The 2-Way 100% Silicone ClearTract Catheter is intended for drainage of the urinary tract. Catheterization is generally accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic placement or other placement of the catheter, such as nephrostomy tract. Intended population is adults and pediatrics.

Device Description

The 2-Way 100% Silicone ClearTract Catheter is a standard single-use 2-way Foley catheter that is constructed of medical grade silicone with a surface modification. It incorporates two (2) lumens, one for inflation/deflation of the balloon and the other for drainage of the urinary tract. The drainage inlet is located distal to the catheter's balloon. The connection to the urinary bag is a standard noninterconnectable connector.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for a 2-Way 100% Silicone Cleartract Catheter. This document describes the device, its intended use, a comparison to predicate devices, and the non-clinical testing performed to support its substantial equivalence.

Crucially, this document is for a medical device (a catheter) and not for an AI/ML-based diagnostic or prognostic device. Therefore, many of the requested criteria related to AI/ML device performance (such as sensitivity, specificity, MRMC studies, human reader improvement, and ground truth establishment for training/test sets) are not applicable to this type of submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the regulatory requirements for medical device clearance (specifically, demonstrating substantial equivalence to a legally marketed predicate device) rather than performance metrics for an AI algorithm.

Here's a breakdown of the information that is applicable or inferred from the document, and why other points are not relevant:

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

For this medical device, "acceptance criteria" relate to demonstrating substantial equivalence to a predicate device in terms of indications for use, technological characteristics, and performance. The "performance" is assessed through non-clinical testing to ensure safety and effectiveness for the expanded indications.

Acceptance Criteria (Regulatory Goal)	Reported Device Performance / Evidence
Expanded Indications for Use Equivalence	The subject device (K222118) expands the indications for use of its predicate (K221625) to include suprapubic placement or nephrostomy tract drainage, in addition to urethral insertion. This expansion is supported by the fact that no changes were made to the device design, manufacture, or any physical attributes compared to the predicate device. The reference device (K181616) already includes suprapubic placement and nephrostomy.
Technological Characteristics Equivalence	Subject Device Characteristics (Compared to Predicate K221625):- Type: Same as Predicate (2-Way Foley Catheter with inflation and drainage lumens)- Size/Balloon: Same as Predicate (14Fr/10cc, 16Fr/5cc, 18Fr/10cc)- Materials of Construction: Same as Predicate (Silicone, Medical Grade)- Zwitterionic Polymer Surface Modification: Same as Predicate (Yes)- Performance Standard: Same as Predicate (ASTM F623)- Indwelling Time: Same as Predicate (Up to 30 days)- Single Use? Same as Predicate (Yes)- Prescription Use? Same as Predicate (Yes)- Sterile? Same as Predicate (Yes)- Sterilization Method: Same as Predicate (Ethylene Oxide Gas)Conclusion: Technologically identical to the predicate device.
Safety and Biocompatibility (for new indications)	Non-Clinical Testing Performed:- Biocompatibility: Genotoxicity Study per ISO 10993-3:2014, Biological Evaluation of Medical Devices, Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.- Bacterial Endotoxins Test (BET) / LAL Test: per USP <85>.Conclusion: "All testing was successfully completed and provided objective evidence to demonstrate the ClearTract catheter is substantially equivalent to the predicate device." The submission states "the proposed additions to the indications for use do not change or add new risks to the ClearTract catheter."
Compliance with Design Control Regulations	"All changes [the updated IFU] were made in compliance with 21 CFR 820.30 for design controls."

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

This information is not applicable in the context of this 510(k) submission. There is no "test set" of patient data in the sense of an AI/ML algorithm evaluation. The testing involved controlled laboratory studies for biocompatibility and endotoxins, not clinical sample data.

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)

Not applicable. There is no "test set" requiring ground truth establishment by clinical experts, as this is a physical medical device, not an AI diagnostic.

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

Not applicable. No clinical test set requiring adjudication was used.

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

Not applicable. This pertains to AI-assisted diagnostic devices. This submission is for a physical medical catheter.

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

Not applicable. This pertains to AI diagnostic algorithms.

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

Not applicable. There is no "ground truth" in the clinical data sense required for this type of device. The "ground truth" for device performance is established through adherence to quality standards (e.g., ASTM F623), biocompatibility testing (ISO 10993-3), and endotoxin testing (USP <85>).

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the context of machine learning.

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

Not applicable. This device does not have a "training set" or "ground truth" in the machine learning sense.

