MICROVASIVE GOLD PROBE

K970278 · Boston Scientific Corp · KNS · Apr 11, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K970278
• Device Name: MICROVASIVE GOLD PROBE
• Applicant: Boston Scientific Corp
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: Apr 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Gold Probe is indicated for use in transendoscopic electrocautery of visible bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus, stomach, duodenum, and colon. The indications include peptic ulcers, Mallory-Weiss tears, arteriovenous malfunctions (AVMs), Dieulafoy lesions, bleeding polyp stocks, angiomata, Watermelon Stomach, Barrett’s Esophagus, angiodysplasia, and esophageal tumors.

Device Story

Bipolar electrosurgical probe; 7 Fr and 10 Fr sizes; 217-350 cm catheter length. Features circumactive tip for en fosse and tangential electrocautery; central irrigation channel for site washing. Used in GI tract via endoscope; operated by gastroenterologists/surgeons. Delivers electrical energy to tissue to achieve hemostasis or treat lesions. Benefits patient by providing controlled coagulation of bleeding sites and tissue ablation.

Clinical Evidence

Bench testing only. Biocompatibility assessment performed on patient- and fluid-contact materials with satisfactory results.

Technological Characteristics

Bipolar electrosurgical catheter; 7 Fr and 10 Fr diameters; 217-350 cm length. Includes central irrigation port. Materials biocompatibility verified.

Indications for Use

Indicated for patients requiring transendoscopic electrocautery for bleeding or non-bleeding GI tract lesions, including peptic ulcers, Mallory-Weiss tears, AVMs, Dieulafoy lesions, bleeding polyp stalks, angiomata, Watermelon Stomach, Barrett’s Esophagus, angiodysplasia, and esophageal tumors.

Regulatory Classification

Identification

An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

Predicate Devices

• Microvasive Gold Probe
• ACMI Bicap Tumor Probe

Submission Summary (Full Text)

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APR 11 1997
142
SECTION 9
510(K) SUMMARY
K970278

# FOI RELEASABLE

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification “...adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person.” Boston Scientific Corporation chooses to submit a summary of information respecting safety and effectiveness.

> DATE: January 22, 1997
> COMMON/USUAL NAMES: Endoscopic Electrosurgical Unit
> TRADE/PROPRIETARY NAME: Microvasive Gold Probe
> CLASSIFICATION NAME & DEVICE CLASSIFICATION: Class II
| Name | Number | 21 CFR Ref. |
| --- | --- | --- |
| Unit, Electrosurgical | 78 KNS | 876.4300 |
> DEVICE PANEL/BRANCH: Gastroenterology-Urology (GU) Gastro-Renal (GRDB)
> OWNER/OPERATOR: Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760
> CONTACT PERSON: Lisa M. Quaglia, Senior Regulatory Affairs Specialist

## DESCRIPTION OF DEVICE

The Microvasive Gold Probe and is a bipolar probe available in 7 Fr and 10 Fr. The catheter length is 217 - 350 cm long and is designed as circumactive probes which deliver effective electrocautery en fosse and tangentially. A central irrigation channel allows for site washing.

## INDICATIONS FOR USE

The Gold Probe is indicated for use in transendoscopic electrocautery of visible bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus, stomach, duodenum, and colon. The indications include peptic ulcers, Mallory-Weiss tears,

Premarket Notification, Gold Probe, January 22, 1997
Proprietary and Confidential Information of Boston Scientific Corporation
124

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arteriovenous malfunctions (AVMs), Dieulafoy lesions, bleeding polyp stocks, angiomata, Watermelon Stomach, Barrett’s Esophagus, angiodysplasia, and esophageal tumors.

## DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES

Boston Scientific Corporation believes that the Gold Probe is substantially equivalent to the currently-marketed Microvasive Gold Probe and the ACMI Bicap Tumor Probe. The major components of the Gold Probe are the catheter shaft, the tip, and the irrigation port. A thorough comparison of the descriptive characteristics between the Gold Probe and the predicate devices show equivalence.

## PERFORMANCE CHARACTERISTICS

Laboratory testing regarding characteristics was performed on the Gold Probe to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluid-contact materials of the Gold Probe with satisfactory results.

## CONCLUSION

Boston Scientific Corporation believes that Gold Probe is substantially equivalent to the currently-marketed Gold Probe and ACMI Bicap Tumor Probe. A comparison of the descriptive characteristics of these products demonstrate the Gold Probe is equivalent in its indications for use, while being very similar in design and materials. In addition, Boston Scientific Corporation has presented biocompatibility information. The information presented provides assurance that the Gold Probe will meet the minimum requirements that are considered acceptable for its intended use.

Premarket Notification, Gold Probe, January 22, 1997
Proprietary and Confidential Information of Boston Scientific Corporation
125