The Insulator Wire Guide will be used either inside or alongside a urological catheter or electrosurgical catheter for catheter positioning or exchange in the urinary tract. When used with an electrosurgical catheter, the Insulator Wire Guide will decrease the risk of alternate site burns to the patient. This device is intended for one-time use.

Device Description

The Insulator Wire Guide is used either inside or alongside a urological catheter or electrosurgical catheter for catheter positioning or exchange in the urinary tract. When used with a electrosurgical catheter, the Insulator Wire Guide will decrease the risk of alternate site burns to the primary material used in this device is TFE. TFE is widely used in the medical field and biocompatibility is assured. Performance testing was performed showing the device to meet requirements for a safe and effective insulated wire guide.

AI/ML Overview

The Insulator Wire Guide is intended for use in the urinary tract for catheter positioning or exchange, either inside or alongside a urological or electrosurgical catheter. When used with an electrosurgical catheter, it aims to reduce the risk of alternate site burns to the patient. The device is for one-time use.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety: Device decreases the risk of alternate site burns to the patient when used with an electrosurgical catheter.	"Performance testing was performed showing the device to meet requirements for a safe and effective insulated wire guide."
Effectiveness: Use for catheter positioning or exchange in the urinary tract.	"Performance testing was performed showing the device to meet requirements for a safe and effective insulated wire guide."
Biocompatibility: Materials used are safe for medical application.	"The primary material used in this device is TFE. TFE is widely used in the medical field and biocompatibility is assured."
Substantial Equivalence: Design, construction, materials, and indications for use are similar to predicate insulated wire guides (e.g., Protector Plus by Wilson-Cook Medical Inc.).	"The Insulator Wire Guide is substantially equivalent to predicate insulated wire guides in terms of indications for use, design, construction and materials equivalence."

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Performance testing was performed."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide information on the number of experts used, their qualifications, or how ground truth was established for any test set.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This section is not applicable. The device described is an "Insulator Wire Guide," a physical medical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance would not be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is not applicable. As mentioned above, this is a physical medical device, not an algorithm, so standalone performance in the context of AI is not relevant.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document does not explicitly state the type of ground truth used for "performance testing." It broadly refers to "requirements for a safe and effective insulated wire guide," suggesting the ground truth would be based on established engineering standards, material properties, and potentially bench testing results to demonstrate insulation and functional capabilities. For biocompatibility, the ground truth is established by the widespread and assured biocompatibility of TFE in the medical field.

8. The Sample Size for the Training Set

The document does not mention a "training set" as this is a physical device and not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

The document does not mention a "training set" or its ground truth, as this is a physical device.

Summary of Study Information:

The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than detailed performance study results with specific acceptance criteria and outcome metrics. The submission relies on the established safety and effectiveness of the existing predicate devices and the known biocompatibility of the material (TFE). The "performance testing" mentioned is general and lacks specific details regarding methodology, sample sizes, or results against quantified acceptance criteria.

Summary

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510(k) Premarket Notification STU(K)
Insulator Wire Guide Cook Urological

5772977

OCT 10 1997

510(k) SUMMARY L

Submitted By:

Tammy Bacon Cook Urological 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-4891 August 8, 1997

Device

Trade Name:

Proposed Classification Name:

Insulator Wire Guide

Electrosurgical Cutting & Coagulation Device & Accessories

Predicate Devices:

The Insulator Wire Guide is substantially equivalent to predicate insulated wire guides in terms of indications for use, design, construction and materials equivalence. Specifically, this device is similar to the Protector Plus manufactured by Wilson-Cook Medical Inc.

Device Description:

Substantial Equivalence:

This device will be manufactured according to specified process controls and a Quality Assurance Program. This device will undergo packaging similar to devices currently marketed and distributed by Cook Urological. Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.

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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Tammy Bacon Regulatory Affairs Technical Writer Cook Urological, Inc. 1100 West Morgan Street Spencer, Indiana 47460

Re: K972977 Insulator Wire Guide OCT 10 1997 Dated: August 8, 1997 Received: August 11, 1997 Regulatory class: II 21 CFR §876.5130/Product code: 78 KNY

Dear Ms. Bacon:

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 Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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.

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 QS 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 vito diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation wititled, "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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

W.Liau Yu

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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PREMARKET NOTIFICATION

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): Not yet assigned

Device Name: Insulator Wire Guide

Indications for Use: The Insulator Wire Guide will be used either inside or alongside a urological catheter or electrosurgical catheter for catheter positioning or exchange in the urinary tract. When used with an electrosurgical catheter, the Insulator Wire Guide will decrease the risk of alternate site burns to the patient. This device is intended for one-time use.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEE!DED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

(Division Sign-C Division of Reproductive, Abdominal, EN and Radiological Device

510(k) Number K972977

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _________

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.