(57 days)
Intermittent Catheters are indicated for routine short term drainage of the bladder. The catheter is inserted through the urethra.
The GentleCath™ Intermittent Urinary Catheter is labelled as a single use, sterile device and is sterilized by Ethylene Oxide to a Sterility Assurance Level of 10-6 A urological catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids from the bladder. tip/distal end of the tube is inserted into the urethra and the funnel/connector end is used to drain the urine or can be connected to a urine drainage bag. Both components of the device are made using Polyvinyl chloride (PVC) as base material and bonded with Cyclohexanone. The products are designed for transient use only and are available in various diameters; Six FR/CH sizes: CH08, CH10, CH12, CH16, CH18. An increasing Charrière corresponds to a larger external diameter.
This document is a 510(k) premarket notification for a medical device and therefore does not contain acceptance criteria for an AI/ML device. It is for a physical medical device, the GentleCath™ Intermittent Urinary Catheter.
The acceptance criteria typically found in such a document would relate to the physical and functional properties of the device, rather than performance metrics of an AI algorithm. The study details included focus on demonstrating substantial equivalence to predicate physical devices.
Based on the provided text, here's what can be extracted regarding the device performance and comparative studies:
The document describes performance testing for the GentleCath™ Intermittent Urinary Catheter to demonstrate its substantial equivalence to two predicate devices:
- Primary Predicate: GentleCath™ Male Coudé Olive Tip Intermittent Urinary Catheter (K140953)
- Secondary Predicate: Self-Cath® Intermittent Urinary Catheter (K100878)
1. Table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in the format of a requirement with a "pass" or "fail" threshold. Instead, it presents a comparison of various parameters between the subject device and the predicate devices to demonstrate equivalence. The "reported device performance" is given as quantitative measurements for each parameter.
| Parameter | Subject Device (GentleCath™ Intermittent Urological Catheter) | Primary Predicate (K140953) | Secondary Predicate (K100878) | Performance/Outcome |
|---|---|---|---|---|
| Flow Rate (ml/min) | 150.5 to 1403.8 ml/min | 148.7 to 1321.5 ml/min | 115.1 to 1380.7 ml/min | Similarities: All products comply with ASTM F623-99.Differences: Subject device demonstrated a slightly higher flow rate. |
| Catheter Tensile Properties (N) | 67.7 to 207.1 N | 60.7 to 203.3 N | 60.1 to 152.5 N | Similarities: Tensile properties comparable for strength of tube and connector attachment.Differences: Slightly greater force is needed for disconnection of tube and connector in the subject device. |
| K Dimension (mm) | 4.7 to 8.4 mm | 5 to 7.9 mm | 5 to 8.1 mm | Similarities: Coudé tip angle comparable to predicate devices.Differences: K Dimension of subject device and predicate devices are considered substantially equivalent. (This reads like a similarity despite being listed under "Differences" column, indicating slight numerical variations that are not clinically significant enough to deem non-equivalent). |
| Catheter tube - outer diameter (mm) | Varies by CH size (e.g., CH08 - 2.6, CH18 - 6.00) | Varies by CH size (e.g., CH08 - 2.67, CH18 - 6.00) | Varies by CH size (e.g., CH08 - 2.66, CH18 - 5.99) | Similarities: Subject device and primary predicate diameters are the same.Differences: Secondary predicate diameters are considered substantially equivalent to GentleCath™ products. |
| Catheter tube - inner diameter (mm) | Varies by CH size (e.g., CH08 - 1.65, CH18 - 4.30) | Varies by CH size (e.g., CH08 - 1.65, CH18 - 4.30) | Varies by CH size (e.g., CH08 - 1.65, CH18 - 4.30) | Similarities: Subject device and primary predicate diameters are the same.Differences: Secondary predicate diameters are considered substantially equivalent to GentleCath™ products. |
| Eyelet size - width (mm) | Varies by CH size (e.g., CH08 - 1.65, CH18 - 4.30) | Varies by CH size (e.g., CH08 - 1.65, CH18 - 4.30) | Varies by CH size (e.g., CH08 - 0.97, CH18 - 2.67) | Similarities: Subject device and primary predicate eyelets are the same.Differences: Secondary predicate eyelet dimensions are slightly smaller. |
| Eyelet size - length (mm) | Varies by CH size (e.g., CH08 - 2.50, CH18 - 5.90) | Varies by CH size (e.g., CH08 - 2.50, CH18 - 5.90) | Varies by CH size (e.g., CH08 - 2.01, CH18 - 5.03) | Similarities: Subject device and primary predicate eyelets are the same.Differences: Secondary predicate eyelet dimensions are slightly smaller. |
