IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1

K011965 · Boston Scientific Corp · KOD · Jul 13, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K011965
• Device Name: IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1
• Applicant: Boston Scientific Corp
• Product Code: KOD · Gastroenterology, Urology
• Decision Date: Jul 13, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Intended Use

The Imager™ II Urology Torque Catheter is indicated for use in facilitating access to the urinary tract, either through a retrograde or antegrade route, and may he used in conjunction with a guidewire or for the infusion of radiopaque contrast material.

Device Story

The Imager II Urology Torque Catheter is a single-lumen urological catheter used to facilitate access to the urinary tract. It consists of a flexible tip bonded to a reinforced, torqueable shaft with a proximal Luer lock hub. The device is used by urologists or trained clinicians in clinical settings to navigate the urinary tract, often in conjunction with a guidewire or for the infusion of radiopaque contrast media. By providing torqueability and various tip styles, the catheter allows for precise navigation, aiding in diagnostic or therapeutic urological procedures. It is a mechanical device and does not involve electronic processing or software.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Single-lumen urological catheter; reinforced, torqueable shaft; flexible distal tip; proximal Luer lock hub. Available in various lengths and tip styles. Mechanical device; no energy source, software, or connectivity.

Indications for Use

Indicated for patients requiring urinary tract access via retrograde or antegrade routes; facilitates guidewire placement or radiopaque contrast infusion.

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

• Imager Torque Catheter (K965229)

Submission Summary (Full Text)

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Special 510(k) Premarket Notification Imager! 11 Crology Torque Catheter June 22, 2001

Boston Scientific Corporation-Microvasive One Roston Scientific Place Natick, MA 01760-1537

> 12011965 PG. I OF

## Appendlx C: Regulatory Submission Summary (510k Summary)

Submission Summary (per 21 CFR 808.92)

SPONSOR:

CONTACT PERSON:

SUBMISSION DATE:

TRADE/PROPRIETARY NAME:

COMMON/USUAL NAMES:

PROCODE:

CLASSIFICATION CODE: CLASS NAME:

INTENDED USE:

DESCRIPTION OF DEVICE:

## SUBSTANTIAL EQUIVALENCE:

Boston Scientific Corporation (BSC) Microvasive Urology One Scientific Place Natick, MA 01760-1537

Lorraine M. Hanley, RAC Director, Global Regulatory Affairs Boston Scientific / Microvasive

Robert J. Michalik, RAC Principal Specialist, Global Regulatory Affairs Boston Scientific / Microvasive

June 22, 2001

or

Imager II TM Urology Torque Catheter

Urological Catheter

78 KOD

CFR 876.5130 Urological Catheters and Accessories, Class II

The Imager™ II Urology Torque Catheter is indicated for use in facilitating access to the urinary tract, either through a retrograde or antegrade route, and may he used in conjunction with a guidewire or for the infusion of radiopaque contrast material.

The Imager™ II Urology Torque Catheter is a single-lumen urological catheter comprised of a flexible tip bonded to the distal end of a reinforced, torqueable. A lucr lock hub is attached to the proximal end of the shaft. The catherer is supplied in a variety of standard lengths and with an array of tip styles commonly used in urological procedures,

The proposed device is substantially equivalent to other urological catheters classified under 21 CFR 876.5130, more specifically with Boston Scientific Corporation's Imager Torque Catheter (K965229). The substantial equivalence determination is based upon test results that confirm the proposed device is biocompatible and substantially similar to the legally marketed predicate device in terms of material composition and performance parameters.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings or feathers. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 3 2001

Robert J. Michalik, RAC Principal Specialist, Global Regulatory Affairs Boston Scientific Corporation Microvasive Urology One Boston Scientific Place NATICK MA 01760-1537

Re: K011965

Imager™ II Urology Torque Catheter Dated: June 22, 2001 Received: June 25, 2001 Regulatory Class: II 21 CFR \$876.5130/Procode: 78 KOD

Dear Mr. Michalik:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have arealiente anyings We have reviewed your Section 210(x) notications of the enclosure) to legally markets predicate devices area and device is substantially equivalent (of the materies) in the enactment atte Medical Device Amendments, or to devices of to devices of to devices of to devices of the May 201 marketed in interstate commerce provisions of the Federal Food, Drug, and Comments Act (Act.). You may, a
that have been reclassified in accordance with the provisions of th that have been reclassified in accordance will the provisions of the Act. The general controls provisions of the Active therefore, market the device, subject on the gultions pro research of the one of the of the may of the may and misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Prematice Approval), it nay be subjicos If your device is classified (see above) nine elder class it (openal obtaring or the cause in the Code of Feeral Regulations) to such additional controls. Existing major regulations arecting to research the Current Good Manufacturing
Title 21, Parts 800 to 895. A substantialiy equivalent (OS) (OS) Title 21, Parts 800 to 895. A subsallians equiral decimination (QS) for Medical Devices: Cencral regulation (21 CFR Part Practice requirements, as set form in the Quality System to (PD) will verify such assumptions. Failure 820) and that, through periodic QS inspections, the Francesses of the may poblish further announcements.
to comply with the GMP regulation may result in regulatory action. I to comply with the UNY regulation may result in regulation, recentralient of the mission dess not concerning your device in the Federal Register. Trease now and response of the Electronic Product 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) premarkt notification for your device and This letter will allow you to begally 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 additionally of the reserved If you desire specific advice tor your device of Compliance at [phone]. Additionally, for questions on the promotion diagnostic devices), please contact the Office of Complanes at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your entitled, "Misbranding of Peterice to prehalker in the Division of Scoal Manufactures Assistance at its toll-free number (800)
responsibilities under the Act may be obtained responsibilities under the Acc may be obtained from also events of the started this in the

Sincerely yours

Nancy C Brogdon

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

Enclosure (s)

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Appendix D: Indications for Use Enclosure

Page 1 of 1

Koll965 510(k) Number (if known):

Device Name: Microvasive®

Indications For Use:

The Microvasive ® Imager™ II Urology Torque Catheter is indicated for use in facilitating access to the urinary tract, either through a retrograde or antegrade route, and may be used in conjunction with a guidewire or for the infusion of radiopaque contrast material.

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

or

Over-The-Counter Use

(Optional Format 1-2-96)

Maurice Broglon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K011965