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. The Imager II Urology Torque Catheter is also indicated for the infusion of gels, such as BackStop™, intended for use in the urinary tract.

Device Description

The Imager II Urology Torque Catheter is single lumen, torqueable catheter that is offered with one of a variety of tip configurations, each uniquely designed to facilitate access to the urinary tract. This device is made of a bio-compatible polymer reinforced with a stainless steel braided wire with one hole at the distal tip and a luer lock hub is attached to the proximal end. The catheter may be used with a guidewire up to .038 in. diameter.

AI/ML Overview

The provided FDA 510(k) summary (K180530) for the Imager™ II Urology Torque Catheter describes performance data related to material changes, not diagnostic accuracy. Therefore, many of the requested criteria regarding expert review, specific ground truth methods, and comparative effectiveness with human readers are not applicable or cannot be extracted from this document.

Here's the information that can be extracted or that indicates inapplicability:

A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Reported Device Performance (Summary)
Mechanical Performance	Meets predefined product specifications for:
	- Shaft and Tip Bond (Bond Tensile)
	- Tensile Strength (Shaft Tensile)
	- Tip Tensile Strength
Biocompatibility	No new risks or issues of safety or effectiveness introduced by new colorant. Tested via:
	- In Vitro Cytotoxicity MEM Elution
	- ISO Guinea Pig Maximization Sensitization
	- ISO Intracutaneous Reactivity

Sample size used for the test set and the data provenance
- The document states "Verification activity has been performed on representative devices of the proposed Imager™ II Urology Torque Catheters." A specific numerical sample size is not provided.
- Data Provenance: Not explicitly stated, but implies laboratory testing performed on manufactured devices. No information on country of origin of data or whether it's retrospective/prospective in a clinical sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a urological catheter, and the performance testing relates to physical properties and biocompatibility, not diagnostic interpretation requiring expert clinical consensus.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable, as no expert adjudication of diagnostic findings is involved for this type of device.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithmic or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For mechanical performance: The ground truth implicitly derives from the device's "predefined product specifications." These specifications define what constitutes acceptable shaft and tip bond, and tensile strengths.
- For biocompatibility: The ground truth for safety and effectiveness is established by the results of standardized ISO biological evaluation tests, indicating whether the material elicits a cytotoxic, sensitization, or intracutaneous reactivity response beyond acceptable limits.
The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
How the ground truth for the training set was established
- Not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

April 10. 2018

Boston Scientific Corporation Daniel FitzDaniel Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, Massachusetts 01752

Re: K180530

Trade/Device Name: Imager™ II Urology Torque Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: Class II Product Code: KOD Dated: April 5, 2018 Received: April 6, 2018

Dear Daniel FitzDaniel:

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. 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 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);

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Page 2 - Daniel FitzDaniel

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Joyce M. Whang -S

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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	DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below
	Indications for Use
510(k) Number (if known)	K180530
Device Name	Imager™ II Urology Torque Catheter
Indications for Use (Describe)	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. The Imager II Urology Torque Catheter is also indicated for the infusion of gels, such as BackStop™, intended for use in the urinary tract.
Type of Use (Select one or both, as applicable)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
	CONTINUE ON A SEPARATE PAGE IF NEEDED.
	This section applies only to requirements of the Paperwork Reduction Act of 1995.DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
	The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
	Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@fda.hhs.gov
	"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)	Page 1 of 1	PSC Publishing Services (301) 443-6740

্রামের

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510(k) SUMMARY

1. Submitter:

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752

Primary Contact: Dan FitzDaniel Regulatory Affairs Specialist Boston Scientific Corporation 100 Boston Scientific Way Marlborough MA 01752 Email: dan.fitzdaniel@bsci.com Tel: (508) 683-4156 Fax: (508) 683-5827

Secondary Contact: Virginia Garcia Regulatory Affairs Manager Boston Scientific Corporation 100 Boston Scientific Way Marlborough MA 01752 Email: virginia.garcia@bsci.com Tel: (508) 683-4430 Fax: (508) 683-5827

Date Prepared: 10 April 2018

2. Proposed Device:

Trade Name: Imager™ II Urology Torque Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: Class II Common Name: Catheter, Urological Product Code: KOD

3. Predicate Device:

Trade name: Imager™ II Urology Torque Catheter Clearance Number: K102527 Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: Class II Common Name: Catheter, Urological Product Code: KOD

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4. Device Description:

5. Intended use/ Indications for Use:

6. Technological Characteristics:

The Imager™ II Urology Torque Catheters are braided torqueable catheters that facilitate access to the urinary tract through either a retrograde route or an antegrade (percutaneous) route. Once access is achieved through either route, the devices may be used to facilitate guidewire exchange or to introduce radiopaque contrast media into the urinary tract. The devices are made of a biocompatible polymer reinforced with a stainless steel braided wire with one hole at the distal tip and a connector (hub) is attached to the proximal end. The black colorant used in manufacturing the currently cleared Imager™ II Urology Torque Catheter's distal tip is being replaced due to the discontinuation of the original black colorant by the vendor.

7. Performance Data:

Verification activity has been performed on representative devices of the proposed Imager™ II Urology Torque Catheters. This evaluation demonstrates that the black colorant does not affect the performance of the device and the device still meets the predefined product specifications for Shaft and Tip Bond (Bond Tensile), Tensile Strength (Shaft Tensile), and Tip Tensile Strength. Furthermore, the product was evaluated to confirm that the new colorant does not introduce any new risks and does not introduce any new issues of safety or effectiveness. To support this statement, the following testing was conducted: In Vitro Cytotoxicity MEM Elution, ISO Guinea Pig Maximization Sensitization, and ISO Intracutaneous Reactivity.

8. Conclusion:

The information provided in this submission demonstrates that the proposed Imager™ II Urology Torque Catheter is substantially equivalent to the predicate device (Imager™ II Urology Torque Catheter), cleared in K102527.

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.