(130 days)
Intermittent catheters are indicated for routine transient intermittent drainage of the bladder. The cather is inserted through the urethra.
GentleCath Glide intermittent catheter is intended for adult use only.
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 document provided is a 510(k) premarket notification for a medical device called "GentleCath Glide Intermittent Catheter." It describes the device, its intended use, and a comparison to predicate devices to demonstrate substantial equivalence. However, it does not contain a study that establishes acceptance criteria for specific performance metrics and then reports the device's performance against those criteria in the format requested.
The "Performance Testing - Bench" section (Page 4) mentions that the following comparison tests were performed to demonstrate equivalence:
- Flow Rate
- Catheter Tensile properties
- Coefficient of Friction
It states: "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."
However, detailed numerical acceptance criteria for these tests or specific reported performance values for the GentleCath Glide, linked to a formal study with defined sample sizes, ground truth, or expert involvement, are not provided in this document. The document focuses on demonstrating substantial equivalence through a feature-by-feature comparison with predicates rather than presenting a performance study with acceptance criteria.
Therefore, most of the requested information cannot be extracted directly from this document.
Missing Information:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Details of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or its effect size.
- Details of a standalone (algorithm only) performance study.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
The document only broadly states that the device's flow rate, tensile properties, and coefficient of friction were "similar or superior" to predicate devices, without providing specific quantitative data or acceptance thresholds for these performance parameters.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three overlapping profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 20, 2016
ConvaTec Limited Elinor Jones Regulatory Affairs Specialist GDC, First Avenue, Deeside Industrial Park Deeside, Flintshire CH5 2NU United Kingdom
Re: K161344 Trade/Device Name: GentleCath Glide Intermittent Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: GBM Dated: May 10, 2016 Received: August 22, 2016
Dear Elinor Jones:
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.
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.
{1}------------------------------------------------
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Joyce M. Whang -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
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K161344
Device Name
GentleCath Glide Intermittent Catheter
Indications for Use (Describe)
Intermittent catheters are indicated for routine transient intermittent drainage of the bladder. The cather is inserted through the urethra.
GentleCath Glide intermittent catheter is intended for adult use only.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image features the logo of ConvaTec, a global medical products and technologies company. The logo consists of a stylized blue icon resembling a building with columns, followed by the company name "ConvaTec" in a bold, sans-serif font, also in blue. A curved blue 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 Tel: +44(0) 1244584176
Date Prepared: 10 May 2016
Device Identification:
Trade Name: GentleCath Glide Intermittent Urinary Catheter.
Common Name: Catheter, urethral
Regulation Number: 21 CFR §876.5130
Classification Panel: Gastroenterology and Urology
Classification Name: Urological Catheter and accessories
Regulatory Class: II
Product Code: GBM
Product Reference: 421565, 421566,421567, 421568, 421571, 421572, 421574
{4}------------------------------------------------
Predicate Devices: 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.
Intended Use
Intermittent catheters are indicated for routine transient intermittent drainage of the bladder. The catheter is inserted through the urethra.
GentleCath intermittent catheters are intended for adult use only.
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
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 Urinary 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.
{5}------------------------------------------------
Substantial Equivalence Discussion
The following table compares the similarities and differences between the subject GentleCath Glide Low Friction Intermittent Urinary Catheter and the predicates Rüsch Quick (ref; K00070) and LoFric Primo (ref; K050874, determined substantially equivalent on May 5 2005) 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 Glide Low Friction intermittent urinary catheter remains the same as those of the predicate devices.
