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.

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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a medical device, specifically a PSM 3-Way Silicone Foley Catheter. As such, it is not a study proving the device meets acceptance criteria in the context of an AI/ML medical device. Instead, it demonstrates substantial equivalence to a predicate device based on similar technological characteristics and performance standards.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, sample size for training set) are not applicable to this type of regulatory submission for a traditional medical device (not an AI/ML device).

However, I can extract the acceptance criteria and reported device performance related to the physical and functional attributes of the Foley catheter based on the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

The document doesn't explicitly state "acceptance criteria" values in a table format with corresponding "reported performance." Instead, it highlights that testing was performed "in accordance to FDA guidance and recognized performance states" and that "Successful results were achieved with all evaluations conducted." This implies that the device met the standards for these tests. The "performance standards" column in the comparison table indirectly serves as acceptance criteria.

Acceptance Criteria (Performance Standard)	Reported Device Performance
ASTM F623	Successful; Met standard
Biocompatibility	Successful
Sterilization	Successful
Packaging Integrity (Sterile Barrier)	Successful
Transportation	Successful
Shelf-Life	Successful
Performance/Functionality	Successful

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

Sample Size: Not specified for any of the tests.
Data Provenance: Not specified. This is a regulatory submission, not a clinical study report. The tests are likely performed by the manufacturer or their contracted labs.

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. This is not an AI/ML device. "Ground truth" in this context would refer to the standards applied in the physical and functional tests, not expert interpretation of medical images or data. Testing is based on established engineering and material standards.

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

Not Applicable. Not an AI/ML device.

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 is not an AI/ML device, so no MRMC study would be performed.

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

Not Applicable. This is not an AI/ML device, so no algorithm standalone performance would be done.

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

The "ground truth" for this medical device would be adherence to recognized engineering and material standards (e.g., ASTM F623 for catheters, ISO standards for biocompatibility and sterilization), and the device's functional performance against its design specifications. It's based on objective measurements and established scientific test methods, not expert consensus in a diagnostic sense.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device.

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

Not Applicable. This is not an AI/ML device.

Summary

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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.

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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)

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.	ProductCode	510(K)Number	ClearanceDate
3 Way Silicone Foley Balloon Catheter(MFG: Cook)	876.5130Urological catheter and accessories	EZL	K091767	October 9,2009

Device Description

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

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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

Comparison Feature	PSM 3-Way Silicone Foley Catheter	Predicate Device3 Way Silicone Foley Balloon Catheter
Indications for Use	Urological catheter intended fordrainage/irrigation of the urinary tract.Catheterization is accomplished throughthe urinary tract, but also suprapubicplacement or by nephrostomy. Intendedpopulation is adults and pediatrics.	Used to provide continuous bladderirrigation of fluids and drainage of urinefrom the urinary tract. Urinary tract accessis generally accomplished by insertion ofthe catheter through the urethra and intothe bladder but may also be accomplishedby suprapubic placement or byNephrostomy.
Type	3-way with inflation, drainage, andirrigation lumens	3-way with inflation, drainage, andirrigation 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 .

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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.

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.