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.

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.

AI/ML Overview

This document is a 510(k) summary for the Covalon SilverCoat™ Silicone Foley Catheter, comparing it to the predicate device, Medline SilverTouch™ Silicone Foley Catheter. This is a premarket notification for a medical device and therefore does not contain information about studies of AI performance or clinical studies. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing.

Here's a breakdown of the requested information based on the provided text, with clarifications where the information is not applicable or not present in a 510(k) summary:

1. A table of acceptance criteria and the reported device performance

The document does not provide a formal table of acceptance criteria with specific numerical thresholds and corresponding device performance values for each test. Instead, it lists the types of performance tests conducted to demonstrate substantial equivalence to the predicate device and compliance with recognized standards.

Test Type	Reported Performance / Outcome
Resistance to microbial colonization and zone of inhibition (Kirby-Bauer)	Performed (implied acceptable results for substantial equivalence, specific metrics not provided).
Real time aging and stability	Performed (implied acceptable results for substantial equivalence, specific metrics not provided).
Distribution simulation (journey hazards)	Performed (implied acceptable results for substantial equivalence, specific metrics not provided).
Biocompatibility (AMES assay, cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, extractables/leachables, toxicological risk assessment (TRA), and biological evaluation (BE))	Performed (implied acceptable results for substantial equivalence, specific metrics not provided).
Physical properties and functional & dimensional testing per ASTM F623-99 and EN 1616, Annex A/D	Complies with ASTM F623-99 and EN 1616, Annex A/D (specific results not provided).
Silver distribution/content, and silver elution	Performed (implied acceptable results for substantial equivalence, specific metrics not provided).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for the "test set" for each type of performance testing. This is common for 510(k) submissions, which typically focus on demonstrating compliance with recognized standards and substantial equivalence rather than detailed statistical analysis of clinical studies.

The data provenance is not explicitly stated as "country of origin." However, the sponsor, Covalon Technologies, Inc., is based in Mississauga, Ontario, Canada, and the testing would have been conducted by or for them, likely in Canada or a facility compliant with international standards for medical device testing. The testing described is generally prospective in nature, as it involves newly manufactured devices undergoing specific tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable. The provided document describes non-clinical performance testing for a urological catheter. "Ground truth" and "experts" in the context of diagnostic performance (e.g., radiologists interpreting images) are concepts relevant to AI/diagnostic device studies, which are not described here. The "ground truth" for these tests would be the established scientific methods, physical properties, and safety standards against which the device is evaluated.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or clinical endpoints where agreement among reviewers is required to establish a gold standard. The tests described are laboratory-based performance tests (e.g., physical properties, biocompatibility, microbial resistance) that do not involve human adjudication in this manner.

5. 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

This section is not applicable. The document is a 510(k) summary for a physical medical device (Foley catheter) and does not involve AI, human readers, or image interpretation. Therefore, no MRMC comparative effectiveness study or AI assistance evaluation was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable. The device is a physical medical device and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

As mentioned in point 3, the concept of "ground truth" as it applies to diagnostic performance is not relevant here. For the performance tests listed (e.g., physical properties, biocompatibility, microbial resistance, silver elution), the "ground truth" is based on:

Recognized consensus standards: ASTM F623-99 and EN 1616, Annex A/D.
Established scientific methodologies: For tests like Kirby-Bauer, AMES assay, cytotoxicity, etc.
Predetermined specifications: Derived from the predicate device and design requirements.

8. The sample size for the training set

This section is not applicable. There is no "training set" as this device does not involve machine learning or AI.

9. How the ground truth for the training set was established

This section is not applicable for the same reasons as point 8.

Summary

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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

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

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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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Indications for Use

510(k) Number (if known) K150550

Device Name SilverCoat™ Silicone Foley Catheter

Indications for Use (Describe)

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)

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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.1660 Tech Avenue, Unit 5Mississauga, Ontario, Canada L4W 5S7
Contact Person:	Kim CrooksVP 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,SCC1630GU, SCC1805GU, SCC1830GU,SCC2005GU, SCC2030GU, SCC2205GU,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

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

IV) Device Description

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;

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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.

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.