(371 days)
aoni Natural Rubber Latex Condom [Smooth/Dotted/Combined]
a) Smooth 52mm/54mm/55mm natural
b) Dotted 52mm natural
c) Combined [smooth+girdling] 52mm natural
d) Combined [dotted+girdling] 52mm natural
The Condom is used for contraception and for prophylactic purpose ( to help prevent pregnancy and the transmission of sexually transmitted infections.)
aoni Natural Rubber Latex Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. These condoms conform to ISO 4074:2002 Natural Rubber Latex Condoms – Requirements and Test Methods, ASTM D3492-14 Standard Specification for Rubber Contraceptives (Male Condom), and ISO 10993-1 Biological Evaluation of Medical Devices - Part 1(2009). These condoms have repeated contact potential for a duration of
Acceptance Criteria and Device Performance for aoni Natural Rubber Latex Condom
This document summarizes the acceptance criteria and reported device performance for the "aoni Natural Rubber Latex Condom," as described in the provided 510(k) summary (K153016).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the aoni Natural Rubber Latex Condom are based on recognized international and national standards for rubber contraceptives and biocompatibility. The reported device performance indicates that the product met these specifications.
Table 1: Acceptance Criteria and Reported Device Performance
| Parameter / Test | Acceptance Criteria | Reported Device Performance | Standard(s) Applied |
|---|---|---|---|
| Physical Performance Tests | |||
| Water Leakage (Freedom from Holes) | Met specifications of ISO 4074:2002 and ASTM D3492-14 | "met the specifications" | ISO 4074:2002, ASTM D3492-14 |
| Burst Volume and Pressure | Met specifications of ISO 4074:2002 and ASTM D3492-14 | "met the specifications" | ISO 4074:2002, ASTM D3492-14 |
| Dimensions (Length, Width, Thickness) | Within specified ranges (e.g., Nominal Length 180mm, Width 52/54/55mm, Thickness 0.036-0.080mm) | Conformed to nominal dimensions and thickness ranges | ISO 4074:2002, ASTM D3492-14 |
| Biocompatibility Tests | |||
| Cytotoxicity | Met acceptance criteria of ISO 10993-5:2009 | "passed each biocompatibility test" | ISO 10993-5:2009 |
| Skin Irritation | Met acceptance criteria of ISO 10993-10:2010 | "passed each biocompatibility test" | ISO 10993-10:2010 |
| Vaginal Irritation | Met acceptance criteria of ISO 10993-10:2010 | "passed each biocompatibility test" | ISO 10993-10:2010 |
| Sensitization | Met acceptance criteria of ISO 10993-10:2010 | "passed each biocompatibility test" | ISO 10993-10:2010 |
| Acute Systemic Toxicity | Met acceptance criteria of ISO 10993-11:2006 | "passed each biocompatibility test" | ISO 10993-11:2006 |
| Shelf Life | 5 years (60 months) | "has a five years (60 month) shelf life based on the results of real time storage and testing" | 21 CFR 801.435, ISO 4074:2012 (Note: Document specifies 2012, while performance tests mention 2002 version for ISO 4074) |
Note on Standards: The document refers to ISO 4074:2002 for performance testing and ISO 4074:2012 for shelf life. Both are relevant versions of the standard for natural rubber latex condoms.
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical testing for performance and biocompatibility. It does not refer to a "test set" in the context of clinical studies with human subjects.
- Sample Size for performance and biocompatibility testing: The specific sample sizes for each non-clinical test (e.g., number of condoms for burst testing, number of animals for toxicity tests) are not explicitly stated in the provided 510(k) summary. The summary only broadly states that "Each variant of aoni Natural Rubber Latex Condom was tested".
- Data Provenance: The testing was conducted by Guangzhou Daming United Rubber Products Ltd. or its contracted laboratories. The information does not specify the country of origin for the data for individual tests beyond the manufacturer's location in Guangzhou, China. All testing appears to be retrospective (i.e., conducted on finished products to demonstrate compliance with standards) rather than prospective clinical trials.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable as the evaluation described is for ex-vivo device performance and biocompatibility testing against established standards, not a clinical study requiring expert assessment of "ground truth" for a test set (e.g., diagnosis of disease). The "ground truth" in this context is defined by the technical specifications and requirements outlined in the referenced ISO and ASTM standards.
4. Adjudication Method for the Test Set
This section is not applicable. The evaluation described involves objective physical and chemical testing against pre-defined performance criteria in established standards, not interpretation by human adjudicators.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed as this device (a condom) is not a diagnostic device that relies on human interpretation for an outcome. The evaluation is based on objective physical and chemical tests.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
This section is not applicable. The device is a physical medical device (condom), not an algorithm or AI-driven system. Therefore, standalone algorithm performance is not relevant.
7. Type of Ground Truth Used
The "ground truth" for demonstrating device compliance is defined by:
- Performance Specifications: Quantitative and qualitative requirements outlined in ISO 4074: Natural Rubber Latex Condoms – Requirements and Test Methods and ASTM D3492-14 Standard Specification for Rubber Contraceptives (Male Condom). These standards define acceptable ranges for parameters like burst volume and pressure, freedom from holes, and dimensions.
- Biocompatibility Standards: Criteria for various biological responses (cytotoxicity, irritation, sensitization, systemic toxicity) outlined in ISO 10993-1: Biological Evaluation of Medical Devices - Part 1, and its sub-parts (e.g., ISO 10993-5, ISO 10993-10, ISO 10993-11).
In essence, the ground truth is derived from established scientific and engineering standards and accepted laboratory test methods.
8. Sample Size for the Training Set
This section is not applicable. As a physical device, there is no "training set" in the context of machine learning or AI models. The manufacturing process is validated (and products routinely tested) to ensure consistent quality and adherence to specifications.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the reasons stated in point 8. The "ground truth" for manufacturing a condom to meet specifications is established through the development and validation of manufacturing processes to consistently produce a product that passes the non-clinical tests detailed above.
§ 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.