The overarching "acceptance criterion" for this type of submission is to demonstrate substantial equivalence to legally marketed predicate devices, meaning that "the device performs similarly to the predicate devices" and that "all the results are similar or superior for the GentleCath™ Intermittent Urinary Catheter."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states, "Details relating to performance testing of the subject device and the two predicate devices can be found in section 18 of this submission." However, Section 18 is not included in the provided text. Therefore, the specific sample sizes for the test sets are not available in this extract. The data provenance is also not available from the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to this type of device and study. The testing described is bench testing of physical properties (flow rate, tensile strength, dimensions), not clinical evaluation requiring expert interpretation of results for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to this type of device and study. Bench testing of physical properties does not involve human adjudication in the way clinical studies with AI/ML devices might.
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
This is not applicable. This document is for a physical medical device (urinary catheter), not an AI/ML device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This document is for a physical medical device (urinary catheter), not a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance testing mentioned (Flow Rate, Catheter Tensile Properties, K Dimension), the "ground truth" would be the measurement results obtained through standardized laboratory test methods. This is not "expert consensus, pathology, or outcomes data" in the typical sense. The standard for flow rate is mentioned as ASTM F623-99.
8. The sample size for the training set
This is not applicable. This submission is for a physical medical device, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. This submission is for a physical medical device, not an AI/ML device that requires a training set.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
November 21, 2017
ConvaTec Limited Hannah Sharp Regulatory Affairs Specialist First Avenue, Deepside Industrial Park Deeside, Flintshire CH5 2NU United Kingdom
Re: K172924
Trade/Device Name: GentleCath™ Intermittent Urinary Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: KOD Dated: September 26, 2017 Received: September 28, 2017
Dear Hannah Sharp:
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.
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You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The name is written in black and is centered on a white background. The letters are clear and easy to read. The image is simple and straightforward, with the focus on the name.
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™ Intermittent Urinary Catheter
Indications for Use (Describe)
Intermittent Catheters are indicated for routine short term drainage of the bladder. The catheter 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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K172924 Page 1 of 11
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Section 5 510(k) Summary
Applicant: ConvaTec Limited.
Applicant Address: ConvaTec Limited (GDC), First Avenue, Deeside Industrial Park, Deeside, Flintshire, CH5 2NU, UK
The Establishment Registration number is 1000317571
Contact: Hannah Sharp Regulatory Affairs Specialist ConvaTec Limited (GDC)
First Avenue, Deeside industrial Park Deeside Flintshire, CH5 2NU UK Tel: +44(0) 1244584145
Date Prepared: 20th October 2017
Device Identification:
Trade Name: GentleCath™ 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: KOD
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Product Reference: 419800, 501002, 501003, 501004, 501005, 501006, 501011, 501006, 501011, 501012, 501013, 501014, 501015, 501016, 501019, 501020, 501021, 501022, 501023
Predicate Devices:
Primarv Predicate: 510(K) number: K140953-GentleCath™ Male Coudé Olive Tip Intermittent Urinary Catheter
Secondary Predicate: 510(k) number: K100878-Self-Cath® Intermittent Urinary Catheter
Device Description
The GentleCath™ Intermittent Urinary Catheter is labelled as a single use, sterile device and is sterilized by Ethylene Oxide to a Sterility Assurance Level of 10°6 A urological catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids from the bladder. tip/distal end of the tube is inserted into the urethra and the funnel/connector end is used to drain the urine or can be connected to a urine drainage bag. Both components of the device are made using Polyvinyl chloride (PVC) as base material and bonded with Cyclohexanone. The products are designed for transient use only and are available in various diameters; Six FR/CH sizes: CH08, CH10, CH12, CH16, CH18. An increasing Charrière corresponds to a larger external diameter.
