(147 days)
Intermittent drainage of the urinary bladder of females who need assistance with drainage due to conditions causing urinary retention or dysfunction of the urinary system.
GentleCath Air for Women is a sterile, single use, disposable, hydrophilic, intermittent urethral catheter. A urethral catheter is a tubular device intended for being introduced into the urinary bladder through the urethra in order to provide drainage of the bladder. The catheter tube is made using Thermoplastic Elastomer (TPE) with a hydrophilic additive in the base material which when wetted activates and lubricates the catheter. GentleCath Air for Women is designed for portability, ease of use and discreet disposal. Catheters are individually packed and are wetted ready for use upon removal from the case. Catheters are available in the following product sizes: CH10, 12, and 14.
This document describes the GentleCath Air for Women intermittent urinary catheters (CH10, CH12, CH14). The information provided is from a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, the details about specific acceptance criteria and the study proving it are largely in reference to a comparison with established standards and the predicate device.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a direct table of specific acceptance criteria with corresponding performance metrics like a typical medical device performance study would. Instead, it refers to performance testing conducted per applicable sections of voluntary and FDA consensus standards. The "Performance Data" section lists the types of testing performed and the standards used, indicating that the device met the requirements of these standards.
Here's a summary of the performance testing categories and the standards referenced, which imply the acceptance criteria are adherence to these standards:
| Acceptance Criteria (Implied by Standard) | Reported Device Performance (Implied adherence to Standard) |
|---|---|
| Sterilization Validation (Dose) | Performed and met requirements (no specific value given). |
| Biocompatibility (Cytotoxicity, Irritation, Sensitization, Chemical Characterization) | According to ISO-10993-1:2018 and FDA Guidance "Use of International Standards ISO 10993-1" 2020. Met requirements. |
| Sterile Packaging | According to ISO-11607-1:2019 and 11607-2:2019. Met requirements. |
| Accelerated Real-Time Aged Shelf-Life Testing | According to ASTM F1980-16. Met requirements. |
| Performance Testing of Shipper Containers and Systems | According to ASTM D4169-22. Met requirements. |
| Package Integrity Testing | According to ASTM F2096-11. Met requirements. |
| Tensile Testing | According to ISO 20696:2018. Met requirements. |
| Flow Rate Testing | According to ISO 20696:2018. Met requirements. |
| Coefficient of Friction | According to ASTM D1894:2014. Met requirements. |
| Sterility Assurance Level (SAL) | 10⁻⁶ (for both subject and X-ray sterilized reference device) |
2. Sample size used for the test set and the data provenance
The document does not provide specific sample sizes for any of the performance tests. It lists the types of tests performed and the standards followed, implying that the sample sizes were appropriate for those standards.
The provenance of the data is not explicitly stated as "country of origin" or "retrospective/prospective." However, the submission is from "ConvaTec, Ltd., First Avenue, Deeside Industrial Park, Deeside, Flintshire CH5 2NU, United Kingdom," suggesting the testing was likely conducted in or overseen by this entity.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information (expert review for truth establishment) is not present in the provided document, as it pertains to device performance testing against engineering and biological standards, not diagnostic interpretation.
4. Adjudication method for the test set
Not applicable, as this is related to expert review of diagnostic cases, which is not the focus of this 510(k) submission.
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
Not applicable. This device is an intermittent urinary catheter and does not involve AI or human "readers" or diagnostic interpretation in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this device does not involve an algorithm.
7. The type of ground truth used
The "ground truth" for the device's performance is established by adherence to the referenced international and FDA consensus standards. For example, for biocompatibility, the ground truth is defined by the criteria within ISO-10993-1. For flow rate, the "ground truth" is meeting the specified flow rate limits of ISO 20696.
8. The sample size for the training set
Not applicable. This device is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
January 25, 2024
ConvaTec Kim Jones Senior Regulatory Affairs Specialist First Avenue, Deeside Industrial Park Deeside Flintshire, CH5 2NU United Kingdom
Re: K232665
Trade/Device Name: GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZD Dated: December 26, 2023 Received: December 26, 2023
Dear Kim 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 (the 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 available 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
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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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product: and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica K. Nguyen -S
Jessica K. Nguyen, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
GentleCath Air for Women (CH10); GentleCath Air for Women (CH12);
GentleCath Air for Women (CH14)
Indications for Use (Describe)
Intermittent drainage of the urinary bladder of females who need assistance with drainage due to conditions causing urinary retention or dysfunction of the urinary system.
