Durex Patronus CloseFit and Durex Patronus Regular condoms are used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).

Device Description

Durex Patronus CloseFit and Durex Patronus Regular are natural rubber latex-based condoms indicated for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs). Durex Patronus CloseFit and Durex Patronus Regular are made of a non-colored natural rubber latex with silicone lubricant and are taper shaft, teat ended smooth shaped condoms. Durex Patronus CloseFit and Durex Patronus Regular have a nominal length of 190 mm and 195 mm, width of 52.5 mm and 56 mm, and thickness of 52 microns and 54 microns, respectively. The condoms are available in regular and extra lubricant varieties with 400 mg and 480 mg silicone lubricant, respectively. The condoms are packaged in individually sealed flexible laminate foils made of polyethylene terephthalate, polyethylene, and aluminum. The foils are packaged in an outer consumer cardboard carton. The number of condoms in the carton may vary. Durex Patronus CloseFit and Durex Patronus Regular condoms are intended for over-the-counter (OTC) use. These condoms conform with FDA-recognized standards ASTM D3492-16 and ISO 4074:2015.

AI/ML Overview

The provided document is a 510(k) summary for Durex Patronus CloseFit and Durex Patronus Regular condoms. This document describes the device, its intended use, comparison to a predicate device, and a summary of non-clinical performance testing. It is not an AI/ML medical device submission, therefore, much of the requested information regarding AI/ML study design characteristics (e.g., test set sample size, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set sample size, ground truth for training set) is not applicable.

However, I can extract the acceptance criteria and reported device performance for the physical performance testing and shelf-life as described in the document.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance
Biocompatibility
ISO 10993-5:2009/R 2014 Cytotoxicity	The subject device is non-cytotoxic.
ISO 10993-10:2010/R 2014 Sensitization	The subject device is non-sensitizing.
ISO 10993-10:2010/R 2014 Vaginal Irritation	The subject device is non-irritating.
ISO 10993-11:2017 Acute Systemic Toxicity	The subject device is not acutely, systemically toxic.
Physical Performance Testing
ISO 4074:2015 Requirements and Test Methods	The device met all requirements.
ASTM D3492-16 Requirements	The device met all requirements.
Shelf Life
Predefined acceptance criteria based on 21 CFR 801.435	All samples met predefined acceptance criteria for a 5-year shelf life.

Study Details:

Sample size used for the test set and the data provenance: Not specified in the provided summary for performance testing. The document states "All samples" for the shelf-life testing, but a specific number is not given. Data provenance is not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is not an AI/ML product requiring expert ground truth for image interpretation or similar tasks.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is not an AI/ML device that requires MRMC studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm.
The type of ground truth used: For biocompatibility, the ground truth is established through standardized biological tests. For physical performance, the ground truth is defined by the requirements outlined in international and national standards (ISO 4074:2015 and ASTM D3492-16). For shelf life, the ground truth is based on the device maintaining its performance over time as per 21 CFR 801.435.
The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no "training set."
How the ground truth for the training set was established: Not applicable.

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, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 7, 2022

RB Health (US) LLC Kaitlyn Chan Regulatory Specialist 399 Interpace Parkway Parsippany, NJ 07054-1133

Re: K220489

Trade/Device Name: Durex Patronus CloseFit and Durex Patronus Regular Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: October 4, 2022 Received: October 5, 2022

Dear Kaitlyn Chan:

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 (QS) 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,

Monica D. Garcia -S

Monica D. Garcia, 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

510(k) Number (if known) K220489

Device Name

Durex Patronus CloseFit and Durex Patronus Regular

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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K220489 Page 1 of 3

510(k) Summarv K220489 Durex Patronus CloseFit and Durex Patronus Regular

1. Submitter Information

Applicant:	RB Health (US) LLC
Address:	399 Interpace Parkway ParsippanyNJ 07054-0024
Phone:	(862) 325-0012

2. Correspondent Information

Company:	RB Health (US) LLC
Contact:	Kaitlyn Chan
Phone:	(862) 325-0012
Email:	Kaitlyn.Chan@reckitt.com

3. Device Information

Device Name:	Durex Patronus CloseFit and Durex Patronus Regular
Common Name:	Male Natural Rubber Latex Condom
Regulation Number:	21 CFR 884.5300
Regulation Name:	Condom
Product Code:	HIS (Condom)
Regulatory Class:	Class II

4. Predicate Device Information

Device Name:	Durex Patronus Wide
510(k) Number:	K213647
Sponsor:	RB Health (US) LLC
Manufacturer:	Reckitt Benckiser LLC

The predicate device has not been subject to a design-related recall.

