IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1 by BOSTON SCIENTIFIC CORP.

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 Description

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,

AI/ML Overview

This document does not contain the acceptance criteria or a study proving the device meets acceptance criteria. It is a 510(k) Premarket Notification for the Imager II Urology Torque Catheter, which primarily focuses on establishing substantial equivalence to a predicate device.

Here's what the document does provide:

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 be used in conjunction with a guidewire or for the infusion of radiopaque contrast material."
Description of Device: "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."
Substantial Equivalence Claim: The device is claimed to be "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."

Missing Information:

The document explicitly states that "test results... confirm the proposed device is biocompatible and substantially similar to the legally marketed predicate device in terms of material composition and performance parameters." However, it does not provide:

A table of acceptance criteria and reported device performance.
Details about a specific "study that proves the device meets the acceptance criteria." This would typically involve performance data, measurement metrics, and specific thresholds for acceptance.
Sample size used for the test set and data provenance.
Number of experts used to establish ground truth or their qualifications.
Adjudication method.
Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
Information about a standalone (algorithm only) performance study. (This is not an AI device, so this is not applicable but listed for completeness based on your request).
Type of ground truth used.
Sample size for the training set.
How the ground truth for the training set was established.

In the context of a 510(k) submission for a device like a urological catheter, "performance parameters" often refer to physical and mechanical characteristics (e.g., tensile strength, torqueability, lubricity, burst pressure, material compatibility, biocompatibility) rather than diagnostic accuracy metrics seen in AI/imaging devices. The "study" mentioned would be a series of engineering and bench tests, not a clinical study in the sense of comparing diagnostic outcomes, nor does it typically involve expert readers or ground truth in the way a diagnostic AI device would. The core of a 510(k) is demonstrating similarity to an already approved predicate device.

Summary

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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

Imager II TM Urology Torque Catheter

Urological Catheter

78 KOD

CFR 876.5130 Urological Catheters and Accessories, Class II

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 (301) 594-4639. Additionally, for questions on the promotion diagnostic devices), please contact the Office of Complanes at (301) 594-4639. 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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

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

Regulation Number and Section

§ 876.5130 Urological catheter and accessories.

(a)
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).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.