Durex Patronus Wide 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 Wide are natural rubber latex-based condoms that completely cover the penis with a closely fitted membrane. Durex Patronus Wide is made of a non-colored natural rubber latex with silicone lubricant and is a taper shaft, teat ended smooth shaped condom. Durex Patronus Wide has a nominal length of 200 mm, width of 60 mm, and thickness of 62 um. It will be packaged in individually sealed flexible laminate foils made of polyethylene terephthalate, polyethylene, and aluminum. The foils will come packaged in an outer consumer cardboard carton. The number of condoms in the carton may vary. Durex Patronus Wide 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

Here's an analysis of the acceptance criteria and study information provided in the document for the "Durex Patronus Wide" condom.

It is important to note that this document is a 510(k) summary for a condom, not a medical device driven by an algorithm or AI. Therefore, many of the typical questions regarding AI-driven medical devices (like sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, and standalone algorithm performance) are not applicable or will not be found in this type of submission.

Acceptance Criteria and Study Information: Durex Patronus Wide Condom (K213647)

1. Table of acceptance criteria and the reported device performance

The acceptance criteria are generally based on recognized international and national standards for male natural rubber latex condoms. The reported device performance indicates that the Durex Patronus Wide met all requirements of these standards.

Acceptance Criteria (Standard Reference)	Reported Device Performance (Durex Patronus Wide)
Biocompatibility:
Cytotoxicity (ISO 10993-5:2009/R 2014)	Met requirement: Non-cytotoxic
Sensitization (ISO 10993-10:2010/R 2014)	Met requirement: Non-sensitizing
Vaginal Irritation (ISO 10993-10:2010/R 2014)	Met requirement: Non-irritating
Acute Systemic Toxicity (ISO 10993-11:2017)	Met requirement: Not acutely, systemically toxic
Physical Performance:
ISO 4074:2015 - Natural rubber latex male condoms – Requirements and test methods	Met all requirements
ASTM D3492-16 - Standard Specification for Rubber Contraceptives (Male Condoms)	Met all requirements
Shelf Life: (21 CFR 801.435)
Predefined acceptance criteria for accelerated stability	Met predefined acceptance criteria
Specific Device Specifications (from Comparison Table - Section 8):
Nominal Width	$60 \pm 2$ mm
Nominal Length	$200 \pm 10$ mm
Nominal Thickness	$0.062 \pm 0.01$ mm
Air Burst Pressure	> 1.0 kPa (met)
Air Burst Volume	22.0 L (met)

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: The document does not specify a distinct "test set" sample size in the way an AI/algorithm study would. Instead, performance testing was conducted according to the specified standards (ISO 4074:2015 and ASTM D3492-16) and biocompatibility test methods (ISO 10993 series). These standards prescribe specific sampling plans and test methods for evaluating parameters like burst pressure, burst volume, dimensions, and biocompatibility. The exact number of units tested for each specific criterion is not provided in this summary but would be detailed in the full test reports.
Data Provenance: The studies were conducted by the manufacturer (RB Health (US) LLC) or contracted labs as part of the regulatory submission process. This data is generally prospective, generated specifically for the device under evaluation. The country of origin of the data is not explicitly stated but would be derived from the testing facilities used by the applicant.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to a condom's performance evaluation as described. The "ground truth" for condom testing is based on objective physical measurements and biological assays against established, quantitative pass/fail criteria defined in international and national standards. It does not involve expert interpretation or consensus in the way a diagnostic imaging device might.

4. Adjudication method for the test set

Not applicable. Condom testing is based on objective measurements and established standards, not judgmental adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The Durex Patronus Wide is a physical medical device (condom), not an AI-driven system, and therefore, MRMC studies are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used

The ground truth for physical and biological testing of the Durex Patronus Wide condom is based on:

Quantitative metrics defined in recognized standards: e.g., minimum air burst pressure, minimum air burst volume, dimensional tolerances (Nominal Width, Length, Thickness).
Biological assay outcomes: Demonstrating non-cytotoxicity, non-sensitization, non-irritation, and absence of acute systemic toxicity, as per ISO 10993 series standards.

8. The sample size for the training set

Not applicable. There is no "training set" for a physical device like a condom. Manufacturing processes are validated through quality control and process validation, not machine learning training.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 17, 2022

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

Re: K213647

Trade/Device Name: Durex Patronus Wide Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: November 17, 2021 Received: November 19, 2021

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,

for

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) K213647

Device Name Durex Patronus Wide

Indications for Use (Describe)

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

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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510(k) Summarv K213647 Durex Patronus Wide

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@rb.com

February 14, 2022 3. Date prepared:

4. Device Information

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

5. Predicate Device Information

Device Name:	Durex Penck Standard, Durex Penck XL
510(k) Number:	K200672
Sponsor:	RB Health (US) LLC
Manufacturer:	Reckitt Benckiser LLC

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

6. Device Description

Device specifications are listed in Table 1 below.

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7. Indications for Use Statement

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

8. 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 DeviceDurex Patronus WideK213647	Predicate DeviceDurex Penck Standard,Durex Penck XLK200672
Device & Predicate Device	Durex Patronus Wide	Durex Penck StandardDurex Penck XL
510(K) Number	K213647	K200672
Product Code	HIS	HIS
Regulation Number	21 CFR 884.5300	21 CFR 884.5300
Regulation Name	Condom	Condom
Indications for Use	Durex Patronus Widecondoms are used forcontraception and forprophylactic purposes (tohelp reduce the risk ofpregnancy and thetransmission of sexuallytransmitted infections, STIs).	The Durex Penck StandardCondom is used forcontraception and forprophylactic purposes (tohelp reduce the risk ofpregnancy and thetransmission of sexuallytransmitted infections, STIs).The Durex Penck XLCondom is 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	$60 \pm 2$ mm	Durex Penck Standard: $54 \pm 2$ mmDurex Penck XL: $57 \pm 2$ mm
Nominal Length	$200 \pm 10$ mm	$190 \pm 10$ mm
Nominal Thickness	$0.062 \pm 0.01$ mm	Durex Penck Standard: 0.048 +0.004 / - 0.002 mmDurex Penck XL:0.050 + 0.004 /
		- 0.002 mm
Lubricant	Silicone	Silicone
Lubricant Quantity	$400 \pm 50$ mg	Durex Penck Standard: $400 \pm$ 50 mgDurex Penck XL: $480 \pm 50$ mg
Air Burst Pressure	> 1.0 kPa	> 1.0 kPa
Air Burst Volume	22.0 L	Durex Penck Standard:Minimum 18.0 LDurex Penck XL: Minimum22.0 L
Sterilization	Non-Sterile	Non-sterile
Texture	Taper shaft, teat endedsmooth condom	Smooth, straight walled, andteat ended
Shelf Life	5 Years	5 Years
Color Additives	N/A	N/A
Flavor Additives	N/A	N/A

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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 do have different technological characteristics, including different dimensions and specifications (e.g., burst volume). However, the different technological characteristics of the subject devices do not raise different questions of safety and effectiveness.

9. 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 Wide was 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).

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Shelf Life:

The Durex Patronus Wide has 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 Wide is as safe and effective as the predicate device and supports 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.