(123 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a standard Foley catheter, with no mention of AI or ML capabilities.
No
The device is a Foley catheter used for drainage of the urinary tract, which is a supportive function rather than a therapeutic one designed to treat a disease or condition.
No
The device is described as a "catheter" intended for "drainage of the urinary tract". Its function is to facilitate the outflow of fluids, not to diagnose 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 device, not software-only.
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 (urethra, suprapubic, or nephrostomy). This is a direct intervention on the patient's body for therapeutic or diagnostic purposes (in the sense of collecting a sample, but not analyzing it in vitro).
- Device Description: The device is a physical catheter designed to be inserted into the body to facilitate drainage. It's a medical device used in vivo.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information about a physiological state, health, disease, or congenital abnormality. This device does not perform any analysis or testing of a specimen in vitro. It's a tool for collecting or draining a specimen.
Therefore, the 2-Way 100% Silicone ClearTract Catheter is a medical device used in vivo, not an IVD.
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, but also suprapubic placement or by nephrostomy. Intended population is adults and pediatrics.
Product codes
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 between the catheter and the urinary bag is accomplished by using a standard non- interconnector. Catheterization is accomplished by inserting the catheter through the urethra. Drainage can also be accomplished by suprapubic placement or nephrostomy tract placement of the catheter.
Catheter sizes 14Fr., 16Fr., and 18Fr. were cleared under the predicate, K222118. Subject catheter of size 24 Fr. is new and being requested for clearance as part of this submission.
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
Below is a list of the tests that were performed and successfully completed for the subject device per the specified guidance and standards:
- Biocompatibility testing according to ISO 10993-1:2018 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and FDA Guidance "Use of International Standard ISO 10993-1" (2016).
- The EO sterilization process was validated in accordance with ANSI/AAMI/ISO 11135:2014.
- The following bench performance testing were conducted per ASTM F623-19 and the FDA guidance document, 'Conventional Foley Catheters - Performance Criteria for Safety and Performance Based Pathway'-
- Flow Rate through Drainage Lumen O
- Balloon Integrity (Resistance to Rupture) O
- O Inflated Balloon Response to Traction
- Balloon Volume Maintenance O
- Balloon Size and Shaft Size O
- Deflation Reliability (Failure to Deflate) o
All pre-determined acceptance criteria were met.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
January 23, 2024
Silg Technologies Corporation % Aaron Rogers Director of Regulatory and Quality Pathway, LLC. 8779 Cottonwood Avenue, Suite 105 Santee, CA 92071
Re: K233013
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: December 18, 2023 Received: December 19, 2023
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
For comprehensive regulatory information about medical devices and radiation-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 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
3
Indications for Use
510(k) Number (if known) K233013
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 accomplished by inserting the catheter through the urethra and into the bladder, but also suprapubic placement or by nephrostomy. 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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4
TRADITIONAL 510(K) SUMMARY
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 |
| Date Prepared | January 16, 2024 |
| 2. DEVICE NAME | |
| Trade Name of the Device | 2-Way 100% Silicone Cleartract Catheter |
| Common Name: | Foley Catheter |
| Classification Name: | Urological Catheter and Accessories |
| Classification Regulation: | 21 CFR 876.5130 |
| Device Class: | II |
| Product Code: | EZL |
| Panel: | Gastroenterology/Urology |
| 3. PREDICATE AND REFERENCE
DEVICE IDENTIFICATION | Predicate: 2-Way 100% Silicone Cleartract Catheter (K222118)
Reference: Silicone Foley Catheter for single use (K172807) |
4. 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 between the catheter and the urinary bag is accomplished by using a standard non- interconnector. Catheterization is accomplished by inserting the catheter through the urethra. Drainage can also be accomplished by suprapubic placement or nephrostomy tract placement of the catheter.
Catheter sizes 14Fr., 16Fr., and 18Fr. were cleared under the predicate, K222118. Subject catheter of size 24 Fr. is new and being requested for clearance as part of this submission.
5
5. 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, but also suprapubic placement or by nephrostomy. Intended population is adults and pediatrics.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE AND REFERENCE DEVICES
| | Subject Device:
Comparison Element 2-Way 100% Silicone ClearTract
Catheter | Predicate Device:
2-Way 100% Silicone
ClearTract Catheter | Reference Device:
Silicone Foley Catheter for single
use |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K233013 | K222118 | K172807 |
| 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, but also
suprapubic placement or
by nephrostomy. 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, but also
suprapubic placement or
by nephrostomy.
Intended population is
adults and pediatrics. | Two-way Disposable
Silicone Foley Catheter:
Urethral catheterization for
bladder drainage for
urological use only; the
indwelling time is no more
than 30 days. Three-way
Disposable Silicone Foley
Catheter:
Urethral
catheterization for bladder
drainage and bladder
irrigation for urological use
only; the indwelling time is
no more than 30 days. |
| Device Type | 2-Way Foley Catheter with
inflation and drainage
lumens | 2-Way Foley Catheter
with inflation and
drainage lumens | 2-Way with inflation and
drainage lumens
3-Way with inflation,
drainage and irrigation
lumens |
| Size | 24Fr | 14Fr, 16Fr, 18Fr | 6Fr, 8Fr, 10Fr, 12Fr, 14Fr,
16Fr, 18Fr, 20Fr, 22Fr, 24Fr |
| Balloon Volume | 30ml | 5ml, 10ml | 3ml, 5ml, 10ml, 15ml, 30ml |
| Length | 405 mm | 405 mm | 400 mm |
| Materials of
Construction | Silicone, Medical Grade | Silicone, Medical Grade | Silicone, Medical Grade |
| Polymer Surface
Modification | Yes | Yes | No |
| Indwelling Time | Up to 30 days | Up to 30 days | Up to 30 days |
| Single Use? | Yes | Yes | Yes |
| Prescription Use? | Yes | Yes | Yes |
| Sterile? | Yes | Yes | Yes |
As evidenced by the above table, both the subject and the predicate devices have same intended use, but the subject and predicate devices have different technological characteristics. However, performance testing was conducted on the subject device, and it was established that the differences in technological characteristics between the subject and the predicate does not raise different questions of safety or effectiveness.
6
7. SUMMARY OF NONCLINICAL TESTING:
Below is a list of the tests that were performed and successfully completed for the subject device per the specified guidance and standards:
- Biocompatibility testing according to ISO 10993-1:2018 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and FDA Guidance "Use of International Standard ISO 10993-1" (2016).
- The EO sterilization process was validated in accordance with ANSI/AAMI/ISO 11135:2014. ●
- . The following bench performance testing were conducted per ASTM F623-19 and the FDA guidance document, 'Conventional Foley Catheters - Performance Criteria for Safety and Performance Based Pathway'-
- Flow Rate through Drainage Lumen O
- Balloon Integrity (Resistance to Rupture) O
- O Inflated Balloon Response to Traction
- Balloon Volume Maintenance O
- Balloon Size and Shaft Size O
- Deflation Reliability (Failure to Deflate) o
All pre-determined acceptance criteria were met.
8. CONCLUSIONS
Based on the information presented in this submission, it can be concluded that the subject device is substantially equivalent to the predicate.