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510(k) Data Aggregation
(106 days)
TROJAN® MAGNUM® Latex Condom with FIRE & ICE™ Lubricant is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
TROJAN® MAGNUM® Latex Condom with FIRE & ICE™ Lubricant is a male condom consisting of a sheath of natural rubber latex which covers the penis with a fitted membrane, coated with a lubricant consisting of low levels of sensory ingredients to create a perception of warming and tingling. The condom is a taper-walled, non-textured, nipple-end condom with an integral formed ring at the open end.
This 510(k) notification is for a condom, not an AI/ML powered device. Therefore, many of the requested fields are not applicable. I will provide the information that is available in the document.
Acceptance Criteria and Device Performance for TROJAN® MAGNUM® Latex Condom with FIRE & ICE™ Lubricant
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety | Biocompatibility with human tissues | TROJAN® MAGNUM® Latex Condom with FIRE & ICE™ Lubricant is considered safe for consumer use under normal and reasonably foreseeable misuse conditions, based on: in vitro cytotoxicity extract test, vaginal irritation test, acute systemic toxicity, sensitive toxitization test, and bacterial reverse mutation assay. |
| Physical Properties | Meets specifications of ASTM D 3492-08 Standard Specifications for Rubber Contraceptives (Male Condoms) | Three (3) lots of condoms with the FIRE & ICE™ lubricant were tested and met the specifications of ASTM D 3492-08. |
| Shelf-life / Stability | Maintains safety and effectiveness over time, chemical compatibility with lubricant | Established through physical testing data using a protocol guided by 21 CFR §801.435. Initial expiration date set at 36 months, to be verified through real-time stability for five (5) years in compliance with 21 CFR §801.435. Chemical compatibility between latex condom and lubricant was also established. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Safety Studies: Not explicitly stated in terms of number of samples, but "studies" were performed.
- Sample Size for Physical Testing: Three (3) lots of condoms were tested.
- Data Provenance: Not specified, but generally, such testing is conducted in a controlled laboratory setting. The document does not indicate country of origin for the data or whether it was retrospective or prospective in the context of a clinical study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This device is a physical product (condom), and its performance is evaluated against established physical and biocompatibility standards, not against expert interpretation of data like in medical imaging.
4. Adjudication Method
Not applicable for this type of device and testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI-powered diagnostic or assistive device.
6. Standalone (Algorithm Only) Performance
Not applicable. This is not an AI/ML algorithm.
7. Type of Ground Truth Used
- Safety: Established through standard biocompatibility tests (e.g., in vitro cytotoxicity, irritation tests) which have defined endpoints for safety.
- Physical Properties: Established by the specifications defined in ASTM D 3492-08 Standard Specifications for Rubber Contraceptives (Male Condoms).
- Shelf-life: Established by physical testing data and compliance with 21 CFR §801.435, which guides expiration date labeling requirements.
8. Sample Size for the Training Set
Not applicable. There is no "training set" as this is a physical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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(125 days)
The Billy Boy condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections). The condoms are available in Cylindrical shape, in transparent color and with Nivesse aroma. The models include the BillyBoy, BillyBoy Scented, BillyBoy Special Comfort and BillyBoy Extra Lubricated.
The BillyBoy condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The condom is shaped with a reservoir end and is Cylindrical. These condoms have a length of 175 -185mm ±10mm, a width of 52.0 -55.0 mm ±2.0mm. The thickness is 0.04-0.08 mm. The air burst test pressure is ≥1 k Pa and air burst test volume is ≥18 dm². The primary packaging material is a foil package. The on surface lubricant is silicon oil.
The provided document describes the acceptance criteria and a study demonstrating that the Billy Boy Male Latex Condoms meet those criteria, primarily through compliance with ASTM D3492.
Here's a breakdown of the requested information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Billy Boy Male Latex Condoms are defined by their compliance with ASTM D3492, which is the standard for male latex condoms. The reported device performance is that the condoms passed all required specifications of this standard.
| Acceptance Criteria (Defined by ASTM D3492) | Reported Device Performance (Billy Boy Male Latex Condoms) |
|---|---|
| Compliant with ASTM D3492 | Passed all required specifications of ASTM D3492 |
| Air burst test pressure ≥ 1 k Pa | ≥ 1 k Pa (stated as characteristic, implicitly passed) |
| Air burst test volume ≥ 18 dm² | ≥ 18 dm² (stated as characteristic, implicitly passed) |
Additionally, specific dimensional characteristics are detailed and compared to predicate devices for substantial equivalence:
| Characteristic | ASTM D3492/Predicate Criteria (examples) | Billy Boy Performance |
|---|---|---|
| Length | 160mm (Twin Lotus), 195mm (Kimono Maxx), 205mm (Trojan Her Pleasure) | 175 - 185mm ±10mm (BillyBoy), ≥ 175 mm (Special Comfort) |
| Width | 52 ± 2mm (Twin Lotus), 52mm (Kimono Maxx), 55mm (Trojan Her Pleasure) | 52.0 - 55.0 mm ±2.0mm (BillyBoy), (55 ± 2) mm (Special Comfort) |
| Thickness | 0.08 ± 0.01 mm (Twin Lotus), 0.07 mm (Kimono Maxx) | 0.04-0.08 mm |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "BillyBoy condoms were tested to the standard and passed all required specifications." However, it does not specify the sample size used for this functional testing.
The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the device is not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" for condom performance is established by objective physical testing against a recognized standard (ASTM D3492).
4. Adjudication Method for the Test Set
This information is not applicable for physical device testing against a standard.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
This information is not applicable as this is not an AI/imaging device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as this is a physical device and not an algorithm.
7. The Type of Ground Truth Used
The ground truth used is based on objective performance measurements against established engineering and material standards, specifically ASTM D3492 for male latex condoms. This standard covers physical properties such as dimensions, air burst pressure and volume, and biocompatibility.
8. The Sample Size for the Training Set
This information is not applicable. This is not an AI device that requires a training set. The manufacturing process of condoms involves quality control and testing, but these are not referred to as "training sets" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as this is not an AI device.
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