DUALFLEX RX ERCP CANNULA, MODELS 4681, 4682

K041827 · Boston Scientific Corp · GCJ · Aug 6, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K041827
• Device Name: DUALFLEX RX ERCP CANNULA, MODELS 4681, 4682
• Applicant: Boston Scientific Corp
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Aug 6, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The DualFlex™ RX ERCP 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

DualFlex™ RX ERCP Cannula is a rapid exchange, wire-guided catheter. Used by physicians during ERCP procedures to cannulate the biliary duct and deliver contrast media. Input: manual manipulation by clinician; Output: contrast media delivery to biliary duct. Facilitates fluoroscopic or x-ray imaging to obtain a cholangiogram. Device aids in diagnostic visualization of the biliary system.

Clinical Evidence

Bench testing only; no clinical data provided. Substantial equivalence supported by physical comparison and functional testing.

Technological Characteristics

Rapid exchange, wire-guided catheter design. Operates as an injection cannula for contrast media delivery. No electronic components or software.

Indications for Use

Indicated for use to cannulate and inject contrast media to obtain a cholangiogram of the biliary duct system in patients undergoing ERCP procedures.

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

• Boston Scientific Tandem™ RX ERCP Cannula (K970054)

Submission Summary (Full Text)

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## 510 (k) SUMMARY

| SPONSOR: | Boston Scientific Corporation<br>One Boston Scientific Place<br>Natick, MA 01760 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Paige K. Sweeney<br>Senior Regulatory Affairs Specialist |
| DEVICE: | |
| Trade Name: | DualFlex™ RX ERCP Cannula |
| Common Name: | Injection Cannula |
| Classification: | Class II, per 21 CFR Part 876, Section 1500 |
| PREDICATE DEVICE: | Boston Scientific Tandem™ RX ERCP Cannula<br>(K970054). |
| DESCRIPTION: | The DualFlex™ RX ERCP Cannula is a rapid exchange<br>wire-guided catheter used to cannulate and for delivery<br>of contrast media in the biliary duct. |
| INTENDED USE: | The DualFlex™ RX ERCP is indicated for use to<br>cannulate and inject contrast media to obtain a<br>cholangiogram of the biliary duct system. The contrast<br>media is injected through the cannula and fluoroscopy or<br>x-ray is performed to obtain the cholangiogram. |
| COMPARISON OF<br>CHARACTERISTICS: | The modified device is substantially equivalent to the<br>predicate device, as they have the same operating<br>principal and intended use. In addition, the results of<br>design control activities do not raise any new issues of<br>safety or effectiveness. |
| PERFORMANCE DATA: | FDA's "Guidance for the Content of Premarket<br>Notifications", and the results of physical comparison<br>and functional testing support a determination of<br>substantial equivalence for the modified device when<br>compared to the predicate device(s). The modified<br>device is substantially equivalent to the currently |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 6 2004

Ms. Paige Sweeney Senior Regulatory Affairs Specialist Boston Scientific Corporation Microvasive Endoscopy One Boston Scientific Place NATICK MA 01760-1537

Re: K041827

Trade/Device Name: Dualflex™ RX ERCP Cannula Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 GCJ Dated: July 6, 2004 Received: July 7, 2004

Dear Ms. Sweeney:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becament in ad the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to regard nent date of the Medical Device Amendments, or to conniner to may 20, 1978, in accordance with the provisions of the Federal Food, Drug, de necs that have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Tou may, dicience, manner the act include requirements for annual registration, listing of general controls provisions of practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device is classified (500 above). Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act mat I Dri has made a docemmancis in administered by other Federal agencies. You must of any I ederal studess and regulations, including, but not limited to: registration and listing Compry with an the Hot 5 requiremEl Part 801); good manufacturing practice requirements as set (21 CFR Part 607), laooming (21 CFR Part 820); and if applicable, the electronic ford in the quanty 25 Events (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k)
the successful and and of the first of also which anywalance of your device 10 This letter will allow you to begin marketing your convealerse of your device to a legally premarket notification - The F17A midming of sessuation of your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our his regularion of the regulation number at the top of the letter.

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
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Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the promotion and the regulation entitled, "Misloranding
Office of Compliance at [phone]. Association may obtesin. Other general Othice of Compliance at [phone]. Facts, promosed from the Division of Sma by reference to premarket nonmeation (210) it is a very obtained from the Division of Strall
information on your responsibilities under the Act may be since sumber (800) 638, information on your responsibilities and critic and its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its todal demagain http:// Manufacturers, International and Coulsamer Absocative and Could Chicker and main.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

| 510(k) Number | K041827 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | DualFlex™ RX ERCP Cannula |
| Indications For Use | 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. |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use । ਅ (Per 21 CFR 801.109) OR

Over the Counter Use _________________________________________________________________________________________________________________________________________________________

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

___________________________

Nancy C Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K041821