(90 days)
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).
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.
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.
§ 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.