GentleCath Glide Intermittent Urinary Catheter

K181206 · Convatec Limited · GBM · Aug 16, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K181206
• Device Name: GentleCath Glide Intermittent Urinary Catheter
• Applicant: Convatec Limited
• Product Code: GBM · Gastroenterology, Urology
• Decision Date: Aug 16, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Intermittent Catheters are indicated for routine transient intermittent drainage of the bladder. The catheter is inserted through the urethra.

Device Story

GentleCath™ Glide is a hydrophilic intermittent urinary catheter for transient bladder drainage. Device consists of a flexible polyolefin-based synthetic thermoplastic elastomer (TPE) tube with a funnel connector and two drainage eyes. Surface includes an integrated hydrophilic additive that becomes slippery when wetted with sterile water (provided in a sachet). Available in various diameters (CH08-CH18) and tip shapes (Nelaton or bent/Tiemann). Used by patients or clinicians in clinical or home settings to drain urine from the bladder via the urethra. The device is inserted, urine is drained, and the catheter is withdrawn and disposed of. The hydrophilic surface reduces friction during insertion, potentially increasing patient comfort and reducing urethral trauma. No-touch sleeve included for hygienic handling.

Clinical Evidence

Bench testing only. Comparison tests performed: flow rate, catheter tensile properties, coefficient of friction, and angle of Coudé (Tiemann) tip. Results demonstrated that the subject device is equivalent or superior to predicate devices in all tested parameters. Biocompatibility testing conducted per ISO 10993-1 (cytotoxicity, sensitization, irritation, genotoxicity, subchronic toxicity, EtO residuals) confirms safety for intended use.

Technological Characteristics

Materials: Polyolefin-based synthetic TPE (tube), PVC/DEHT (connector). Principle: Hydrophilic surface additive activated by sterile water. Dimensions: 150-405mm length; CH08-CH18 diameters. Connectivity: Standalone. Sterilization: Ethylene Oxide (EtO). Design: Nelaton or Tiemann tip; staggered eyelets; no-touch sleeve.

Indications for Use

Indicated for routine transient intermittent drainage of the bladder in male, female, and pediatric patients (including adolescents and transitional adolescents).

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

• GentleCath Glide Intermittent Catheter (K161344)
• Rüsch FloCath Quick (K000070)
• LoFric Primo (K050874)

Submission Summary (Full Text)

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August 16, 2018

ConvaTec Limited Elinor Jones Regulatory Affairs Specialist GDC, First Avenue, Deepside Industrial Park Deeside. CH5 2NU United Kingdom

Re: K181206

Trade/Device Name: GentleCath™ Glide Intermittent Urinary Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: GBM Dated: July 12, 2018 Received: July 16, 2018

Dear Elinor Jones:

We have reviewed vour 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. 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 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 ([e-mail]) or phone [phone] 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known)

K181206

Device Name

GentleCath™ Glide Intermittent Urinary Catheter

Indications for Use (Describe)

Intermittent Catheters are indicated for routine transient intermittent drainage of the bladder. The cather is inserted through the urethra.

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)

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

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K181206 Page 1 of 9

Image /page/3/Picture/1 description: The image features the ConvaTec logo. The logo consists of a blue icon resembling a building with three columns, followed by the text "ConvaTec" in a matching blue color. A light blue curved line extends from the logo, adding a subtle design element to the composition.

Section 5 510(k) Summary

Applicant: ConvaTec Limited.

Applicant Address: GDC, First Avenue Deeside Industrial Park Deeside Flintshire CH5 2NU UK The Establishment Registration number is 1000317571

Contact: Elinor Jones Regulatory Affairs Specialist ConvaTec Ltd. GDC, First Avenue, Deeside industrial Park Deeside Flintshire, CH5 2NU UK Email: [e-mail] Tel: [phone]

Secondary Contact: Jason Skramsted (Email: [e-mail])

15th August 2018 Date Prepared:

Device Identification:

Trade Name: GentleCath™ Glide Intermittent Urinary Catheter.

Common Name: Catheter, urethral

Regulation Number: 21 CFR §876.5130

Panel: Gastroenterology and Urology

Requlation Name: Urological Catheter and accessories

Regulatory Class: II

Product Code: GBM

Product Reference: 421564, 421565, 421566, 421568, 421569, 421570, 421571, 421572, 421573, 421574, 421907, 421908, 421909, 421910, 421911, 421912

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### Submission Purpose

The purpose of this submission is to add additional CH8 and CH18 sizes to the male GentleCath Glide Intermittent Urinary Catheter range and size CH8 to the female GentleCath Glide Intermittent Urinary Catheter range. The purpose of this submission is to also add an additional bent (Tiemann) catheter tip shape variant to the male catheter range, for sizes CH8 to CH18. GentleCath Glide Intermittent Urinary Catheter products were evaluated previously in K161344 (primary predicate).