Indication for Use
GentleCath™ Intermittent Urinary Catheter are indicated for routine short term drainage of the bladder. The catheter is inserted through the urethra.
The Indications for Use statement for the GentleCath™ Intermittent Urinary Catheter is identical to the primary predicate, GentleCath™ Male Coudé Olive Tip Intermittent Urinary Catheter but differs from the Secondary Predicate, Self-Cath® Intermittent Urinary Catheter. Self-Cath® Intermittent Urinary Catheters do not state a usage duration, however, the differences do not alter the intended therapeutic use of the devices nor do they affect the safety and effectiveness of the devices relative to the predicate. Both the subject and predicate devices have the same intended use for bladder drainage.
Intended Use Population
GentleCath™ Intermittent Urinary Catheter is intended for male, female and paediatric patients (children, adolescents and transitional adolescents).
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Comparison of the Technological Characteristics with the Predicate Devices.
Intermittent bladder drainage is the technological principle for both the subject and predicate devices. It is based on the use of an intermittent catheter facilitating bladder drainage when required by the end user. The subject device and predicate devices are based on the following same technological elements:
- All products inserted through urethra ●
- Singe use products
- Intended for intermittent catheterization ●
- Device configuration is the same, consisting of a tube and connector with funnel
- Use of Ethylene Oxide as sterilization method ●
- Same colour coding of connectors .
- All devices are uncoated catheters .
The following technological differences exist between the subject and predicate devices.
- Use of different plasticizer (DEHP) within secondary predicate device .
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)K Dimension
The laboratory testing shows the GentleCath™ Intermittent Urinary Catheter performs similarly to the predicate devices. All the results are similar or superior for the GentleCath™ Intermittent Urinary Catheter. Therefore, the testing has demonstrated substantial equivalence of the GentleCath™ 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 are substantially equivalent; see following pages. The bench testing performed on the subject device and the predicate devices supports the safety of the devices, this demonstrates that the GentleCath™ Intermittent Urinary Catheter should perform as intended. This data demonstrates that the subject device performs comparably to the predicate devices that are currently marketed for the same intended use.
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Substantial Equivalence Discussion
ConvaTec Limited has been manufacturing intermittent urinary catheters for several decades, dating back to the clearance of K896729- Nelaton, Female or Tiemann Catheter determined substantially equivalent on 500.
The catheters associated with K896729 are essentially the same product as the subject device, GentleCath™ Internittent Urinary Catheter. The key difference between the products listed in K896729 and those covered within this submission are the materials of construction, namely the use of DEHT plasticizer as opposed to DEHP.
The following table compares the similarities and differences between the subject, GentleCath™ Intermittent Urinary Catheter, and the predicate devices, GentleCath™ Male Coudé Olive Tip Intermittent Urinary Catheter (ref; K140553, determined substantially equivalent on 1* August 2014) and Self-Cath® Intermittent Urinary Catheter (ref; K100878, determined substantially equivalent on 26th May 2010) and outlines the product characteristics and specifications which form the basis of the substantial equivalence discussion.
The intended use, technological characteristics and principles of operation of the GentleCath™ Intermittent Urinary Catheter remains the same as those of the predicate devices.
