(147 days)
No
The device description and performance studies focus on material properties, sterilization, packaging, and physical performance characteristics of a catheter, with no mention of AI or ML.
Yes.
The device is intended to drain the urinary bladder, which is a therapeutic intervention for conditions causing urinary retention or dysfunction.
No
The device description clearly states its purpose as "intermittent drainage of the urinary bladder," indicating a therapeutic function rather than a diagnostic one.
No
The device description clearly states it is a physical, sterile, single-use, disposable, hydrophilic, intermittent urethral catheter made of Thermoplastic Elastomer (TPE), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the intermittent drainage of the urinary bladder. This is a direct intervention on the body for therapeutic purposes (draining urine), not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The device is a physical catheter designed to be inserted into the urethra and bladder. It's a mechanical device for fluid drainage.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like urine itself for diagnostic markers), reagents, or any process related to in vitro testing.
IVD devices are typically used to test samples like blood, urine, tissue, etc., outside of the body to gain information about a person's health status. This device is used within the body for a therapeutic function.
N/A
Intended Use / 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.
Product codes
EZD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary bladder, urethra
Indicated Patient Age Range
Not Found
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 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, Irritation Sensitization and Checmical Charachterization) accodording to ISO-10993-1:2018 and FDA Guidance "Use of International Standards ISO 10993-1" 2020 Sterile packaging in accordance with ISO-11607-1: 2019 and 11607-2:2019 Accelerated Real Time aged shelf-life testing according to ASTM F1980-16 Performance testing of Shipper Containers and Systems according to ASTM D4169-22 Package integrity testing according to ASTM F2096-11 Tensile testing performed in accordance with ISO 20696:2018 Flow Rate testing performed in accordance with ISO 20696:2018 Coefficient of friction according to ASTM D1894:2014
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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
1
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.
2
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
3
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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4
510(k) Summary
| Date Prepared | 24-Jan-2024 |
|---|---|
| Submitter | ConvaTec, Ltd. |
| First Avenue | |
| Deeside Industrial Park | |
| Deeside | |
| Flintshire CH5 2NU | |
| Contact person | Kim Jones |
| +44 7590333564 | |
| kim.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 device |
| GentleCath 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, Irritation | |
| Sensitization and Checmical Charachterization) accodording | |
| to ISO-10993-1:2018 and FDA Guidance "Use of | |
| International Standards ISO 10993-1" 2020 Sterile packaging in accordance with ISO-11607-1: 2019 | |
| and 11607-2:2019 Accelerated Real Time aged shelf-life testing according to | |
| ASTM F1980-16 Performance testing of Shipper Containers and Systems | |
| according to ASTM D4169-22 Package integrity testing according to ASTM F2096-11 Tensile testing performed in accordance with ISO | |
| 20696:2018 Flow Rate testing performed in accordance with ISO | |
| 20696:2018 Coefficient of friction according to ASTM D1894:2014 | |
| Technological Comparison | Hydrophilic Intermittent Urinary Catheters is the intended |
| technological principle for both the subject and predicate devices. It is | |
| based on the use to provide an intermittent pathway for the drainage of | |
| urine from the urinary bladder. The catheter is inserted through the | |
| urethra | |
| At 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 via | |
| the urethra Hydrophilic catheter Catheter tube has rounded tip and | |
| rounded eyelets a All materials biocompatible for contact with the urethra and | |
| urine over cumulative use GentleCath Air for Men (reference) and GentleCath Air for | |
| Women (subject) are sterilized by X-ray Single Use | |
| The following technological difference exists between the subject and | |
| the predicate devices: A sterile 'Air Case' that houses the catheter, funnel and | |
| wetting mechanism Discreet disposal Wetting chamber which wets catheter surface on withdrawal compact primary pack designed to look like a cosmetic | |
| product The differences in technological characteristics do not raise different | |
| questions of safety and effectiveness. |
5
6
| Conclusion | The data information provided in this submission support the
conclusion that GentleCath Air for Women (K232665) is substantially
equivalent in safety and performance to the predicate device
(K181206). |
| ------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
7
| 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 urinary | |||
| bladder of females who need | ||||
| assistance with drainage due to | ||||
| conditions causing urinary retention | ||||
| or dysfunction of the urinary system. | Intermittent drainage of the urinary | |||
| bladder of those who need assistance | ||||
| with drainage due to conditions | ||||
| causing urinary retention or | ||||
| dysfunction of the urinary system | Intermittent drainage of the urinary | |||
| bladder of adults who need | ||||
| assistance with drainage due to | ||||
| conditions causing urinary retention | ||||
| or dysfunction of the urinary system. | Same. | |||
| The subject device is indicated for | ||||
| use in females. The predicate device | ||||
| and reference device are indicated | ||||
| for 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 not | ||||
| raise different questions of safety and | ||||
| effectiveness than the predicate | ||||
| device. | ||||
| Effective Length | 90mm | 140mm | 140mm | Substantially equivalent. |
| The difference in catheter length | ||||
| does not raise different questions of | ||||
| safety and effectiveness than the | ||||
| predicate device. | ||||
| Catheter Tube | ||||
| Outer Diameter | ||||
| (mm) | CH10 3.3 | |||
| CH12 4.0 | ||||
| CH14 4.7 | CH10 3.3 | |||
| CH12 4.0 | ||||
| CH14 4.7 | CH10: 3.3 | |||
| CH12: 4.0 | ||||
| CH14: 4.7 | Same. | |||
| *The predicate and reference device | ||||
| include 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 device | ||||
| include 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 water | |||
| reservoir | Pouch with water sachet | Pouch with water sachet | Substantially equivalent. | |
| The packaging difference does not | ||||
| raise different questions of safety and | ||||
| effectiveness than the predice device | ||||
| Sterilization | X-Ray | |||
| SAL: 10-6 | Ethylene Oxide | |||
| SAL: 10-6 | X-Ray | |||
| SAL: 10-6 | Substantially equivalent. | |||
| The subject device uses the same | ||||
| sterilization method as the reference | ||||
| device |
8