(25 days)
Not Found
No
The document describes a standard medical device (catheter) and does not mention any AI or ML components or functionalities.
No.
The device is a catheter intended for drainage of the urinary tract, which is a supportive function rather than a therapeutic one that directly treats a disease or condition.
No
The device is described as a catheter for drainage of the urinary tract, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical catheter made of silicone with lumens and a balloon, indicating it is a hardware 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 by inserting the catheter into the body. This is a direct interaction with the patient's anatomy for a therapeutic or diagnostic purpose within the body.
- Device Description: The device is a catheter designed for insertion into the urethra and bladder. It has lumens for balloon inflation and drainage.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. This device does not perform any analysis of specimens.
Therefore, the 2-Way 100% Silicone ClearTract Catheter is a medical device, but it falls under the category of devices used for direct patient care and intervention, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
EZL
Device Description
The 2-Way 100% Silicone ClearTract Catheter (previously known as the HDX 100% Silicone 2-Way Foley 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 non-interconnectable connector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract, urethra, bladder
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 bench testing was performed to support the additional information added to the product labeling:
- Friction testing based on ASTM D1894-14 which demonstrates a significant reduction in the coefficient of friction between the untreated and treated silicone surface.
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.
HDX 100% Silicone 2-Way Foley Catheter (K192034)
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.
Not Found
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, there 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 1, 2022
Silq Technologies Corporation Sigi Caron, MBA, RAC Vice President of Regulatory Affairs 323 Sunny Isles Blvd. Sunny Isles Beach, FL 33160
Re: K221625
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: June 3, 2022 Received: June 6, 2022
Dear Sigi Caron:
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.
1
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 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-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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,
For. Jessica K. 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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Indications for Use
510(k) Number (if known)
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 winnary tract. Catheterization is accomplished by inserting the catheter through the wethra and into the bladder. Intended population is adults and pediatrics.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
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FORM FDA 3881 (6/20)
PSC Publishing Services (101)-46-6740
Silq Technologies Corporation Special 510(k) Submission
CONFIDENTIAL
3
1. SPECIAL 510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| DATE PREPARED | June 16, 2022 |
|---|---|
| APPLICANT | Silq Technologies Corporation |
| 323 Sunny Isles Blvd, 7th Floor | |
| Sunny Isles, FL 33160 | |
| OFFICIAL | |
| CORRESPONDENT | Sigi Caron, MBA, RAC |
| Biologics and Medical Device Consulting Group (BioMDg) | |
| 377 Second Tee Dr, #5868 | |
| Incline Village, NV 89451 | |
| phone: (831) 346-6970 | |
| e-mail: sigi@bioMDg.com | |
| TRADE NAME | 2-Way 100% Silicone ClearTract Catheter |
| COMMON NAME | Foley Catheter |
| DEVICE CLASSIFICATION | Name: Urological Catheter and Accessories |
| Regulation No: 21 CFR §876.5130 | |
| Product Code: EZL - Catheter, Retention Type, Balloon | |
| Class: II | |
| PREDICATE DEVICE | HDX 100% Silicone 2-Way Foley Catheter (K192034) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The 2-Way 100% Silicone ClearTract Catheter (previously known as the HDX 100% Silicone 2-Way Foley 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 non-interconnectable connector.
INDICATIONS FOR USE:
The indications for use remain the same. 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.
PREDICATE DEVICE
The renamed 2-Way 100% Silicone ClearTract Catheter has not been modified in any way. It is exactly the same as the HDX 100% Silicone 2-Way Catheter cleared under 510(k)
4
premarket notification K192034.
SUMMARY OF MODIFICATIONS
This special 510(k) premarket notification only proposes an update to the product labeling. The following information has been added to the Instructions For Use:
Device description - "The 2-Way 100% Silicone ClearTract Catheter is a standard singleuse 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."
Performance Characteristics - "The surface of the ClearTract Catheter has a surface modification that reduces surface friction."
No physical changes or modifications are proposed to the cleared device.
PERFORMANCE STANDARDS:
No performance standards have been established by the Agency to date that apply to this device.
SUMMARY OF NONCLINICAL TESTING:
The following bench testing was performed to support the additional information added to the product labeling:
- Friction testing based on ASTM D1894-14 which demonstrates a significant reduction in the coefficient of friction between the untreated and treated silicone surface.
SUBSTANTIAL EQUIVALENCE - COMPARISON TO PREDICATE DEVICE
The 2-Way 100% Silicone ClearTract Catheter has not been modified in any way. It is exactly the same as the HDX 100% Silicone 2-Way Catheter cleared under 510(k) premarket notification K192034. Following is the SE Table.
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| Element | Subject Device:
2-Way 100% Silicone
ClearTract Catheter | Predicate Device:
HDX 100% Silicone 2-Way
Foley Catheter | Comparison |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) Number | K221625 | K192034 | --- |
| Indications for use | ... 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. | ... 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. | Same |
| Design Features | | | |
| Type | 2-Way Foley Catheter with
inflation and drainage lumens | 2-Way Foley Catheter with
inflation and drainage lumens | Same |
| Size/Balloon | 14Fr/10cc
16Fr/5cc
18Fr/10cc | 14Fr/10cc
16Fr/5cc
18Fr/10cc | Same |
| Material of Construction | Silicone, Medical Grade | Silicone, Medical Grade | Same |
| Zwitterionic Polymer
Surface Modification | Yes | Yes | Same |
| Performance Standard | ASTM F623 | ASTM F623 | Same |
| Single Use? | Yes | Yes | Same |
| Prescription Use? | Yes | Yes | Same |
| Sterile? | Yes | Yes | Same |
| Sterilization Method | Ethylene Oxide Gas | Ethylene Oxide Gas | Same |
CONCLUSION:
All changes were made in compliance with 21 CFR 820.30 for design controls. Based on a risk assessment, the proposed additions to the labeling do not change or add new risks to the CleartTract catheter. All performance bench testing was successfully completed and provided objective evidence on the performance characteristics of the ClearTract catheter. The ClearTract catheter is substantially equivalent to the predicate device.