| Subject Device | Comparison | ||||
|---|---|---|---|---|---|
| Parameter | GentleCath Glide Catheter | Predicate 1Teleflex: Rüsch FloCath Quick | Predicate 2Wellspect: Lo-Fric Primo | Similarities | Differences |
| FDA ProductCode | GBM | KOD | GBM | GentleCath Glide andFloCath Quick have beenclassified as urologicalcatheters. | Lo-Fric Primo has beenclassified as a urethralcatheter. |
| FDAClassificationRegulation | 21 CFR 876.5130 | 21 CFR 876.5130 | 21 CFR 876.5130 | All devices are the same | None |
| RegulatoryClass | Class II | Class II | Class II | All devices are the same | 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 w ith water.The catheter is providedtogether w ith a sterile w atersachet for lubrication | The Rüsch FloCath catheterconsists of a tubular PVC shaftw ith attached drainage funnel.The catheter is designed w ith aNelaton, Olive or Tiemann tip.There are tw o 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 as anintermittent pathw ay for drainage ofthe bladder. The device consists ofa catheter, coated w ith ahydrophilic low -friction coating.The surface is hydrophilic andw hen the catheter is activated w iththe w ater integrated in thepackage, it becomes slippery andready to use.The catheter is provided in avariety of lengths and sizes.The catheter and the activationw ater is separated, sealed in onebag.By holding the product upright andexerting a light pressure on thefolded w ater pocket, the w ater w ill | All devices are developedaround the same basicdesign of a tube w ith afunnel and tw o drainageeyes. With surfaceproperties that becomehydrophilic w hen wet. | GentleCath Glide containsan additive w ithin thebase material w hile bothFloCath Quick and Lo-FricPrimo have a coating. |
{6}------------------------------------------------
| run dow n and w et the catheter. Thebag is opened and the catheter isinserted into the patient's urethra | ||||||
|---|---|---|---|---|---|---|
| -- | -- | -- | ------------------------------------------------------------------------------------------------------------------ | -- | -- | -- |
| Subject Device | Comparison | ||||
|---|---|---|---|---|---|
| Parameter | GentleCath Glide 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. | 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 are intendedfor bladder catheterizationthrough the urethra | GentleCath does notinclude the intended useof administration of fluidsto the bladder, unlikeFloCath does |
| Cautions | Single usePrescription only | Single usePrescription only | Single usePrescription only | All devices are the same | None |
| Tube Material | POBE | DEHP-free PVC | POBE | The base material ofGentleCath Glide is thesame as LoFric Primo | FloCath Quick has adifferent base material toGentleCath Glide andLoFric Primo |
| Coating/additive | Additive within the basematerial | PVP (polyvinyl pyrrolidone) | PVP (polyvinyl pyrrolidone) andsodium chloride | All three devices havesurface properties thatbecome hydrophilic andslippery when wet. | The addition of theadditive is a different wayof achieving a hydrophilicsurface from the PVPcoating. Biocompatibilitystudies of the deviceconclude that the materialcompound is safe for theintended use. |
| ConnectorMaterial | PVC + DEHT | DEHP-free PVC | POBE | All three connectors aresimilar in design. | The exact materialcomposition of competitorproducts is unknown toConvaTec However,GentleCath Glide funnel isexactly the same asmarketed GentleCathmale Olive tip K140953 |
{7}------------------------------------------------
| Glue forassembly | Loctite | Not known | Loctite | The glue used to produceLoFric Primo andGentleCath Glideproducts is exactly thesame. | The assembly methodused for FloCath Quick isnot known to ConvaTec |
|---|---|---|---|---|---|
| ---------------------- | --------- | ----------- | --------- | ------------------------------------------------------------------------------------------------------ | --------------------------------------------------------------------------- |
| Subject Device | Comparison | ||||
|---|---|---|---|---|---|
| Parameter | GentleCath Glide Catheter | Predicate 1Teleflex: Rüsch FloCath Quick | Predicate 2Wellspect: Lo-Fric Primo | Similarities | Differences |
| Biocompatibility | Evaluation and testing withinrisk management processISO 10993-1Cytotoxicity ISO 10993-5Sensitization ISO10993-10Skin Irritation ISO10993-10Genotoxicity ISO10993-3Subchronic Toxicity ISO10993-11EtO sterilization residualsISO 10993-7 | Not known | Not known | The exact biocompatibilitytests performed onFloCath Quick and LoFricPrimo are not known toConvatec.GentleCath Glide is testedin compliance with ISO10993-1:2009 for surfacedevices in contact withmucosal membrane for alimited time period.Genotoxicity andsubchronic toxicity arealso included due to theprolonged use somepatients may be exposedto overtime.Biocompatibility studies ofthe device conclude thatthe material compound issafe for the intended use | Not Known |
