(88 days)
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No
The summary describes a standard menstrual tampon and does not mention any AI or ML components or functionalities.
No
The device is described as a menstrual tampon used to absorb menstrual fluid, which is a supportive function rather than a therapeutic one that treats or prevents a disease or condition.
No
The document describes tampons, which are used to absorb menstrual fluid, not to diagnose a condition.
No
The device description clearly states that the device is a physical tampon made from rayon and cotton, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to absorb menstrual fluid, which is a physical function within the body. IVDs are used to examine specimens from the body (like blood, urine, or tissue) to diagnose diseases or conditions.
- Device Description: The device is a physical product (a tampon) made of materials like rayon and cotton, designed for absorption. It does not involve any reagents, instruments, or software for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information.
- Using reagents or analytical methods.
- Measuring biomarkers or other biological indicators.
The information provided clearly describes a medical device used for a physical function (absorption of menstrual fluid), not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Femtex Gentle Touch tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
Femtex Gentle Touch Tampons are menstrual tampons used to absorb menstrual fluid. Femtex Gentle Touch Tampons will be provided with 3 absorbencies, regular, super and super plus. Femtex Gentle Touch Tampons are made from rayon and, cotton cord and sewing thread.
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
vagina
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)
Non-Clinical Testing: Biocompatability testing of the Femtex Gentle Touch Tampons was carried out. The results of these tests demonstrate that Femtex Tampons are equivalent in terms of safety and effectiveness to legally marketed tampons. Standard Syngyna testing confirmed the absorbency of Femtex Tampons. In addition to the review of existing toxicological data in the public literature, the following tests were conducted relevant to the safety of Femtex tampons.
- 0 irritation testing
- sensitization testing
- vaginal irritation testing
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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§ 884.5470 Unscented menstrual tampon.
(a)
Identification. An unscented 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. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).
0
510K SUMMARY
Device Name: Femtex Gentle Touch Tampons
Legally marketed device: These Femtex Gentle Touch Tampons are substantially equivalent to legally marketed Femtex tampons with applicators.
Device description: Femtex Gentle Touch Tampons are menstrual tampons used to absorb menstrual fluid. Femtex Gentle Touch Tampons will be provided with 3 absorbencies, regular, super and super plus.
Femtex Gentle Touch Tampons are made from rayon and, cotton cord and sewing thread.
The material used in Femtex Gentle Touch tampons are similar to those used in other legally marketed tampons.
Intended Use: Femtex Gentle Touch tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
Assessment of Performance Standards: Not Applicable
Non-Clinical Testing: Biocompatability testing of the Femtex Gentle Touch Tampons was carried out. The results of these tests demonstrate that Femtex Tampons are equivalent in terms of safety and effectiveness to legally marketed tampons. Standard Syngyna testing confirmed the absorbency of Femtex Tampons. In addition to the review of existing toxicological data in the public literature, the following tests were conducted relevant to the safety of Femtex tampons.
- 0 irritation testing
- � sensitization testing
- vaginal irritation testing �