Secondary predicates Rüsch FloCath Quick (K000070) and LoFric Primo (K050874) have been included due to additional GentleCath Glide Internittent Urinary Catheter range sizes and the addition of the Tiemann tip shape variant in this submission.

### Predicate Devices

510(K) number (Primary Predicate): K161344 GentleCath Glide Intermittent Catheter

510(K) number: K000070 Rüsch FloCath Quick

510(k) number: K050874 LoFric Primo

#### Device Description

A hydrophilic urological catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids from the bladder. The tip/distal end of the tube are inserted into the urethra and the funnel/connector end is used to drain the urine or can be connected to a urine drainage bag. The device is made using Polyolefin Based Synthetic Thermoplastic Elastomer (TPE) as base material with the addition of an additive material is hydrophilic and makes the surface slippery when wetted with water. The products are designed for transient use only and are available in male and female lengths. The products are available in various diameters; Six FR/CH sizes: CH08, CH10, CH12, CH14, CH16, CH18. An increasing Charrière corresponds to a larger external diameter. The male catheter range also consists of variants with a bent (Tiemann) catheter tip shape.

#### Indication for Use

Intermittent Catheters are indicated for routine transient intermittent drainage of the bladder. The catheter is inserted through the urethra.

#### Intended Use Population

GentleCath™ Glide Intermittent Urinary Catheter is intended for male, female and paediatric patients (children, adolescents and transitional adolescents B (18 years old to less than 22 years old but treated like and adult)).

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## Performance Testing - Bench

Details relating to performance testing of the subject device and the two predicate devices can be found in section 18 of this submission. The Following comparison tests were performed to demonstrate equivalence:

- 1) Flow Rate
- 2) Catheter Tensile properties
- 3) Coefficient of Friction
- 4) Angle of Coudé (Tiemann)Tip

The laboratory testing shows no differences that would indicate the GentleCath Glide Intermittent Urinary Catheter would be any less safe or effective than the predicate devices. All the parameters are similar or superior for the GentleCath Glide Intermittent Urinary Catheter. Therefore the testing has demonstrated substantial equivalence of the GentleCath Glide intermittent Catheter to predicate devices.

### Substantial Equivalence Conclusion

It has been demonstrated through comparison of design features and performance testing, that the proposed device and its predicates have been found to be substantially equivalent; see following pages.

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# Substantial Equivalence Discussion

The following table compares the similarities and differences between the subject, GentleCath Gibeter and the predicates Rüsch FloCath Quick and LoFric Primo Catheter and outlines the product characteristic's and specifications which form the basis of the substantial equivalence discussion.

The intended use, technological characteristics and principles of operation of the GentleCath Catheter remains the same as those of the predicate devices.

| | | | | | Comparison | |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Parameter | GentleCath Glide Intermittent<br>Urinary Catheter<br>Subject Device | Primary Predicate<br>GentleCath Glide Intermittent<br>Urinary Catheter | Predicate 2<br>Teleflex: Rüsch FloCath Quick | Predicate 3<br>Wellspect: Lo-Fric Primo | Similarities | Differences |
| FDA Product<br>Code | GBM | GBM | KOD | GBM | GentleCath Glide and<br>FloCath Quick have<br>been classified as<br>urological catheters. | Lo-Fric Primo has<br>been classified as a<br>urethral catheter. |
| FDA<br>Classification<br>Regulation | 21 CFR 876.5130 | 21 CFR 876.5130 | 21 CFR 876.5130 | 21 CFR 876.5130 | All devices are the<br>same | None |
| Regulatory<br>Class | Class II | Class II | Class II | Class II | All devices are the<br>same | None |
| Device<br>description | A hydrophilic urinary catheter<br>is a flexible tubular device that<br>is inserted through the urethra<br>and used to pass fluids from<br>the bladder. It includes a<br>substance that makes the<br>surface slippery when it<br>comes into contact with water.<br>The catheter is provided<br>together with a sterile water<br>sachet for lubrication | A hydrophilic urinary catheter is<br>a flexible tubular device that is<br>inserted through the urethra and<br>used to pass fluids from the<br>bladder. It includes a substance<br>that makes the surface slippery<br>when it comes into contact with<br>water. The catheter is provided<br>together with a sterile water<br>sachet for lubrication | The Rüsch FloCath catheter<br>consists of a tubular PVC shaft<br>with attached drainage funnel.<br>The catheter is designed with a<br>Nelaton, Olive or Tiemann tip.<br>There are two drainage eyes in<br>various configurations (straight<br>through, staggered, vertical<br>orientated). This device shaft<br>may be uncoated or Hydrogel /<br>Hydrophilic coated. The coating<br>has been tested for both its<br>safety and function. | The LoFric Primo Single Use<br>Urinary Catheter is designed as<br>an intermittent pathway for<br>drainage of the bladder. The<br>device consists of a catheter,<br>coated with a hydrophilic low-<br>friction coating.<br>The surface is hydrophilic and<br>when the catheter is activated<br>with the water integrated in the<br>package, it becomes slippery<br>and ready to use.<br>The catheter is provided in a<br>variety of lengths and sizes.<br>The catheter and the activation<br>water is separated, sealed in<br>one bag.<br>By holding the product upright<br>and exerting a light pressure on<br>the folded water pocket, the<br>water will run down and wet the | All devices are<br>developed around the<br>same basic design of<br>a tube with a funnel<br>and two drainage<br>eyes. With surface<br>properties that<br>become hydrophilic<br>when wet. | GentleCath Glide<br>contains an additive<br>within the base<br>material while both<br>FloCath Quick and<br>Lo-Fric Primo have<br>a coating. |