| Subject Device | Comparison | ||||
|---|---|---|---|---|---|
| Parameter | GentleCath™ IntermittentUrological Catheter | Primary Predicate:GentleCath™ Male CoudéOlive Tip Intermittent UrinaryCatheter (K140953) | Secondary Predicate:Self-Cath® IntermittentUrinary Catheter (Coloplast)(K100878) | Similarities | Differences |
| FDA ProductCode | KOD | KOD | EZD | GentleCath™Intermittent UrologicalCatheter andGentleCath™ MaleCoudé Olive TipIntermittent UrinaryCatheter are classifiedunder the productcode "KOD-Catheter,Urological" | Self-Cath®Intermittent UrinaryCatheter has beenclassified under theproduct code "EZD-Catheter, Straight",however Coudé tipcatheters are alsoincluded withinsubmissionK100878. |
| Subject Device | Comparison | ||||
| Parameter | GentleCath™ IntermittentUrological Catheter | Primary Predicate:GentleCath™ Male CoudéOlive Tip Intermittent UrinaryCatheter (K140953) | Secondary Predicate:Self-Cath® IntermittentUrinary Catheter (Coloplast)(K100878) | Similarities | Differences |
| FDAClassificationRegulation | 21 CFR 876.5130 | 21 CFR 876.5130 | 21 CFR 876.5130 | All devices are thesame classificationRegulation Number. | None. |
| RegulatoryClass | Class II | Class II | Class II | All devices are thesame classification. | None. |
| IntendedUse/Indication forUse | Catheters are intended forroutine short termdrainage of the bladder.The catheter is insertedthrough the urethra. | Catheters are intended forroutine short term drainage ofthe bladder. The catheter isinserted through the urethra. | Intended for use in patientsrequiring bladder drainage asdetermined by theirphysician. | All devices areintended for bladdercatheterizationthrough the urethra. | Self-Cath®Intermittent UrinaryCatheters do not statea usage duration. |
| Cautions | For single useDiscard after usePrescription only | For single useDiscard after usePrescription only | For single useDiscard after usePrescription only | All devices carry thesame cautions. | None. |
| Method ofSterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | All devices aresterilized by EthyleneOxide. | None. |
| Functionalconfiguration | A tube and connector withfunnel | A tube and connector withfunnel | A tube and connector withfunnel | All devices are tosame configuration. | None. |
| Subject Device | Comparison | ||||
| Parameter | GentleCath™ IntermittentUrological Catheter | Primary Predicate:GentleCath™ Male CoudéOlive Tip Intermittent UrinaryCatheter (K140953) | Secondary Predicate:Self-Cath® IntermittentUrinary Catheter (Coloplast)(K100878) | Similarities | Differences |
| Tube | PVC material with DEHTplasticizer | PVC material with DEHTplasticizer | PVC material with DEHPplasticizer | GentleCath™Intermittent UrologicalCatheter andGentleCath™ MaleCoudé Olive TipIntermittent Urinary | Materials forGentleCath™ havebeen replaced toswitch DEHPplasticizer to DEHT.The plasticizer used |
| Connector | PVC material with DEHTplasticizer and pigment | PVC material with DEHTplasticizer and pigment | PVC material with DEHPplasticizer | Catheter aremanufactured with thesame materials. | for the Self-Cath®Intermittent UrinaryCatheter is DEHP. Thesolvent and lubricant |
| Solvent | Cyclohexanone | Cyclohexanone | Unknown | used for themanufacture of Self-Cath® IntermittentUrinary Catheter isunknown. | |
| Lubricant fortip end | Pluronic RPE non-ionicsurfactant | Pluronic RPE non-ionicsurfactant | Unknown | ||
| Subject Device | Comparison | ||||
| Parameter | GentleCath™ IntermittentUrological Catheter | Primary Predicate:GentleCath™ Male CoudéOlive Tip Intermittent UrinaryCatheter (K140953) | Secondary Predicate:Self-Cath® IntermittentUrinary Catheter (Coloplast)(K100878) | Similarities | Differences |
