INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT

K960173 · Gabriel Medical, Inc. · FAT · Jun 27, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K960173
• Device Name: INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT
• Applicant: Gabriel Medical, Inc.
• Product Code: FAT · Gastroenterology, Urology
• Decision Date: Jun 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5365
• Device Class: Class 2

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.

Device Story

Disposable bougie device; utilizes infrared transillumination to assist surgeons in identifying and locating anatomical structures (esophagus, rectum, rectosigmoid) and surgically created cavities. Used during laparoscopic, thoracoscopic, or open procedures. Device features translucent tapered or rounded tips; diameters 13-60 Fr; 80 cm sheath length. Operates by emitting infrared light to illuminate internal structures, allowing visualization through tissue. Benefits include improved anatomical identification during surgery, reducing risk of accidental injury to surrounding tissues. Operated by surgeons in OR settings.

Clinical Evidence

Bench testing only. Comparative study performed using simulated test tissue to measure thermal output. InfraVision™ dual fiber emitters compared against EndoLumina device energized with Cabot Medical System 3000 Xenon Videolap Light at full power. Results showed significantly less tissue heating with the InfraVision™ system.

Technological Characteristics

Disposable bougie; diameters 13 Fr to 60 Fr; 80 cm sheath length; 250 cm total length. Translucent tapered or rounded tip. Infrared light source/emitter. Dual fiber emitter technology. Non-sterile/disposable.

Indications for Use

Indicated for patients undergoing laparoscopic, thoracoscopic, or open surgical procedures requiring identification and location of the esophagus, rectum, rectosigmoid, or other natural/surgically produced cavities via infrared transillumination.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• BioEnterics Corp. EndoLumina Illuminated Bougie (K934084)
• Gabriel Medical Ureteral Illuminator System II (K945088)
• InfraVision™ Imaging System (K945297)

Submission Summary (Full Text)

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K 960173

510(k) Summary

Gabriel Medical, Incorporated

InfraVision™ Bougie

JUN 27 1996

1. SUBMITTER NAME AND ADDRESS

Dr. Mark Fontenot
Gabriel Medical, Incorporated
2014 West Pinhook Road
Suite 604
Lafayette, LA 70508
Telephone: [phone]
Facsimile: [phone]

2. DEVICE NAME

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)
InfraVision™ 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

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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.

## 6. TECHNOLOGICAL CHARACTERISTICS

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 InfraVision™ Bougies is 250 cm. The InfraVision™ Bougie has a translucent tip that is either tapered or rounded in shape and varies in length.

## 7. TESTING

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.

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