UROLOGICAL BALLOON DILATATION CATHETER

K980795 · Boston Scientific Corp · EZN · Apr 22, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K980795
• Device Name: UROLOGICAL BALLOON DILATATION CATHETER
• Applicant: Boston Scientific Corp
• Product Code: EZN · Gastroenterology, Urology
• Decision Date: Apr 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BD-3 Catheters are intended for urological dilatation; ureteral and urethral.

Device Story

BD-3 Catheters are urological balloon dilatation catheters used for the dilation of the ureter and urethra. The device is operated by a clinician in a clinical setting. It functions by inflating a balloon to apply radial force to the target anatomical structure to achieve dilatation. The device is intended for prescription use.

Clinical Evidence

No clinical data provided; substantial equivalence is based on performance characteristics.

Technological Characteristics

Urological balloon dilatation catheter. Class II device (21 CFR 876.5470, 876.5520).

Indications for Use

Indicated for urological dilatation of the ureter and urethra.

Regulatory Classification

Identification

A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.

Submission Summary (Full Text)

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K980795 plofl

## APR 22 1998

## ATTACHMENT H

## SUMMARY OF SAFETY AND EFFECTIVENESS

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification either an "... adequate summary of any information respecting to submit "rith this remaintent will be made available upon request of any person." Boston Scientific Corporation choose to submit a summary of information respecting safety and effectiveness. According to §513(i)(3)(B), "Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data concerning adverse health effects..."

The summary regarding the adverse health effects of the proposed BD-3 Catheters is as follows:

| Sponsor: | Boston Scientific Corporation<br>One Boston Scientific Place<br>Natick, MA 01760-1537 |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Linda S. Pollitz<br>Senior Regulatory Affairs Specialist<br>or<br>Lorraine M. Hanley<br>Manager, Regulatory Affairs |
| Submission Date: | February 24, 1998 |
| Common/Usual Names: | Urological Balloon Dilatation Catheter |
| Trade/Proprietary Name: | To Be Determined |
| Device Classification and Name: | According to Section 13 of the Federal Food, Drug and Cosmetic Act,<br>the device classification is Class II, Performance Standards<br>Product Code: 78 EZN and 78 KOE |
| Substantial Equivalence: | The proposed modified devices are Substantially Equivalent to devices<br>previously cleared by the FDA via the 510(k) Notification process and<br>indicated for dilatation of the urinary tract. |
| Performance: | The proposed modified device is Substantially Equivalent to the predicate<br>devices in terms of performance characteristics tested. |

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Image /page/1/Picture/0 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 2 1998

Ms. Linda S. Pollitz Senior Regulatory Affairs Specialist Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760-1537

Re: K980795 BD-3 Urological Balloon Dilatation Catheters Dated: February 27, 1998 Received: March 2, 1998 Regulatory class: II 21 CFR §876.5470/Product code 78 EZN 21 CFR §876.5520/Product code 78 KOE

Dear Ms. Pollitz:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976; the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

William Yu, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510(k) Number (if known): | T ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>มมากที่ 1977 เป็นที่มีสินค้ามา |
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Device Name:

To Be Determined

Indications For Use:

BD-3 Catheters are intended for urological dilatation; ureteral and urethral.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription Use
(Per 21 CFR 801.109)
or
Over-The-Counter Use

Robert D Mathing/
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

(Optional Format

510(k) Number K980795

(Optional Format 1-2-96)