(98 days)
Durex latex condom used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).
The condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The device is a straight walled , teat ended, coloured condom containing either red, yellow, orange or green pigment. The condoms are lubricated with a water based flavoured lubricant containing either lychee, guava, pineapple, mango or kiwi scent.
The device is designed to conform to national and international voluntary standards, including ISO 4074:2002 and ASTM D3492-03.
Here's an analysis of the provided information regarding the Durex Male Latex Colored Condom with Scented Lubricants, focusing on acceptance criteria and supporting studies:
It's important to note that this 510(k) application (K052959) is for a medical device that is a physical product (a condom), not a software-based AI/ML device. Therefore, many of the typical AI/ML-specific questions (like effect size of AI assistance, standalone algorithm-only performance, training set details, or complex ground truth establishment) are not applicable in this context. The "acceptance criteria" here refer to the device's conformance to established international and domestic standards for condoms, rather than performance metrics of an AI algorithm.
Acceptance Criteria and Device Performance for Durex Male Latex Colored Condom with Scented Lubricants
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Conformance) | Reported Device Performance |
|---|---|
| Material: Natural Rubber Latex | Conforms: Made of natural rubber latex sheath. |
| Design: Straight-walled, Teat-ended, Colored | Conforms: Straight walled, teat ended, colored (red, yellow, orange, green pigment). |
| Lubrication: Water-based, Scented | Conforms: Lubricated with water-based flavored lubricant (lychee, guava, pineapple, mango, kiwi scent). |
| Regulatory Conformance (General): Domestic and International Regulations | Conforms: Designed to conform to national and international voluntary standards. |
| Specific Standard 1: ISO 4074:2002 (Natural latex rubber condoms — Requirements and test methods) | Conforms: Device design conforms to ISO 4074:2002. Physical testing and release testing revealed results in conformance with required specifications. |
| Specific Standard 2: ASTM D3492-03 (Standard Specification for Rubber Contraceptives (Male Condoms)) | Conforms: Device design conforms to ASTM D3492-03. Physical testing and release testing revealed results in conformance with required specifications. |
| Intended Use Equivalence: Contraception and Prophylaxis (STD prevention) | Conforms: Same intended use as predicate devices (K980174 & K900679). Used for contraception and for prophylactic purposes. |
| Technological Characteristics Equivalence: Material, Form, Lubricant Base, Pigments | Conforms: Same technological characteristics as predicate condoms. Same basic formulation as predicate devices (K980174 & K900679), same pigments, aqueous based lubricants. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a numerical sample size for the "test set" in the context of device testing. It states: "Physical testing and release testing of the finished product revealed results in conformance with required specifications."
- Sample Size: Not explicitly stated. The testing would have been done on a manufacturing batch or sample of the produced condoms.
- Data Provenance: Not explicitly stated, but it would be prospective testing conducted on manufacturing samples of the device itself. The country of origin of the data would likely be where the manufacturing and quality control testing took place (e.g., the manufacturer's facility or a contracted lab).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This question is not applicable to this type of device (physical condom). "Ground truth" in this context refers to the established standards (ISO 4074:2002 and ASTM D3492-03) and the objective measurements performed against these standards (e.g., burst pressure, dimensions, tensile strength, freedom from holes).
- The "experts" involved would be a combination of engineers, quality control specialists, and regulatory affairs personnel who conduct and interpret the physical and chemical tests according to the established methodologies outlined in the referenced standards. Their qualifications would typically include expertise in materials science, mechanical engineering, and quality assurance relevant to rubber products.
4. Adjudication Method for the Test Set
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling discordant expert interpretations of data in diagnostic or AI studies. For a physical device like a condom, conformance to standards is determined through objective physical and chemical testing with pre-defined pass/fail criteria, not consensus among experts adjudicating subjective findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, And Effect Size
- No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices (especially imaging) where human readers interpret patient cases, often with and without AI assistance, to assess the AI's impact on human performance. This is irrelevant for a physical contraceptive device like a condom.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- No, this is not applicable. The device is a physical product (condom), not an algorithm or software. There is no AI component to assess in a standalone mode.
7. The Type of Ground Truth Used
- The "ground truth" for this device's acceptance is based on objective measurements against established engineering and material standards. Specifically, the ground truth is defined by the requirements and test methods outlined in ISO 4074:2002 and ASTM D3492-03. This includes parameters like:
- Dimensions (length, width, thickness)
- Burst volume and pressure (critical for tensile strength and hole prevention)
- Freedom from holes
- Package integrity
- Material composition properties
- Lubricant quantity and type
8. The Sample Size for the Training Set
- This question is not applicable as there is no AI/ML model being "trained" for this physical device. The "training" for such a device involves developing and refining the manufacturing process, which is based on material science, engineering principles, and previous experience with similar products, rather than a data-driven training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable for the same reasons as #8. The establishment of "ground truth" (i.e., performance characteristics) for manufacturing and design would be based on:
- Extensive material science research and development for rubber latex.
- Adherence to internationally recognized standards (ISO, ASTM) which are developed through expert consensus, rigorous testing, and clinical experience over many years to define what constitutes a safe and effective condom.
- Feedback from previous product generations and market surveillance.
§ 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.