(90 days)
The Durex Penck III Regular condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).
Durex Penck III Regular are natural rubber latex-based condoms that completely cover the penis with a closely fitted membrane. Durex Penck III Regular are made of a non-colored natural rubber latex with silicone lubricant and are taper shaft, teat ended smooth shaped condoms. Durex Penck III Regular have a nominal length of 195 mm, width of 56 mm, and thickness of 48 um and are provided 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 Penck III Regular condoms are intended for over-the-counter (OTC) use. These condoms conform with FDA-recognized standards ASTM D3492-16 and ISO 4074:2015.
The provided document is a 510(k) Summary for a medical device called "Durex Penck III Regular," which is a male natural rubber latex condom. It describes the device, its intended use, comparison with a predicate device, and a summary of non-clinical performance testing.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document explicitly states that "The Durex Penck III Regular 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)."
Therefore, the acceptance criteria are defined by these two international standards. The document also provides specific performance characteristics for the Durex Penck III Regular and compares them to the predicate device.
| Acceptance Criterion | Durex Penck III Regular Performance (Reported) | Predicate Device Performance |
|---|---|---|
| Material | Natural Rubber Latex | Natural Rubber Latex |
| Width | Nominal: $56 \pm 2$ mm, Mid Body: $54 \pm 2$ mm | Durex Penck Standard: $54 \pm 2$ mm, Durex Penck XL: $57 \pm 2$ mm |
| Nominal Length | $195 \pm 10$ mm | $190 \pm 10$ mm |
| Nominal Thickness | $0.048 \pm 0.008$ mm | Durex Penck Standard: 0.048 mm, Durex Penck XL: $0.050 +0.004 / -0.002$ mm |
| Lubricant | Silicone | Silicone |
| Lubricant Quantity | Regular: $400 \pm 50$ mg, Extra Lubricant: $480 \pm 50$ 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 | $18.0$ 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 |
| Biocompatibility | Non-irritating, non-sensitizing, not acutely systemically toxic (met ISO 10993-5, -10, -11 requirements) | (Not explicitly detailed for predicate, but similar expectations apply for condoms) |
| Physical Performance | Met all requirements of ISO 4074:2015 and ASTM D3492-16 | (Predicate also conforms to these standards as implied by its clearance) |
| Shelf Life Stability | All samples met predefined acceptance criteria based on accelerated stability evaluations per 21 CFR 801.435 | (Similar evaluations would have been done for predicate) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes for each test (e.g., air burst, physical dimensions, biocompatibility). It states that the device was "tested and met all the requirements."
For biocompatibility, the methods listed (ISO 10993 series) often involve in-vivo (animal) and in-vitro studies. For physical performance (ISO 4074 and ASTM D3492), samples would be taken from production lots.
Data Provenance: The document does not explicitly state the country of origin of the data. Given it's a 510(k) submission to the US FDA, the tests would have been performed by a recognized laboratory, potentially in various locations. The studies are retrospective in the sense that they are performed on manufactured devices and evaluated against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and study. The "ground truth" for condom performance is established by recognized international and national standards (ISO 4074:2015 and ASTM D3492-16). These standards define the test methodologies and acceptance criteria for physical properties and safety. Expert consensus in medical imaging or diagnosis is not relevant here. The experts involved would be those who author and maintain these standards, and laboratory technicians and engineers who perform the tests according to these standards.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers evaluate medical images or clinical outcomes that might have subjective interpretations. For objective physical and chemical testing of medical devices like condoms, there is no "adjudication" in this sense. The results are quantitative and compared directly to predefined numerical criteria in the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where the performance of human readers, sometimes aided by AI, is evaluated against a ground truth. The Durex Penck III Regular is a physical barrier device, not a diagnostic tool, so an MRMC study is not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone "algorithm only" study was not done. This concept applies to AI/ML-driven devices. The Durex Penck III Regular is a physical medical device whose performance is assessed through physical, chemical, and biological testing as per established standards, not through algorithmic evaluation.
7. The Type of Ground Truth Used
The "ground truth" for the Durex Penck III Regular device is based on established international and national standards and regulatory requirements.
- Physical Performance: ISO 4074:2015 (Natural rubber latex male condoms – Requirements and test methods) and ASTM D3492-16 (Standard Specification for Rubber Contraceptives (Male Condoms)). These standards specify the test methods and the acceptable ranges/thresholds for properties like dimensions, air burst pressure/volume, and integrity.
- Biocompatibility: ISO 10993-1:2009/R 2014, ISO 10993-5:2009/R 2014, ISO 10993-10:2010/R 2014, and ISO 10993-11:2017. These standards define the acceptable biological responses for device materials.
- Shelf Life: 21 CFR 801.435 for accelerated stability evaluations.
8. The Sample Size for the Training Set
This information is not applicable. The concept of a "training set" is relevant for machine learning algorithms. The Durex Penck III Regular is a physical medical device, not an AI/ML algorithm. Its performance is validated through defined physical, chemical, and biological tests, not by training a model on a dataset.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8. There is no training set for this type of device.
§ 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.