The Advance® Salivary Balloon Catheter is an over-the-wire catheter available with an inflated balloon diameter of 1.5. 2.0, 2.5 and 3.0 millimeters in a balloon length of 2 centimeters. The catheter is available in an outer diameter of 2.5 French and in a length of 30 centimeters. Hydrophilic coating is applied to the distal 15 centimeters of the catheter shaft, which provides a lubricious surface when wetted. The balloon catheter is supplied with a 0.014 inch (0.36 millimeter) diameter stainless steel mandrel wire guide in a length of 50 centimeters. It is sterile and intended for one-time use.

AI/ML Overview

Acceptance Criteria and Device Performance Study

The provided text describes the Advance® Salivary Balloon Catheter with Wire Guide and the studies conducted to demonstrate its reliable design and performance.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Bond Strength	Tensile force during proper clinical use should not fracture or rupture the balloon catheter bonds. Conforms to ISO 10555-1.	Predetermined acceptance criteria were met.
Balloon Minimum Burst Strength	Balloons will burst at or above the minimum rated burst pressure, with all failure modes being linear tears.	Predetermined acceptance criterion was met.
Balloon Fatigue	Balloons are free from leakage and damage on inflation after 10 cycles of inflation and deflation.	Predetermined acceptance criteria were met.
Inflation and Deflation Time	Balloon will inflate to rated burst pressure within 60 seconds and fully deflate within 60 seconds.	Predetermined acceptance criteria were met.
Resistance to Corrosion	After being subjected to a corrosive environment, the wire guide withstands a tensile force greater than or equal to 5 N.	Predetermined acceptance criterion was met.
Visual and Dimensional Analysis	Visually and dimensionally, the wire guide and balloon catheter meet the design requirements.	Predetermined acceptance criteria were met.
Simulated Use	Wire guide and balloon catheter pass through a simulated stricture, and the force required to remove the balloon catheter is less than 0.95 lbf.	Predetermined acceptance criteria were met.
Balloon Working Length and Catheter Integrity	After simulated use testing, the catheter shows no signs of damage, and the balloon length is 2.0 centimeters ± 0.1 centimeter.	Predetermined acceptance criteria were met.
Simulated Clinical Use (Human cadaver model)	Balloon catheter has an atraumatic tip, safely and reliably introduces and tracks to the intended location, is compatible with the wire guide, can be removed from the salivary duct and/or sheath, and its location is verifiable within the salivary duct.	Predetermined acceptance criteria were met.

2. Sample Size for Test Set and Data Provenance

The document does not explicitly state the specific numerical sample sizes for each of the performance tests. It refers to "testing shows" and implies that sufficient samples were tested to meet the predetermined acceptance criteria for each test. The data provenance is not specified beyond the tests being conducted for regulatory submission for a device to be marketed in the USA. Given the nature of these engineering and performance tests, they are typically conducted in a controlled laboratory environment. The "Simulated Clinical Use" test specifically mentions a "human cadaver model," implying prospective testing in a controlled lab setting, likely in the country of manufacture (USA, given the applicant is Cook Incorporated in Bloomington, IN).

3. Number of Experts and Qualifications for Ground Truth for Test Set

Not applicable for most of the tests. The tests are engineering and performance-based, not reliant on expert interpretation for ground truth. For the "Simulated Clinical Use" test using a human cadaver model, while clinical utility is being assessed, the document does not specify the number or qualifications of experts who established the "ground truth" or evaluated the performance of the device in this context. It simply states that the "predetermined acceptance criteria were met," which would likely align with successful navigation and deployment as observed by the testing personnel.

4. Adjudication Method for Test Set

Not applicable. The tests described are objective, quantitative, or pass/fail engineering and performance tests, not requiring an adjudication method akin to clinical studies where multiple readers interpret results.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed. The studies described are focused on the device's inherent design and performance characteristics, not on a comparison of human reader performance with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was performed. The entire section "Technological Characteristics" details various tests conducted on the device itself (e.g., bond strength, burst strength, fatigue, inflation/deflation time, corrosion resistance, visual/dimensional analysis, simulated use, balloon working length/catheter integrity, simulated clinical use). These tests assess the algorithm/device's performance in isolation from a human-in-the-loop scenario.