5. Device Description

Device specifications are listed in Table 1 below.

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6. Indications for Use Statement

7. Comparison of Intended Use and Technological Characteristics with the Predicate Device

The table below includes a comparison of the intended use and technological characteristics of the subject and predicate devices.

	Subject Device:Durex Patronus CloseFitand Durex PatronusRegular	Predicate Device:Durex Patronus WideK213647
Device & Predicate Device	Durex Patronus CloseFit andDurex Patronus Regular	Durex Patronus Wide
510(K) Number	K220489	K213647
Product Code	HIS	HIS
Regulation Number	21 CFR 884.5300	21 CFR 884.5300
Regulation Name	Condom	Condom
Indications for Use	Durex Patronus CloseFit andDurex Patronus Regularcondoms are used forcontraception and forprophylactic purposes (tohelp reduce the risk ofpregnancy and thetransmission of sexuallytransmitted infections, STIs).	Durex Patronus Widecondoms are used forcontraception and forprophylactic purposes (tohelp reduce the risk ofpregnancy and thetransmission of sexuallytransmitted infections, STIs).
Prescription or Over-The-Counter Use	Over-The-Counter	Over-The-Counter
Condom Material	Natural Rubber Latex	Natural Rubber Latex
Nominal Width	CloseFit: $52.5 \pm 2$ mmRegular: $56 \pm 2$ mm	$60 \pm 2$ mm
Nominal Length	CloseFit: $190 \pm 10$ mmRegular: $195 \pm 10$ mm	$200 \pm 10$ mm
Nominal Thickness	CloseFit: $0.052 \pm 0.01$ mmRegular: $0.054 \pm 0.01$ mm	$0.062 \pm 0.01$ mm
Lubricant	Silicone	Silicone
Lubricant Quantity	Regular: $400 \pm 50$ mgExtra Lubricated: $480 \pm 50$mg	$400 \pm 50$ mg
Air Burst Pressure	> 1.0 kPa	> 1.0 kPa
Air Burst Volume	22.0 L	22.0 L
Sterilization	Non Sterile	Non Sterile

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Texture	Taper shaft, teat endedsmooth condom	Taper shaft, teat endedsmooth condom
Shelf Life	5 Years	5 Years
Color Additives	N/A	N/A
Flavor Additives	N/A	N/A

The subject and predicate device have similar indications for use and have the same intended use. The technological characteristics of the subject device and predicate device are similar in that they are natural rubber latex-based, are lubricated with silicone, and have the same shelf-life duration. The subject and predicate devices have different technological characteristics, including different lubricant quantities, dimensions, and specifications However, the different technological characteristics of the subject devices do not raise different questions of safety and effectiveness.

8. Summary of Non-Clinical Performance Testing

Biocompatibility:

Biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Cytotoxicity and Sensitization testing were performed in accordance with the 2020 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process" and ISO 10993-1:2009 as follows:

· Cytotoxicity (ISO 10993-5:2009/R 2014)
· Sensitization (ISO 10993-10:2010/R 2014)
· Vaginal Irritation (ISO 10993-10:2010/R 2014)
· Acute Systemic Toxicity (ISO 10993-11:2017)

The results of testing demonstrate that the subject device is non-irritating, non-sensitizing, and not acutely, systemically toxic.

Physical Performance Testing:

The Durex Patronus CloseFit and Durex Patronus Regular were tested and met all the requirements of ISO 4074:2015 - Natural rubber latex male condoms - Requirements and test methods and ASTM D3492-16 - Standard Specification for Rubber Contraceptives (Male Condoms).

Shelf Life:

The Durex Patronus CloseFit and Durex Patronus Regular have a five-year shelf life based on the results of accelerated stability evaluations conducted as required in 21 CFR 801.435. All samples met predefined acceptance criteria.

10. Conclusion

The results of the performance testing described above demonstrate that the Durex Patronus CloseFit and Durex Patronus Regular are as safe and effective as the predicate device and support a determination of substantial equivalence.

Regulation Number and Section

§ 884.5300 Condom.

(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.