(163 days)
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No
The device description and intended use focus solely on infrared transillumination for visualization. There is no mention of any computational analysis, pattern recognition, or learning algorithms applied to the infrared data. The performance studies also focus on physical properties (tissue heating) rather than algorithmic performance.
No
The device is used for identification and location of structures using infrared transillumination and does not provide therapy.
No
The device is intended to aid in the identification and location of structures using infrared transillumination, which is a method of visualization to assist in surgical procedures, not to diagnose a disease or condition. While "identification" and "location" are often associated with diagnostics, the context here is for surgical guidance, similar to an endoscope, which is typically considered an interventional or visualization tool rather than a diagnostic one based on its primary intended use.
No
The device description explicitly states it is a "disposable device" with physical dimensions (diameters, lengths) and a "translucent tip," indicating it is a physical hardware device, not software only.
Based on the provided information, the InfraVision™ Bougie is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The InfraVision™ Bougie is used in vivo (within the living body) to transilluminate structures during surgical procedures. It does not analyze blood, tissue samples, or other bodily fluids in vitro (outside the body).
- The intended use is for surgical guidance and identification of anatomical structures. This is a surgical tool, not a diagnostic test performed on a sample.
- The device description and performance studies focus on the physical characteristics and tissue heating during use. There is no mention of analyzing biological markers or performing diagnostic tests on specimens.
Therefore, the InfraVision™ Bougie falls under the category of a surgical instrument or device used for visualization and guidance during procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The InfraVision™ Bougie is intended to aid in the identification of the esophagus, rectum, rectosigmoid, other structures, and surgically produced cavities using infrared transillumination during laparoscopy, thoracoscopy, or open procedures. The indications for use are detailed below:
- a. Infrared transillumination of the esophagus to assist in the identification and location of the esophagus and its surrounding tissues during laparoscopic, thoracoscopic, and open procedures;
- b. Infrared transillumination of the rectum and rectosigmoid to assist in the identification and location of these structures and surrounding tissues during gynecological and colorectal laparoscopic and open procedures; and
- C. Infrared transillumination of other organs or provide transillumination or illumination to other natural or surgically produced cavities.
Product codes
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Device Description
The InfraVision™ Bougie is intended to aid in the identification of the esophagus, rectum, rectosigmoid, other structures, and surgically produced cavities using infrared transillumination during laparoscopy, thoracoscopy, or open procedures. The InfraVision™ Bougie is a disposable device ranging in diameters from 13 Fr to 60 Fr, all having bougie sheath lengths of 80 cm. The overall length of the Infra Vision™ Bougies is 250 cm. The Infra Vision™ Bougie has a translucent tip that is either tapered or rounded in shape and varies in length.
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
esophagus, rectum, rectosigmoid, other structures, surgically produced cavities, other organs
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
Testing was performed using simulated test tissue to measure heating of tissues using the InfraVision™ Bougie Emitting Fiber and the EndoLumina predicate device. There was significantly less tissue heating observed using the InfraVision™ System dual fiber emitters compared to the EndoLumina energized with a Cabot Medical System 3000 Xenon Videolap Light set to full power.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5365 Esophageal dilator.
(a)
Identification. An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
510(k) Summary Gabriel Medical, Incorporated Infra Vision™ Bougie
JUN 2 7 1996
1. SUBMITTER NAME AND ADDRESS
Dr. Mark Fontenot Gabriel Medical, Incorporated 2014 West Pinhook Road Suite 604 Lafayette, LA 70508 Telephone: (318) 237-3600 Facsimile: (318) 237-3634
2. DEVICE NAME
। ਜ
| Proprietary Name: | InfraVision™ Bougie, InfraVision™ Esophageal Kit |
|---|---|
| Common/Usual: | Esophageal Dilator, Rectal Dilator |
| Classification Name: | Esophageal and Gastrointestinal Bougie |
| Urological Bougie |
3. PREDICATE DEVICES
BioEnterics Corp. EndoLumina Illuminated Bougie (K934084) Gabriel Medical Ureteral Illuminator System II(K945088) Infra Vision™ Imaging System(K945297).
4. INTENDED USE
The InfraVision™ Bougie is intended to aid in the identification of the esophagus, rectum, rectosigmoid, other structures, and surgically produced cavities using infrared transillumination during laparoscopy, thoracoscopy, or open procedures.
5. DEVICE DESCRIPTION
The InfraVision™ Bougie is intended to aid in the identification of the esophagus, rectum, rectosigmoid, other structures, and surgically produced cavities using infrared
1
transillumination during laparoscopy, thoracoscopy, or open procedures. The indications for use are detailed below:
- a. Infrared transillumination of the esophagus to assist in the identification and location of the esophagus and its surrounding tissues during laparoscopic, thoracoscopic, and open procedures;
- b. Infrared transillumination of the rectum and rectosigmoid to assist in the identification and location of these structures and surrounding tissues during gynecological and colorectal laparoscopic and open procedures; and
- C. Infrared transillumination of other organs or provide transillumination or illumination to other natural or surgically produced cavities.
TECHNOLOGICAL CHARACTERISTICS 6.
The InfraVision™ Bougie is a disposable device ranging in diameters from 13 Fr to 60 Fr, all having bougie sheath lengths of 80 cm. The overall length of the Infra Vision™ Bougies is 250 cm. The Infra Vision™ Bougie has a translucent tip that is either tapered or rounded in shape and varies in length.
7. TESTING
ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
Testing was performed using simulated test tissue to measure heating of tissues using the InfraVision™ Bougie Emitting Fiber and the EndoLumina predicate device . There was significantly less tissue heating observed using the InfraVision™ System dual fiber emitters compared to the EndoLumina energized with a Cabot Medical System 3000 Xenon Videolap Light set to full power.