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)
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510(k) Summary
| Date Prepared | 24-Jan-2024 |
|---|---|
| Submitter | ConvaTec, Ltd.First AvenueDeeside Industrial ParkDeesideFlintshire CH5 2NU |
| Contact person | Kim Jones+44 7590333564kim.jones@convatec.com |
| Name of Device | GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) |
| Common Name | Catheter, Straight |
| Product Code | EZD |
| Classification | Class II |
| Regulation Number | 21 CFR 876.5130 |
| Regulation Name | Urological catheter and accessories. |
| Primary Predicate Device | GentleCath Glide Intermittent Catheter (K181206) |
| Recalls | No design related recalls have been submitted for the predicate deviceGentleCath Glide (K181206) |
| Purpose of Submission | New Submission |
| Device Description | GentleCath Air for Women is a sterile, single use, disposable, hydrophilic, intermittent urethral catheter. A urethral catheter is a tubular device intended for being introduced into the urinary bladder through the urethra in order to provide drainage of the bladder. The catheter tube is made using Thermoplastic Elastomer (TPE) with a hydrophilic additive in the base material which when wetted activates and lubricates the catheter. GentleCath Air for Women is designed for portability, ease of use and discreet disposal. Catheters are individually packed and are wetted ready for use upon removal from the case. Catheters are available in the following product sizes: CH10, 12, and 14. |
| Indications for Use | Intermittent drainage of the urinary bladder of females who need assistance with drainage due to conditions causing urinary retention or dysfunction of the urinary system. |
| Performance Data | Performance testing for GC Air for Women was conducted per applicable sections of voluntary and FDA consensus standards.Sterilization Validation was performed by conducting dose |
| Biocompatibilituy testing (cytotoxicity, IrritationSensitization and Checmical Charachterization) accodordingto ISO-10993-1:2018 and FDA Guidance "Use ofInternational Standards ISO 10993-1" 2020 Sterile packaging in accordance with ISO-11607-1: 2019and 11607-2:2019 Accelerated Real Time aged shelf-life testing according toASTM F1980-16 Performance testing of Shipper Containers and Systemsaccording to ASTM D4169-22 Package integrity testing according to ASTM F2096-11 Tensile testing performed in accordance with ISO20696:2018 Flow Rate testing performed in accordance with ISO20696:2018 Coefficient of friction according to ASTM D1894:2014 | |
| Technological Comparison | Hydrophilic Intermittent Urinary Catheters is the intendedtechnological principle for both the subject and predicate devices. It isbased on the use to provide an intermittent pathway for the drainage ofurine from the urinary bladder. The catheter is inserted through theurethraAt a high level GentleCath Glide (predicate), GentleCath Air for Men(reference) and GentleCath Air for Women (subject).Are based on the following same technological elements: Indications for Use To drain the bladder on an intermittent basis as required viathe urethra Hydrophilic catheter Catheter tube has rounded tip androunded eyelets a All materials biocompatible for contact with the urethra andurine over cumulative use GentleCath Air for Men (reference) and GentleCath Air forWomen (subject) are sterilized by X-ray Single Use |
| The following technological difference exists between the subject andthe predicate devices: A sterile 'Air Case' that houses the catheter, funnel andwetting mechanism Discreet disposal Wetting chamber which wets catheter surface on withdrawal compact primary pack designed to look like a cosmeticproduct The differences in technological characteristics do not raise differentquestions of safety and effectiveness. |
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| Conclusion | The data information provided in this submission support theconclusion that GentleCath Air for Women (K232665) is substantiallyequivalent in safety and performance to the predicate device(K181206). |
|---|---|
| ------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| escription | Subject Device | Primary Predicate Device | Reference Device | Comparison |
|---|---|---|---|---|
| Name | GentleCath Air for Women | GentleCath Glide | GentleCath Air for Men | N/A |
| Manufacturer | Convatec | Convatec | Convatec | Same |
| 510(k) Clearance | Subject of this submission | K181206 | K213283 | N/A |
| Prescription/Over- the-Counter Use | Prescription Use | Prescription Use | Prescription Use | Same |
| Product Code | EZD | GBM | GBM | Same |
| Classification Regulation | 876.5130 - Urological catheter and accessories | 876.5130 - Urological catheter and accessories | 21 CFR 876.5130 - Urological catheter and accessories | Same |
| Classification | II | II | II | Same |
| Indications for Use | Intermittent drainage of the urinarybladder of females who needassistance with drainage due toconditions causing urinary retentionor dysfunction of the urinary system. | Intermittent drainage of the urinarybladder of those who need assistancewith drainage due to conditionscausing urinary retention ordysfunction of the urinary system | Intermittent drainage of the urinarybladder of adults who needassistance with drainage due toconditions causing urinary retentionor dysfunction of the urinary system. | Same.The subject device is indicated foruse in females. The predicate deviceand reference device are indicatedfor use in females and males. |
| Tube Material | Hydrophilic TPE | Hydrophilic TPE | Hydrophilic TPE | Same |
| Funnel Material | HDPE + EVA | PVC + DEHT | PVC + DEHT | Substantially equivalent.The material difference does notraise different questions of safety andeffectiveness than the predicatedevice. |
| Effective Length | 90mm | 140mm | 140mm | Substantially equivalent.The difference in catheter lengthdoes not raise different questions ofsafety and effectiveness than thepredicate device. |
| Catheter TubeOuter Diameter(mm) | CH10 3.3CH12 4.0CH14 4.7 | CH10 3.3CH12 4.0CH14 4.7 | CH10: 3.3CH12: 4.0CH14: 4.7 | Same.*The predicate and reference deviceinclude additional catheter tube outer diameters. |
| Eyelets | 2 Smooth eyelets on opposite sides | 2 Smooth eyelets on opposite sides | 2 Smooth eyelets on opposite sides | Same |
| Tip Type | Straight / Nelaton | Straight / Nelaton | Straight / Nelaton | Same.*The predicate and reference deviceinclude additional catheter tip types. |
| Use Type | Single use | Single use | Single use | Same |
| escription | Subject Device | Primary Predicate Device | Reference Device | Comparison |
| Primary Packaging | Discreet carry housing with waterreservoir | Pouch with water sachet | Pouch with water sachet | Substantially equivalent.The packaging difference does notraise different questions of safety andeffectiveness than the predice device |
| Sterilization | X-RaySAL: 10-6 | Ethylene OxideSAL: 10-6 | X-RaySAL: 10-6 | Substantially equivalent.The subject device uses the samesterilization method as the referencedevice |
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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.