(90 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a latex condom, with no mention of AI or ML technology.
No
Explanation: The device is described as being for contraception and reducing the risk of STIs, which are prophylactic and preventative in nature, not therapeutic (treating an existing condition).
No
The device is a condom used for contraception and prophylactic purposes, not for diagnosing medical conditions.
No
The device description clearly states it is a physical product made of natural rubber latex, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description and Intended Use: The description clearly states that the Durex Patronus Wide condoms are used for contraception and prophylactic purposes (reducing the risk of pregnancy and STIs). They are a physical barrier device applied to the penis.
- Lack of Specimen Examination: The device does not involve the examination of any bodily specimens (like blood, urine, tissue, etc.) to provide diagnostic information.
The information provided describes a Class II medical device used for physical barrier contraception and disease prevention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
HIS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility studies 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. Specific tests included: Cytotoxicity (ISO 10993-5:2009/R 2014), Sensitization (ISO 10993-10:2010/R 2014), Vaginal Irritation (ISO 10993-10:2010/R 2014), and Acute Systemic Toxicity (ISO 10993-11:2017). The results demonstrated that the subject device is non-irritating, non-sensitizing, and not acutely, systemically toxic.
Physical performance testing was conducted according to ISO 4074:2015 - Natural rubber latex male condoms – Requirements and test methods and ASTM D3492-16 - Standard Specification for Rubber Contraceptives (Male Condoms). The Durex Patronus Wide met all requirements.
Accelerated stability evaluations were conducted as required in 21 CFR 801.435 to determine shelf life. All samples met predefined acceptance criteria, establishing a five-year shelf life.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
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) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summarv K213647 Durex Patronus Wide
1. Submitter Information
| Applicant: | RB Health (US) LLC |
|---|---|
| Address: | 399 Interpace Parkway Parsippany |
| NJ 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
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.
Device specifications are listed in Table 1 below.
4
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 Device
Durex Patronus Wide
K213647 | Predicate Device
Durex Penck Standard,
Durex Penck XL
K200672 |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device & Predicate Device | Durex Patronus Wide | Durex Penck Standard
Durex 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 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). | The Durex Penck Standard
Condom is used for
contraception and for
prophylactic purposes (to
help reduce the risk of
pregnancy and the
transmission of sexually
transmitted infections, STIs).
The Durex Penck XL
Condom is used for
contraception and for
prophylactic purposes (to
help reduce the risk of
pregnancy and the
transmission of sexually
transmitted 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: $54 \pm 2$ mm
Durex 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 mm
Durex Penck XL:0.050 + 0.004 / |
| | | - 0.002 mm |
| Lubricant | Silicone | Silicone |
| Lubricant Quantity | $400 \pm 50$ mg | Durex Penck Standard: $400 \pm$ 50 mg
Durex 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 L
Durex Penck XL: Minimum
22.0 L |
| Sterilization | Non-Sterile | Non-sterile |
| Texture | Taper shaft, teat ended
smooth condom | Smooth, straight walled, and
teat ended |
| Shelf Life | 5 Years | 5 Years |
| Color Additives | N/A | N/A |
| Flavor Additives | N/A | N/A |
5
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).
6
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.