(101 days)
Intermittent Catheters are indicated for routine transient intermittent drainage of the bladder. The cather is inserted through the urethra.
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.
The provided document is a 510(k) summary for the ConvaTec GentleCath™ Glide Intermittent Urinary Catheter. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices based on performance testing and comparison of characteristics.
Here's an analysis of the acceptance criteria and study in the context of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for a medical device's clinical performance (e.g., sensitivity, specificity for diagnostic devices). Instead, it demonstrates "substantial equivalence" to predicate devices through a series of bench tests and comparison of device characteristics. The acceptance criteria are implicitly that the subject device's performance in these tests is "similar or superior" to the predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Similar or Superior Flow Rate to predicate devices. | "All the parameters are similar or superior for the GentleCath Glide Intermittent Urinary Catheter." (Page 6) |
| Similar or Superior Catheter Tensile Properties to predicate devices. | "All the parameters are similar or superior for the GentleCath Glide Intermittent Urinary Catheter." (Page 6) |
| Similar or Superior Coefficient of Friction to predicate devices. | "All the parameters are similar or superior for the GentleCath Glide Intermittent Urinary Catheter." (Page 6) |
| Similar or Superior Angle of Coudé (Tiemann) Tip to predicate devices (for relevant variants). | "All the parameters are similar or superior for the GentleCath Glide Intermittent Urinary Catheter." (Page 6) |
| Compliance with ISO 10993-1, 10993-3, 10993-5, 10993-7, 10993-10, 10993-11 for biocompatibility for surface devices in contact with mucosal membrane for a limited time. | The subject device was tested in compliance with these ISO standards and "Biocompatibility studies of the device conclude that the material compound is safe for the intended use." (Pages 8-9) |
| Compliance with EN1616:1997 Sterile Urethral Catheters for Single Use, Table 1. Shaft dimensions for catheter length. | "All devices are in compliance with EN1616:1997 Sterile Urethral Catheters for Single Use, Table 1. Shaft dimensions." (Page 10) |
| Compliance with ISO 8836:2014 Suction catheters for use in the respiratory tract for connector color coding. | "Connector colour coding all comply with ISO 8836:2014 Suction catheters for use in the respiratory tract" (Page 11) |
| Compliance with EN1616:1997 Sterile Urethral Catheters for Single Use for catheter outer diameter. | "Catheter outer diameters all comply with the requirements of EN1616:1997 Sterile Urethral Catheters for Single Use." (Page 11) |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample size used for the bench tests (flow rate, tensile properties, coefficient of friction, angle of Coudé tip).
The data provenance is from laboratory testing performed by ConvaTec Limited (UK-based company). It is implicitly retrospective as it compares the new device to existing predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. Given that the testing consisted of bench tests, the "ground truth" would likely be established by validated test methods and instrumentation, rather than expert review of clinical cases.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not applicable as the document describes bench testing, not a clinical study involving human judgment 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
An MRMC comparative effectiveness study was not done. This document describes a 510(k) submission for a physical medical device (intermittent urinary catheter), not an AI-assisted diagnostic tool. Therefore, effects on human readers or AI assistance are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical medical device and does not involve an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation mostly relies on bench test measurements against established engineering and material science standards (e.g., ISO and EN standards) and comparative performance against legally marketed predicate devices. For biocompatibility, the ground truth is established by the results of specific ISO-standardized biological evaluations (e.g., cytotoxicity, sensitization, irritation reports).
8. The Sample Size for the Training Set
This is not applicable. The device is a physical medical device (catheter); there is no "training set" in the context of machine learning or AI models. The design and manufacturing process are based on engineering principles and materials science.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reason as point 8.
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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: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right is written in blue and is stacked in two lines.
