(101 days)
Not Found
No
The description focuses on the physical properties and function of a urological catheter, with no mention of AI or ML.
No.
Explanation: A therapeutic device is used to treat a disease or condition. This device is a catheter used for routine drainage of the bladder, which is a supportive function rather than a direct treatment for a disease.
No.
The device is described as an intermittent catheter used for drainage of the bladder, which is a therapeutic function, not diagnostic.
No
The device description clearly states it is a flexible tubular device made of TPE, which is a physical material, and describes its physical characteristics and function for draining the bladder. This is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Function: The description clearly states the device is an intermittent catheter used for the physical drainage of the bladder. It is inserted into the body through the urethra to facilitate the flow of urine.
- No Mention of Testing Samples: There is no indication that this device is used to analyze or test urine or any other bodily fluid for diagnostic purposes. Its function is purely mechanical drainage.
Therefore, the device described is a therapeutic/drainage device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Intermittent Catheters are indicated for routine transient intermittent drainage of the bladder. The cather is inserted through the urethra.
Product codes (comma separated list FDA assigned to the subject device)
GBM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urethra, Bladder
Indicated Patient Age Range
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)).
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing - Bench, 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
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
See PRA Statement below.
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3
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
4
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)).
5
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.
6
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 | |||||
| Urinary Catheter | ||||||
| Subject Device | Primary Predicate | |||||
| GentleCath Glide Intermittent | ||||||
| Urinary Catheter | Predicate 2 | |||||
| Teleflex: Rüsch FloCath Quick | Predicate 3 | |||||
| Wellspect: Lo-Fric Primo | Similarities | Differences | ||||
| FDA Product | ||||||
| Code | GBM | GBM | KOD | GBM | GentleCath Glide and | |
| FloCath Quick have | ||||||
| been classified as | ||||||
| urological catheters. | Lo-Fric Primo has | |||||
| been classified as a | ||||||
| urethral catheter. | ||||||
| FDA | ||||||
| Classification | ||||||
| Regulation | 21 CFR 876.5130 | 21 CFR 876.5130 | 21 CFR 876.5130 | 21 CFR 876.5130 | All devices are the | |
| same | None | |||||
| Regulatory | ||||||
| Class | Class II | Class II | Class II | Class II | All devices are the | |
| same | None | |||||
| Device | ||||||
| description | A hydrophilic urinary catheter | |||||
| is a flexible tubular device that | ||||||
| is inserted through the urethra | ||||||
| and used to pass fluids from | ||||||
| the bladder. It includes a | ||||||
| substance that makes the | ||||||
| surface slippery when it | ||||||
| comes into contact with water. | ||||||
| The catheter is provided | ||||||
| together with a sterile water | ||||||
| sachet for lubrication | A hydrophilic urinary catheter is | |||||
| a flexible tubular device that is | ||||||
| inserted through the urethra and | ||||||
| used to pass fluids from the | ||||||
| bladder. It includes a substance | ||||||
| that makes the surface slippery | ||||||
| when it comes into contact with | ||||||
| water. The catheter is provided | ||||||
| together with a sterile water | ||||||
| sachet for lubrication | The Rüsch FloCath catheter | |||||
| consists of a tubular PVC shaft | ||||||
| with attached drainage funnel. | ||||||
| The catheter is designed with a | ||||||
| Nelaton, Olive or Tiemann tip. | ||||||
| There are two drainage eyes in | ||||||
| various configurations (straight | ||||||
| through, staggered, vertical | ||||||
