Device Information
The GentleCath Air for Women is a sterile, single-use, intermittent urethral catheter. It uses a hydrophilic coating that activates when in contact with water. The catheter is made of Thermoplastic Elastomer (TPE) and is available in three sizes: CH10, CH12, and CH14. It is packaged in a compact, discreet carrying case for ease of use and disposal.
Indications
The GentleCath Air for Women is indicated for intermittent urinary bladder drainage in females with conditions causing urinary retention or dysfunction.
Intended Use
The device is designed for female patients who need intermittent catheterization due to urinary retention or dysfunction. It is suitable for short-term bladder drainage, typically when the patient cannot urinate independently.
Availability
This device is available by prescription only.
Study Results
- Nonclinical and Safety Testing: The device underwent various nonclinical tests, including sterilization validation (ISO 11137-1:2015), biocompatibility testing (ISO 10993-1:2018), and packaging integrity (ISO 11607-1). The results confirmed that the GentleCath Air for Women met all relevant safety standards.
Regulatory Information
- Regulation Number: 21 CFR § 876.5130
- Regulatory Class: Class II
- Product Code: EZD
- 510(k) Number: K232665
The device must comply with additional FDA regulations, such as the Quality System Regulation (21 CFR Part 820), labeling (21 CFR Part 801), and medical device reporting (21 CFR Part 803).
Manufacturer Information
- Name: ConvaTec, Ltd.
- Address: First Avenue, Deeside Industrial Park, Deeside, Flintshire CH5 2NU, United Kingdom
- Contact Person: Kim Jones
Predicate Device Information
- Primary Predicate Device: GentleCath Glide Intermittent Catheter (K181206)
- Reference Device: GentleCath Air for Men (K213283)
The predicate device is not an earlier version of the subject device. The key difference is that the predicate does not include the compact primary packaging and wetting chamber present in the GentleCath Air for Women.
Implications
The GentleCath Air for Women offers female patients a discreet, easy-to-use option for intermittent catheterization. Its design features, such as the compact carry case, aim to improve portability and usability. Its hydrophilic coating reduces friction, potentially lowering the risk of urethral damage.
References
- GentleCath Air for Women. K232665. ConvaTec, Ltd. FDA Summary: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K232665
- ConvaTec website:https://www.convatec.com/
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