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| | | catheter. The bag is opened<br>and the catheter is inserted into<br>the patient's urethra | | |
|--|--|-------------------------------------------------------------------------------------------|--|--|
|--|--|-------------------------------------------------------------------------------------------|--|--|

| | Subject Device | | | | | Comparison | |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Parameter | GentleCath Glide Intermittent<br>Urinary Catheter | Primary Predicate<br>GentleCath Glide Intermittent<br>Urinary Catheter | Predicate 1<br>Teleflex: Rüsch FloCath Quick | Predicate 2<br>Wellspect: Lo-Fric Primo | Similarities | Differences | |
| Intended use /<br>Indication for<br>Use | Intermittent catheters are<br>indicated for routine transient<br>drainage of the bladder. The<br>catheter is inserted through<br>the urethra.<br>For adult use only. | Intermittent catheters are<br>indicated for routine transient<br>drainage of the bladder. The<br>catheter is inserted through<br>the urethra. | Rüsch FloCath catheter is<br>flexible tubular device that is<br>inserted through the urethra and<br>is used to pass fluids to or from<br>urinary tracts | The LoFric Primo Single Use<br>Urinary Catheter is intended for<br>intermittent catheterization of the<br>urethra | All devices are<br>intended for bladder<br>catheterization<br>through the urethra | GentleCath Glide<br>does not include the<br>intended use of<br>administration of fluids<br>to the bladder, unlike<br>FloCath does | |
| Cautions | Single use<br>Prescription only | Single use<br>Prescription only | Single use<br>Prescription only | Single use<br>Prescription only | All devices are the<br>same | None | |
| Tube Material | POBE | POBE | DEHP-free PVC | POBE | The base material of<br>GentleCath Glide is<br>the same as LoFric<br>Primo | FloCath Quick has a<br>different base material<br>to GentleCath Glide<br>and LoFric Primo | |
| Coating/<br>additive | Additive compounded into the<br>base material | Additive compounded into the<br>base material | PVP (polyvinyl pyrrolidone) | PVP (polyvinyl pyrrolidone) and<br>sodium chloride | All three devices have<br>surface properties that<br>become hydrophilic<br>and slippery when<br>wet. | The addition of the<br>additive is a different<br>way of achieving a<br>hydrophilic surface<br>from the PVP coating.<br>Biocompatibility<br>studies of the device<br>conclude that the<br>material compound is<br>safe for the intended<br>use. | |

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| Connector<br>Material | PVC + DEHT | PVC + DEHT | DEHP-free PVC | POBE | All three connectors<br>are similar in design. | The exact material<br>composition of<br>competitor products<br>unknown to ConvaTec<br>however, GentleCath<br>Glide funnel is exactly<br>the same as marketed<br>GentleCath male<br>Olive tip K140953 |
|-----------------------|-------------------------------|-------------------------------|---------------|---------|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Glue for<br>assembly | Loctite (UV acrylic adhesive) | Loctite (UV acrylic adhesive) | Not known | Loctite | The glue used to<br>produce LoFric Primo<br>and GentleCath Glide<br>products is exactly the same. | The assembly method<br>used for FloCath<br>Quick is not known to<br>ConvaTec |

