← Product Code [ODD](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/ODD) · K963051

# ERCP CANNULA (K963051)

_United States Endoscopy Group, Inc. · ODD · Mar 28, 1997 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/ODD/K963051

## Device Facts

- **Applicant:** United States Endoscopy Group, Inc.
- **Product Code:** [ODD](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/ODD.md)
- **Decision Date:** Mar 28, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.1500
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Indications for Use

The ERCP cannula serves as the pathway by which contrast media is injected for the purpose of identifying the reason for blockage. Patients with diagnosed biliary tract calculi or strictures can then be treated with an assortment of therapeutic modalities.

## Device Story

ERCP cannula; pathway for contrast media injection into bile ducts; used during diagnostic ERCP procedures for biliary tract obstruction (strictures/stones). Operated by physicians in clinical settings. Facilitates visualization of blockages to guide subsequent therapeutic interventions. Benefits include identification of pathology to inform treatment planning.

## Clinical Evidence

No clinical data provided; summary relies on general procedure safety and effectiveness data available at time of submission.

## Technological Characteristics

Materials certified to standards appropriate for use; quality assurance based on MIL-STD-9858; device functions as a mechanical conduit for contrast media.

## Regulatory 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.

## Submission Summary (Full Text)

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>
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K963051
MAR 28 1997
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# SECTION II
## SUMMARY AND CERTIFICATION

### ENDOSCOPIC RETROGRADE CHOLANGOPANCREATOGRAPHY (ERCP) SUMMARY

The Summary of Safety and Effectiveness on the endoscopic procedure for bile duct pathology and the ERCP cannulas used reflects data available and presented at the time the submission was prepared, but, caution should be exercised in interpreting the data. The results of future studies may require alterations of the conclusions or recommendations set forth.

### Procedure/Product Overview

ERCP is a diagnostic procedure for suspected biliary tract obstruction such as strictures or stones. The ERCP cannula serves as the pathway by which contrast media is injected for the purpose of identifying the reason for blockage. Patients with diagnosed biliary tract calculi or strictures can then be treated with an assortment of therapeutic modalities.

### Contraindications for ERCP Procedure

ERCP is contraindicated in patients with/or:

1) Acute pancreatitis, unless clinical situation necessitates procedure
2) Recent myocardial infarction, unless surgical intervention is required
3) Presence of barium in the GI tract
4) Pregnancy
5) Severe pulmonary disease
6) Allergy to contrast media
7) Uncooperative or unable to tolerate procedure

The physician will determine patient’s appropriateness for the procedure.

### Manufacturing Overview

U.S.E. manufactured and tested the product to performance specifications based on predicate and/or substantially equivalent devices.

U.S.E. manufacturing processes and procedures are based on good manufacturing practices. Quality assurance methods and procedures based on MIL-STD-9858 are utilized to assure conformance to design specifications.

Materials used in the manufacturing process are certified to standards appropriate for their use.

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/ODD/K963051](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/ODD/K963051)

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