SilverCoat Silicone Foley Catheter

K150550 · Covalontechnologies, Inc. · EZL · Nov 24, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K150550
• Device Name: SilverCoat Silicone Foley Catheter
• Applicant: Covalontechnologies, Inc.
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: Nov 24, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

To be used as a urological catheter inserted through the urethra to pass urine from the urinary tract by individuals that are ≥ 30kg and over 12 years of age. SilverCoat™ Silicone Foley Catheters should not be used on patients with known hypersensitivity or allergy to silver or silver-containing organics or inorganics.

Device Story

SilverCoat™ Silicone Foley Catheter is a 100% silicone, two-lumen urological catheter featuring a lubricious, silver-ion-impregnated hydrophilic coating. Designed for urethral insertion to facilitate urine drainage; used in healthcare facilities, home, and ambulatory settings by clinicians or patients. Silver ions are ionically bonded within the coating and covalently bonded to the silicone surface to prevent peeling or flaking. Coating hydrates rapidly to maintain lubricity for at least seven days. Device includes a proximal funnel, inflation valve, and distal retaining balloon. Supplied sterile in single-use pouches. Intended to provide a lubricious surface for patient comfort during catheterization.

Clinical Evidence

Bench testing only. Performance evaluated via resistance to microbial colonization (Kirby-Bauer), real-time aging/stability, distribution simulation, and comprehensive biocompatibility (AMES assay, cytotoxicity, sensitization, irritation, acute systemic toxicity, extractables/leachables). Physical/functional testing performed per ASTM F623-99 and EN 1616. Silver distribution and elution profiles were characterized. No clinical data provided.

Technological Characteristics

100% silicone construction; two-lumen shaft with proximal funnel, inflation valve, and distal balloon. Lubricious hydrophilic coating impregnated with silver ions. Complies with ASTM F623-99 and EN 1616. Sterilized via ethylene oxide. Single-use, prescription-only device.

Indications for Use

Indicated for patients > 30 kg and > 12 years old requiring urinary catheterization. Contraindicated in patients with known hypersensitivity or allergy to silver or silver-containing organics or inorganics.

Regulatory Classification

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).

Predicate Devices

• Medline SilverTouch™ Silicone Foley Catheter (K052168)

Submission Summary (Full Text)

{0}------------------------------------------------

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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

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

November 24, 2015

Covalon Technologies, Inc. Kim Crooks VP Of Operations 1660 Tech Avenue, Unit 5 Mississauga, Ontario, Canada L4W 5S7

Re: K150550

> Trade/Device Name: SilverCoat™ Silicone Foley Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter And Accessories Regulatory Class: Class II Product Code: EZL Dated: November 17, 2015 Received: November 19, 2015

Dear Kim Crooks,

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 (reporting of medical device

{1}------------------------------------------------

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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/1/Picture/8 description: The image shows the text "Herbert P. Lerner -S" in a large, bold font. The text is black and appears to be centered. The background is white, and there is a faint watermark in the background.

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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K150550

Device Name SilverCoat™ Silicone Foley Catheter

Indications for Use (Describe)

To be used as a urological catheter inserted through the urinary tract by individuals that are > 30 kg and over 12 years of age. SilverCoat™ Silicone Foley Catheters should not be used on patients with known hypersensitivity or allergy to silver or silver-containing organics or inorganics.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">Prescription Use (Part 21 CFR 801 Subpart D)</span> </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

### 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 Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@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."

{3}------------------------------------------------

# 510(k) Summary

In accordance with 21 CFR 807.92, the following information is provided for Covalon's SilverCoat™ Silicone Foley Catheter 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.

#### I) Sponsor Information

| Contact Address: | Covalon Technologies, Inc.<br>1660 Tech Avenue, Unit 5<br>Mississauga, Ontario, Canada L4W 5S7 |
|------------------|------------------------------------------------------------------------------------------------|
| Contact Person: | Kim Crooks<br>VP of Operations |
| Phone Number: | 1-905-568-8400 x265 |
| Fax Number: | 1-905-568-5200 |
| Date of Summary: | 17 November 2015 |

#### II) Device Name and Classification

| Common Name: | Urological Catheter |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | SilverCoat™ Silicone Foley Catheter |
| Classification Name: | Urological catheter and accessories |
| Regulation: | 21 CFR 876.5130 |
| Model No(s).: | SCC1205GU, SCC1405GU, SCC1605GU,<br>SCC1630GU, SCC1805GU, SCC1830GU,<br>SCC2005GU, SCC2030GU, SCC2205GU,<br>SCC2230GU, SCC2405GU, SCC2430GU |
| Device Classification: | Class II |
| Product Code: | EZL |
| Classification Panel: | Gastroenterology/Urology |

#### III) Predicate Device

| Manufacturer: | Medline Industries, Inc. |
|---------------|----------------------------------------------|
| Device: | Medline SilverTouch™ Silicone Foley Catheter |

{4}------------------------------------------------

| 510(k) Number: | K052168 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | To be used as a urological catheter inserted through<br>the urethra to pass urine from urinary tract. |
| Contraindications: | Those individuals with a known sensitivity or allergy to<br>metallic silver or silver containing organics or<br>inorganics are excluded from the use of this device. |

#### IV) Device Description

SilverCoat™ Silicone Foley Catheters are 100% silicone Foley catheters that have a lubricious coating impregnated with silver ions. The silver is retained in the hydrophilic coating through ionic bonding and is covalently bonded to the silicone surface. The coating will not peel, flake or crack. The coating hydrates rapidly becoming slippery (lubricious) and maintains its lubricity for at least seven days. The SilverCoat™ catheter complies with the FDA recognized consensus standard, ASTM F623-99 Standard Performance Specification for Foley Catheter. The catheters are comprised of a twolumen shaft with proximal funnel, inflation valve, and distal retaining balloon. Balloon fill volumes are in millimeters and the shaft size is in French (Fr.) which is indicated on the funnel of each individual catheters are supplied in individually packaged, sealed single use pouches and they are sterilized by ethylene oxide. The SilverCoat™ Foley Catheter is a prescription-only device and it is intended to be used in healthcare facility/hospital, home, and ambulatory settings.

#### V) Indications for Use

To be used as a urological catheter inserted through the urethra to pass urine from the urinary tract by individuals that are ≥ 30kg and over 12 years of age. SilverCoat™ Silicone Foley Catheters should not be used on patients with known hypersensitivity or allergy to silver or silver-containing organics or inorganics.

#### VI) Performance Testing

The following tests were conducted to evaluate performance of the subject device*:

- -Resistance to microbial colonization and zone of inhibition (Kirby-Bauer);
- -Real time aging and stability;
- -Distribution simulation (journey hazards);
- -Biocompatibility including: bacterial mutagenicity (AMES assay), cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, extractables/leachables, toxicological risk assessment (TRA), and biological evaluation (BE);

-Physical properties and functional & dimensional testing per ASTM F623-99 and EN 1616, Annex A/D;

-Silver distribution/content, and silver elution;

{5}------------------------------------------------

* In vitro effectiveness does not predict clinical performance.

#### VII) Substantial Equivalence

Covalon's SilverCoat™ Silicone Foley Catheter has identical technological characteristics and performance specifications as the predicate device, Medline Industries, Inc.'s SilverTouch™ Silicone Foley Catheter (K052168). Both devices are manufactured from 100% silicone, have a lubricious coating impregnated with silver ions, and possess the same design features and indications for use. In conclusion, the subject device is substantially equivalent to the predicate device and nonclinical test data demonstrates that the subject device is safe and effective.