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 (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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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
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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: elinor.jones@convatec.com Tel: +44(0) 1244584176
Secondary Contact: Jason Skramsted (Email: Jason.skramsted@convatec.com)
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:
-
- Flow Rate
-
- Catheter Tensile properties
-
- Coefficient of Friction
-
- 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 IntermittentUrinary CatheterSubject Device | Primary PredicateGentleCath Glide IntermittentUrinary Catheter | Predicate 2Teleflex: Rüsch FloCath Quick | Predicate 3Wellspect: Lo-Fric Primo | Similarities | Differences |
| FDA ProductCode | GBM | GBM | KOD | GBM | GentleCath Glide andFloCath Quick havebeen classified asurological catheters. | Lo-Fric Primo hasbeen classified as aurethral catheter. |
| FDAClassificationRegulation | 21 CFR 876.5130 | 21 CFR 876.5130 | 21 CFR 876.5130 | 21 CFR 876.5130 | All devices are thesame | None |
| RegulatoryClass | Class II | Class II | Class II | Class II | All devices are thesame | None |
| Devicedescription | A hydrophilic urinary catheteris a flexible tubular device thatis inserted through the urethraand used to pass fluids fromthe bladder. It includes asubstance that makes thesurface slippery when itcomes into contact with water.The catheter is providedtogether with a sterile watersachet for lubrication | A hydrophilic urinary catheter isa flexible tubular device that isinserted through the urethra andused to pass fluids from thebladder. It includes a substancethat makes the surface slipperywhen it comes into contact withwater. The catheter is providedtogether with a sterile watersachet for lubrication | The Rüsch FloCath catheterconsists of a tubular PVC shaftwith attached drainage funnel.The catheter is designed with aNelaton, Olive or Tiemann tip.There are two drainage eyes invarious configurations (straightthrough, staggered, verticalorientated). This device shaftmay be uncoated or Hydrogel /Hydrophilic coated. The coatinghas been tested for both itssafety and function. | The LoFric Primo Single UseUrinary Catheter is designed asan intermittent pathway fordrainage of the bladder. Thedevice consists of a catheter,coated with a hydrophilic low-friction coating.The surface is hydrophilic andwhen the catheter is activatedwith the water integrated in thepackage, it becomes slipperyand ready to use.The catheter is provided in avariety of lengths and sizes.The catheter and the activationwater is separated, sealed inone bag.By holding the product uprightand exerting a light pressure onthe folded water pocket, thewater will run down and wet the | All devices aredeveloped around thesame basic design ofa tube with a funneland two drainageeyes. With surfaceproperties thatbecome hydrophilicwhen wet. | GentleCath Glidecontains an additivewithin the basematerial while bothFloCath Quick andLo-Fric Primo havea coating. |
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| catheter. The bag is openedand the catheter is inserted intothe patient's urethra | ||||
|---|---|---|---|---|
| -- | -- | ------------------------------------------------------------------------------------------- | -- | -- |
| Subject Device | Comparison | ||||||
|---|---|---|---|---|---|---|---|
| Parameter | GentleCath Glide IntermittentUrinary Catheter | Primary PredicateGentleCath Glide IntermittentUrinary Catheter | Predicate 1Teleflex: Rüsch FloCath Quick | Predicate 2Wellspect: Lo-Fric Primo | Similarities | Differences | |
| Intended use /Indication forUse | Intermittent catheters areindicated for routine transientdrainage of the bladder. Thecatheter is inserted throughthe urethra.For adult use only. | Intermittent catheters areindicated for routine transientdrainage of the bladder. Thecatheter is inserted throughthe urethra. | Rüsch FloCath catheter isflexible tubular device that isinserted through the urethra andis used to pass fluids to or fromurinary tracts | The LoFric Primo Single UseUrinary Catheter is intended forintermittent catheterization of theurethra | All devices areintended for bladdercatheterizationthrough the urethra | GentleCath Glidedoes not include theintended use ofadministration of fluidsto the bladder, unlikeFloCath does | |