7. Type of Ground Truth Used

The ground truth used for these tests is based on engineering specifications, predetermined quantitative thresholds, and observable physical properties. For example:

Bond Strength: Conformance to ISO 10555-1 standards.
Balloon Minimum Burst Strength: Bursting at or above a specified pressure.
Inflation and Deflation Time: Within 60 seconds.
Resistance to Corrosion: Withstanding a tensile force greater than or equal to 5 N.
Simulated Use: Catheter passing through a simulated stricture, removal force less than 0.95 lbf.
Balloon Working Length: 2.0 cm ± 0.1 cm.
Simulated Clinical Use: Observable successful introduction, tracking, compatibility, removal, and verifiable location in a cadaver model.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical instrument (catheter, balloon, wire guide), not an AI algorithm or a device that uses a "training set" in the machine learning sense. The "training set" concept is not relevant here.

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

Not applicable, as there is no "training set" for this type of medical device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 15,2014

Cook Incorporated Mr. Larry Pool Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404

Re: K140593

Trade/Device Name: Advance® Salivary Balloon Catheter with Wire Guide Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: November 12, 2014 Received: November 13, 2014

Dear Mr. Pool:

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.

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Page 2 - Mr. Pool

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 (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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runco DDS, MA

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K140593

Device Name

Advance® Salivary Balloon Catheter with Wire Guide

Indications for Use (Describe)

The Advance® Salivary Balloon Catheter is intended for the dilation of lesions and strictures in the submandibular and parotid salivary ducts.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of a red rectangle with the word "COOK" in white, bold letters on the top line. Below the word "COOK" is the word "MEDICAL" in white, bold letters. A registered trademark symbol is located to the right of the word "COOK".

5.0 510(k) SUMMARY

K140593 Advance® Salivary Balloon Catheter with Wire Guide 21 CFR §807.92 Date Prepared: December 12, 2014

Submitted By:

Applicant:	Cook Incorporated
Contact:	Larry D. Pool
Applicant Address:	Cook Incorporated750 Daniels WayBloomington, IN 47404
Contact Phone Number:	(812) 335-3575 x102628
Contact Fax Number:	(812) 332-0281

Device Information:

Trade Name:	Advance® Salivary Balloon Catheter with Wire Guide
Common Name:	Endoscopes and accessories
Classification Name:	Laparoscope, General & Plastic Surgery
Regulation:	21 CFR §876.1500
Product Code:	GCJ

Predicate Devices:

. K072749 Sialo Dilatation Balloon Catheter (Sialo Technologies, Ltd.). The Sialo Balloon Dilatation Catheter is designed to allow dilatation of the salivary duct under endoscopic or radiological guidance. Dilatation can be therapeutic by itself (for duct strictures), or provide endoscopic access for stone removal.
K122940 Advance Micro" 14 Ultra Low-Profile PTA Balloon Catheter (Cook ● Incorporated). The Advance Micro™ 14 Ultra Low-Profile PTA Balloon Catheter is an over-the-wire balloon catheter indicated for vascular use.

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. K011084 Mandrel Guidewires (Lake Region Manufacturing). The Mandrel Guidewires are a stainless steel core wire with a stainless steel coil tip indicated for diagnostic and interventional procedures.

Device Description:

Intended Use:

The Advance Salivary Balloon Catheter is intended for the dilation of lesions and strictures in the submandibular and parotid salivary ducts.

Comparison to Predicates:

The Advance® Salivary Balloon Catheter with Wire Guide and the predicate device, the Sialo Dilatation Balloon Catheter (K072749), are substantially equivalent in that these devices have similar design and indications for use. Additionally, the proposed Advance Salivary Balloon Catheter with Wire Guide is identical in technological characteristics, materials, and methods of construction to the Advance Micro" 14 Ultra Low-Profile PTA Balloon Catheter (K122940) and the Mandrel Guidewires (K011084) devices indicated for vascular use.

A comparison between the proposed and predicate devices is shown in the following table.

