TANDEMRX

K970054 · Boston Scientific Corp · GCJ · Feb 10, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K970054
• Device Name: TANDEMRX
• Applicant: Boston Scientific Corp
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Feb 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The TandemRX is indicated for use to cannulate and inject contrast media to obtain a cholangiogram of the biliary duct system. The contrast media is injected through the cannula and fluoroscopy or x-ray is performed to obtain the cholangiogram.

Device Story

Triple lumen ERCP cannula; facilitates biliary duct cannulation and contrast media injection. Features one open channel for .035” guidewire passage and two lumens for contrast media injection (joined at proximal end for single-port access). Allows guidewire exchange isolated from injection agents; eliminates need for stylet during scope passage. Used in clinical settings by gastroenterologists/endoscopists during ERCP procedures. Enables visualization of biliary duct system via fluoroscopy/x-ray; assists in diagnostic or therapeutic biliary interventions.

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 cannula; components include shaft, hub, guidewire introducer, and outer sheath. Compatible with .035” guidewire. Materials are biocompatible. Non-powered, manual surgical instrument.

Indications for Use

Indicated for patients requiring cannulation of the biliary duct system for cholangiogram procedures via contrast media injection and fluoroscopy/x-ray.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Microvasive Tandem XL Cannula

Submission Summary (Full Text)

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K 97 0054
SECTION 9
510(K) SUMMARY

FEB 10 1997

## 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:** Injection Cannula
> **TRADE/PROPRIETARY NAME:** Unknown at this Time
> **CLASSIFICATION NAME & DEVICE CLASSIFICATION:** Class I

| Name | Number | 21 CFR Ref. |
| --- | --- | --- |
| Cannula, Injection | 79 FGY | KNS |

&gt; **DEVICE PANEL/BRANCH:** Gastroenterology-Urology (GU)<br/>
Gastro-Renal (GRDB)

&gt; **OWNER/OPERATOR:** Boston Scientific Corporation<br/>
One Boston Scientific Place<br/>
Natick, MA 01760

&gt; **CONTACT PERSON:** Lisa M. Quaglia, Senior Regulatory Affairs Specialist

## DESCRIPTION

The Microvasive TandemRX is a triple lumen ERCP cannula capable of accepting an .035” guidewire in one open channel while simultaneously injecting contrast media through the other two lumens. The two lumens are joined at the proximal end so that injection of contrast medium can be accomplished through a single injection port. The open channel allows for the quick exchange of a guidewire completely isolated from injection agents. No stylet is necessary for scope passage. The TandemRX may be placed with or without the aid of a guidewire.

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

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# INDICATIONS FOR USE

The TandemRX is indicated for use to cannulate and inject contrast media to obtain a cholangiogram of the biliary duct system. The contrast media is injected through the cannula and fluoroscopy or x-ray is performed to obtain the cholangiogram.

# DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES

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

# PERFORMANCE CHARACTERISTICS

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

# CONCLUSION

Boston Scientific Corporation believes that TandemRX is substantially equivalent to the currently-marketed Microvasive Tandem XL. The Modified TandemRX 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 TandemRX will meet the minimum requirements that are considered acceptable for its intended use.

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