| Length(Inches) | Male: 16"Female: 6.5" | Male: 16" | Male: 16"Female: 6"Pediatric: 10" | The length of the malecatheters available inall devices is 16". Thelength of the femalecatheters within thefor GentleCath™Intermittent UrologicalCatheter range andthe Self-Cath®Intermittent UrinaryCatheter range areboth a standard lengthfor female catheters.Lengths in compliancewith ENISO1616:1997. | The Self-Cath®Intermittent UrinaryCatheter is available ina specific 10", CH05pediatric size.GentleCath™ MaleCoudé Olive TipIntermittent Catheter isonly available as amale product. |
| French/Charrière(FR/CH)Size | Devices are delivered inCH/FR sizes from CH08 toCH18 | Devices are delivered inCH/FR sizes from CH08 toCH18 | Devices are delivered inCH/FR sizes from CH05 toCH18 | The same FR/CHrange is available forGentleCath™Intermittent UrologicalCatheter andGentleCath™ MaleCoudé Olive TipIntermittent UrinaryCatheter. | |
| Connectorcolordifferencesbetweensizes | CH08 - blueCH10 - blackCH12 - whiteCH14 - greenCH16 - orangeCH18 - red | CH08 - blueCH10 - blackCH12 - whiteCH14 - greenCH16 - orangeCH18 - red | CH08 - blueCH10 - blackCH12 - whiteCH14 - greenCH16 - orangeCH18 - red | The same colourcoding for theconnectors is appliedacross all products. | None. |
| Subject Device | Comparison | ||||
| Parameter | GentleCath™ IntermittentUrological Catheter | Primary Predicate:GentleCath™ Male CoudéOlive Tip Intermittent UrinaryCatheter (K140953) | Secondary Predicate:Self-Cath® IntermittentUrinary Catheter (Coloplast)(K100878) | Similarities | Differences |
| Cathetertube -outerdiameter(mm) | CH08 - 2.6CH10 - 3.33CH12 - 4.00CH14 - 4.67CH16 - 5.33CH18 - 6.00 | CH08 - 2.67CH10 - 3.33CH12 - 4.00CH14 - 4.67CH16 - 5.33CH18 - 6.00 | CH08 - 2.66CH10 - 3.29CH12 - 4.16CH14 - 4.65CH16 - 5.37CH18 - 5.99 | The diameters ofGentleCath™Intermittent UrologicalCatheter andGentleCath™ MaleCoudé Olive Tip | The diameters of theSelf-Cath®Intermittent UrinaryCatheter can beconsideredsubstantially |
| Cathetertube -innerdiameter(mm) | CH08 - 1.65CH10 - 2.25CH12 - 2.65CH14 - 3.25CH16 - 3.65CH18 - 4.30 | CH08 - 1.65CH10 - 2.25CH12 - 2.65CH14 - 3.25CH16 - 3.65CH18 - 4.30 | CH08 - 1.65CH10 - 2.15CH12 - 2.60CH14 - 3.10CH16 - 3.65CH18 - 4.30 | Intermittent UrinaryCatheter are thesame. | equivalent to thediameter ofGentleCath™products. |
| CatheterFlow Rate(ml/min) | 150.5 to 1403.8 ml/min | 148.7 to 1321.5 ml/min | 115.1 to 1380.7 ml/min | All products found tocomply with therequirements of ASTMF623 -99 | GentleCath™Intermittent UrologicalCatheter hasdemonstrated aslightly higher flowrate |
| CatheterTensileProperties(N) | 67.7 to 207.1 N | 60.7 to 203.3 N | 60.1 to 152.5 N | The tensile propertiesof the GentleCath™Intermittent UrinaryCatheter was found tobe comparable to thatof both predicates forthe strength of thetube and connectorattachment. | Slightly greater force isneeded fordisconnection of thetube and connector inthe subject device,GentleCath™Intermittent UrinaryCatheter. |
| Subject Device | Comparison | ||||
| Parameter | GentleCath™ IntermittentUrological Catheter | Primary Predicate:GentleCath™ Male CoudéOlive Tip Intermittent UrinaryCatheter (K140953) | Secondary Predicate:Self-Cath® IntermittentUrinary Catheter (Coloplast)(K100878) | Similarities | Differences |
| K Dimension(mm) | 4.7 to 8.4 mm | 5 to 7.9 mm | 5 to 8.1 mm | The coudé tip angle ofthe GentleCath™Intermittent UrinaryCatheter was found tobe comparable to thatof predicate devices. | The K Dimension ofsubject device andpredicate devices canbe consideredsubstantiallyequivalent. |
| Tube surface | Uncoated | Uncoated | Uncoated | All devices areuncoated catheters. | None. |
| Eyelets | Smooth eyelet edges | Smooth eyelet edges | Smooth eyelet edges | All devices havesmooth eyelet edges. | None. |
