OCCLUDER OCCLUSION BALLOON CATHETER

K133750 · Boston Scientific Corporation · EYB · Jan 8, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K133750
• Device Name: OCCLUDER OCCLUSION BALLOON CATHETER
• Applicant: Boston Scientific Corporation
• Product Code: EYB · Gastroenterology, Urology
• Decision Date: Jan 8, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Occluder™ Occlusion Balloon Catheters are indicated for use for temporary Ureteral occlusion and applications including, renal opacification, dislodgment of calculi and preventative calculi migration.

Device Story

Occlusion balloon catheter designed for temporary ureteral occlusion; used for renal opacification, calculi dislodgement, and prevention of calculi migration. Device consists of soft compliant latex balloon mounted on radiopaque catheter shaft; features two color-coded lumens: one for balloon inflation, one for guidewire passage and contrast medium infusion. Used by clinicians in urological procedures. Radiopaque shaft allows fluoroscopic visualization during placement. Single-use, sterile device.

Clinical Evidence

Bench testing only. Performance testing conducted on samples at T=0 and 7-months accelerated aging to validate balloon and shaft material changes. Results demonstrate equivalence to predicate device.

Technological Characteristics

Soft compliant latex balloon; radiopaque catheter shaft; two-lumen design (inflation and guidewire/infusion); supplied sterile for single use; includes stopcock and syringe; packaged in thermoformed tray within heat-sealed poly/Tyvek pouch.

Indications for Use

Indicated for temporary ureteral occlusion in patients requiring renal opacification, calculi dislodgement, or prevention of calculi migration.

Regulatory Classification

Identification

A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

Predicate Devices

• Van-Tec Occlusion Balloon Catheter (K841941/A)

Submission Summary (Full Text)

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Occluder™ Occlusion Balloon Catheter Traditional 510(k) .

Boston Scientific

| | | Acres of Acres of Acres | 2014 |
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| SECTION 5 | | 510(k) SUMMARY<br>IN IN AN R LEWINDS SHEENDERS ANNUAL BOOK OF ALL - I BELLENIN - A LA | |

# 510(k) Summary for Occluder™ Occlusion Balloon Catheter

## A. Sponsor

Boston Scientific Corporation Urology and Women's Health Division 100 Boston Scientific Way Marlborough, MA 01756

#### B. Contact

Christine Shoemaker Specialist II, Regulatory Affairs 508-683-4214 [e-mail]

Or

Lisa Sullivan Manager, Regulatory Affairs 508-683-4745 [e-mail]

## C. Device Name

Occluder™ Occlusion Balloon Catheter Trade name: Common/usual name: Catheter, Ureteral, Gastro-Urology Classification Name: EYB - Catheter, Ureteral, Gastro-Urology

## I). Predicate Device

Occluder™ Occlusion Balloon Catheter (Boston Scientific) Trade name: Common/usual name: Catheter, Urological Classification Name: KOD - Catheter, Urological

Premarket Notification: Van-Tec Occlusion Balloon Catheter (submitted by Van-Tec. Inc.), K841941/A, August 8, 1984.

### E. Device Description

Occluder Occlusion Balloon Catheters are designed for use for temporary occlusion of the ureter and applications including renal opacification, dislodgement of calculi and preventative calculi migration. The devices are provided sterile and are intended for single use.

The Occluder Occlusion Balloon Catheters are constructed of a soft compliant latex balloon mounted on the tip of a catheter shaft. Catheter shafts are radiopaque, maximizing fluoroscopic visibility.

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## SECTION 5

#### 510(k) SUMMARY

The Occluder Occlusion Balloon Catheters have two lumens that are marked and color-coded. The balloon tubing, marked BALLOON is a balloon inflation lumen. The tubing marked DISTAL, is the essential lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire. This lumen can also be used for infusion of contrast medium.

## F. Intended Use

The Occluder™ Occlusion Balloon Catheters are indicated for use for temporary Ureteral occlusion and applications including, renal opacification, dislodgment of calculi and preventative calculi migration.

## G. Technological Characteristics

The Occluder Occlusion Balloon Catheters have the same technological characteristics and fundamental occlusion balloon catheter design as the predicate device. The proposed Occluder Occlusion Balloon Catheters are packed using a thermoformed, multi-product tray and supplied with a stopcock and syringe. A tray lid is applied to help secure the device inside the tray cavities. The lidded tray is then placed into a heal-sealed poly/Tyvek pouch. The pouch is labeled and placed into a labeled shelf carton along with a DFU.

## H. Substantial Equivalence

A direct comparison of key characteristics has been performed and demonstrates that the proposed Occluder Occlusion Balloon Catheter is substantially equivalent to the predicate device in terms of intended use. The proposed device is substantially equivalent to the reference devices in terms of technological characteristics, types of materials and performance characteristics. The proposed Occluder Occlusion Balloon Catheter is as safe, as effective, and performs as well as the predicate device.

#### I. Performance Testing (Bench Evaluation)

Boston Scientific has conducted performance testing with samples aged at T=0 and 7-months Accelerated Aging in support of the balloon material and shaft material changes.

The results of the performance testing demonstrate equivalence of the Occluder Catheter to the predicate device. The Occluder Occlusion Balloon Catheter is considered safe and effective for its intended use.

Boston Scientific

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-00002

January 8, 2014

Boston Scientific Corporation Urology and Women's Health Christine Shoemaker, MS, RAC Specialist II, Regulatory Affairs 100 Boston Scientific Way Mariborough, MA 01752

K133750 Re:

> Trade/Device Name: Occluder™ Occlusion Balloon Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EYB Dated: December 11, 2013 Received: December 12, 2013

Dear Christine Shoemaker,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. 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 or any Federal statutes and regulations administered by other Federal agencies.

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Page 2 - Christine Shoemaker, MS, RAC

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/3/Picture/7 description: The image shows the name "Herbert P. Lerner -S" in a bold, sans-serif font. The text is black against a white background. The letters are evenly spaced and easily readable.

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### SECTION 4 1 INDICATIONS FOR USE

## Indications for Use Statement

## 510(k) Number : K133750

Device Name Occluder™ Occlusion Balloon Catheter

Indications For Use

The Occluder™ Occlusion Balloon Catheters are indicated for use for temporary Ureteral occlusion and applications including, renal opacification, dislodgment of calculi and preventative calculi migration.

Prescription Use X (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)

Herbert P. Lerner 2014.01.08 15:46:09

Proprietary and Confidential Information of Boston Scientific Corporation