(94 days)
Not Found
No
The device description details a purely mechanical catheter with lumens and a balloon. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The performance studies focus on physical and biological properties, not algorithmic performance.
No.
A therapeutic device is one that performs treatment or therapy. This device is for drainage and irrigation, which are supportive functions, not direct treatment of a disease or condition.
No
The device is a urological catheter used for drainage and irrigation of the urinary tract. Its intended use and description do not mention any diagnostic capabilities or functions.
No
The device description clearly details a physical, hardware-based medical device (a Foley catheter) and does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "drainage/irrigation of the urinary tract." This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The description details a physical device (catheter) used for fluid management within the body. It does not describe a test or assay performed on a sample taken from the body to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing diagnostic information.
- Performance Studies: The performance studies focus on the physical and functional aspects of the device (biocompatibility, sterilization, performance/functionality), not on diagnostic accuracy metrics like sensitivity or specificity.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device is a medical device used for a therapeutic procedure.
N/A
Intended Use / Indications for Use
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.
Product codes
EZL
Device Description
The subject device is a single-use, latex-free, 3-way Foley catheter that is constructed of medical grade silicone. It incorporates three (3) lumens, one for inflation/deflation of the balloon, another for drainage, and the remainder for irrigation of the urinary tract.
The balloon, at the distal end of the catheter, is inflated to fill volume between 10-30 ml and remains inflated via the incorporated two-way valve in the connector at the proximal end of the inflation lumen. The connector engages with slip/taper luer connection that is standard on syringes. With the balloon inflated, the catheter maintains position in the urinary tract for the duration of the clinical application. Prior to removal, the balloon is deflated via the two-way valve connection.
The drainage inlet is located distal to the catheter's balloon. The urinary bag is a standard non-interconnectable connector.
The irrigation outlet is located just proximal of the catheter's balloon. It is positioned underneath a sleeve, which directs fluid in the proximal direction towards the 3-way connection. The purpose of the sleeve is to disperse the irrigation fluids gently down the urinary tract. The connector for the irrigation lumen 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
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 test program was performed in accordance to FDA guidance and recognized performance states, which includes the following:
- Biocompatibility
- Sterilization
- Packaging Integrity (i.e., Sterile Barrier)
- Transportation
- Shelf-Life
- Performance/Functionality
Successful results were achieved with all evaluations conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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September 21, 2018
Pathway, LLC David Stroup Managing Partner 8779 Cottonwood Avenue, Suite 105 Santee, CA 92071
Re: K181616
Trade/Device Name: PSM 3-Way Silicone Foley Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZL Dated: August 20, 2018 Received: August 21, 2018
Dear David Stroup:
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 mav, 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 avare 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Glenn B. Bell -S
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) K181616
Device Name PSM 3-Way Silicone Foley Catheter
Indications for Use (Describe)
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.
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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PSM 3-Way Silicone Foley Catheter - Pathway LLC Traditional 510(k) Premarket Notification
Page 1of 1
CONFIDENTIAL
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510(K) SUMMARY - K181616
Submitter Information
Company Name: Pathway, LLC. Company Address: 8779 Cottonwood Avenue, Suite 105 Santee, CA 92071 Company Phone: (619) 415-0103 Contact Person: David Stroup Managing Partner dkstroup@pathwaynpi.com Date: August 20, 2018 Device Identification Device Trade Name: PSM 3-Way Silicone Foley Catheter Common Name: Foley Catheter Classification Name(s): Urological catheter and accessories Classification Regulation(s): 876.5130 Device Class: Class II Product Code(s): EZL Advisory Panel: Gastroenterology/Urology
Identification of Predicate Devices
| Device Name | Regulation No. | Product
Code | 510(K)
Number | Clearance
Date |
|------------------------------------------------------|-------------------------------------------------|-----------------|------------------|--------------------|
| 3 Way Silicone Foley Balloon Catheter
(MFG: Cook) | 876.5130
Urological catheter and accessories | EZL | K091767 | October 9,
2009 |
Device Description
The subject device is a single-use, latex-free, 3-way Foley catheter that is constructed of medical grade silicone. It incorporates three (3) lumens, one for inflation/deflation of the balloon, another for drainage, and the remainder for irrigation of the urinary tract.
The balloon, at the distal end of the catheter, is inflated to fill volume between 10-30 ml and remains inflated via the incorporated two-way valve in the connector at the proximal end of the inflation lumen. The connector engages with slip/taper luer connection that is standard on syringes. With the balloon inflated, the catheter maintains position in the urinary tract for the
4
duration of the clinical application. Prior to removal, the balloon is deflated via the two-way valve connection.
The drainage inlet is located distal to the catheter's balloon. The urinary bag is a standard non-interconnectable connector.
The irrigation outlet is located just proximal of the catheter's balloon. It is positioned underneath a sleeve, which directs fluid in the proximal direction towards the 3-way connection. The purpose of the sleeve is to disperse the irrigation fluids gently down the urinary tract. The connector for the irrigation lumen is a standard non-interconnectable connector.
Indications for Use
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.
| Comparison Feature | PSM 3-Way Silicone Foley Catheter | Predicate Device
3 Way Silicone Foley Balloon Catheter |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | 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. | Used to provide continuous bladder
irrigation of fluids and drainage of urine
from the urinary tract. Urinary tract access
is generally accomplished by insertion of
the catheter through the urethra and into
the bladder but may also be accomplished
by suprapubic placement or by
Nephrostomy. |
| Type | 3-way with inflation, drainage, and
irrigation lumens | 3-way with inflation, drainage, and
irrigation lumens |
| Size Offering | 14, 16, 18 Fr | 16, 18, 20, 22, 24, 26 Fr |
| Material | Silicone, Medical Grade | Silicone, Medical Grade |
| Working Length | 36 cm | 34 cm |
| Inflation Volume | 10-30 ml | 30 ml |
| Performance Standard | ASTM F623 | ASTM F623 |
| Indwelling Time | Up to 30 days | Up to 30 days |
| Single-Use? | Yes | Yes |
| Prescription Use? | Yes | Yes |
| Sterile? | Yes | Yes |
Comparison of Technological Characteristics with Predicate Device
Summary of Testing Performed
The test program was performed in accordance to FDA guidance and recognized performance states, which includes the following:
- Biocompatibility ●
- Sterilization ●
- Packaging Integrity (i.e., Sterile Barrier) ●
- . Transportation
- Shelf-Life .
5
- Performance/Functionality .
Successful results were achieved with all evaluations conducted.
Conclusion
The PSM 3-Way Silicone Foley Catheter has demonstrated it is substantially equivalent to the commercially available predicate.