(238 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a standard condom, with no mention of AI or ML.
No.
A therapeutic device is typically used for treating or curing a disease or condition. While this device has a prophylactic purpose (reducing the risk of pregnancy and STI transmission), it does not actively treat a condition.
No
Explanation: The Durex Penck Standard Condom is described as being used for contraception and prophylactic purposes, not for diagnosing conditions or diseases.
No
The device description clearly states it is a "natural rubber latex condom," which is a physical, hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Durex Condom Function: The Durex Penck condoms are physical barriers used on the body (in vivo) for contraception and to reduce the risk of STI transmission. They do not perform any diagnostic tests on bodily samples.
The provided text clearly describes the condoms as physical devices for contraception and prophylaxis, not for diagnostic testing.
N/A
Intended Use / Indications for Use
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).
Product codes
HIS
Device Description
Durex Penck Standard and Durex Penck XL are natural rubber latex condoms that completely cover the penis with a closely fitted membrane. They are intended to be used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs). These are straight-walled, parallel sided, teat ended, smooth, and non-colored condoms with a silicone-based lubricant. Durex Penck Standard has a nominal length of 190 mm and width of 54 mm with a thickness of 48 microns. Durex Penck XL has a nominal length of 190 mm and width of 57 mm with a thickness of 50 microns. Durex Penck Standard and Durex Penck XL 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. Durex Penck Standard and Durex Penck XL 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, 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 this testing demonstrated that the subject devices are biocompatible.
Physical Testing: The Durex Penck Standard and Durex Penck XL 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 Penck Standard and Durex Penck XL 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.
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
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.
November 6, 2020
RB Health (US) LLC Kyle Prince Regulatory Specialist 399 Interpace Parkway Parsippany, NJ 07054
Re: K200672
Trade/Device Name: Durex Penck Standard; Durex Penck XL Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: October 9, 2020 Received: October 9, 2020
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,
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) K200672
Device Name Durex Penck Standard; Durex Penck XL
Indications for Use (Describe)
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).
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) |
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3
510(k) Summary - K200672
1. Submitter Information
| Applicant: | RB Health (US) LLC |
|---|---|
| Address: | 399 Interpace Parkway |
| Parsippany NJ 07054-0224 | |
| Phone: | 973-404-2715 |
2. Correspondent Information
| Contact: | Kyle Prince |
|---|---|
| Regulatory Specialist | |
| RB Health (US) LLC | |
| Phone: | 973-404-2715 |
| Email: | kyle.prince@rb.com |
November 4, 2020 3. Date prepared:
4. Device Information
| Device Name: | Durex Penck Standard; Durex Penck XL |
|---|---|
| Common Name: | Male Natural Rubber Latex Condom |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Regulatory Class: | Class II |
| Product Code: | HIS (Condom) |
5. Predicate Device Information
| Device Name: | Lifestyles Zero Lubricated Latex Male Condom |
|---|---|
| 510(k) Number: | K163107 |
| Manufacturer: | Ansell Healthcare Products, LLC |
| Regulatory Class: | Class II |
| Product Code: | HIS (Condom) |
The predicate device has not been subject to a design-related recall.
6. Device Description
Durex Penck Standard and Durex Penck XL are natural rubber latex condoms that completely cover the penis with a closely fitted membrane. They are intended to be used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs). These are straight-walled, parallel sided, teat ended, smooth, and non-colored condoms with a silicone-based lubricant. Durex Penck Standard has a nominal length of 190 mm and width of 54 mm with a thickness of 48 microns. Durex Penck XL has a nominal length of 190 mm and width of 57 mm with a thickness of 50 microns. Durex Penck Standard and Durex Penck XL will be packaged in individually sealed flexible laminate foils made of
4
polyethylene terephthalate, polyethylene, and aluminum. The foils will come packaged in an outer consumer cardboard carton. Durex Penck Standard and Durex Penck XL condoms are intended for over-the-counter (OTC) use. These condoms conform with FDA-recognized standards ASTM D3492-16 and ISO 4074:2015.
7. Indications for Use
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).
8. Comparison of Intended Use and Technological Characteristics with the Predicate Device
The table below includes a comparison of the indications for use and technological characteristics of the subject and predicate devices.
Table 1: Indications for Use and Technological Characteristics of the Subject Devices Compared to Predicate
| Predicate Device | Subject Devices | Comparison | |
|---|---|---|---|
| Trade Name | Lifestyles ZERO Lubricated | ||
| Latex Male Condom | Durex Penck Standard & Durex | ||
| Penck XL | Not applicable | ||
| 510(k) number | K163107 | K200672 | Not applicable |
| Submitter | Ansell Healthcare Products LLC | RB Health (US) LLC | Not applicable |
| Product Code | HIS | HIS | Same |
| Regulation Number | 21 CFR 884.5300 | 21 CFR 884.5300 | Same |
| Regulation Name | Condom | Condom | Same |
| Indications for Use | The Lifestyles ZERO Lubricated | ||
| Latex Male 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 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). | Same | ||
| Prescription or Over- | |||
| The- Counter-Use | Over-The-Counter-Use | Over-The-Counter-Use | Same |
| Materials | Natural Rubber Latex | Natural Rubber Latex | Same |
5
| Lubricant Coating | Silicone | Silicone | Same |
|---|---|---|---|
| Lubricant Quantity | 400-600 mg | Durex Penck Standard: 400 ± 50 mg | |
| Durex Penck XL: 480 ± 50 mg | Similar | ||
| Form | Straight wall, nipple ended condom | Straight walled, parallel sided, teat ended, smooth condom | Similar |
| Use (single or multiple use) | Single use | Single Use | Same |
| Length | $180 \pm 10$ mm | Durex Penck Standard: $190 \pm 10$ mm | |
| Durex Penck XL: $190 \pm 10$ mm | Different | ||
| Width | $52 \pm 2$ mm | Durex Penck Standard: $54 \pm 2$ mm | |
| Durex Penck XL: $57 \pm 2$ mm | Different | ||
| Thickness | 0.045 +/- 0.005 mm | Durex Penck Standard:0.048 + 0.004 / - 0.002 mm | |
| Durex Penck XL:0.050 + 0.004 / - 0.002 mm | Different | ||
| Air Burst Pressure | Minimum 1 kPa | Burst Pressure $\geq 1.0$ kPa | Same |
| Air Burst Volume | Minimum 18 L | Durex Penck Standard: Burst Volume $\geq 18.0$ L | |
| Durex Penck XL: Burst Volume $\geq 22.0$ L | Different | ||
| Sterilization | Non-sterile | Non-sterile | Same |
| Shelf Life | 5 years | 5 years | Same |
The subject and predicate device have similar indications for use and have the same intended use. The technological characteristics of the subject devices and predicate are similar in that they are natural rubber latex-based, are lubricated with silicone oil, 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 types of safety and effectiveness questions.
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:
6
- . 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 this testing demonstrated that the subject devices are biocompatible.
Physical Testing
The Durex Penck Standard and Durex Penck XL 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 Penck Standard and Durex Penck XL 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 Penck Standard and Durex Penck XL are as safe and effective as the predicate device and supports a determination of substantial equivalence.