(238 days)
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).
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.
The provided text describes the 510(k) summary for the Durex Penck Standard and Durex Penck XL condoms. Here's a breakdown of the acceptance criteria and the studies that prove the devices meet them:
1. A table of acceptance criteria and the reported device performance:
| Parameter | Acceptance Criteria (Predicate/Standard or Subject Device) | Reported Device Performance (Subject Devices) |
|---|---|---|
| Biocompatibility | Meet requirements of ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11. | Demonstrated to be biocompatible (met all testing requirements). |
| Physical Testing | Meet requirements of ISO 4074:2015 and ASTM D3492-16. | Durex Penck Standard and Durex Penck XL met all the requirements of ISO 4074:2015 and ASTM D3492-16. |
| Condom Materials | Natural Rubber Latex | Natural Rubber Latex |
| Lubricant Coating | Silicone | Silicone |
| Lubricant Quantity | Predicate: 400-600 mg | Durex Penck Standard: 400 ± 50 mg |
| Durex Penck XL: 480 ± 50 mg | ||
| Form | Predicate: Straight wall, nipple ended condom | Straight walled, parallel sided, teat ended, smooth condom |
| Use | Single use | Single Use |
| Length | Predicate: $180 \pm 10$ mm | Durex Penck Standard: $190 \pm 10$ mm |
| Durex Penck XL: $190 \pm 10$ mm | ||
| Width | Predicate: $52 \pm 2$ mm | Durex Penck Standard: $54 \pm 2$ mm |
| Durex Penck XL: $57 \pm 2$ mm | ||
| Thickness | Predicate: 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 | ||
| Air Burst Pressure | Minimum 1 kPa (Predicate) / $\geq 1.0$ kPa (Subject) | Burst Pressure $\geq 1.0$ kPa |
| Air Burst Volume | Minimum 18 L (Predicate) | Durex Penck Standard: Burst Volume $\geq 18.0$ L |
| Durex Penck XL: Burst Volume $\geq 22.0$ L | ||
| Sterilization | Non-sterile | Non-sterile |
| Shelf Life | 5 years | 5 years (based on accelerated stability evaluations) |
Note: For parameters where the subject device specifications differ from the predicate, the document states: "the different technological characteristics of the subject devices do not raise different types of safety and effectiveness questions." This implies that the observed differences are within acceptable limits or are supported by the physical testing results against the recognized standards.
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample size for any of the test sets (biocompatibility or physical testing). It generally refers to "results of this testing" or "all samples."
The data provenance is not explicitly mentioned in terms of country of origin or retrospective/prospective for the described non-clinical testing. These types of tests are typically conducted in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this submission. The device described is a medical device (condom) that undergoes physical and biocompatibility testing against established international and national standards (ISO 4074:2015, ASTM D3492-16, ISO 10993 series). The "ground truth" for these tests is defined by the objective criteria within these standards, not by expert consensus in a medical diagnostic sense.
4. Adjudication method for the test set:
This information is not applicable. As explained above, the assessment is based on objective measurements against predefined criteria in recognized standards, not subjective interpretations requiring 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:
This information is not applicable to this device. An MRMC comparative effectiveness study is relevant for diagnostic devices (often AI-assisted) where human interpretation is involved. This submission is for a physical barrier contraceptive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable to this device. This device is not an algorithm or AI-based system. Its performance is assessed through physical and biological testing.
7. The type of ground truth used:
The ground truth used for this device is based on:
- Specifications and criteria defined in recognized international and national standards:
- ISO 4074:2015 - Natural rubber latex male condoms - Requirements and test methods
- ASTM D3492-16 - Standard Specification for Rubber Contraceptives (Male Condoms)
- ISO 10993-1:2009 & 2020 FDA guidance (Biological Evaluation of Medical Devices)
- ISO 10993-5:2009/R 2014 (Cytotoxicity)
- ISO 10993-10:2010/R 2014 (Sensitization, Vaginal Irritation)
- ISO 10993-11:2017 (Acute Systemic Toxicity)
- Established material properties and performance characteristics for condoms.
8. The sample size for the training set:
This information is not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
This information is not applicable. As there is no training set for this type of device, this question is irrelevant.
§ 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.