(67 days)
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Not Found
No
The summary describes a standard menstrual tampon and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device is described as a menstrual tampon used to absorb fluid, which is not a therapeutic function. Its safety and effectiveness are compared to other legally marketed tampons for absorbency.
No
Explanation: The device description states that Femtex Digital Tampons are "used to absorb menstrual fluid." There is no mention of any diagnostic function or capability, such as detecting or monitoring medical conditions.
No
The device description clearly states it is a physical tampon made from rayon, polyethylene, polypropylene, and cotton cord, 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" by being "inserted into the vagina." This is a physical function within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The description details the materials and form of a standard menstrual tampon. There is no mention of reagents, assays, or any components typically associated with diagnostic testing.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, or tissue), detecting specific substances, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on biocompatibility and absorbency, which are relevant to the physical function of a tampon, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Femtex Digital 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)
Not Found
Device Description
Femtex Digital Tampons are menstrual tampons used to absorb menstrual fluid. Femtex Digital Tampons will be provided with 3 absorbencies, regular, super and super plus. Femtex Digital Tampons are made from rayon, polyethylene and polypropylene overwrap and cotton cord. There is no applicator. The material used in Femtex Digital tampons are comparable to those used in other legally marketed tampons.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
vagina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 Digital Tampons was carried out. The results of these tests demonstrate that Femtex Digital Tampons are equivalent in terms of safety and effectiveness to legally marketed tampons. Standard Syngyna testing confirmed the absorbency of Femtex Digital 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 Digital tampons. - irritation testing - sensitization testing - cytotoxicity testing - vaginal irritation testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Femtex tampons with applicators
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).
Not Found
§ 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
FIRST QUALITY HYGIEN CLINTON COUNTY INDUSTRIAL F P.O. BOX 330/NORTH ROAD/MCELHATTAN. PA 177
TEL 717-769-6900
FAX 717-769-7481
963032
OCT III ladde
510K SUMMARY
Device Name: Femtex Digital Tampons
Legally marketed device: Femtex Digital Tampons are substantially equivalent to legally marketed Femtex tampons with applicators.
Device description: Femtex Digital Tampons are menstrual tampons used to absorb menstrual fluid. Femtex Digital Tampons will be provided with 3 absorbencies, regular, super and super plus.
Femtex Digital Tampons are made from rayon, polyethylene and polypropylene overwrap and cotton cord. There is no applicator
The material used in Femtex Digital tampons are comparable to those used in other legally marketed tampons.
Intended Use: Femtex Digital 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 Digital Tampons was carried out. The results of these tests demonstrate that Femtex Digital Tampons are equivalent in terms of safety and effectiveness to legally marketed tampons. Standard Syngyna testing confirmed the absorbency of Femtex Digital 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 Digital tampons.
- � irritation testing
- 0 sensitization testing
- 0 cytotoxicity testing
- vaginal irritation testing 0