GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter

K213283 · Convatec Limited · GBM · Jun 22, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K213283
• Device Name: GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter
• Applicant: Convatec Limited
• Product Code: GBM · Gastroenterology, Urology
• Decision Date: Jun 22, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To provide an intermittent pathway for drainage of fluids from the urinary bladder. The catheter is inserted through the urethra.

Device Story

Sterile, single-use, hydrophilic, intermittent urethral catheter for male adults. Input: manual activation by user (bursting internal sterile water sachet to lubricate hydrophilic coating). Operation: user inserts flexible TPE tube through urethra into bladder to drain urine; handling sleeve minimizes direct contact. Output: intermittent bladder drainage. Used in home or clinical settings by patients (including those with minimal dexterity impairment) or caregivers. Benefits: portability, ease of use, discreet disposal, and reduced residue via FeelClean technology.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility (ISO 10993-1), sterilization validation (ISO 11137-1), packaging integrity (ISO 11607, ASTM F2096), shelf-life (ASTM F1980), shipping container performance (ASTM D4169), and mechanical performance (flow rate, tensile testing, coefficient of friction per ISO 20696 and ASTM D1894).

Technological Characteristics

Materials: TPE tube (hydrophilic additive), PVC/DEHT funnel. Dimensions: 405mm length, CH08-CH18 sizes. Principle: Hydrophilic lubrication via sterile water sachet. Sterilization: X-Ray irradiation (SAL 10^-6). Connectivity: None. Software: None.

Indications for Use

Indicated for intermittent drainage of the urinary bladder of adults (including transitional adolescents B, 18-22 years) who need assistance with drainage due to conditions causing urinary retention or dysfunction of the urinary system.

Regulatory Classification

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).

Predicate Devices

• GentleCath Glide Intermittent Catheter (K181206)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 22, 2022

ConvaTec Limited Louise Hollywood Principal Regulatory Affairs Specialist GDC, First Avenue, Deeside industrial Park Deeside, Flintshire CH5 2NU United Kingdom

Re: K213283

> Trade/Device Name: GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: GBM Dated: May 11, 2022 Received: May 23, 2022

Dear Louise Hollywood:

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. 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.

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For 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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Expiration Date: 06/30/2023

See PRA Statement below.

Form Approved: OMB No. 0910-0120

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known)

K213283

Device Name

GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter

Indications for Use (Describe)

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

The target population for GC Air for Men is male adults and includes Transitional Adolescents B (18 year old to less than 22 years old but treated like adult).

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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FORM FDA 3881 (6/20)

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Image /page/3/Picture/1 description: The image shows the logo for Convatec. The logo consists of a purple abstract shape on the left and the word "convatec" in purple on the right. Below the word "convatec" is the phrase "- forever caring -" in a smaller font.

# Section 5 Traditional 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92 (c).

- Submitted bv: ConvaTec Limited. GDC, First Avenue Deeside Industrial Park Deeside Flintshire CH5 2NU UK
- Contact Person: Louise Hollywood Principle Regulatory Affairs Specialist ConvaTec Ltd. GDC, First Avenue, Deeside industrial Park Deeside, Flintshire, CH5 2NU, UK [e-mail] Tel: [phone]
- Date of Summary: 22 June 2022
- Trade Name: GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter
- Common Name: Catheter, urethral
- Regulation Name: Urological Catheter and accessories
- Regulation Number: 21 CFR 876.5130
- Classification: Class II
- Product Code: GBM (catheter, urethral)
- Panel: Gastroenterology and Urology
- Predicate Device: GentleCath Glide Intermittent Catheter, K181206 The predicate device has not been subject to a design related recall

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Image /page/4/Picture/1 description: The image shows the logo for Convatec. The logo consists of a circular graphic on the left and the word "convatec" on the right. The graphic is a stylized representation of a sphere surrounded by curved shapes in shades of pink and purple. Below the word "convatec" is the tagline "- forever caring -" in a smaller font.

