ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE

K140593 · Cook, Inc. · GCJ · Dec 15, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K140593
• Device Name: ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE
• Applicant: Cook, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Dec 15, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The Advance Salivary Balloon Catheter is an over-the-wire catheter used for dilating salivary duct strictures. It consists of a catheter shaft (polyimide/polyurethane/PTFE) with a hydrophilic coating and a nylon balloon, supplied with a stainless steel mandrel wire guide. The device is used by clinicians in a clinical setting. The clinician inserts the wire guide and tracks the balloon catheter to the target lesion under endoscopic or radiological guidance. The balloon is inflated to dilate the stricture, then deflated and removed. This mechanical dilation restores duct patency, potentially improving salivary flow and reducing symptoms associated with ductal strictures. The device is sterile and intended for single use.

Clinical Evidence

No clinical data. Evidence consists of bench testing and simulated clinical use in a human cadaver model. Bench tests included bond strength, balloon burst strength, fatigue, inflation/deflation time, corrosion resistance, and dimensional analysis. Simulated clinical use confirmed atraumatic tip, trackability, compatibility with wire guide, and verifiability of balloon location within the salivary duct. All predetermined acceptance criteria were met.

Technological Characteristics

Over-the-wire balloon catheter; 2.5 French OD; 30 cm length. Materials: Polyimide/Polyurethane/PTFE shaft, Nylon balloon, Polycarbonate Y-fitting. Hydrophilic coating on distal 15 cm. Includes 0.014 inch stainless steel mandrel wire guide. Max balloon pressure 16 atm. Sterile, single-use. Conforms to ISO 10555-1 for bond strength.

Indications for Use

Indicated for dilation of lesions and strictures in submandibular and parotid salivary ducts.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Sialo Dilatation Balloon Catheter (K072749)
• Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter (K122940)
• Mandrel Guidewires (K011084)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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 Incorporated<br>750 Daniels Way<br>Bloomington, IN 47404 |
| Contact Phone Number: | [phone] x102628 |
| Contact Fax Number: | [phone] |

# 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:

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.

### 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® Salivary<br>Balloon Catheter<br>with Wire Guide<br>(This submission) | Sialo Balloon<br>Dilatation<br>Catheter<br>(K072749) | Advance Micro™ 14 Ultra<br>Low-Profile PTA Balloon<br>Catheter<br>(K122940) | Mandrel<br>Guidewires<br>(K011084) |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The Advance Salivary<br>Balloon Catheter is<br>intended for the<br>dilation of lesions and<br>strictures in the<br>submandibular and<br>parotid salivary ducts. | The Sialo device is<br>a medical device<br>for use by qualified<br>surgeons in the<br>treatment of<br>salivary gland<br>diseases. | The Advance Micro 14<br>Ultra Low-Profile PTA<br>Balloon Catheter is<br>intended for percutaneous<br>transluminal angioplasty<br>(PTA) of lesions in<br>peripheral arteries<br>including internal<br>pudendal, iliac, renal;<br>popliteal, femoral,<br>iliofemoral, anterior tibial,<br>posterior tibial, peroneal,<br>pedal, radial, brachial, and<br>ulnar, as well as<br>obstructive lesions of<br>native or synthetic<br>arteriovenous dialysis<br>fistulae. Not for use in the<br>coronary arteries. | To facilitate<br>the placement<br>of devices for<br>diagnostic and<br>interventional<br>procedures. |
| Catheter OD<br>(French) | 2.5 | Not available in<br>510(k) Summary | 2.5 | Not applicable |
| Catheter Length<br>(cm) | 30 | Not available in<br>510(k) Summary | 50, 90, and 150 | Not applicable |
| Hydrophilic<br>Coating | Yes | Not available in<br>510(k) Summary | Yes | Not applicable |
| Catheter Material | Polyimide/Polyurethane/<br>PTFE | Not available in<br>510(k) Summary | Polyimide/Polyurethane/<br>PTFE | Not applicable |
| Y-fitting<br>Material | Polycarbonate | Not available in<br>510(k) Summary | Polycarbonate | Not applicable |
| Inflated Balloon<br>OD (mm) | 1.5, 2.0, 2.5, and 3.0 | Not available in<br>510(k) Summary | 1.5, 2.0, 2.5, and 3.0 | Not applicable |
| Inflated Balloon<br>Length (cm) | 2.0 | Not available in<br>510(k) Summary | 2.0, 3.0, 4.0, 6.0, 8.0, 10.0<br>and 12.0 | Not applicable |
| Balloon Material | Nylon | Not available in<br>510(k) Summary | Nylon | Not applicable |
| Maximum<br>Balloon<br>Pressure (atm) | 16 | 16 | 16 | Not applicable |
| Wire Guide OD<br>(inch) | 0.014 | Not applicable | Not applicable | 0.014 - 0.045 |
| Wire Guide<br>Length (cm) | 50 | Not applicable | Not applicable | 20 - 500 |
| Wire Guide<br>Material | 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:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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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9. 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).