| | Subject Device | | | | Comparison | |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Parameter | GentleCath Glide Intermittent<br>Urinary Catheter | Primary Predicate<br>GentleCath Glide Intermittent<br>Urinary Catheter | Predicate 1<br>Teleflex: Rüsch FloCath Quick | Predicate 2<br>Wellspect: Lo-Fric Primo | Similarities | Differences |
| Biocompatibility | ISO 10993-1, Biological<br>evaluation of medical devices<br>– Part 1: Evaluation and<br>testing within a risk<br>management process-<br>Guidance for Industry and<br>Food and Drug Administration<br>Staff".<br>Cytotoxicity ISO 10993-5<br>Sensitization ISO10993-10<br>Skin Irritation ISO10993-10<br>Genotoxicity ISO10993-3<br>Subchronic Toxicity ISO<br>10993-11<br>EtO sterilization residuals ISO<br>10993-7 | ISO 10993-1, Biological<br>evaluation of medical devices -<br>Part 1: Evaluation and testing<br>within a risk management<br>process- Guidance for Industry<br>and Food and Drug<br>Administration Staff".<br>Cytotoxicity ISO 10993-5<br>Sensitization ISO10993-10<br>Skin Irritation ISO10993-10<br>Genotoxicity ISO10993-3<br>Subchronic Toxicity ISO 10993-11<br>EtO sterilization residuals ISO<br>10993-7 | Not known | Not known | The exact<br>biocompatibility<br>tests performed on<br>FloCath Quick and<br>LoFric Primo are not<br>known to Convatec.<br>GentleCath Glide is<br>tested in<br>compliance with<br>ISO 10993-1:2009<br>for surface devices<br>in contact with<br>mucosal membrane<br>for a limited time<br>period. Genotoxicity<br>and subchronic<br>toxicity are also<br>included due to the<br>prolonged use some<br>patients may be<br>exposed to | Not Known |

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| | | | | | | overtime.<br>Biocompatibility<br>studies of the<br>device conclude<br>that the material<br>compound is safe<br>for the intended use | |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Principal of<br>operation –<br>short<br>description of<br>use | Squeeze water pocket<br>Peel pack open<br>Insert catheter<br>Empty bladder<br>Withdraw catheter<br>Dispose device | Squeeze water pocket<br>Peel pack open<br>Insert catheter<br>Empty bladder<br>Withdraw catheter<br>Dispose device | Squeeze water pocket<br>Hang and let soak for 30sec<br>Peel pack open<br>Insert catheter<br>Empty bladder<br>Withdraw catheter<br>Dispose device | Unfold pack<br>Squeeze water pocket<br>Hang and let soak for 30sec<br>Peel pack open<br>Insert catheter<br>Empty bladder<br>Withdraw catheter<br>Dispose device | Principal of<br>operation is similar<br>for all three devices | GentleCath Glide does<br>not require soaking<br>before use | |
| Length<br>(mm) | Male: 405mm<br>Female: 150-200mm | Male: 405mm<br>Female: 150-200mm | Male: 400mm<br>Female: 200mm<br>Pediatric: 300mm | Male: 400mm<br>Female: 200mm / 150mm<br>Pediatric: 200mm | Catheter lengths all<br>comply with the<br>requirements of<br>EN1616:1997<br>Sterile Urethral<br>Catheters for Single<br>Use, Table 1. Shaft<br>dimensions | Some differences in<br>length between the<br>products, but all in<br>compliance with<br>EN1616:1997 Sterile<br>Urethral Catheters for<br>Single Use, Table 1.<br>Shaft dimensions. | |

| Parameter | Subject Device | | | | Comparison | |
|-----------|---------------------------------------------------|------------------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | GentleCath Glide Intermittent<br>Urinary Catheter | Primary Predicate<br>GentleCath Glide Intermittent<br>Urinary Catheter | Predicate 1<br>Teleflex: Rüsch FloCath Quick | Predicate 2<br>Wellspect: Lo-Fric Primo | Similarities | Differences |
| FR Size | Male: CH08-CH18<br>Female: CH08-CH16 | Male: CH10-CH16<br>Female: CH10-CH16 | Male: CH08-CH20<br>Female: CH08-CH20<br>Pediatric: CH06-CH10 | Male: CH08-CH18<br>Female: CH08-CH18<br>Pediatric: CH06-CH10 | All sizes of<br>GentleCath Glide<br>are included within<br>the ranges of the<br>predicate devices | Predicate devices have<br>a bigger size range.<br>Additional catheter sizes<br>will be added to the<br>GentleCath Glide<br>product range in the<br>future. |