| Principal ofoperation - shortdescription ofuse | Squeeze water pocketPeel pack openInsert catheter | Squeeze water pocketHang and let soak for 30secPeel pack openInsert catheter | Unfold packSqueeze water pocketHang and let soak for 30secPeel pack openInsert catheter | Principal of operation issimilar for all threedevices | GentleCath Glide does notrequire soaking before use |
| Empty bladder | Empty bladder | Empty bladder |
{8}------------------------------------------------
| Withdraw catheterDispose device | Withdraw catheterDispose device | Withdraw catheterDispose device | |||
|---|---|---|---|---|---|
| Length(mm) | Male: 405mmFemale: 150-200mm | Male: 400mmFemale: 200mmPediatric: 300mm | Male: 400mmFemale: 200mm / 150mmPediatric: 200mm | Catheter lengths allcomply w ith therequirements ofEN1616:1997 SterileUrethral Catheters forSingle Use, Table 1. Shaftdimensions | Some differences in lengthbetw een the products, butall in compliance w ithEN1616:1997 SterileUrethral Catheters forSingle Use, Table 1. Shaftdimensions. |
| Subject Device | Comparison | ||||
|---|---|---|---|---|---|
| Parameter | GentleCath Glide Catheter | Predicate 1Teleflex: Rüsch FloCath Quick | Predicate 2Wellspect: Lo-Fric Primo | Similarities | Differences |
| FR Size | Male: CH10-CH16Female: CH10-CH16 | Male: CH08-CH20Female: CH08-CH20Pediatric: CH06-CH10 | Male: CH08-CH18Female: CH08-CH18Pediatric: CH06-CH10 | All sizes of GentleCathGlide are included w ithinthe ranges of thepredicate devices | Predicate devices have abigger size range.GentleCath Glide is beinginitially launched w ith asmaller size range. |
| Connector colorindicating size | CH10: BlackCH12: WhiteCH14: GreenCH16: Orange | CH06: greenCH08: BlueCH10: BlackCH12: WhiteCH14: GreenCH16: OrangeCH18: RedCH20: Yellow | CH06: greenCH08: BlueCH10: BlackCH12: WhiteCH14: GreenCH16: OrangeCH18: Red | Connector colour codingall comply w ith ISO8836:2007 Suctioncatheters for use in therespiratory tract : Table 1 | None |
| Catheter tube -outer diameter(mm) | CH10: 3.33CH12: 4.00CH14: 4.67CH16: 5.33 | CH06: 2.00CH08: 2.67CH10: 3.33CH12: 4.00CH14: 4.67CH16: 5.33 | CH06: 2.00CH08: 2.67CH10: 3.33CH12: 4.00CH14: 4.67CH16: 5.33 | Catheter outer diametersall comply w ith therequirements ofEN1616:1997 SterileUrethral Catheters forSingle Use, Table 2. | Predicate devices have abigger size range.GentleCath Glide is beinginitially launched w ith asmaller size range. |
{9}------------------------------------------------
| CH18: 6.00 | CH18: 6.00 | ||||
|---|---|---|---|---|---|
| Eyelets | Smooth eyelet | Gently rounded catheter eyeswhich arevertically cut and heat polished | Smooth catheter eyes | All three eyelets aresimilar in design. | None |
| Eyelet position | Staggered | Staggered | Staggered | All three eyelets aresimilar in design. | None |
| Subject Device | Comparison | ||||
|---|---|---|---|---|---|
| Parameter | GentleCath Glide Catheter | Predicate 1Teleflex: Rüsch FloCath Quick | Predicate 2Wellspect: Lo-Fric Primo | Similarities | Differences |
| Tip types inrange | Nelaton | NelatonTiemann/Coude | NelatonTiemann/Coude | All three product rangesinclude the same tipshapes | Predicate devices alsohave a range oftiemenn/Coude tip shapes |
| No-touchfunctionality | Sleeve | Sleeve | Sleeve | GentleCath Glide issimilar to FloCath Quick | LoFric primo is different inthat the sleeve is part ofthe packaging and not astandalone accessory |
| Liquid forwetting | Sterile water | 0.9% Sterile saline solution | Sterile water | GentleCath Glide issimilar to LoFric Primo | GentleCath Glide isdifferent from FloCathQuick |
| Sticky-dot | Double sided adhesive dot | Double sided adhesive dot | Glue blob | GentleCath Glide issimilar to FloCath Quick | LoFric Primo is different inthat the sticky dot is a gluedot. |
| Primarypackaging | Paper and film peel pack | Paper and film peel pack | Polyethylene with aPET/PE/Aluminium water sachet | GentleCath Glide issimilar to FloCath Quick | LoFric Primo is different inthat its primary packaging ismade frompolyethylene. |
| Secondarypackaging | Corrugated board, Boxquantity: 30 | Corrugated board, Box quantity:30 | Corrugated board, Box quantity:30 | All three product arepacked in similar boxes | None |
| Shipper case | Corrugated board | Corrugated board | Corrugated board | All three product arepacked in similar shipper | None |
| Sterilizationprocess | EO | EO | Radiation | GentleCath is similar toFloCath quick | LoFric primo uses adifferent sterilizationmethod. |
| Shelf life | 18 months | 5 years | Unable to obtain | GentleCath Glide has a | |
| shorter shelf life which will | |||||
| be extended as real-time | |||||
| and additional accelerated | |||||
| stability information | |||||
| becomes available to | |||||
| support. |
{10}------------------------------------------------
§ 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.