ULTRATOMERX

K970053 · Boston Scientific Corp · KNS · Mar 28, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K970053
• Device Name: ULTRATOMERX
• Applicant: Boston Scientific Corp
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: Mar 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The UltratomeRX is indicated for use in transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The Microvasive UltratomeRX can also be used to cannulate and inject contrast medium.

Device Story

Triple lumen sphincterotome; used during endoscopic procedures. Features open channel for .035” guidewire; allows simultaneous guidewire exchange, contrast injection, and electrosurgical cutting. Eliminates need for stylet during scope passage. Operated by gastroenterologists in clinical settings. Provides access and cutting capability for biliary/pancreatic duct procedures; facilitates sphincterotomy.

Clinical Evidence

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

Technological Characteristics

Triple lumen catheter shaft, cutting wire, handle, guidewire introducer, outer sheath. Electrosurgical device. Biocompatible materials.

Indications for Use

Indicated for patients requiring transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi, and for cannulation and injection of contrast medium.

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

• Boston Scientific Ultratome XL

Submission Summary (Full Text)

{0}

K970053
MAR 28 1997
P192
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: Sphincterotome
> TRADE/PROPRIETARY NAME: Unknown this time
> CLASSIFICATION NAME & DEVICE CLASSIFICATION: Class II

| Name | Number | 21 CFR Ref. |
| --- | --- | --- |
| Endoscopic Electrosurgical Unit and Accessories. | 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 UltratomeRX is a triple lumen sphincterotome. The UltratomeRX is capable of accepting a .035” guidewire in one open channel while simultaneously injecting or cutting in another lumen. The open channel allows for the quick exchange of a guidewire completely isolated from injection agents and cutting. No stylet is necessary for scope passage.

# INDICATIONS FOR USE

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

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K970053
p292

The UltratomeRX is indicated for use in transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The Microvasive UltratomeRX can also be used to cannulate and inject contrast medium.

## DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES

Boston Scientific Corporation believes that the UltratomeRX is substantially equivalent to the currently-marketed Boston Scientific Ultratome XL. The major components of the UltratomeRX are the catheter shaft, cutting wire, handle, guidewire introducer, and outer sheath. A thorough comparison of the descriptive characteristics between the UltratomeRX and the predicate device shows equivalence.

## PERFORMANCE CHARACTERISTICS

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

## CONCLUSION

Boston Scientific Corporation believes that UltratomeRX is substantially equivalent to the currently-marketed UltratomeRX. A comparison of the descriptive characteristics of these products demonstrate the UltratomeRX 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 UltratomeRX will meet the minimum requirements that are considered acceptable for its intended use.

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