Kohli Urinary Drainage Catheter

K172422 · Nellie Medical, LLC · EZL · Feb 9, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K172422
• Device Name: Kohli Urinary Drainage Catheter
• Applicant: Nellie Medical, LLC
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: Feb 9, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The Kohli Urinary Drainage Catheter is a single-use, 2-way silicone catheter designed for urethral insertion to facilitate bladder drainage. It features two ports: one for bladder drainage and one for balloon inflation (5cc capacity). The device is inserted by a healthcare professional in a clinical setting. It functions by anchoring in the bladder via the inflated balloon, allowing urine to flow through the drainage lumen. The catheter is constructed from silicone with a polypropylene check valve and a co-extruded radiopaque strip for visualization. It does not contain antimicrobial or hydrophilic coatings. The device provides a passive drainage pathway, assisting patients who cannot void naturally. Clinical benefit is derived from reliable, short-term bladder decompression and management of urinary retention.

Clinical Evidence

Bench testing only. Performance testing included inflation lumen leakage, catheter strength, connector and balloon security, flow rate, balloon volume maintenance/recovery, and resistance to traction. Biocompatibility testing was conducted per ISO 10993. Sterilization validation was performed using an Ethylene Oxide (ETO) cycle identical to the predicate devices.

Technological Characteristics

Materials: Silicone (shaft, funnel, balloon), Silicone RTV (adhesive), Polypropylene (check valve), Co-extruded silicone/barium sulfate (radiopaque strip). Dimensions: 16 FR shaft, 450 mm length, 3.4 mm drainage lumen ID, 1.0 mm inflation lumen ID. Sterilization: Ethylene Oxide (ETO). Design: 2-way lumen, 5cc balloon, no coatings.

Indications for Use

Indicated for urological bladder drainage in patients requiring an indwelling catheter for up to 30 days.

Regulatory Classification

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).

Predicate Devices

• Degania Silicone All Silicone Foley Catheter, 2-Way, 3-Way and with Temperature Sensor (K063442)
• Emmy Medical, LLC, Cystosure Urinary Access System (K142194)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 14-2<br>Substantial Equivalence Comparison Chart - Kohli Urinary Drainage Catheter | | | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Feature/<br>Specification | Proposed<br>Device | Comparison | Primary Predicate | Secondary<br>Predicate | |
| Manufacturer | Nellie<br>Medical | N/A | Degania Silicone, Ltd | Emmy Medical | |
| Device Trade<br>Name | Kohli<br>Urinary<br>Drainage<br>Catheter | N/A | All Silicone Foley Catheter,<br>2-Way, 3 Way and with<br>Temperature Sensor | CystoSure Urinary<br>Access | |
| General<br>Description | Urological<br>catheter | Identical | Urological catheter and<br>accessories | Urological<br>catheter | |
| 510(k) | N/A | N/A | K063442 | K142194 | |
| Product Code | EZL | Identical | EZL | EZL | |
| Device Class | II | Identical | II | II | |
| Regulation<br>Number | 21 CFR<br>876.5130 | Identical | 21 CFR 876.5130 | 21 CFR 876.5130 | |
| Intended Use | Bladder<br>drainage | Identical to<br>2-Way<br>drainage<br>catheters | Bladder irrigation and<br>drainage | Bladder irrigation<br>and drainage | |
| Indications for<br>Use | The 2-Way<br>Kohli<br>Urinary<br>Drainage<br>Catheter is<br>intended for<br>urological<br>bladder<br>drainage only<br>with a<br>maximum<br>patient<br>indwelling<br>time <30<br>days. | Identical to<br>2-Way<br>drainage<br>catheters | All Silicone Foley Catheter<br>intended for urological use<br>only. Foley Catheter 2-way:<br>for routine drainage of the<br>urinary bladder.<br>Foley Catheter 3-way: for<br>drainage of the urinary<br>bladder and bladder<br>irrigation. Foley Catheter<br>with Temperature Sensor:<br>for drainage of the urinary<br>bladder and simultaneous<br>monitoring of temperature. | The CystoSure<br>Access Catheter<br>is used to provide<br>drainage of urine<br>and irrigation<br>fluids for the<br>female bladder<br>and to provide a<br>passageway for<br>the CystoSure<br>cystoscope. | |
| 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 14-2<br>Substantial Equivalence Comparison Chart – Kohli Urinary Drainage Catheter | | | | | |
| Feature/<br>Specification | Proposed<br>Device | Comparison | Primary Predicate | Secondary<br>Predicate | |
| Balloon | Silicone* | Identical | Silicone* | Silicone* | |
| Balloon Adhesive | Silicone RTV* | Identical | Silicone RTV* | Silicone RTV* | |
| Check Valve | polypropylen<br>e | Identical | Polypropylene | polypropylene | |
| Radiopaque strip | Co-Extruded<br>silicone &<br>barium<br>sulfate | Identical | Co-Extruded silicone & barium<br>sulfate | N/A | |
| Occlusion | Glue | Identical | Glue | Glue | |
| Surface<br>Modifications -<br>Pad Printing | black ink** | Identical | black ink** | black ink** | |
| Coatings | None | Identical | None | None | |
| Dimensions | | | | | |
| Shaft | 16 FR (5.3<br>mm) | 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<br>(ID) | 3.4 mm | Identical | 2.5 to 3.7 mm | 3.2 mm | |
| Balloon Inflation<br>Lumen (ID) | 1.0 mm | Identical | 0.5 - 2.0 mm | 2.0 mm | |
| Manufacturing Process | | | | | |
| Extrusion | Shaft<br>formation | Identical | Shaft formation | Shaft formation | |
| Injection Molding | Funnel<br>forming | Identical | Funnel forming | Funnel forming | |
| Balloon<br>attachment | RTV glue | Identical | RTV glue | RTV glue | |
| Manual assembly | Check valve | Identical | Check valve | Check valve | |
| Surgical Approach | Urethral<br>Insertion | Identical | Urethral Insertion | Urethral Insertion | |
| Primary Material | Silicone | Identical | Silicone | Silicone | |
| Sterile | Yes | Yes | Yes | Yes | |
| Sterilization<br>Method | Ethylene<br>Oxide | Identical | Ethylene Oxide | Ethylene Oxide | |
| Table 14-2 | | | | | |
| Substantial Equivalence Comparison Chart – Kohli Urinary Drainage Catheter | | | | | |
| Feature/<br>Specification | Proposed<br>Device | Comparison | Primary Predicate | Secondary<br>Predicate | |
| Biocompatibility | Materials<br>tested per<br>ISO 10993 | Materials<br>tested per<br>ISO 10993 | Materials tested per ISO<br>10993 | Materials tested per<br>ISO 10993 | |
| *Both VMQ and RTV silicones are identical to those of the predicates. Detailed VMQ silicone<br>formulations and silicone RTV are proprietary to manufacturer. | | | | | |
| ** Proprietary formulation of the black ink was developed by Degania Silicone and is included as part<br>of 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