(84 days)
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No
The device description and performance studies focus on the materials and safety of a menstrual tampon, with no mention of AI or ML technology.
No.
The document describes a menstrual tampon, which is used to absorb menstrual fluid and is not intended to treat or cure any medical condition or disease.
No
The device description indicates that Tampax Tampons are used to absorb menstrual fluid, not to diagnose a condition.
No
The device description clearly states it is a physical product (tampons made of cotton and/or rayon fibers) and includes details about materials and an applicator. There is no mention of software as the primary component or function.
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 test performed on a sample taken from the body to diagnose a condition or provide information about a physiological state.
- Device Description: The description focuses on the materials and physical characteristics of the tampon for absorption. There is no mention of reagents, assays, or any components designed to detect or measure substances in a biological sample.
- Lack of IVD Characteristics: The document does not mention any of the typical elements associated with IVDs, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes (proteins, DNA, chemicals, etc.)
- Providing diagnostic information
- Using laboratory equipment or procedures
The testing described (biocompatibility, microbiological, irritation, etc.) is focused on the safety and physical performance of the tampon within the body, which is consistent with a medical device intended for physical use, not an IVD.
N/A
Intended Use / Indications for Use
Tampax Tampons with Additive 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
Tampons with Additive are menstrual tampons used to absorb menstrual fluid. Tampax Tampons with Additive will be provided in 4 absorbencies, junior, regular, super and super plus Tampax Tampons with Additive are made of cotton and/or rayon fibers and overwrap, cotton cord, and an additive. The applicator used in Tampax tampons with Additive is flushable and biodegradable. Except for the additive, the materials used in Tampons with Additive are identical to those used in other legally marketed Tampax tampons. This additive has been adequately characterized and evaluated using scientifically valid safety tests.
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: Biocompatibility and microbiological testing of the additive and Tampax Tampons with Additive was conducted. The results of these tests demonstrate that Tampons with Additive are equivalent in terms of safety and effectiveness to legally marketed tampons. In addition to the review of existing toxicological data, the following tests were conducted related to the safetv of Tampax Tampons with Additive: - Irritation and sensitization testing . - . Cytotoxicity testing - . Genotoxicity testing - In vitro vaginal microflora testing . - . Additional microbiological testing Clinical Testing: A clinical study was done to evaluate the safety of Tampax Tampons with Additive and to compare its safety to its predicates. The study compared Tampax Tampons with Additive to a control tampon during normal menstrual use. Safety was evaluated by comparing the prevalence of product related irritation and other parameters after normal menstrual use. The study results showed no difference in product related irritation, comfort, or other parameters between Tampax Tampons with Additive and the control product. No significant or unexpected adverse events were observed during the study.
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
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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
Appendix 8
510(k) Summarv
Device Name: Tampax Tampons with Additive
Legally marketed device: Tampons with Additive are substantially equivalent to legally marketed Tampax OEF tampons.
Device description: Tampons with Additive are menstrual tampons used to absorb menstrual fluid. Tampax Tampons with Additive will be provided in 4 absorbencies, junior, regular, super and super plus
Tampax Tampons with Additive are made of cotton and/or rayon fibers and overwrap, cotton cord, and an additive. The applicator used in Tampax tampons with Additive is flushable and biodegradable.
Except for the additive, the materials used in Tampons with Additive are identical to those used in other legally marketed Tampax tampons. This additive has been adequately characterized and evaluated using scientifically valid safety tests.
Intended Use; Tampax Tampons with Additive are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
Assessment of performance data
Non-clinical testing: Biocompatibility and microbiological testing of the additive and Tampax Tampons with Additive was conducted. The results of these tests demonstrate that Tampons with Additive are equivalent in terms of safety and effectiveness to legally marketed tampons. In addition to the review of existing toxicological data, the following tests were conducted related to the safetv of Tampax Tampons with Additive:
- Irritation and sensitization testing .
- . Cytotoxicity testing
- . Genotoxicity testing
- In vitro vaginal microflora testing .
- . Additional microbiological testing
Clinical Testing: A clinical study was done to evaluate the safety of Tampax Tampons with Additive and to compare its safety to its predicates. The study compared Tampax Tampons with Additive to a control tampon during normal menstrual use. Safety was evaluated by comparing the prevalence of product related irritation and other parameters after normal menstrual use.
The study results showed no difference in product related irritation, comfort, or other parameters between Tampax Tampons with Additive and the control product. No significant or unexpected adverse events were observed during the study.
1
Conclusions: Results of the non-clinical and clinical tests showed that the additive does not alter the safety or effectiveness of the device and that Tampax Tampons with Additive are as safe and as effective , and perform as well as predicate, legally marketed tampons. Further, the results demonstrated that Tampax Tampons with Additive are substantially equivalent to other legally marketed tampons.