(281 days)
Condoms are latex sheaths, intended to completely cover the penis during sexual intercourse for contraception and prophylaxis, an aid to the prevention of sexually transmitted diseases (STDs). If used properly, latex Condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases.
This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted This condom has the specification as enclosed in membrane. Annexure 2
This is a 510(k) summary for a condom, which is a physical device, not an AI/ML powered medical device. Therefore, many of the requested fields are not applicable. However, I will extract and present the available information regarding acceptance criteria and device performance.
Device Name: Green Love Male Latex Condom
510(k) Number: K051842
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (from ASTM D3492-03) | Reported Device Performance (Likely meets, explicitly stated as conforming to ASTM D3492-03) |
|---|---|---|
| Material | Natural Rubber Latex | Natural Rubber Latex |
| Design | Sheath, completely covers penis, closely fitted | Sheath, completely covers penis, closely fitted |
| Size (Length, Width, Thickness) | As per ASTM D3492-03 | Not explicitly stated in the provided text, but implied to meet the standard. |
| Burst Volume/Pressure | As per ASTM D3492-03 | Not explicitly stated in the provided text, but implied to meet the standard. |
| Lubrication | Silicone lubricated | Silicone lubricated |
| Reservoir Tip | Present | Present |
| Intended Use | Contraception, Prophylaxis (prevention of STDs) | Contraception, Prophylaxis (prevention of STDs, including HIV) |
| Water Leakage | As per ASTM D3492-03 | Not explicitly stated in the provided text, but implied to meet the standard. |
Study Proving Device Meets Acceptance Criteria:
The submission states, "This condom design is in conformance with ASTM Latex Condom Standard D 3492-03 and that the condom is made of natural rubber latex." This indicates that the device was tested against the requirements of ASTM D3492-03 and found to meet all specified acceptance criteria within that standard. While specific numerical outcomes are not provided in this summary, the declaration of conformance is the primary evidence provided for meeting acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided 510(k) summary. Testing typically involves a statistical sampling plan as defined by the ASTM standard, but the exact number of condoms tested is not disclosed here.
- Data Provenance: The device manufacturer is CUPID CONDOM LIMITED, located in Maharashtra, India. The testing would have been conducted by or for the manufacturer. The data is retrospective to the submission date of June 30, 2005.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. For a physical device like a condom, "ground truth" is established by direct physical measurement and performance testing according to an engineering standard (ASTM D3492-03). It does not involve expert interpretation or diagnosis of images or clinical conditions in the same way an AI medical device would. The "experts" in this context would be trained technicians and engineers performing the tests.
4. Adjudication Method for the Test Set:
- Not Applicable. As per point 3, adjudication by multiple experts for "ground truth" establishment is not relevant for this type of device testing. Performance is measured objectively against the standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not Applicable. This type of study is relevant for diagnostic devices where human readers interpret data, often with AI assistance. It is not applicable to the performance testing of a physical contraceptive device like a condom.
6. Standalone Performance Study:
- Yes, a standalone performance assessment was done. The entire 510(k) submission, particularly the statement of conformance to ASTM D3492-03, represents a standalone performance assessment of the device against established engineering and safety standards. This assessment evaluates the condom's physical properties (e.g., burst strength, freedom from holes, dimensions) independent of human-in-the-loop interaction in a diagnostic or interpretive sense.
7. The Type of Ground Truth Used:
- Engineering Standard and Physical Measurement. The "ground truth" for this device's performance is defined by the objective, measurable parameters and test methods outlined in the ASTM Latex Condom Standard D 3492-03. This includes measurements of dimensions, burst volume/pressure, and water leakage tests.
8. Sample Size for the Training Set:
- Not Applicable. As a physical device, there is no "training set" in the context of machine learning. The manufacturing process is controlled and validated, but there isn't a separate data set used to "train" the device itself.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As explained in point 8, 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.