(49 days)
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No
The device description and performance studies focus on the physical properties and safety of menstrual tampons, with no mention of AI or ML.
No.
The intended use of the device is to absorb menstrual fluid, which is a hygienic function and not a therapeutic one.
No
Explanation: The device, TAMPAX Tampons, Plastic Applicator, is described as a product used to absorb menstrual fluid. Its intended use and the provided test results focus on safety and effectiveness for menstrual absorption, not on diagnosing any medical condition.
No
The device description clearly indicates it is a physical product (tampons with a plastic applicator) made of rayon, cotton, and plastic, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "unscented menstrual tampons used to absorb menstrual fluid." This describes a device used in vivo (within the body) for a physical function (absorption).
- Device Description: The description details the physical components of a tampon and its applicator.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances
- Providing information for diagnosis, monitoring, or screening
IVDs are devices used in vitro (outside the body) to examine specimens from the human body to provide information for medical purposes. This description clearly indicates a device used in vivo for a non-diagnostic purpose.
N/A
Intended Use / Indications for Use
unscented menstrual tampons used to absorb menstrual fluid.
Product codes
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Device Description
TAMPAX Tampons, Plastic Applicator will be provided in three absorbencies, regular, super and super plus. TAMPAX Tampons, Plastic Applicator have a colored plastic applicator. TAMPAX Tampons, Plastic Applicator are made of rayon fibers and overwrap, a cotton withdrawal cord, and a colored plastic applicator.
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
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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
A clinical study was done to evaluate the safety of TAMPAX Tampons, Plastic Applicator and to compare its safety to its predicates. The study compared insertion of TAMPAX Tampons, Plastic Applicator to insertion of control tampons during intermenstrual use in 57 women.
Summary of Performance Studies
Non-clinical Testing: Biocompatibility testing of the colorants and the colored applicator used in TAMPAX Tampons, Plastic Applicator was conducted. In addition to the review of existing literature and toxicological data, the following tests were conducted related to the safety of TAMPAX Tampons, Plastic Applicator: - Irritation and sensitization testing . - . Cytotoxicity testing - Extraction assay . The results of these tests demonstrate that TAMPAX Tampons, Plastic Applicator are equivalent in terms of their safety and effectiveness to legally marketed tampons.
Clinical Testing: A clinical study was done to evaluate the safety of TAMPAX Tampons, Plastic Applicator and to compare its safety to its predicates. The study compared insertion of TAMPAX Tampons, Plastic Applicator to insertion of control tampons during intermenstrual use in 57 women. Safety was evaluated by comparing the prevalence of product related irritation after tampon insertion. The study results showed no differences in product related irritation or comfort between TAMPAX Tampons, Plastic Applicator and the control product. No significant or unexpected adverse events were observed during the study.
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
K9622476
1 3 1996
510(k) Summary
as required by 21 CFR 807.92
| Device Name: | Unscented Menstrual Tampon |
|---|---|
| Manufacturer: | Tambrands Inc. |
| Bridge & Springfield Streets | |
| Palmer, MA 01069 | |
| Contact Person: | Jerome B. Wainick |
| Vice President, Research and Development | |
| Phone: (413) 289-3430 | |
| FAX: (413) 289-3433 |
Date Summary Prepared: June 17, 1996
Device Names:
| Trade Name: | TAMPAX Tampons, Plastic Applicator |
|---|---|
| Common Name: | TAMPAX Tampons |
| Classification Name: | Unscented Menstrual Tampons (21 CFR 884.5470) |
Legally Marketed Device: TAMPAX Tampons, Plastic Applicator
Device Description: TAMPAX Tampons, Plastic Applicator will be provided in three absorbencies, regular, super and super plus. TAMPAX Tampons, Plastic Applicator have a colored plastic applicator. TAMPAX Tampons, Plastic Applicator are made of rayon fibers and overwrap, a cotton withdrawal cord, and a colored plastic applicator.
TAMPAX Tampons, Plastic Applicator are unscented menstrual tampons used to absorb Intended Use: menstrual fluid.
How Product Differs from Predicate Device: The new device has a colored applicator. Except for the color of the applicator, TAMPAX Tampons, Plastic Applicator are identical to the predicate product. The colorants used in the colored applicator have been adequately characterized and evaluated using scientifically valid safety tests.
Assessment of Performance Data:
Non-clinical Testing: Biocompatibility testing of the colorants and the colored applicator used in TAMPAX Tampons, Plastic Applicator was conducted. In addition to the review of existing literature and toxicological data, the following tests were conducted related to the safety of TAMPAX Tampons, Plastic Applicator:
- Irritation and sensitization testing .
- . Cytotoxicity testing
- Extraction assay .
The results of these tests demonstrate that TAMPAX Tampons, Plastic Applicator are equivalent in terms of their safety and effectiveness to legally marketed tampons.
1
Clinical Testing: A clinical study was done to evaluate the safety of TAMPAX Tampons, Plastic Applicator and to compare its safety to its predicates. The study compared insertion of TAMPAX Tampons, Plastic Applicator to insertion of control tampons during intermenstrual use in 57 women. Safety was evaluated by comparing the prevalence of product related irritation after tampon insertion.
The study results showed no differences in product related irritation or comfort between TAMPAX Tampons, Plastic Applicator and the control product. No significant or unexpected adverse events were observed during the study.
Results of the non-clinical and clinical tests showed that the addition of colorant to the Conclusions: Plastic Applicator does not alter the safety or effectiveness of the device and that TAMPAX Tampons, Plastic Applicator are as safe and as effective as predicate, legally marketed tampons. Further, the results demonstrated that TAMPAX Tampons, Plastic Applicator are substantially equivalent to other legally marketed tampons.