(184 days)
The Mercator male latex condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)
This condom is made of a natural latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip; nominal length 180-mm, nominal width 52-mm, and nominal thickness 0.06mm. It is lubricated with silicone and cornstarch is used as a dressing material. The condom has either a smooth or textured (dotted and/or ribbed) surface. This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074.
Here's an analysis of the provided text regarding acceptance criteria and study details for the Mercator Male Latex Condom:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly list a table of acceptance criteria with corresponding performance data from a specific study. Instead, it states that the device's design "is in conformance with ASTM Latex Condom Standard D3492" and "ISO 4074." These standards inherently contain acceptance criteria for various condom properties (e.g., burst strength, leakage, dimensions).
Therefore, the table below represents the implied acceptance criteria based on the referenced standards and the device's claim of conformance. The "Reported Device Performance" is inferred from the device's substantial equivalence claim and compliance with these standards.
| Acceptance Criteria Category (Implied from Standards) | Specific Acceptance Criteria (Example from D3492/ISO 4074) | Reported Device Performance (Inferred) |
|---|---|---|
| Dimensions | Nominal length, nominal width, nominal thickness (e.g., ASTM D3492 requirements) | Nominal length 180-mm, nominal width 52-mm, nominal thickness 0.06mm (Conforms to D3492 and ISO 4074) |
| Physical Properties (Water Leakage Test) | No leakage when subjected to specified test methods (e.g., ASTM D3492) | Conforms to ASTM D3492 and ISO 4074 (implies no leakage beyond acceptable limits) |
| Physical Properties (Burst Pressure/Volume) | Meets specified burst pressure and volume requirements (e.g., ASTM D3492/ISO 4074) | Conforms to ASTM D3492 and ISO 4074 (implies meeting burst strength) |
| Lubrication | Acceptable lubrication properties (e.g., type and amount) | Lubricated with silicone (Conforms to D3492 and ISO 4074) |
| Material | Made of natural rubber latex | Made of natural rubber latex (Conforms to D3492 and ISO 4074) |
| Absence of Defects | Free from holes, tears, and other visible defects | Conforms to ASTM D3492 and ISO 4074 |
| Packaging & Labeling | Conforms to relevant labeling regulations for expiry dating (per FDA letter) | Compliant with 21 CFR 801.435 (Expiration Dating), data maintained by manufacturer |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective) for the studies that demonstrate conformance to ASTM D3492 and ISO 4074. The submission primarily relies on the claim of conformance to established voluntary standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable or not provided in the context of this 510(k) notification. The evaluation of condom performance against standards like ASTM D3492 and ISO 4074 typically relies on standardized laboratory testing protocols, not expert consensus on individual "cases" in the medical sense.
4. Adjudication Method for the Test Set
This information is not applicable or not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or diagnostic results by human readers to establish a "ground truth" when a gold standard is not immediately available. For a device like a condom, performance is assessed through objective physical and material testing against predefined criteria in standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or mentioned. This type of study is relevant for diagnostic devices where human readers interpret data, often with and without AI assistance, to assess improvements in diagnostic accuracy. It is not relevant for a male latex condom.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
No, a standalone "algorithm only" study was not conducted or mentioned. This concept applies to AI/ML software as a medical device (SaMD) where the algorithm performs a diagnostic or predictive task without direct human intervention. This device is a physical medical device (condom), not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance, as established by its conformance to ASTM D3492 and ISO 4074, is based on objective, standardized physical and mechanical test results. For example:
- Physical Testing: Water leakage tests, burst pressure and volume tests using specialized equipment.
- Dimensional Measurements: Using calipers or other precision measuring tools.
- Material Analysis: Ensuring the material is natural rubber latex.
These tests are the "ground truth" for determining if the condom meets the performance requirements of the standards.
8. The Sample Size for the Training Set
This information is not applicable or not provided. "Training set" refers to data used to train an AI/ML algorithm. This device is a physical product, not an AI/ML system.
9. How the Ground Truth for the Training Set was Established
This information is not applicable or not provided for the reasons stated above (not an AI/ML 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.