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Characteristic	Advance® SalivaryBalloon Catheterwith Wire Guide(This submission)	Sialo BalloonDilatationCatheter(K072749)	Advance Micro™ 14 UltraLow-Profile PTA BalloonCatheter(K122940)	MandrelGuidewires(K011084)
Indications forUse	The Advance SalivaryBalloon Catheter isintended for thedilation of lesions andstrictures in thesubmandibular andparotid salivary ducts.	The Sialo device isa medical devicefor use by qualifiedsurgeons in thetreatment ofsalivary glanddiseases.	The Advance Micro 14Ultra Low-Profile PTABalloon Catheter isintended for percutaneoustransluminal angioplasty(PTA) of lesions inperipheral arteriesincluding internalpudendal, iliac, renal;popliteal, femoral,iliofemoral, anterior tibial,posterior tibial, peroneal,pedal, radial, brachial, andulnar, as well asobstructive lesions ofnative or syntheticarteriovenous dialysisfistulae. Not for use in thecoronary arteries.	To facilitatethe placementof devices fordiagnostic andinterventionalprocedures.
Catheter OD(French)	2.5	Not available in510(k) Summary	2.5	Not applicable
Catheter Length(cm)	30	Not available in510(k) Summary	50, 90, and 150	Not applicable
HydrophilicCoating	Yes	Not available in510(k) Summary	Yes	Not applicable
Catheter Material	Polyimide/Polyurethane/PTFE	Not available in510(k) Summary	Polyimide/Polyurethane/PTFE	Not applicable
Y-fittingMaterial	Polycarbonate	Not available in510(k) Summary	Polycarbonate	Not applicable
Inflated BalloonOD (mm)	1.5, 2.0, 2.5, and 3.0	Not available in510(k) Summary	1.5, 2.0, 2.5, and 3.0	Not applicable
Inflated BalloonLength (cm)	2.0	Not available in510(k) Summary	2.0, 3.0, 4.0, 6.0, 8.0, 10.0and 12.0	Not applicable
Balloon Material	Nylon	Not available in510(k) Summary	Nylon	Not applicable
MaximumBalloonPressure (atm)	16	16	16	Not applicable
Wire Guide OD(inch)	0.014	Not applicable	Not applicable	0.014 - 0.045
Wire GuideLength (cm)	50	Not applicable	Not applicable	20 - 500
Wire GuideMaterial	Stainless Steel	Not applicable	Not applicable	Stainless Steel

TABLE 1: Comparison of the proposed and predicate devices
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Technological Characteristics:

The following tests have been conducted to ensure reliable design and performance under the specified testing parameters. These tests include:

Bond Strength - Testing shows the tensile force during proper clinical use should not fracture or rupture the balloon catheter bonds. In conformance with the applicable sections of ISO 10555-1, the predetermined acceptance criteria were met.
Balloon Minimum Burst Strength - Testing shows the balloons will burst at or above the minimum rated burst pressure, with all failure modes being linear tears. The predetermined acceptance criterion was met.
Balloon Fatigue - Testing shows that balloons are from leakage and damage on inflation after 10 cycles of inflation and deflation. The predetermined acceptance criteria were met.
Inflation and Deflation Time - Testing shows that the balloon will inflate to rated burst pressure within 60 seconds and fully deflate within 60 seconds. The predetermined acceptance criteria were met.
Resistance to Corrosion - Testing shows that after being subjected to a corrosive environment, the wire guide withstood a tensile force greater than or equal to 5 N. The predetermined acceptance criterion was met.
Visual and Dimensional Analysis - Testing shows that visually and dimensionally the wire guide and balloon catheter meet the design requirements. The predetermined acceptance criteria were met.
Simulated Use – Testing shows that the wire guide and balloon catheter shall pass through a simulated stricture and the force required to remove balloon catheter shall be less than 0.95 1bf. The predetermined acceptance criteria were met.
Balloon Working Length and Catheter Integrity - Testing shows that after the simulated use testing the catheter shall show no signs of damage and the balloon length shall be 2.0 centimeters + 0.1 centimeter. The predetermined acceptance criteria were met.

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Simulated Clinical Use - Testing shows that under a simulated clinical use with a human cadaver model, the balloon catheter shall have an atraumatic tip, must safely and reliably be introduced and track to the intended location, shall be compatible with the wire guide, shall be able to be removed from salivary duct and/or sheath, and location of the balloon catheter shall be verifiable within salivary duct. The predetermined acceptance criteria were met.

Human Factors Analysis:

An analysis of the critical tasks was performed for the proposed device in a Human Factors Analysis document in accordance with ISO 14971. The analysis identified no critical tasks which would or could result in serious harm.

Conclusion:

The results of these tests support a conclusion that the Advance® Salivary Balloon Catheter with Wire Guide met the design input requirements based on the intended use and support the conclusion that this device does not raise new questions of safety or effectiveness and is substantially equivalent to the predicate devices, the Sialo Dilatation Balloon Catheter (Sialo Technologies, Ltd., K072749), the Advance Micro" 14 Ultra Low-Profile PTA Balloon Catheter (Cook Incorporated, K122940), and the Mandrel Guidewires (K011084).

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.