| Cautions | Single usePrescription only | Single usePrescription only | Single usePrescription only | Single usePrescription only | All devices are thesame | None | |
| Tube Material | POBE | POBE | DEHP-free PVC | POBE | The base material ofGentleCath Glide isthe same as LoFricPrimo | FloCath Quick has adifferent base materialto GentleCath Glideand LoFric Primo | |
| Coating/additive | Additive compounded into thebase material | Additive compounded into thebase material | PVP (polyvinyl pyrrolidone) | PVP (polyvinyl pyrrolidone) andsodium chloride | All three devices havesurface properties thatbecome hydrophilicand slippery whenwet. | The addition of theadditive is a differentway of achieving ahydrophilic surfacefrom the PVP coating.Biocompatibilitystudies of the deviceconclude that thematerial compound issafe for the intendeduse. |
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| ConnectorMaterial | PVC + DEHT | PVC + DEHT | DEHP-free PVC | POBE | All three connectorsare similar in design. | The exact materialcomposition ofcompetitor productsunknown to ConvaTechowever, GentleCathGlide funnel is exactlythe same as marketedGentleCath maleOlive tip K140953 |
|---|---|---|---|---|---|---|
| Glue forassembly | Loctite (UV acrylic adhesive) | Loctite (UV acrylic adhesive) | Not known | Loctite | The glue used toproduce LoFric Primoand GentleCath Glideproducts is exactly the same. | The assembly methodused for FloCathQuick is not known toConvaTec |
| Subject Device | Comparison | |||||
|---|---|---|---|---|---|---|
| Parameter | GentleCath Glide IntermittentUrinary Catheter | Primary PredicateGentleCath Glide IntermittentUrinary Catheter | Predicate 1Teleflex: Rüsch FloCath Quick | Predicate 2Wellspect: Lo-Fric Primo | Similarities | Differences |
| Biocompatibility | ISO 10993-1, Biologicalevaluation of medical devices– Part 1: Evaluation andtesting within a riskmanagement process-Guidance for Industry andFood and Drug AdministrationStaff".Cytotoxicity ISO 10993-5Sensitization ISO10993-10Skin Irritation ISO10993-10Genotoxicity ISO10993-3Subchronic Toxicity ISO10993-11EtO sterilization residuals ISO10993-7 | ISO 10993-1, Biologicalevaluation of medical devices -Part 1: Evaluation and testingwithin a risk managementprocess- Guidance for Industryand Food and DrugAdministration Staff".Cytotoxicity ISO 10993-5Sensitization ISO10993-10Skin Irritation ISO10993-10Genotoxicity ISO10993-3Subchronic Toxicity ISO 10993-11EtO sterilization residuals ISO10993-7 | Not known | Not known | The exactbiocompatibilitytests performed onFloCath Quick andLoFric Primo are notknown to Convatec.GentleCath Glide istested incompliance withISO 10993-1:2009for surface devicesin contact withmucosal membranefor a limited timeperiod. Genotoxicityand subchronictoxicity are alsoincluded due to theprolonged use somepatients may beexposed to | Not Known |
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| overtime.Biocompatibilitystudies of thedevice concludethat the materialcompound is safefor the intended use | |||||||
|---|---|---|---|---|---|---|---|
| Principal ofoperation –shortdescription ofuse | Squeeze water pocketPeel pack openInsert catheterEmpty bladderWithdraw catheterDispose device | Squeeze water pocketPeel pack openInsert catheterEmpty bladderWithdraw catheterDispose device | Squeeze water pocketHang and let soak for 30secPeel pack openInsert catheterEmpty bladderWithdraw catheterDispose device | Unfold packSqueeze water pocketHang and let soak for 30secPeel pack openInsert catheterEmpty bladderWithdraw catheterDispose device | Principal ofoperation is similarfor all three devices | GentleCath Glide doesnot require soakingbefore use | |
| Length(mm) | Male: 405mmFemale: 150-200mm | Male: 405mmFemale: 150-200mm | Male: 400mmFemale: 200mmPediatric: 300mm | Male: 400mmFemale: 200mm / 150mmPediatric: 200mm | Catheter lengths allcomply with therequirements ofEN1616:1997Sterile UrethralCatheters for SingleUse, Table 1. Shaftdimensions | Some differences inlength between theproducts, but all incompliance withEN1616:1997 SterileUrethral Catheters forSingle Use, Table 1.Shaft dimensions. |