- GC Air for Men is a sterile, single use, disposable, hydrophilic, Device Description: intermittent, urethral catheter. It is designed for portability, ease of use and discreet disposal, with FeelClean™ technology for superior comfort and less sticky residue. The catheter comprises of a flexible tube and color-coded funnel, both made from plastic materials (Polyvinyl Chloride; PVC). 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.
Catheters are individually packed into a sealed foil primary pouch along with a sterile (E-Beam) water sachet and handling sleeve, prior to secondary and tertiary packing and sterilization by X-Ray irradiation. The water sachet is provided for wetting of the hydrophilic surface and is burst at the point of use. The handling sleeve is provided to minimize touching the catheter shaft directly during insertion and retraction. The following product sizes and tips are available:

- · Size: CH08/10/12/14/10/16/18
- · Tips: Nelaton/straight or Coudè /Tiemann
- · Effective Length: 405mm

Intended use: To provide an intermittent pathway for drainage of fluids from the urinary bladder. The catheter is inserted through the urethra.

## Indication for Use

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.

### The Intended use population

Adult males who need assistance with bladder drainage due to conditions causing dysfunction of the urinary system.

The target population for GC Air for men is male adults and includes Transitional Adolescents B (18-year-old to less than 22 years old but treated like adult). The selection of the CH size of the catheter is based on the size of the patient and is prescribed by a health care professional. The length of the catheter meets the requirements of EN ISO 20967:2018 for the minimum effective shaft length (275 mm) for males.

Additional users are healthcare professionals including nurses, and/or caregivers and family members who help patients with catheterization.

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Image /page/5/Picture/1 description: The image shows the ConvaTec logo. The logo consists of a circular graphic on the left and the word "convatec" on the right. The graphic is a stylized representation of a sphere surrounded by curved shapes in shades of pink and purple. Below the word "convatec" is the tagline "- forever caring -" in a smaller font.

GC Air for Men target users will be those who are able self-catheterize and have no or minimal dexterity impairment. However, users with dexterity impairments are not excluded from the intended users should they wish to use the device with assistance from others.

| <b>Performance Testing:</b> | Performance testing for GC Air for Men was conducted per applicable<br>sections of voluntary and FDA consensus standards: |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------|
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------|

- . Sterilization validation was performed by conducting dose setting per ISO 11137-1:2015
- . Biocompatibility testing (Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity and Subacute/Subchronic Systemic Toxicity) according to ISO 10993-1:2018 and FDA Guidance "Use of International Standard ISO 10993-1" (2020)
- Sterile packaging in accordance with ISO 11607-1 2019 and ISO . 11607-2 2019
- Accelerated and Real Time aged shelf life testing according to ASTM F1980-16
- Performance Testing of Shipping Containers and Systems ● according to ASTM D4169-16
- Packaging integrity testing according to ASTM F2096-11 ●
- Flow rate and Tensile testing performed in accordance with ISO ● 20696:2018
- Coefficient of friction according to ASTM D1894:2014
- Tensile testing in accordance with ISO 20696:2018 ●
- Conclusion: The performance and biocompatibility testing demonstrate that the GC Air for Men poses no additional risk to safety and efficacy than the predicate device GC Glide. All the parameters are similar for the GC Air for Men; therefore, the GC Air for Men is determined to be substantially equivalent to the predicate device.

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Image /page/6/Picture/1 description: The image shows the logo for Convatec. The logo consists of a purple abstract circular design on the left and the word "convatec" in purple on the right. Below the word "convatec" is the phrase "- forever caring -" in a smaller font size.

# Substantial Equivalence discussion

The following table compares the similarities and differences between the subject GC Air for Men and the predicate GC Glide 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 GC Air for Men remains the same as those of the predicate device.

