(40 days)
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No
The summary describes performance studies related to absorbency and toxin testing of tampons, with no mention of AI or ML.
No
The description mentions testing for toxin levels and absorbency in tampons, which are hygiene products, not therapeutic devices.
No
Explanation: The provided text describes testing conducted for tampons (TSS-1, toxin testing, Syngyna test, Dioxin Analysis) and mentions comparisons to a predicate device. This information relates to the safety and performance of a consumer product, not to the diagnosis of a medical condition.
No
The summary describes performance studies related to physical properties of a tampon (TSST-1, Toxin testing, Syngyna test, Dioxin Analysis), indicating a physical medical device, not a software-only one.
Based on the provided information, it is highly unlikely that this device is an IVD (In Vitro Diagnostic). Here's why:
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Lack of IVD-specific information: The document is missing key sections that would be present for an IVD, such as:
- Intended Use / Indications for Use: This is crucial for defining what an IVD is intended to measure or detect.
- Device Description: This would typically describe the reagents, instruments, and procedures used in the diagnostic test.
- Input Imaging Modality, Anatomical Site, Patient Age Range, Intended User/Care Setting: These are often relevant for IVDs, especially those involving imaging or specific patient populations.
- Training and Test Set Descriptions: These are essential for evaluating the performance of an IVD, particularly those using AI/ML.
- Key Metrics (Sensitivity, Specificity, etc.): These are standard performance metrics for IVDs.
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Presence of non-IVD testing: The performance studies described focus on:
- TSST-1, Toxin testing: This relates to the potential for toxic shock syndrome, which is a concern for tampons.
- Syngyna test results: This is a test method used to measure the absorbency of tampons.
- Dioxin Analysis: This is a test for the presence of dioxins, which can be a contaminant in certain products.
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Mention of "tampons": The text explicitly mentions "Playtex Tampons" and "commercially sold tampons." Tampons are medical devices, but they are generally classified as Class II or Class III devices based on their intended use for menstrual fluid absorption, not as IVDs.
In summary, the information provided strongly suggests that this document describes a tampon and its associated testing for safety and performance characteristics relevant to its use as a menstrual product, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
"Toxin testing was conducted; results are in the range of values of commercially sold tampons and there are no significant differences between Playtex Tampons #12496 (Slimfit Tampon) and the predicate device (Exhibit 4). Syngyna test results are reported in Section 6 - Regular and Super absorbency ranges are within 6-9 gms and 9-12 gms respectively. Dioxin Analysis - Not detectable at limits of detection of HRGG/HRMS Method 8290 (Triangle Labs, North Carolina). Summary provided in Exhibit 5."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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§ 884.5460 Scented or scented deodorized menstrual tampon.
(a)
Identification. A scented or scented deodorized menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual tampon) or for deodorizing purposes (scented deodorized menstrual tampon). This generic type of device does not include menstrual tampons treated with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).
0
SUMMARY OF SAFETY AND EFFECTIVENESS 9.
TSST-1, Toxin testing was conducted; results are in the range of values of commercially sold tampons and there are no significant differences between Playtex Tampons #12496 (Slimfit Tampon) and the predicate device (Exhibit 4).
Syngyna test results are reported in Section 6 - Regular and Super absorbency ranges are within 6-9 gms and 9-12 gms respectively.
Dioxin Analysis - Not detectable at limits of detection of HRGG/HRMS Method 8290 (Triangle Labs, North Carolina). Summary provided in Exhibit 5.