| orientated). This device shaft | ||||||
| may be uncoated or Hydrogel / | ||||||
| Hydrophilic coated. The coating | ||||||
| has been tested for both its | ||||||
| safety and function. | The LoFric Primo Single Use | |||||
| Urinary Catheter is designed as | ||||||
| an intermittent pathway for | ||||||
| drainage of the bladder. The | ||||||
| device consists of a catheter, | ||||||
| coated with a hydrophilic low- | ||||||
| friction coating. | ||||||
| The surface is hydrophilic and | ||||||
| when the catheter is activated | ||||||
| with the water integrated in the | ||||||
| package, it becomes slippery | ||||||
| and ready to use. | ||||||
| The catheter is provided in a | ||||||
| variety of lengths and sizes. | ||||||
| The catheter and the activation | ||||||
| water is separated, sealed in | ||||||
| one bag. | ||||||
| By holding the product upright | ||||||
| and exerting a light pressure on | ||||||
| the folded water pocket, the | ||||||
| water will run down and wet the | All devices are | |||||
| developed around the | ||||||
| same basic design of | ||||||
| a tube with a funnel | ||||||
| and two drainage | ||||||
| eyes. With surface | ||||||
| properties that | ||||||
| become hydrophilic | ||||||
| when wet. | GentleCath Glide | |||||
| contains an additive | ||||||
| within the base | ||||||
| material while both | ||||||
| FloCath Quick and | ||||||
| Lo-Fric Primo have | ||||||
| a coating. |
7
| | | catheter. The bag is opened
and the catheter is inserted into
the patient's urethra | | |
| -- | -- | ------------------------------------------------------------------------------------------- | -- | -- |
|---|
| Subject Device | Comparison | ||||||
|---|---|---|---|---|---|---|---|
| Parameter | GentleCath Glide Intermittent | ||||||
| Urinary Catheter | Primary Predicate | ||||||
| GentleCath Glide Intermittent | |||||||
| Urinary Catheter | Predicate 1 | ||||||
| Teleflex: Rüsch FloCath Quick | Predicate 2 | ||||||
| Wellspect: Lo-Fric Primo | Similarities | Differences | |||||
| Intended use / | |||||||
| Indication for | |||||||
| Use | Intermittent catheters are | ||||||
| indicated for routine transient | |||||||
| drainage of the bladder. The | |||||||
| catheter is inserted through | |||||||
| the urethra. | |||||||
| For adult use only. | Intermittent catheters are | ||||||
| indicated for routine transient | |||||||
| drainage of the bladder. The | |||||||
| catheter is inserted through | |||||||
| the urethra. | Rüsch FloCath catheter is | ||||||
| flexible tubular device that is | |||||||
| inserted through the urethra and | |||||||
| is used to pass fluids to or from | |||||||
| urinary tracts | The LoFric Primo Single Use | ||||||
| Urinary Catheter is intended for | |||||||
| intermittent catheterization of the | |||||||
| urethra | All devices are | ||||||
| intended for bladder | |||||||
| catheterization | |||||||
| through the urethra | GentleCath Glide | ||||||
| does not include the | |||||||
| intended use of | |||||||
| administration of fluids | |||||||
| to the bladder, unlike | |||||||
| FloCath does | |||||||
| Cautions | Single use | ||||||
| Prescription only | Single use | ||||||
| Prescription only | Single use | ||||||
| Prescription only | Single use | ||||||
| Prescription only | All devices are the | ||||||
| same | None | ||||||
| Tube Material | POBE | POBE | DEHP-free PVC | POBE | The base material of | ||
| GentleCath Glide is | |||||||
| the same as LoFric | |||||||
| Primo | FloCath Quick has a | ||||||
| different base material | |||||||
| to GentleCath Glide | |||||||
| and LoFric Primo | |||||||
| Coating/ | |||||||
| additive | Additive compounded into the | ||||||
| base material | Additive compounded into the | ||||||
| base material | PVP (polyvinyl pyrrolidone) | PVP (polyvinyl pyrrolidone) and | |||||
| sodium chloride | All three devices have | ||||||
| surface properties that | |||||||
| become hydrophilic | |||||||
| and slippery when | |||||||
| wet. | The addition of the | ||||||
| additive is a different | |||||||
| way of achieving a | |||||||
| hydrophilic surface | |||||||
| from the PVP coating. | |||||||
| Biocompatibility | |||||||