| Table 1:Device Comparison Table | |
|---------------------------------|--|
|---------------------------------|--|

| Parameter | Subject Device | Predicate Device<br>(K181206) | Comparison | |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | GentleCath Air for Men<br>Hydrophilic Intermittent<br>Urinary Catheter | GentleCath Glide<br>Intermittent<br>Catheter<br>(Adult male product<br>variants only) | Similarities | Differences |
| FDA Product Code | GBM | GBM | All devices are<br>the same | None |
| FDA Classification<br>Regulation | 21 CFR 876.5130 | 21 CFR 876.5130 | All devices are<br>the same | None |
| Regulatory Class | Class II | Class II | All devices are<br>the same | None |
| Device description | A sterile, single use,<br>disposable, hydrophilic,<br>intermittent urethral<br>catheter. It is designed for<br>portability, ease of use and<br>discreet disposal with<br>FeelClean™ technology<br>for superior comfort and<br>less sticky residue. The<br>catheter comprises of a<br>flexible tube and color<br>coded funnel, both made<br>from plastic materials<br>(Polyvinyl Chloride; PVC).<br>The catheter tube is made<br>using thermoplastic<br>elastomer (TPE) with a<br>hydrophilic additive in the<br>base material which when<br>wetted activates and<br>lubricates the catheter | A hydrophilic urinary<br>catheter is a flexible<br>tubular device that is<br>inserted through the<br>urethra and used to<br>pass fluids from the<br>bladder. It includes a<br>substance that makes<br>the surface slippery<br>when it comes into<br>contact with water.<br>The catheter is<br>provided together with<br>a sterile water sachet<br>for lubrication | The devices are<br>equivalent | GC Air for Men is<br>designed for portability,<br>ease of use and discreet<br>disposal. The catheter is<br>comprised of equivalent<br>materials, including a<br>hydrophilic additive. |

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Image /page/7/Picture/1 description: The image contains the logo for Convatec. The logo features a circular graphic on the left, composed of curved shapes in shades of purple and pink, resembling a stylized flower or abstract design. To the right of the graphic is the word "convatec" in a bold, purple sans-serif font, and below that, the tagline "- forever caring -" is written in a smaller, lighter font.

