EXTRACTORRX

K970052 · Boston Scientific Corp · FGE · Mar 25, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K970052
• Device Name: EXTRACTORRX
• Applicant: Boston Scientific Corp
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Mar 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ExtractorRX is indicated for use endoscopically to remove stones from the biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.

Device Story

Triple lumen retrieval balloon catheter; used endoscopically for biliary stone removal or duct occlusion during contrast injection. Features .035” guidewire channel; allows simultaneous guidewire exchange and balloon inflation/injection. No stylet required for scope passage; guidewire-compatible. Operated by gastroenterologists/endoscopists in clinical settings. Facilitates stone extraction and diagnostic imaging; improves procedural efficiency by allowing guidewire isolation from inflation/injection media.

Clinical Evidence

Bench testing only. Biocompatibility assessment performed on patient- and fluid-contact materials with satisfactory results. No clinical data presented.

Technological Characteristics

Triple lumen catheter; components include shaft, balloon, bifurcation, guidewire introducer, and outer sheath. Compatible with .035" guidewire. Materials biocompatibility verified.

Indications for Use

Indicated for endoscopic removal of biliary stones or contrast medium injection during duct occlusion in patients requiring biliary intervention.

Regulatory Classification

Identification

A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.

Special Controls

*Classification.* Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, 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

• Microvasive Extractor XL

Submission Summary (Full Text)

{0}

K970052
P172
SECTION 9
510(K) SUMMARY

# 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 6, 1997
> COMMON/USUAL NAMES: Endoscopic Biliary Stone Retrieval Balloon Catheter
> TRADE/PROPRIETARY NAME: Unknown at this Time
> CLASSIFICATION NAME & DEVICE CLASSIFICATION: Class II
| Name | Number | 21 CFR Ref. |
| --- | --- | --- |
| Catheter, Biliary | 78 FGE | 876.5010 |
> 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 ExtractorRX is a triple lumen retrieval balloon catheter. The ExtractorRX is capable of accepting an .035” guidewire in one open channel while simultaneously injecting and/or inflating the balloon in the other two lumens. An open channel allows for the quick exchange of a guidewire completely isolated from injection agents and balloon inflation. No stylet is necessary for scope passage. The ExtractorRX may be placed with or without the aid of a guidewire.

Premarket Notification, ExtractorRX, January 6, 1997
Proprietary and Confidential Information of Boston Scientific Corporation

{1}

K9700052
P2072

## INDICATIONS FOR USE

The ExtractorRX is indicated for use endoscopically to remove stones from the biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.

## DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES

Boston Scientific Corporation believes that the ExtractorRX is substantially equivalent to the currently-marketed Microvasive Extractor XL. The major components of the ExtractorRX are the shaft, balloon, bifurcation, guidewire introducer, and the outer sheath. A thorough comparison of the descriptive characteristics between the ExtractorRX and the predicate device shows equivalence.

## PERFORMANCE CHARACTERISTICS

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

## CONCLUSION

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

Premarket Notification, ExtractorRX, January 6, 1997
Proprietary and Confidential Information of Boston Scientific Corporation
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