| Eyeletposition | Placed on the right and leftside if angled tip of catheteris oriented upwards. | Placed on the right and leftside if angled tip of catheter isoriented upwards. | Placed on the right and leftside if angled tip of catheter isoriented upwards. | All devices have thesame placement ofthe eyelets. | None. |
| Eyelet size -width(mm) | CH08 - 1.65CH10 - 2.25CH12 - 2.65CH14 - 3.25CH16 - 3.65CH18 - 4.30 | CH08 - 1.65CH10 - 2.25CH12 - 2.65CH14 - 3.25CH16 - 3.65CH18 - 4.30 | CH08 - 0.97CH10 - 1.09CH12 - 1.07CH14 - 1.57CH16 - 2.18CH18 - 2.67 | The dimension of theGentleCath™Intermittent UrologicalCatheter andGentleCath™ MaleCoudé Olive TipIntermittent UrinaryCatheter eyelets arethe same. | The dimension of theSelf-Cath®Intermittent UrinaryCatheter eyelets areslightly smaller thanthose of theGentleCath™products. |
| Subject Device | Comparison | ||||
| Parameter | GentleCath™ IntermittentUrological Catheter | Primary Predicate:GentleCath™ Male CoudéOlive Tip Intermittent UrinaryCatheter (K140953) | Secondary Predicate:Self-Cath® IntermittentUrinary Catheter (Coloplast)(K100878) | Similarities | Differences |
| Eyelet size -length(mm) | CH08 - 2.50CH10 - 3.40CH12 - 3.70CH14 - 4.35CH16 - 5.40CH18 - 5.90 | CH08 - 2.50CH10 - 3.40CH12 - 3.70CH14 - 4.35CH16 - 5.40CH18 - 5.90 | CH08 - 2.01CH10 - 2.89CH12 - 3.70CH14 - 4.22CH16 - 4.48CH18 - 5.03 | The dimension of theGentleCath™Intermittent UrologicalCatheter andGentleCath™ MaleCoudé Olive TipIntermittent UrinaryCatheter eyelets arethe same. | The dimension of theSelf-Cath®Intermittent UrinaryCatheter eyelets areslightly smaller thanthose of theGentleCath™products. |
| Tip end | Angled (without ball) | Angled (with ball) | Angled (without ball) | All devices include anangled tip variant. | GentleCath™ MaleCoudé Olive TipIntermittent UrinaryCatheter is the onlydevice that has a ball(Olive) at the end ofthe catheter. |
| Straight (without ball) | N/A | Straight (without ball) | The GentleCath™Intermittent UrologicalCatheter and Self-Cath® IntermittentUrinary Catheter areboth available in astraight tip variant. | The GentleCath™Male Coudé Olive TipIntermittent UrinaryCatheter is onlyavailable in an angledtip. | |
| Subject Device | Comparison | ||||
| Parameter | GentleCath™ IntermittentUrological Catheter | Primary Predicate:GentleCath™ Male CoudéOlive Tip Intermittent UrinaryCatheter (K140953) | Secondary Predicate:Self-Cath® IntermittentUrinary Catheter (Coloplast)(K100878) | Similarities | Differences |
| Coudéindicator | The connector has anindicator which shows theorientation of the coudé tipafter insertion into thebody | The connector has anindicator which shows theorientation of the coudé tipafter insertion into the body | A blue line on the tube showsthe orientation of the coudétip after insertion into thebody | The indicator onGentleCath™Intermittent UrologicalCatheter andGentleCath™ MaleCoudé Olive TipIntermittent UrinaryCatheter is on theconnector componentof the catheter. | The indicator on theSelf-Cath®Intermittent UrinaryCatheter is located onthe tube component ofthe catheter. |
| Packaging | Chevron packagecomprising medical gradepaper and film, Corrugatedboard inner. Corrugatedboard outer case. | Chevron package comprisingmedical grade paper and film,Corrugated board inner.Corrugated board outer case. | Peel pack comprises paperand film. Corrugated boardinner. Corrugated board outercase. | The same materialsare used to packagethe GentleCath™Intermittent UrologicalCatheter andGentleCath™ MaleCoudé Olive TipIntermittent UrinaryCatheter. | The Self-Cath®Intermittent UrinaryCatheter is packagedin a paper/poly peelpack but the exactmaterials areunknown. |
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§ 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.