| Intended use /<br>Indication for Use | To provide an intermittent<br>pathway for drainage of<br>fluids from the urinary<br>bladder. The catheter is<br>inserted through the<br>urethra.<br>For Male adult use<br>including Transitional<br>Adolescents B | Intermittent catheters are<br>indicated for routine<br>transient drainage of the<br>bladder. The catheter is<br>inserted through the<br>urethra.<br>For adult use including<br>Transitional Adolescents<br>B | All devices<br>are the same | Glide is available for<br>male, female adults as<br>well as pediatrics<br>(Children, adolescents,<br>and transitional<br>adolescents B). Device<br>comparison is being<br>made on predicate<br>adult, male variants<br>only. Air is for Adult<br>males only |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cautions | Single use<br>Prescription only | Single use<br>Prescription only | All devices<br>are the same | None |
| Tube Material | TPE hydrophilic M6906-02<br>(Polyolefin Based<br>Synthetic Thermoplastic<br>Elastomer (TPE) M6504 as<br>a base material and<br>Techsurf™ 15560 for<br>hydrophilic additive) | TPE hydrophilic M6906-<br>01 (Polyolefin Based<br>Synthetic Thermoplastic<br>Elastomer (TPE) M6504<br>as a base material and<br>Techsurf™ 15560 for<br>hydrophilic additive) | All devices<br>are equivalent | A different but<br>equivalent hydrophilic<br>additive in the<br>granulate used for the<br>extrusion of the<br>catheter tube is used in<br>the subject device<br>compared to the<br>cleared predicate. The<br>formulation change<br>does not alter the<br>chemical or physical<br>properties of the<br>medical device in its<br>final finished form. |
| Funnel Material | PVC + DEHT | PVC + DEHT | All devices<br>are the same | None |
| Glue for assembly | Loctite | Loctite | All devices<br>are the same | None |
| Biocompatibility | Evaluation and testing<br>• within risk<br>management process<br>ISO 10993-1<br>• Cytotoxicity ISO<br>10993-5<br>• Sensitization<br>ISO10993-10<br>• Skin Irritation<br>ISO10993-10<br>• Sensitization<br>ISO10993-10<br>• Skin Irritation<br>ISO10993-10 | Evaluation and<br>• testing within risk<br>management<br>process ISO 10993-<br>1<br>• Cytotoxicity<br>ISO 10993-5<br>• Sensitization<br>ISO10993-10<br>• Skin Irritation<br>ISO10993-10<br>• Genotoxicity<br>ISO10993-3<br>• Subchronic Toxicity<br>ISO 10993-11<br>• EtO sterilization<br>residuals ISO<br>10993-7 | All devices<br>are the same | Biological equivalency<br>between GC Glide and<br>GC Air for Men was<br>established by<br>providing evidence of<br>Material Equivalency<br>through Chemical and<br>Physical Equivalency as<br>well as endpoint<br>equivalency |
| Principal of<br>operation - short<br>description of use | Squeeze water pocket<br>Peel pack open<br>Insert catheter<br>Empty bladder<br>Withdraw catheter<br>Dispose device | Squeeze water pocket<br>Peel pack open<br>Insert catheter<br>Empty bladder<br>Withdraw catheter<br>Dispose device | All devices<br>are the same | None |
| Length<br>(mm) | Male: 405mm | Male: 405mm | All devices<br>are the same | None |
| FR Size | Male: CH08-CH16 | Male: CH08-CH18 | All devices<br>are the same | Glide is available for<br>male, female adults as<br>well as pediatrics<br>(Children, adolescents,<br>and transitional<br>adolescents B). Device<br>comparison is being<br>made on predicate<br>adult, male variants<br>only. Air is for Adult<br>males only |
| Funnel color<br>indicating size | CH08: Blue<br>CH10: Black<br>CH12: White<br>CH14: Green<br>CH16: Orange<br>CH18: Red | CH08: Blue<br>CH10: Black<br>CH12: White<br>CH14: Green<br>CH16: Orange<br>CH18: Red | All devices<br>are the same | None |
| Catheter tube -<br>outer diameter<br>(mm ±0.33) | CH08: 2.67<br>CH10: 3.33<br>CH12: 4.00<br>CH14: 4.67<br>CH16: 5.33<br>CH18: 6.00 | CH08: 2.67<br>CH10: 3.33<br>CH12: 4.00<br>CH14: 4.67<br>CH16: 5.33<br>CH18: 6.00 | All devices<br>are the same | None |
| Eyelets | Smooth eyelet | Smooth eyelet | All devices<br>are the same | None |
| Eyelet position | Staggered | Staggered | All devices<br>are the same | None |
| Tip types in range | Straight / Nelaton<br>Tiemann / Coudè | Straight / Nelaton<br>Tiemann / Coudè | All devices<br>are the same | None |
| No-touch<br>functionality | Sleeve | Sleeve | All devices<br>are the same | None |
| Liquid for wetting | Sterile water | Sterile water | All devices<br>are the same | None |
| Sticky-dot | Double sided adhesive dot | Double sided adhesive<br>dot | All devices<br>are the same | None |
| Primary packaging | a three-sided seal bag with<br>zipper, composed of<br>12PET/ADH/LLDPE60<br>material | Paper and film peel pack | Devices are<br>different | GC Air for men is<br>packed in foil pack that<br>is suitable for X- Ray<br>sterilization. GC Glide<br>is packed in a paper<br>film peel pack that is<br>suitable for EO<br>sterilization. |
| Secondary<br>packaging | Corrugated board, Box<br>quantity: 30 | Corrugated board, Box<br>quantity: 30 | All devices<br>are the same | None |
| Shipper case | Corrugated board | Corrugated board | All devices<br>are the same | None |
| Sterilization<br>process | X-Ray | EO | Devices are<br>different | Devices are sterilized<br>by different methods,<br>but both achieve a<br>SAL of 10-6 |
| Shelf life | 18 Months | 18 months | All devices<br>are the same | None |

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Image /page/8/Picture/1 description: The image contains the logo for Convatec. The logo consists of a purple and pink abstract circular design on the left, followed by the word "convatec" in purple, and the tagline "- forever caring -" in a smaller font size below the word "convatec". The logo is clean and modern, with a focus on the company name and its caring mission.

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Image /page/9/Picture/1 description: The image shows the logo for Convatec. The logo consists of a circular graphic on the left and the word "convatec" on the right. The graphic is a stylized representation of a sphere surrounded by curved shapes in shades of pink and purple. Below the word "convatec" is the tagline "- forever caring -" in a smaller font.