(78 days)
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No
The device description and performance studies focus on the material composition and absorbency of traditional tampons, with no mention of AI or ML.
No
The device is described as a menstrual tampon used to absorb menstrual fluid, which is not a therapeutic function.
No
The description clearly states the device is a menstrual tampon used to absorb fluid, not to diagnose any condition.
No
The device description clearly states that the device is a physical tampon made from cotton, cotton cord, and sewing thread, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Femtex Tampons' Function: Femtex tampons are designed to absorb menstrual fluid within the body. They do not analyze or test the fluid for diagnostic purposes. Their function is purely physical absorption.
- Intended Use: The intended use clearly states they are for absorbing menstrual fluid, not for any diagnostic testing.
The information provided about biocompatibility and absorbency testing relates to the safety and performance of the device as a physical absorbent, not as a diagnostic tool.
N/A
Intended Use / Indications for Use
Femtex tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
Product codes
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Device Description
Femtex 100% Cotton Tampons are menstrual tampons used to absorb menstrual fluid. Femtex Tampons will be provided with 2 absorbencies, regular, and super.
Femtex 100% Cotton Tampons are made from cotton and, cotton cord and sewing thread.
The material used in Femtex tampons are similar to those used in other legally marketed tampons.
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
Non-Clinical Testing: Biocompatability testing of a cotton tampon which was applicable to the Femtex Tampons was carried out. The results of these tests demonstrate that cotton tamons are equivalent in terms of safety and effectiveness to legally marketed tampons. Standard Syngyna testing confirmed the absorbency of Femtex 100% Cotton Tampons. In addition to the review of existing toxicological data in the public literature, the following tests were conducted relevant to the safety of cotton tampons.
ರಿ cytotoxicity testing
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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 APR - 9 1997
Device Name: Femtex 100% Cotton Tampons
Legally marketed device: These Femtex 100% Cotton Tampons are substantially equivalent to legally marketed Femtex tampons with applicators.
Device description: Femtex 100% Cotton Tampons are menstrual tampons used to absorb menstrual fluid. Femtex Tampons will be provided with 2 absorbencies, regular, and super.
Femtex 100% Cotton Tampons are made from cotton and, cotton cord and sewing thread.
The material used in Femtex tampons are similar to those used in other legally marketed tampons.
Intended Use: Femtex 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 a cotton tampon which was applicable to the Femtex Tampons was carried out. The results of these tests demonstrate that cotton tamons are equivalent in terms of safety and effectiveness to legally marketed tampons. Standard Syngyna testing confirmed the absorbency of Femtex 100% Cotton Tampons. In addition to the review of existing toxicological data in the public literature, the following tests were conducted relevant to the safety of cotton tampons.
ರಿ cytotoxicity testing