mention of AI/ML capabilities or related performance metrics. The "image enhancement devices" are likely standard digital image processing, not AI/ML-based.
No
The device is used for illumination and visualization during surgical procedures and for examining and treating tissues, not for providing therapy itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use in diagnostic and operative arthroscopic, laparoscopic and ENT endoscopic procedures".
No
The device description explicitly lists multiple hardware components including arthroscopes/endoscopes, surgical cameras, video monitors, video recording devices, image enhancement devices, disk recorders, light sources, light guides, and manual surgical instruments.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "diagnostic and operative arthroscopic, laparoscopic and ENT endoscopic procedures to provide illumination and allow visualization of the surgical site" and "endoscopic examination and treatment of the nasal cavity and nasal pharynx." This describes a device used during a surgical or examination procedure to visualize and potentially treat tissues in vivo (within the living body).
- Device Description: The components listed (endoscopes, cameras, monitors, light sources, surgical instruments) are all tools used for direct visualization and manipulation of tissues within the body.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue biopsies) to provide information about a physiological state, health, disease, or congenital abnormality. This device does not perform such tests on in vitro samples.
The device is clearly intended for in vivo use for visualization and surgical intervention, not for analyzing samples in vitro.
N/A
Intended Use / Indications for Use
Smith & Nephew Images Endoscopic Video System and components are indicated for use in diagnostic and operative arthroscopic, laparoscopic and ENT endoscopic procedures to provide illumination and allow visualization of the surgical site.
Smith & Nephew Manual Surgical Instruments for Sinus Surgery are indicated for the endoscopic examination and treatment of the nasal cavity and nasal pharynx.
Product codes
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Device Description
The Smith & Nephew Images Video System offered by Smith & Nephew, Inc., Endoscopy Division includes the following components:
Smith & Nephew Images Arthroscopes/ENT Endoscopes, Surgical Cameras and various video monitors, video recording devices, image enhancement devices, disk recorders and accessories. The surgical cameras and accessories mate to the endoscope by means of various camera couplers, beamsplitters, and video adapters to allow for visualization during the surgical procedure.
Smith & Nephew Images Xenon Light Sources, Light Guides and accessories are designed to supply light to the surgical site through the endoscope. The light guides mate to the endoscope and light source with instrument specific adapters.
Smith & Nephew manual surgical instruments for sinus surgery are utilized to examine and treat tissues in the nasal cavity and nasal pharynx.
Mentions image processing
image enhancement devices
Mentions AI, DNN, or ML
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Input Imaging Modality
Endoscopic video
Anatomical Site
surgical site, nasal cavity, nasal pharynx
Indicated Patient Age Range
Not Found
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): 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.
The predicate devices for this submission are the sinuscopes, video components, surgical cameras, illuminators and accessories and ENT surgical hand instruments manufactured and distributed by Smith & Nephew, Inc., ENT Division.
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).
Not Found
§ 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
510(k) Summary Smith & Nephew, Inc., Endoscopy Division, Images Video System and Hand Instruments
970247
Substantial Equivalence
The Smith & Nephew Images Video System components and manual surgical instruments for sinus surgery offered by Smith & Nephew, Inc., Endoscopy Division are substantially equivalent in both design and intended use to sinuscopes, surgical cameras, video components, illumination products and ENT hand instruments offered by Smith & Nephew, Inc., ENT Division.
The Video Components, Surgical Cameras, Illuminators and accessories offered by the above referenced manufacturers mate with the endoscope to allow for visualization during the surgical procedure. The Illuminators, Light Guides and accessories mate to the light post of the endoscope and deliver light to the surgical site.
Manual Surgical Instruments for Sinus Surgery offered by Smith & Nephew, Inc., Endoscopy Division are substantially equivalent in materials, design and intended use to ENT hand instruments offered by Smith & Nephew, Inc., ENT Division.
Predicate Device:
The predicate devices for this submission are the sinuscopes, video components, surgical cameras, illuminators and accessories and ENT surgical hand instruments manufactured and distributed by Smith & Nephew, Inc., ENT Division.
Summary of Device Function:
The Smith & Nephew Images Video System offered by Smith & Nephew, Inc., Endoscopy Division includes the following components:
Smith & Nephew Images Arthroscopes/ENT Endoscopes, Surgical Cameras and various video monitors, video recording devices, image enhancement devices, disk recorders and accessories. The surgical cameras and accessories mate to the endoscope by means of various camera couplers, beamsplitters, and video adapters to allow for visualization during the surgical procedure.
Smith & Nephew Images Xenon Light Sources, Light Guides and accessories are designed to supply light to the surgical site through the endoscope. The light guides mate to the endoscope and light source with instrument specific adapters.
MAR 2 | 1997
er. MA 01810 U.S.A.
Smith+Nephew
dosconv Division
1
Smith & Nephew manual surgical instruments for sinus surgery are utilized to examine and treat tissues in the nasal cavity and nasal pharynx.
Intended Use of Device:
Smith & Nephew Images Endoscopic Video System and components are indicated for use in diagnostic and operative arthroscopic, laparoscopic and ENT endoscopic procedures to provide illumination and allow visualization of the surgical site.
Smith & Nephew Manual Surgical Instruments for Sinus Surgery are indicated for the endoscopic examination and treatment of the nasal cavity and nasal pharynx.
Comparison of Technological Characteristics of Predicate Devices:
Smith & Nephew Images Arthroscopes/ENT Endoscopes and Manual Surgical Instruments for Sinus Surgery offered by Smith & Nephew, Inc., Endoscopy Division are substantially equivalent to sinuscopes and ENT surgical hand instruments offered by Smith & Nephew, Inc., ENT Division in intended use, materials and technology.
Smith & Nephew Images Surgical Cameras, Video Components, Light Sources and accessories offered by Smith & Nephew, Inc., Endoscopy Division are substantially equivalent in design, materials and function to Smith & Nephew Images devices described in previous premarket notification submissions. All electro-mechanical equipment complies with UL544 and IEC 601-1 requirements for electrical safety of medical devices. The components of the Smith & Nephew Images Video System are substantially equivalent in both design and intended use to surgical cameras, video components, illumination products and accessories offered by Smith & Nephew, Inc. ENT Division.
Dubrah Connors
Deborah Connors
Deborah Connors Regulatory Affairs Department