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).

Device Description

GC Air for Men is a sterile, single use, disposable, hydrophilic, 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.

AI/ML Overview

The provided document describes the Convatec GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter and its substantial equivalence to a predicate device. It does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device.

The document is a 510(k) summary for a medical device (a urinary catheter), not an AI/ML diagnostic or predictive system. Therefore, the typical acceptance criteria and study designs relevant to AI/ML device performance (e.g., sensitivity, specificity, AUC, MRMC studies, ground truth establishment by experts) are not applicable or present in this document.

The "Performance Testing" section on page 5 refers to standard testing for physical medical devices and their materials, sterilization, and packaging, not clinical performance metrics related to AI/ML.

Therefore, an answer formatted as requested cannot be provided from this document.

If you have a document pertaining to an AI/ML medical device, please provide that.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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FORM FDA 3881 (6/20)

Page 1 of 1

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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 louise.hollywood@convatec.com Tel: +44(0) 7776 662499
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.

Performance Testing:	Performance testing for GC Air for Men was conducted per applicablesections of voluntary and FDA consensus standards:
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. 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(K181206)	Comparison
	GentleCath Air for MenHydrophilic IntermittentUrinary Catheter	GentleCath GlideIntermittentCatheter(Adult male productvariants only)	Similarities	Differences
FDA Product Code	GBM	GBM	All devices arethe same	None
FDA ClassificationRegulation	21 CFR 876.5130	21 CFR 876.5130	All devices arethe same	None
Regulatory Class	Class II	Class II	All devices arethe same	None
Device description	A sterile, single use,disposable, hydrophilic,intermittent urethralcatheter. It is designed forportability, ease of use anddiscreet disposal withFeelClean™ technologyfor superior comfort andless sticky residue. Thecatheter comprises of aflexible tube and colorcoded funnel, both madefrom plastic materials(Polyvinyl Chloride; PVC).The catheter tube is madeusing thermoplasticelastomer (TPE) with ahydrophilic additive in thebase material which whenwetted activates andlubricates the catheter	A hydrophilic urinarycatheter is a flexibletubular device that isinserted through theurethra and used topass fluids from thebladder. It includes asubstance that makesthe surface slipperywhen it comes intocontact with water.The catheter isprovided together witha sterile water sachetfor lubrication	The devices areequivalent	GC Air for Men isdesigned for portability,ease of use and discreetdisposal. The catheter iscomprised of equivalentmaterials, including ahydrophilic 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 /Indication for Use	To provide an intermittentpathway for drainage offluids from the urinarybladder. The catheter isinserted through theurethra.For Male adult useincluding TransitionalAdolescents B	Intermittent catheters areindicated for routinetransient drainage of thebladder. The catheter isinserted through theurethra.For adult use includingTransitional AdolescentsB	All devicesare the same	Glide is available formale, female adults aswell as pediatrics(Children, adolescents,and transitionaladolescents B). Devicecomparison is beingmade on predicateadult, male variantsonly. Air is for Adultmales only
Cautions	Single usePrescription only	Single usePrescription only	All devicesare the same	None
Tube Material	TPE hydrophilic M6906-02(Polyolefin BasedSynthetic ThermoplasticElastomer (TPE) M6504 asa base material andTechsurf™ 15560 forhydrophilic additive)	TPE hydrophilic M6906-01 (Polyolefin BasedSynthetic ThermoplasticElastomer (TPE) M6504as a base material andTechsurf™ 15560 forhydrophilic additive)	All devicesare equivalent	A different butequivalent hydrophilicadditive in thegranulate used for theextrusion of thecatheter tube is used inthe subject devicecompared to thecleared predicate. Theformulation changedoes not alter thechemical or physicalproperties of themedical device in itsfinal finished form.
Funnel Material	PVC + DEHT	PVC + DEHT	All devicesare the same	None
Glue for assembly	Loctite	Loctite	All devicesare the same	None
Biocompatibility	Evaluation and testing• within riskmanagement processISO 10993-1• Cytotoxicity ISO10993-5• SensitizationISO10993-10• Skin IrritationISO10993-10• SensitizationISO10993-10• Skin IrritationISO10993-10	Evaluation and• testing within riskmanagementprocess ISO 10993-1• CytotoxicityISO 10993-5• SensitizationISO10993-10• Skin IrritationISO10993-10• GenotoxicityISO10993-3• Subchronic ToxicityISO 10993-11• EtO sterilizationresiduals ISO10993-7	All devicesare the same	Biological equivalencybetween GC Glide andGC Air for Men wasestablished byproviding evidence ofMaterial Equivalencythrough Chemical andPhysical Equivalency aswell as endpointequivalency
Principal ofoperation - shortdescription of use	Squeeze water pocketPeel pack openInsert catheterEmpty bladderWithdraw catheterDispose device	Squeeze water pocketPeel pack openInsert catheterEmpty bladderWithdraw catheterDispose device	All devicesare the same	None
Length(mm)	Male: 405mm	Male: 405mm	All devicesare the same	None
FR Size	Male: CH08-CH16	Male: CH08-CH18	All devicesare the same	Glide is available formale, female adults aswell as pediatrics(Children, adolescents,and transitionaladolescents B). Devicecomparison is beingmade on predicateadult, male variantsonly. Air is for Adultmales only
Funnel colorindicating size	CH08: BlueCH10: BlackCH12: WhiteCH14: GreenCH16: OrangeCH18: Red	CH08: BlueCH10: BlackCH12: WhiteCH14: GreenCH16: OrangeCH18: Red	All devicesare the same	None
Catheter tube -outer diameter(mm ±0.33)	CH08: 2.67CH10: 3.33CH12: 4.00CH14: 4.67CH16: 5.33CH18: 6.00	CH08: 2.67CH10: 3.33CH12: 4.00CH14: 4.67CH16: 5.33CH18: 6.00	All devicesare the same	None
Eyelets	Smooth eyelet	Smooth eyelet	All devicesare the same	None
Eyelet position	Staggered	Staggered	All devicesare the same	None
Tip types in range	Straight / NelatonTiemann / Coudè	Straight / NelatonTiemann / Coudè	All devicesare the same	None
No-touchfunctionality	Sleeve	Sleeve	All devicesare the same	None
Liquid for wetting	Sterile water	Sterile water	All devicesare the same	None
Sticky-dot	Double sided adhesive dot	Double sided adhesivedot	All devicesare the same	None
Primary packaging	a three-sided seal bag withzipper, composed of12PET/ADH/LLDPE60material	Paper and film peel pack	Devices aredifferent	GC Air for men ispacked in foil pack thatis suitable for X- Raysterilization. GC Glideis packed in a paperfilm peel pack that issuitable for EOsterilization.
Secondarypackaging	Corrugated board, Boxquantity: 30	Corrugated board, Boxquantity: 30	All devicesare the same	None
Shipper case	Corrugated board	Corrugated board	All devicesare the same	None
Sterilizationprocess	X-Ray	EO	Devices aredifferent	Devices are sterilizedby different methods,but both achieve aSAL of 10-6
Shelf life	18 Months	18 months	All devicesare 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.

Regulation Number and Section

§ 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.