The Kohli Urinary Drainage Catheter is intended for drainage of the urinary bladder. The Kohli Urinary Drainage Catheter provides a single use access catheter with two ports: One for bladder drainage, and one for balloon inflation. The catheter encompasses only one balloon size (5cc) and length and it does not include any hydrophilic or antimicrobial coating

AI/ML Overview

The document provided is a 510(k) Premarket Notification for a medical device, the Kohli Urinary Drainage Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical study to set and prove acceptance criteria for novel performance claims. Therefore, the information typically requested in a description of acceptance criteria and a study proving device performance (especially for AI/software devices) is not directly applicable in its entirety to this regulatory filing.

However, I can extract the relevant performance testing information that was conducted to demonstrate substantial equivalence.

Here's an analysis based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific acceptance criteria in a quantitative table format with corresponding numerical performance figures as would be expected for a novel performance claim study. Instead, it states that "The bench testing performed verifies that the performance of the substantially equivalent in terms of critical performance characteristics to the predicate device." and lists the types of tests performed.

Implied Acceptance Criteria: The implied acceptance criteria for each test is that the Kohli Urinary Drainage Catheter's performance is comparable to or within acceptable limits relative to the predicate device, ensuring it does not raise new questions of safety or effectiveness.
Reported Device Performance: The document generally states that the device meets the implied criteria, without providing specific numerical results for each test. This is common in 510(k) summaries where the focus is on substantial equivalence rather than novel performance claims with specific outcome metrics.

Acceptance Criteria (Implied)	Reported Device Performance
Performance equivalent to predicate device for critical characteristics.	The bench testing verifies performance is substantially equivalent to the predicate device in critical characteristics.
No inflation lumen leakage.	Bench testing confirmed this.
Catheter strength comparable to predicate.	Bench testing confirmed this.
Connector and balloon security comparable to predicate.	Bench testing confirmed this.
Flow rate comparable to predicate.	Bench testing confirmed this.
Balloon volume maintenance/recovery and integrity comparable to predicate.	Bench testing confirmed this.
Resistance to traction comparable to predicate.	Bench testing confirmed this.
Biocompatibility demonstrated per ISO 10993.	Tests demonstrated the subject device is biocompatible.
Sterilization process effectiveness identical to predicate.	A parametric validation was performed, and both devices can be sterilized using the same cycle.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in the provided text. The phrase "A complete battery of biocompatibility tests was conducted on silicone catheters" suggests multiple samples were used for biocompatibility, and "A parametric validation was performed on silicone catheters" implies a test set for sterilization, but the exact number isn't given.
Data Provenance: The tests are described as "bench testing" and "parametric validation" performed by the manufacturer (Nellie Medical, related to Degania Silicone for some aspects). No information on country of origin of data or whether it was retrospective or prospective in a clinical sense, as these are bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to this type of submission. The performance testing described (bench testing, biocompatibility, sterilization validation) does not involve human expert interpretation of device output that would require establishing a ground truth by experts in a diagnostic context. The "ground truth" for these tests would be established by objective measurements against engineering specifications or established standards.

4. Adjudication method for the test set

Not applicable. As noted in point 3, there's no expert interpretation or diagnostic output involved in these engineering and biocompatibility tests that would require an adjudication method.

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 a medical device (catheter), not an AI/software as a medical device (SaMD) or an AI-assisted diagnostic tool. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not relevant.

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

Not applicable. This device is not an algorithm or AI system.

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

For the bench testing and sterilization validation, the "ground truth" would be objective measurements and adherence to established engineering specifications, published standards (e.g., ISO 10993 for biocompatibility), and validated processes. For biocompatibility, the ground truth is determined by the results of biological tests against predefined pass/fail criteria from standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

February 9, 2018

Nellie Medical, LLC % Christine Santagate Director, Boston Operations R&O Solutions 15 Standish Road Norfolk, MA 02056

Re: K172422

Trade/Device Name: Kohli Urinary Drainage Catheter Regulation Number: 21 CFR& 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZL Dated: December 20, 2017 Received: December 27, 2017

Dear Christine Santagate:

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. 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.

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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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.

Charles Viviano -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) K172422

Device Name Kohli Urinary Drainage Catheter

Indications for Use (Describe)

The 2-Way Kohli urinary drainage catheter is intended for urological bladder drainage only with a maximum patient indwelling time of <30 days.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

Submitter Information

Submitter's Name:	Ron Adams
Address:	18 Hillside Drive, Holliston, MA 01746
Telephone:	775-800-7300
Fax:	844-225-4600
Contact Person:	Ron Adams
Telephone:	775-800-7300
Fax:	844-225-4600
Date Prepared:	December 13, 2017
Trade Name:	Kohli Urinary Drainage Catheter
Common/Usual Name:	Urinary drainage catheter
Device Name:	Catheter, retention type, balloon
Registration Number(s):	21 CFR 876.5130
Regulation Description:	urological catheter and accessories
Class:	II
Product Code(s):	EZL

Predicate Device(s):

Primary: K063442 Degania Silicone All Silicone Foley Catheter, 2-Way, 3-Way and with . Temperature Sensor
. Secondary: K142194 Emmy Medical, LLC, Cystosure Urinary Access System

Device Description:

The Kohli Urinary Drainage Catheter is intended for drainage of the urinary bladder.

The Kohli Urinary Drainage Catheter provides a single use access catheter with two ports: One for bladder drainage, and one for balloon inflation. The catheter encompasses only one balloon size (5cc) and length and it does not include any hydrophilic or antimicrobial coating

Indications for Use:

The 2-Way Kohli Urinary Drainage Catheter is intended for urological bladder drainage only with a maximum patient indwelling time <30 days.