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| Connector<br>color<br>indicating size | CH08: Blue<br>CH10: Black<br>CH12: White<br>CH14: Green<br>CH16: Orange<br>CH18: Red | CH10: Black<br>CH12: White<br>CH14: Green<br>CH16: Orange | CH06: green<br>CH08: Blue<br>CH10: Black<br>CH12: White<br>CH14: Green<br>CH16: Orange<br>CH18: Red<br>CH20: Yellow | CH06: green<br>CH08: Blue<br>CH10: Black<br>CH12: White<br>CH14: Green<br>CH16: Orange<br>CH18: Red | Connector colour<br>coding all comply<br>with ISO 8836:2014<br>Suction catheters<br>for use in the<br>respiratory tract | None |
|---------------------------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Catheter tube<br>-outer<br>diameter<br>(mm) | CH08: 2.67<br>CH10: 3.33<br>CH12: 4.00<br>CH14: 4.67<br>CH16: 5.33<br>CH18: 6.00 | CH10: 3.33<br>CH12: 4.00<br>CH14: 4.67<br>CH16: 5.33 | CH06: 2.00<br>CH08: 2.67<br>CH10: 3.33<br>CH12: 4.00<br>CH14: 4.67<br>CH16: 5.33<br>CH18: 6.00 | CH06: 2.00<br>CH08: 2.67<br>CH10: 3.33<br>CH12: 4.00<br>CH14: 4.67<br>CH16: 5.33<br>CH18: 6.00 | Catheter outer<br>diameters all<br>comply with the<br>requirements of<br>EN1616:1997<br>Sterile Urethral<br>Catheters for Single<br>Use. | Predicate devices have<br>a bigger size range.<br>Additional catheter sizes<br>will be added to the<br>GentleCath Glide<br>product range in the<br>future. |
| Eyelets | Smooth eyelet | Smooth eyelet | Gently rounded catheter eyes<br>which are vertically cut and<br>heat polished | Smooth catheter eyes | All three eyelets are<br>similar in design. | None |
| Eyelet position | Staggered | Staggered | Staggered | Staggered | All three eyelets are<br>similar in design. | None |

| | Subject Device | | | | Comparison | |
|---------------------------|---------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------|-----------------------------------------|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Parameter | GentleCath Glide Intermittent<br>Urinary Catheter | Primary Predicate<br>GentleCath Glide Intermittent<br>Urinary Catheter | Predicate 1<br>Teleflex: Rüsch FloCath Quick | Predicate 2<br>Wellspect: Lo-Fric Primo | Similarities | Differences |
| Tip types in<br>range | Nelaton<br>Tiemann/Coude | Nelaton | Nelaton<br>Tiemann/Coude | Nelaton<br>Tiemann/Coude | All three product<br>ranges include the<br>same tip shapes | None |
| No-touch<br>functionality | Sleeve | Sleeve | Sleeve | Sleeve | GentleCath Glide is<br>similar to FloCath<br>Quick | LoFric primo is<br>different in that the<br>sleeve is part of the<br>packaging and not a<br>standalone accessory |

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| Liquid for<br>wetting | Sterile water | Sterile water | 0.9% Sterile saline solution | Sterile water | GentleCath Glide is<br>similar to LoFric<br>Primo | GentleCath Glide is<br>different from FloCath<br>Quick |
|--------------------------|---------------------------------------|---------------------------------------|---------------------------------------|------------------------------------------------------|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sticky-dot | Double sided adhesive dot | Double sided adhesive dot | Double sided adhesive dot | Glue blob | GentleCath Glide is<br>similar to FloCath<br>Quick | LoFric Primo is<br>different in that the<br>sticky dot is a glue dot. |
| Primary<br>packaging | Paper and film peel pack | Paper and film peel pack | Paper and film peel pack | Polyethylene with a<br>PET/PE/Aluminium water sachet | GentleCath Glide is<br>similar to FloCath<br>Quick | LoFric Primo is different<br>in that its primary<br>packaging is made from<br>polyethylene. |
| Secondary<br>packaging | Corrugated board, Box<br>quantity: 30 | Corrugated board, Box quantity:<br>30 | Corrugated board, Box<br>quantity: 30 | Corrugated board, Box quantity: 30 | All three product are<br>packed in similar<br>boxes | None |
| Shipper<br>case | Corrugated board | Corrugated board | Corrugated board | Corrugated board | All three product are<br>packed in similar<br>shipper | None |
| Sterilization<br>process | EO | EO | EO | Radiation | GentleCath Glide is<br>similar to FloCath<br>quick | LoFric primo uses a<br>different primary<br>sterilization method. |
| Shelf life | 18 months | 18 months | 5 years | Unable to obtain | | GentleCath Glide has<br>a shorter shelf life<br>which will be extended<br>as real-time and<br>additional accelerated<br>stability information<br>becomes available to<br>support. |