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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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