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Substantial Equivalence

The below table demonstrates that the Kohli subject device is substantially equivalent to the predicate devices.

Table 14-2Substantial Equivalence Comparison Chart - Kohli Urinary Drainage Catheter
Feature/Specification	ProposedDevice	Comparison	Primary Predicate	SecondaryPredicate
Manufacturer	NellieMedical	N/A	Degania Silicone, Ltd	Emmy Medical
Device TradeName	KohliUrinaryDrainageCatheter	N/A	All Silicone Foley Catheter,2-Way, 3 Way and withTemperature Sensor	CystoSure UrinaryAccess
GeneralDescription	Urologicalcatheter	Identical	Urological catheter andaccessories	Urologicalcatheter
510(k)	N/A	N/A	K063442	K142194
Product Code	EZL	Identical	EZL	EZL
Device Class	II	Identical	II	II
RegulationNumber	21 CFR876.5130	Identical	21 CFR 876.5130	21 CFR 876.5130
Intended Use	Bladderdrainage	Identical to2-Waydrainagecatheters	Bladder irrigation anddrainage	Bladder irrigationand drainage
Indications forUse	The 2-WayKohliUrinaryDrainageCatheter isintended forurologicalbladderdrainage onlywith amaximumpatientindwellingtime <30days.	Identical to2-Waydrainagecatheters	All Silicone Foley Catheterintended for urological useonly. Foley Catheter 2-way:for routine drainage of theurinary bladder.Foley Catheter 3-way: fordrainage of the urinarybladder and bladderirrigation. Foley Catheterwith Temperature Sensor:for drainage of the urinarybladder and simultaneousmonitoring of temperature.	The CystoSureAccess Catheteris used to providedrainage of urineand irrigationfluids for thefemale bladderand to provide apassageway forthe CystoSurecystoscope.
Single Use	Yes	Yes	Yes	Yes
Lumen	2-way	2-way	2 and 3-way	4-way
Materials
Shaft	Silicone*	Identical	Silicone*	Silicone*
Funnel	Silicone*	Identical	Silicone*	Silicone*
Table 14-2Substantial Equivalence Comparison Chart – Kohli Urinary Drainage Catheter
Feature/Specification	ProposedDevice	Comparison	Primary Predicate	SecondaryPredicate
Balloon	Silicone*	Identical	Silicone*	Silicone*
Balloon Adhesive	Silicone RTV*	Identical	Silicone RTV*	Silicone RTV*
Check Valve	polypropylene	Identical	Polypropylene	polypropylene
Radiopaque strip	Co-Extrudedsilicone &bariumsulfate	Identical	Co-Extruded silicone & bariumsulfate	N/A
Occlusion	Glue	Identical	Glue	Glue
SurfaceModifications -Pad Printing	black ink**	Identical	black ink**	black ink**
Coatings	None	Identical	None	None
Dimensions
Shaft	16 FR (5.3mm)	Identical	12-22 Fr (4.0-7.3mm)	18 FR (6.0 mm)
Length	450 mm	Identical	400 to 450 mm	175 mm
Drainage Lumen(ID)	3.4 mm	Identical	2.5 to 3.7 mm	3.2 mm
Balloon InflationLumen (ID)	1.0 mm	Identical	0.5 - 2.0 mm	2.0 mm
Manufacturing Process
Extrusion	Shaftformation	Identical	Shaft formation	Shaft formation
Injection Molding	Funnelforming	Identical	Funnel forming	Funnel forming
Balloonattachment	RTV glue	Identical	RTV glue	RTV glue
Manual assembly	Check valve	Identical	Check valve	Check valve
Surgical Approach	UrethralInsertion	Identical	Urethral Insertion	Urethral Insertion
Primary Material	Silicone	Identical	Silicone	Silicone
Sterile	Yes	Yes	Yes	Yes
SterilizationMethod	EthyleneOxide	Identical	Ethylene Oxide	Ethylene Oxide
Table 14-2
Substantial Equivalence Comparison Chart – Kohli Urinary Drainage Catheter
Feature/Specification	ProposedDevice	Comparison	Primary Predicate	SecondaryPredicate
Biocompatibility	Materialstested perISO 10993	Materialstested perISO 10993	Materials tested per ISO10993	Materials tested perISO 10993
*Both VMQ and RTV silicones are identical to those of the predicates. Detailed VMQ siliconeformulations and silicone RTV are proprietary to manufacturer.
** Proprietary formulation of the black ink was developed by Degania Silicone and is included as partof the biocompatibility testing assessments.

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Non-Clinical Performance testing

The bench testing performed verifies that the performance of the substantially equivalent in terms of critical performance characteristics to the predicate device. Testing included inflation lumen leakage, catheter strength, connector and balloon security, flow rate, balloon volume maintenance/recovery and integrity, and resistance to traction.

Biocompatibility

A complete battery of biocompatibility tests was conducted on silicone catheters using the same materials and same processes as the Kohli catheter. The results of the tests demonstrate that the subject device is biocompatible.

Sterilization

The ETO sterilization process is identical to the cycle employed for both predicate devices. A parametric validation was performed on silicone catheters whose length and lumen diameter challenge far exceed those of the proposed Kohli catheter. Both the proposed device and the predicate can be sterilized using the same cycle.

Based on the performance testing, biocompatibility evaluation, the Kohli Urinary Drainage Catheter is substantially equivalent to the primary predicate device for its intended use.

Conclusion:

The Kohli Urinary Drainage Catheter is substantially equivalent in design, materials, intended use, and manufacturing processes to the predicate devices. The geometric and mass properties are the same. Based on the results of the testing and the comparability to the predicate devices, we believe that the Kohli urinary drainage catheter does not present new concerns of safety or efficacy and is thus substantially equivalent to the legally marketed predicate devices

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.