(59 days)
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No
The device description and performance studies focus on the physical properties and absorbency of a menstrual tampon, with no mention of AI or ML technology.
No
The device is described as a menstrual tampon used to absorb menstrual fluid, which is a supportive function rather than a therapeutic one (treating or curing a disease/condition).
No
This device, a tampon, is used to absorb menstrual fluid. Its intended use and description do not mention any diagnostic capabilities; it is a sanitary product.
No
The device description clearly states it is a physical product (tampons made of cotton) and does not mention any software components.
Based on the provided information, the Femtex 100% Cotton Gentle Touch tampons are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to absorb menstrual fluid, which is a physical function within the body. IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health or condition.
- Device Description: The description focuses on the materials and physical function of the tampon. There is no mention of analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies described are related to biocompatibility and absorbency, which are relevant to a physical device inserted into the body, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples, using reagents, or providing diagnostic results, all of which are hallmarks of IVD devices.
Therefore, the Femtex 100% Cotton Gentle Touch tampons are a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Femtex 100% Cotton Gentle Touch 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 Gentle Touch Tampons are menstrual tampons used to absorb menstrual fluid. Femtex 100% Cotton Gentle Touch Tampons will be provided with 2 absorbencies, regular and super.
Femtex 100% Cotton Gentle Touch Tampons are made from cotton absorbent, cotton cord and cotton sewing thread.
The material used in Femtex 100% Cotton Gentle Touch 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
Biocompatability testing of the Femtex 100% Cotton 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.
- irritation testing
- cytotoxicity testing
- sensitization testing
- vaginal irritation 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
MAR 2 | 1997
510K SUMMARY
Device Name: Femtex 100% Cotton Gentle Touch Tampons
Legally marketed device: These Femtex 100% Cotton Gentle Touch Tampons are substantially equivalent to legally marketed Femtex Gentle Touch tampons with applicators.
Device description: Femtex 100% Cotton Gentle Touch Tampons are menstrual tampons used to absorb menstrual fluid. Femtex 100% Cotton Gentle Touch Tampons will be provided with 2 absorbencies, regular and super.
Femtex 100% Cotton Gentle Touch Tampons are made from cotton absorbent, cotton cord and cotton sewing thread.
The material used in Femtex 100% Cotton Gentle Touch tampons are similar to those used in other legally marketed tampons.
Intended Use: Femtex 100% Cotton 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 100% Cotton 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.
- � irritation testing
- 0 cytotoxicity testing
- sensitization testing 0
- vaginal irritation testing 0