SINGLE USE BALLOON DILATOR MAXPASSTM

K050502 · Olympus Winter & Ibe GmbH · FGE · Jul 8, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K050502
• Device Name: SINGLE USE BALLOON DILATOR MAXPASSTM
• Applicant: Olympus Winter & Ibe GmbH
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Jul 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Single use balloon dilator Maxpass ™ to be used in conjunction with Olympus endoscopes for dilating strictures of the biliary tree and the major papilla during endoscopic applications.

Device Story

Single use balloon dilator MaxPass is a triple lumen catheter featuring a balloon at the distal end. Device is used in conjunction with Olympus endoscopes to exert radial force for dilating narrow duct segments of the biliary tree and the major papilla. Operated by physicians during endoscopic applications. Output is mechanical radial dilation force. Benefits include relief of biliary strictures.

Clinical Evidence

No clinical data; substantial equivalence is based on non-clinical testing and comparison to predicate devices.

Technological Characteristics

Triple lumen catheter with distal balloon. Single-use. Mechanical radial dilation principle. No electronic components or software.

Indications for Use

Indicated for patients requiring dilation of strictures of the biliary tree and the major papilla during endoscopic procedures using Olympus endoscopes.

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 Rapid ExchangeTM Biliary Balloon Dilation Catheter (K001338)
• Bard biliary Balloon Dilators (K920361)

Submission Summary (Full Text)

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#### SMDA 510(k) SUMMARY

### A. Submitter's Name, Address, Phone and Fax Numbers

| Applicant: | Olympus Winter & Ibe, GmbH | | |
|---------------------------------|--------------------------------------------------------|--|--|
| Address: | Kuehnstr. 61<br>Hamburg 22045, Germany | | |
| Establishment Registration No.: | 8010313 | | |
| Submission Correspondent: | OLYMPUS AMERICA Inc. | | |
| Address: | Two Corporate Center Drive,<br>Melville, NY 11747-9058 | | |
| B. Name of Contact Person | | | |
| Contact: | Laura Storms-Tyler | | |
| Title: | Director Regulatory Affairs | | |
| Telephone: | 631-844-5688 | | |
| Facsimile: | 631-844-5554 | | |

Initial Importer: Address:

Establishment Registration No.:

Establishment Registration No.:

। ।

2429304

OLYMPUS AMERICA Inc. Two Corporate Center Drive,
Melville, NY 11747-9058 2429304

## C. Device Name, Common Name, Classification Name and Predicate Devices

| Trade Name: | Single use balloon dilator MaxPassTM | |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Common Name: | Balloon dilation catheter | |
| Classification: | Biliary catheter and accessories<br>21 CFR 876.5010 | |
| Predicate Device: | Microvasive Rapid ExchangeTM Biliary Balloon<br>Dilation Catheter<br>(K001338 Boston Scientific Corporation)<br>Bard biliary Balloon Dilators<br>(K920361 C.R.Bard, Inc.) | |

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#### D. Description of the Device(s)

Single use balloon dilator Maxpass ™ is a triple lumen catheter with a balloon Single use banoon and of the catheter. Balloon dilators are used to exert radial force to dilate narrow duct segments, as well as the Sphincter of Oddi.

#### E. Intended Use of the Device(s)

Single use balloon dilator Maxpass ™ to be used in conjunction with Olympus endoscopes for dilating strictures of the biliary tree and the major papilla during endoscopic applications.

## F. Summary including Conclusions drawn from Non-clinical Tests

When compared to the predicate device, the Single use balloon dilator Maxpass TM
an and the predicate in the same in Which compared to the p significant changes in the intended use, method of operation, material, or design that could affect safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows a black and white drawing of a bird in flight. The bird is facing to the right and has three lines running through its body. There is some text in a circular pattern to the left of the bird. The text is not clear enough to read.

JUL - 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Laura Storms-Tyler Executive Director Regulatory Affairs & Quality Assurance Olympus America, Inc. Two Corporate Center Drive MELVILLE NY 11747-3157

Re: K050502

K050302
Trade/Device Name: Single use balloon dilator MaxPass™ Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: July 5, 2005 Received: July 6, 2005

Dear Ms. Storms-Tyler:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced We have reviewed your booked by equivalent (for the indications for use stated in above and nave occommod the ad predicate devices marketed in interstate commerce prior to the enclosure) to tegary maneloce presented Device Antendments, or to devices that have been May 20, 1 770, the chaounce with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordation war are novel application (PMA). You may, therefore, market the do not require approval of a premation of the Act. The general controls provisions of the Act device, subject to the general controls provises, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket n your device is classifica (see abore) into stirols. Existing major regulations affecting your Approval), It 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 Please be advised that I DA s issualled of a successions of the requirements of the Act of any FDA has made a decemination mail four control and receives. You must comply with all the Federal statues and regulations administed to registration and listing (21 CFR Part 807); labeling Act s requirements, including, but hot million is regultements as set forth in the quality systems (QS) (21 CFR Part 801); and 801); and if applicable, the electronic product radiation control provisions (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 5 10(k)
1 a legally This letter will allow you to begin marketing your antial equivalence of your device to a legally premarket notification. The FDA Inding of substantial equive 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 laboring regarmed on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to prematiket notification" (21 CFR Also, please note the regulation entitled, "virsonalians" of our responsibilities under the Act from the 807.97). You may obtain other gelleral mionnation on your copied on its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours, -

Nancy C. Hogdon

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

510(k) Number (if known): None Koso 50 Z Device Name: Single use balloon dilator MaxPass™

Indications For Use: Single use balloon dilator Maxpass ™ to be used in conjunction with Olympus endoscopes for dilating strictures of the biliary tree and the major papilla during endoscopic applications.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon

(Division Sign-Off) ive. Abdomina Division of Reproduct and Radiological Device 510(k) Number.

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