| Parameter | Subject Device | Comparison | ||||
|---|---|---|---|---|---|---|
| GentleCath Glide IntermittentUrinary Catheter | Primary PredicateGentleCath Glide IntermittentUrinary Catheter | Predicate 1Teleflex: Rüsch FloCath Quick | Predicate 2Wellspect: Lo-Fric Primo | Similarities | Differences | |
| FR Size | Male: CH08-CH18Female: CH08-CH16 | Male: CH10-CH16Female: CH10-CH16 | Male: CH08-CH20Female: CH08-CH20Pediatric: CH06-CH10 | Male: CH08-CH18Female: CH08-CH18Pediatric: CH06-CH10 | All sizes ofGentleCath Glideare included withinthe ranges of thepredicate devices | Predicate devices havea bigger size range.Additional catheter sizeswill be added to theGentleCath Glideproduct range in thefuture. |
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| Connectorcolorindicating size | CH08: BlueCH10: BlackCH12: WhiteCH14: GreenCH16: OrangeCH18: Red | CH10: BlackCH12: WhiteCH14: GreenCH16: Orange | CH06: greenCH08: BlueCH10: BlackCH12: WhiteCH14: GreenCH16: OrangeCH18: RedCH20: Yellow | CH06: greenCH08: BlueCH10: BlackCH12: WhiteCH14: GreenCH16: OrangeCH18: Red | Connector colourcoding all complywith ISO 8836:2014Suction cathetersfor use in therespiratory tract | None |
|---|---|---|---|---|---|---|
| Catheter tube-outerdiameter(mm) | CH08: 2.67CH10: 3.33CH12: 4.00CH14: 4.67CH16: 5.33CH18: 6.00 | CH10: 3.33CH12: 4.00CH14: 4.67CH16: 5.33 | CH06: 2.00CH08: 2.67CH10: 3.33CH12: 4.00CH14: 4.67CH16: 5.33CH18: 6.00 | CH06: 2.00CH08: 2.67CH10: 3.33CH12: 4.00CH14: 4.67CH16: 5.33CH18: 6.00 | Catheter outerdiameters allcomply with therequirements ofEN1616:1997Sterile UrethralCatheters for SingleUse. | Predicate devices havea bigger size range.Additional catheter sizeswill be added to theGentleCath Glideproduct range in thefuture. |
| Eyelets | Smooth eyelet | Smooth eyelet | Gently rounded catheter eyeswhich are vertically cut andheat polished | Smooth catheter eyes | All three eyelets aresimilar in design. | None |
| Eyelet position | Staggered | Staggered | Staggered | Staggered | All three eyelets aresimilar in design. | None |
| Subject Device | Comparison | |||||
|---|---|---|---|---|---|---|
| Parameter | GentleCath Glide IntermittentUrinary Catheter | Primary PredicateGentleCath Glide IntermittentUrinary Catheter | Predicate 1Teleflex: Rüsch FloCath Quick | Predicate 2Wellspect: Lo-Fric Primo | Similarities | Differences |
| Tip types inrange | NelatonTiemann/Coude | Nelaton | NelatonTiemann/Coude | NelatonTiemann/Coude | All three productranges include thesame tip shapes | None |
| No-touchfunctionality | Sleeve | Sleeve | Sleeve | Sleeve | GentleCath Glide issimilar to FloCathQuick | LoFric primo isdifferent in that thesleeve is part of thepackaging and not astandalone accessory |
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| Liquid forwetting | Sterile water | Sterile water | 0.9% Sterile saline solution | Sterile water | GentleCath Glide issimilar to LoFricPrimo | GentleCath Glide isdifferent from FloCathQuick |
|---|---|---|---|---|---|---|
| Sticky-dot | Double sided adhesive dot | Double sided adhesive dot | Double sided adhesive dot | Glue blob | GentleCath Glide issimilar to FloCathQuick | LoFric Primo isdifferent in that thesticky dot is a glue dot. |
| Primarypackaging | Paper and film peel pack | Paper and film peel pack | Paper and film peel pack | Polyethylene with aPET/PE/Aluminium water sachet | GentleCath Glide issimilar to FloCathQuick | LoFric Primo is differentin that its primarypackaging is made frompolyethylene. |
| Secondarypackaging | Corrugated board, Boxquantity: 30 | Corrugated board, Box quantity:30 | Corrugated board, Boxquantity: 30 | Corrugated board, Box quantity: 30 | All three product arepacked in similarboxes | None |
| Shippercase | Corrugated board | Corrugated board | Corrugated board | Corrugated board | All three product arepacked in similarshipper | None |
| Sterilizationprocess | EO | EO | EO | Radiation | GentleCath Glide issimilar to FloCathquick | LoFric primo uses adifferent primarysterilization method. |
| Shelf life | 18 months | 18 months | 5 years | Unable to obtain | GentleCath Glide hasa shorter shelf lifewhich will be extendedas real-time andadditional acceleratedstability informationbecomes available tosupport. |
§ 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.