(387 days)
No
The device description and performance studies focus on the physical properties, biocompatibility, and shelf life of a condom with a desensitizing agent. There is no mention of any computational or analytical functions that would suggest the use of AI or ML.
No.
The primary intended uses are contraception and disease prevention (STIs), and while it has an additive (benzocaine) for temporary effect, its main functions are not therapeutic in nature.
No
Explanation: The device is a condom used for contraception and prophylactic purposes, not for diagnosing any medical condition.
No
The device is a physical condom made of natural rubber latex with lubricant and benzocaine, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- Device Function: The Durex Condom with Benzocaine is a physical barrier device used for contraception and preventing the transmission of STIs. It is applied externally and does not involve testing samples from the body.
- Intended Use: The intended use clearly states contraception and prophylactic purposes, not diagnostic testing.
- Device Description: The description focuses on the physical characteristics of the condom and its lubricant, not on any diagnostic testing components or processes.
Therefore, based on the provided information, the Durex Condom with Benzocaine falls under the category of a medical device, specifically a contraceptive and prophylactic device, but not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Durex Condom with Benzocaine is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).
Product codes
HIS
Device Description
The Durex Condom with Benzocaine is a natural rubber latex-based condom used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs). This is a textured condom with a silicone-based lubricant. Durex Condom with Benzocaine has a nominal length of 195 mm and width of 56 mm with a thickness of 65 um. The Durex Condom with Benzocaine is packaged with 480 mg of silicone lubricant. In addition, the Benzocaine male genital desensitizer paste on the condom helps in temporarily prolonging the time until ejaculation. This condom is a surface device that comes into contact with skin and mucosal membranes. Durex Condom with Benzocaine is packaged in individually sealed flexible laminate foils made of polyethylene terephthalate, polyethylene, and aluminum. The foils come packaged in an outer consumer cardboard carton. The Durex Condom with Benzocaine is 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, 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. The results of testing demonstrate that the subject device is non-irritating, non-sensitizing, and not acutely, systemically toxic.
Physical Performance Testing: The Durex Condom with Benzocaine 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).
Shelf Life: The Durex Condom with Benzocaine 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
May 11, 2022
RB Health (US) LLC Kyle Prince Regulatory Specialist 399 Interpace Parkway Parsippany, NJ 07054
Re: K211152
Trade/Device Name: Durex Condom with Benzocaine Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: April 7, 2022 Received: April 8, 2022
Dear Kyle Prince:
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,
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) K211152
Device Name Durex Condom with Benzocaine
Indications for Use (Describe)
The Durex Condom with Benzocaine is 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 K211152 Durex Condom with Benzocaine
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: | Kyle Prince |
| Phone: | (973) 404-2600 |
| Email: | kyle.prince@rb.com |
3. Date prepared: May 9, 2022
4. Device Information
| Device Name: | Durex Condom with Benzocaine |
|---|---|
| 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 Latex Condom with Male Genital Desensitizer Lubricant |
|---|---|
| 510(k) Number: | K020659 |
| Sponsor: | Ssl Americas, Inc. |
The predicate device has not been subject to a design-related recall.
6. Device Description
The Durex Condom with Benzocaine is a natural rubber latex-based condom used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs). This is a textured condom with a silicone-based lubricant. Durex Condom with Benzocaine has a nominal length of 195 mm and width of 56 mm with a thickness of 65 um. The Durex Condom with Benzocaine is packaged with 480 mg of silicone lubricant. In addition, the Benzocaine male genital desensitizer paste on the condom helps in temporarily prolonging the time until ejaculation. This condom is a surface device that comes into contact with skin and mucosal membranes. Durex Condom with Benzocaine is packaged in individually sealed flexible laminate foils made of polyethylene terephthalate, polyethylene, and aluminum. The foils come packaged in an outer consumer cardboard carton. The Durex Condom with Benzocaine is intended for over-the-counter (OTC) use. These condoms conform with FDA-recognized standards ASTM D3492-16 and ISO 4074:2015.
4
Device specifications are listed in Table 1 below.
7. Indications for Use Statement
The Durex Condom with Benzocaine is 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
Table 1. below includes a comparison of the intended use and technological characteristics of the subject and predicate devices.
| Subject Device | Predicate Device | |
|---|---|---|
| Durex Condom with | ||
| Benzocaine | ||
| K211152 | Durex Latex Condom With | |
| Male Genital Desensitizer | ||
| Lubricant | ||
| K020659 | ||
| Device & Predicate Device | Durex Condom with | |
| Benzocaine | Durex Latex Condom With | |
| Male Genital Desensitizer | ||
| Lubricant | ||
| 510(K) Number | K211152 | K020659 |
| Product Code | HIS | HIS |
| Regulation Number | 21 CFR 884.5300 | 21 CFR 884.5300 |
| Regulation Name | Condom | Condom |
| Indications for Use | The Durex Condom with | |
| Benzocaine 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® Latex | |
| Condom with Male Genital | ||
| Desensitizer Lubricant is used | ||
| for contraception and for | ||
| prophylactic purposes (to | ||
| help reduce the risk of | ||
| pregnancy and the | ||
| transmission of sexually | ||
| transmitted infections, STIs. | ||
| The male genital desensitizer | ||
| lubricant on the condom | ||
| helps in temporarily | ||
| prolonging the time until | ||
| ejaculation. | ||
| Prescription or Over-The- | ||
| Counter Use | Over-The-Counter | Over-The-Counter |
| Condom Material | Natural Rubber Latex | Natural Rubber Latex |
| Nominal Width | 56 $\pm$ 2 mm | 52 $\pm$ 2 mm |
| Nominal Length | 195 $\pm$ 10 mm | 180 $\pm$ 10 mm |
| Nominal Thickness | 0.065 $\pm$ 0.01 mm | 0.065 mm minimum |
| Lubricant | Silicone gel with | |
| Transatak odor | ||
| masker | Silicone gel with | |
| Zeus odor masker | ||
| Lubricant Quantity | 480 $\pm$ 50 mg | 400 $\pm$ 50 mg |
5
| Benzocaine Quantity | $140 \pm 20$ mg
5% Benzocaine | 140 mg 4.75 – 5.25%
Benzocaine |
|---------------------|----------------------------------|-----------------------------------------------|
| | | |
| Air Burst Pressure | > 1.0 kPa | > 1.0 kPa |
| Air Burst Volume | $\geq 18.0$ L | $\geq 18.0$ L |
| Sterilization | Non-Sterile | Non-sterile |
| Texture | Nipple ended, textured
condom | Straight wall, nipple ended,
smooth condom |
| Shelf Life | 5 Years | 5 Years |
Table 1. Comparison of intended use and technological characteristics of the subject and predicate device
The subject and predicate device have similar indications for use and have the same intended use - for contraception and for prophylactic purposes. The technological characteristics of the subject device and predicate device are similar in that they are natural rubber latex-based, include Benzocaine in similar quantities, are lubricated with silicone, and have the same shelf-life duration. The subject and predicate devices have different technological characteristics, including different dimensions, form, and specifications (e.g., burst volume). However, the different technological characteristics of the subject and predicate 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 Condom with Benzocaine 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).
Shelf Life:
The Durex Condom with Benzocaine 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.
6
10. Conclusion
The results of the performance testing described above demonstrate that the Durex Condom with Benzocaine is as safe and effective as the predicate device and supports a determination of substantial equivalence.