Summary

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December 1, 2022

SILQ Technologies, Corp. % Aaron Rogers Director of Regulatory and Quality Pathway LLC 8779 Cottonwood Ave, Suite 105 Santee, California 92071

Re: K222118

Trade/Device Name: 2-Way 100% Silicone Cleartract Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZL Dated: October 25, 2022 Received: October 25, 2022

Dear Aaron Rogers:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jessica K. Nguyen -S

Jessica Nguyen, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222118

Device Name

2-Way 100% Silicone Cleartract 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

DATE PREPARED December 1, 2022

1. SUBMITTER INFORMATION

APPLICANT SILQ Technologies, Corporation 323 Sunny Isles Blvd., 7th Floor Sunny Isles Beach, FL 33160

OFFICIAL CORRESPONDENT	Aaron RogersPathway, LLC.8779 Cottonwood Ave., Suite 105Santee, CA 92071619-415-0103 x704arogers@pathwaynpi.com
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2. SUBJECT DEVICE INFORMATION

DEVICE TRADE NAME	2-Way 100% Silicone ClearTract Catheter
COMMON NAME	Foley Catheter
CLASSIFICATION NUMBER	21 CFR §876.5130
CLASSIFICATION NAME	Urological Catheter and Accessories
PRODUCT CODE	EZL
PRODUCT CODE NAME	Catheter, Retention Type, Balloon
REGULATORY CLASS	II

3. PREDICATE DEVICE INFORMATION

PREDICATE DEVICE	2-Way 100% Silicone ClearTract Catheter (K221625)
IDENTIFICATION

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REFERENCE DEVICE PSM 3-Way Silicone Foley Catheter (K181616) IDENTIFICATION

4. DESCRIPTION OF SUBJECT DEVICE

The objective of this 510(k) was only to update the indications for use (IFU) statement to include bladder urine drainage by either suprapubic or nephrostomy in addition through the urethra. No changes were made to the device design, manufacture or any of its physical attributes when compared to the predicate device.

5. INDICATIONS FOR USE

Comparison Item	Subject Device:2-Way 100% SiliconeClearTract Catheter	Predicate Device:2-Way 100% SiliconeClearTract Catheter	Reference Device:PSM 3-Way Silicone FoleyCatheter
510(k) Number	K222118	K221625	K181616
Indications for Use	The 2-Way 100% SiliconeClearTract Catheter isintended for drainage of theurinary tract. Catheterizationis generally accomplished byinserting the catheter throughthe urethra and into thebladder. However, drainageis sometimes accomplishedby suprapubic placement orother placement of thecatheter, such asnephrostomy tract. Intendedpopulation is adults andpediatrics.	The 2-Way 100% SiliconeClearTract Catheter isintended for drainage of theurinary tract. Catheterizationis accomplished by insertingthe catheter through theurethra and into the bladder.Intended population is adultsand pediatrics.	Urological catheter intendedfor drainage/irrigation of theurinary tract. Catheterizationis accomplished through theurinary tract, but alsosuprapubic placement or bynephrostomy. Intendedpopulation is adults andpediatrics.
Design Features
Type	Same as Predicate	2-Way Foley Catheter withinflation and drainagelumens	3-Way Foley Catheter withinflation, drainage andirrigation lumens
Size/Balloon	Same as Predicate	14Fr/10cc16Fr/5cc18Fr/10cc	14Fr/10cc - 30cc16Fr/10cc-30cc18Fr/10cc-30cc
Materials of Construction	Same as Predicate	Silicone, Medical Grade	Silicone, Medical Grade

6. TECHNOLOGICAL CHARACTERISTICS COMPARISON

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Comparison Item	Subject Device:2-Way 100% SiliconeClearTract Catheter	Predicate Device:2-Way 100% SiliconeClearTract Catheter	Reference Device:PSM 3-Way Silicone FoleyCatheter
Zwitterionic PolymerSurface Modification	Same as Predicate	Yes	No
Performance Standard	Same as Predicate	ASTM F623	ASTM F623
Indwelling Time	Same as Predicate	Up to 30 days	Up to 30 days
Single Use?	Same as Predicate	Yes	Yes
Prescription Use?	Same as Predicate	Yes	Yes
Sterile?	Same as Predicate	Yes	Yes
Sterilization Method	Same as Predicate	Ethylene Oxide Gas	Ethylene Oxide Gas

7. SUMMARY OF NON-CLINICAL TESTING

The following testing was performed to support the additional indications for use.

. Biocompatibility Genotoxicity Study per 10993-3:2014, Biological Evaluation of Medical Devices, Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.
Bacterial Endotoxins Test (BET) / Limulus amebocyte lysate (LAL) test per USP <85>.

8. CONCLUSIONS

All changes were made in compliance with 21 CFR 820.30 for design controls. Based on a risk assessment, the proposed additions to the indications for use do not change or add new risks to the ClearTract catheter All testing was successfully completed and provided objective evidence to demonstrate the ClearTract catheter is substantially equivalent to the predicate device.

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.