| studies of the device | |||||||
| conclude that the | |||||||
| material compound is | |||||||
| safe for the intended | |||||||
| use. |
8
| Connector
Material | PVC + DEHT | PVC + DEHT | DEHP-free PVC | POBE | All three connectors
are similar in design. | The exact material
composition of
competitor products
unknown to ConvaTec
however, GentleCath
Glide funnel is exactly
the same as marketed
GentleCath male
Olive tip K140953 |
|-----------------------|-------------------------------|-------------------------------|---------------|---------|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Glue for
assembly | Loctite (UV acrylic adhesive) | Loctite (UV acrylic adhesive) | Not known | Loctite | The glue used to
produce LoFric Primo
and GentleCath Glide
products is exactly the same. | The assembly method
used for FloCath
Quick is not known to
ConvaTec |
| Subject Device | Comparison | |||||
|---|---|---|---|---|---|---|
| Parameter | GentleCath Glide Intermittent | |||||
| Urinary Catheter | Primary Predicate | |||||
| GentleCath Glide Intermittent | ||||||
| Urinary Catheter | Predicate 1 | |||||
| Teleflex: Rüsch FloCath Quick | Predicate 2 | |||||
| Wellspect: Lo-Fric Primo | Similarities | Differences | ||||
| Biocompatibility | ISO 10993-1, Biological | |||||
| evaluation of medical devices | ||||||
| – Part 1: Evaluation and | ||||||
| testing within a risk | ||||||
| management process- | ||||||
| Guidance for Industry and | ||||||
| Food and Drug Administration | ||||||
| Staff". | ||||||
| Cytotoxicity ISO 10993-5 | ||||||
| Sensitization ISO10993-10 | ||||||
| Skin Irritation ISO10993-10 | ||||||
| Genotoxicity ISO10993-3 | ||||||
| Subchronic Toxicity ISO | ||||||
| 10993-11 | ||||||
| EtO sterilization residuals ISO | ||||||
| 10993-7 | ISO 10993-1, Biological | |||||
| evaluation of medical devices - | ||||||
| Part 1: Evaluation and testing | ||||||
| within a risk management | ||||||
| process- Guidance for Industry | ||||||
| and Food and Drug | ||||||
| Administration Staff". | ||||||
| Cytotoxicity ISO 10993-5 | ||||||
| Sensitization ISO10993-10 | ||||||
| Skin Irritation ISO10993-10 | ||||||
| Genotoxicity ISO10993-3 | ||||||
| Subchronic Toxicity ISO 10993-11 | ||||||
| EtO sterilization residuals ISO | ||||||
| 10993-7 | Not known | Not known | The exact | |||
| biocompatibility | ||||||
| tests performed on | ||||||
| FloCath Quick and | ||||||
| LoFric Primo are not | ||||||
| known to Convatec. | ||||||
| GentleCath Glide is | ||||||
| tested in | ||||||
| compliance with | ||||||
| ISO 10993-1:2009 | ||||||
| for surface devices | ||||||
| in contact with | ||||||
| mucosal membrane | ||||||
| for a limited time | ||||||
| period. Genotoxicity | ||||||
| and subchronic | ||||||
| toxicity are also | ||||||
| included due to the | ||||||
| prolonged use some | ||||||
| patients may be | ||||||
| exposed to | Not Known |
9
| | | | | | | overtime.
Biocompatibility
studies of the
device conclude
that the material
compound is safe
for the intended use | |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Principal of
operation –
short
description of
use | Squeeze water pocket
Peel pack open
Insert catheter
Empty bladder
Withdraw catheter
Dispose device | Squeeze water pocket
Peel pack open
Insert catheter
Empty bladder
Withdraw catheter
Dispose device | Squeeze water pocket
Hang and let soak for 30sec
Peel pack open
Insert catheter
Empty bladder
Withdraw catheter
Dispose device | Unfold pack
Squeeze water pocket
Hang and let soak for 30sec
Peel pack open
Insert catheter
Empty bladder
Withdraw catheter
Dispose device | Principal of
operation is similar
for all three devices | GentleCath Glide does
not require soaking
before use | |
| Length
(mm) | Male: 405mm
Female: 150-200mm | Male: 405mm
Female: 150-200mm | Male: 400mm
Female: 200mm
Pediatric: 300mm | Male: 400mm
Female: 200mm / 150mm
Pediatric: 200mm | Catheter lengths all
comply with the
requirements of
EN1616:1997
Sterile Urethral
Catheters for Single
Use, Table 1. Shaft
dimensions | Some differences in
length between the
products, but all in
compliance with
EN1616:1997 Sterile
Urethral Catheters for
Single Use, Table 1.
