(136 days)
No
The summary describes a standard physical medical device (a catheter) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on biocompatibility and endotoxin testing, not algorithmic performance.
No.
The device is intended for drainage of the urinary tract, which is a supportive function rather than a therapeutic one that directly treats or cures a disease.
No
Explanation: The device description clearly states its purpose is for "drainage of the urinary tract." It is a catheter used for fluid removal, not for identifying a condition or disease.
No
The device description clearly describes a physical catheter made of silicone with lumens and a balloon, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the drainage of the urinary tract. This is a direct intervention on the body for therapeutic purposes (removing urine), not for the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The device is a catheter, a physical tool inserted into the body. It does not involve reagents, calibrators, control materials, or other components typically associated with IVD tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like urine itself for diagnostic markers), processing samples, or providing diagnostic information. The function is purely mechanical drainage.
Therefore, the 2-Way 100% Silicone ClearTract Catheter is a medical device, specifically a catheter, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
EZL
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract, urethra, bladder, suprapubic, nephrostomy tract
Indicated Patient Age Range
adults and pediatrics
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 .
All testing was successfully completed and provided objective evidence to demonstrate the ClearTract catheter is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
Indications for Use
510(k) Number (if known) K222118
Device Name
2-Way 100% Silicone Cleartract Catheter
Indications for Use (Describe)
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.
| 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 Rogers
Pathway, LLC.
8779 Cottonwood Ave., Suite 105
Santee, CA 92071
619-415-0103 x704
arogers@pathwaynpi.com |
| ------------------------ | ------------------------------------------------------------------------------------------------------------------------------------- |
|---|
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 |
4
REFERENCE DEVICE PSM 3-Way Silicone Foley Catheter (K181616) IDENTIFICATION
4. DESCRIPTION OF SUBJECT DEVICE
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.
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
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.
| Comparison Item | Subject Device:
2-Way 100% Silicone
ClearTract Catheter | Predicate Device:
2-Way 100% Silicone
ClearTract Catheter | Reference Device:
PSM 3-Way Silicone Foley
Catheter |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K222118 | K221625 | K181616 |
| Indications for Use | 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. | The 2-Way 100% Silicone
ClearTract Catheter is
intended for drainage of the
urinary tract. Catheterization
is accomplished by inserting
the catheter through the
urethra and into the bladder.
Intended population is adults
and pediatrics. | Urological catheter intended
for drainage/irrigation of the
urinary tract. Catheterization
is accomplished through the
urinary tract, but also
suprapubic placement or by
nephrostomy. Intended
population is adults and
pediatrics. |
| Design Features | | | |
| Type | Same as Predicate | 2-Way Foley Catheter with
inflation and drainage
lumens | 3-Way Foley Catheter with
inflation, drainage and
irrigation lumens |
| Size/Balloon | Same as Predicate | 14Fr/10cc
16Fr/5cc
18Fr/10cc | 14Fr/10cc - 30cc
16Fr/10cc-30cc
18Fr/10cc-30cc |
| Materials of Construction | Same as Predicate | Silicone, Medical Grade | Silicone, Medical Grade |
6. TECHNOLOGICAL CHARACTERISTICS COMPARISON
5
| Comparison Item | Subject Device:
2-Way 100% Silicone
ClearTract Catheter | Predicate Device:
2-Way 100% Silicone
ClearTract Catheter | Reference Device:
PSM 3-Way Silicone Foley
Catheter |
|----------------------------------------------|---------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------|
| Zwitterionic Polymer
Surface 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 .
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.