Shaft dimensions. | |
| Parameter | Subject Device | Comparison | ||||
|---|---|---|---|---|---|---|
| GentleCath Glide Intermittent | ||||||
| Urinary Catheter | Primary Predicate | |||||
| GentleCath Glide Intermittent | ||||||
| Urinary Catheter | Predicate 1 | |||||
| Teleflex: Rüsch FloCath Quick | Predicate 2 | |||||
| Wellspect: Lo-Fric Primo | Similarities | Differences | ||||
| FR Size | Male: CH08-CH18 | |||||
| Female: CH08-CH16 | Male: CH10-CH16 | |||||
| Female: CH10-CH16 | Male: CH08-CH20 | |||||
| Female: CH08-CH20 | ||||||
| Pediatric: CH06-CH10 | Male: CH08-CH18 | |||||
| Female: CH08-CH18 | ||||||
| Pediatric: CH06-CH10 | All sizes of | |||||
| GentleCath Glide | ||||||
| are included within | ||||||
| the ranges of the | ||||||
| predicate devices | Predicate devices have | |||||
| a bigger size range. | ||||||
| Additional catheter sizes | ||||||
| will be added to the | ||||||
| GentleCath Glide | ||||||
| product range in the | ||||||
| future. |
10
| Connector
color
indicating size | CH08: Blue
CH10: Black
CH12: White
CH14: Green
CH16: Orange
CH18: Red | CH10: Black
CH12: White
CH14: Green
CH16: Orange | CH06: green
CH08: Blue
CH10: Black
CH12: White
CH14: Green
CH16: Orange
CH18: Red
CH20: Yellow | CH06: green
CH08: Blue
CH10: Black
CH12: White
CH14: Green
CH16: Orange
CH18: Red | Connector colour
coding all comply
with ISO 8836:2014
Suction catheters
for use in the
respiratory tract | None |
|---------------------------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Catheter tube
-outer
diameter
(mm) | CH08: 2.67
CH10: 3.33
CH12: 4.00
CH14: 4.67
CH16: 5.33
CH18: 6.00 | CH10: 3.33
CH12: 4.00
CH14: 4.67
CH16: 5.33 | CH06: 2.00
CH08: 2.67
CH10: 3.33
CH12: 4.00
CH14: 4.67
CH16: 5.33
CH18: 6.00 | CH06: 2.00
CH08: 2.67
CH10: 3.33
CH12: 4.00
CH14: 4.67
CH16: 5.33
CH18: 6.00 | Catheter outer
diameters all
comply with the
requirements of
EN1616:1997
Sterile Urethral
Catheters for Single
Use. | Predicate devices have
a bigger size range.
Additional catheter sizes
will be added to the
GentleCath Glide
product range in the
future. |
| Eyelets | Smooth eyelet | Smooth eyelet | Gently rounded catheter eyes
which are vertically cut and
heat polished | Smooth catheter eyes | All three eyelets are
similar in design. | None |
| Eyelet position | Staggered | Staggered | Staggered | Staggered | All three eyelets are
similar in design. | None |
| Subject Device | Comparison | |||||
|---|---|---|---|---|---|---|
| Parameter | GentleCath Glide Intermittent | |||||
| Urinary Catheter | Primary Predicate | |||||
| GentleCath Glide Intermittent | ||||||
| Urinary Catheter | Predicate 1 | |||||
| Teleflex: Rüsch FloCath Quick | Predicate 2 | |||||
| Wellspect: Lo-Fric Primo | Similarities | Differences | ||||
| Tip types in | ||||||
| range | Nelaton | |||||
| Tiemann/Coude | Nelaton | Nelaton | ||||
| Tiemann/Coude | Nelaton | |||||
| Tiemann/Coude | All three product | |||||
| ranges include the | ||||||
| same tip shapes | None | |||||
| No-touch | ||||||
| functionality | Sleeve | Sleeve | Sleeve | Sleeve | GentleCath Glide is | |
| similar to FloCath | ||||||
| Quick | LoFric primo is | |||||
| different in that the | ||||||
| sleeve is part of the | ||||||
| packaging and not a | ||||||
| standalone accessory |
11
| Liquid for
wetting | Sterile water | Sterile water | 0.9% Sterile saline solution | Sterile water | GentleCath Glide is
similar to LoFric
Primo | GentleCath Glide is
different from FloCath
Quick |
|--------------------------|---------------------------------------|---------------------------------------|---------------------------------------|------------------------------------------------------|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sticky-dot | Double sided adhesive dot | Double sided adhesive dot | Double sided adhesive dot | Glue blob | GentleCath Glide is
similar to FloCath
Quick | LoFric Primo is
different in that the
sticky dot is a glue dot. |
| Primary
packaging | Paper and film peel pack | Paper and film peel pack | Paper and film peel pack | Polyethylene with a
PET/PE/Aluminium water sachet | GentleCath Glide is
similar to FloCath
Quick | LoFric Primo is different
in that its primary
packaging is made from
polyethylene. |
| Secondary
packaging | Corrugated board, Box
quantity: 30 | Corrugated board, Box quantity:
30 | Corrugated board, Box
quantity: 30 | Corrugated board, Box quantity: 30 | All three product are
packed in similar
boxes | None |
| Shipper
case | Corrugated board | Corrugated board | Corrugated board | Corrugated board | All three product are
packed in similar
shipper | None |
| Sterilization
process | EO | EO | EO | Radiation | GentleCath Glide is
similar to FloCath
quick | LoFric primo uses a
different primary
sterilization method. |
| Shelf life | 18 months | 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. |