(146 days)
Not Found
No
The 510(k) summary describes a standard menstrual tampon and the testing performed to demonstrate its safety and effectiveness for absorbing menstrual fluid. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No.
The device is intended to absorb menstrual fluid, which is a supportive function and not a therapeutic purpose, and it does not treat or prevent any disease.
No
Explanation: The device, Playtex® Gentle Glide Scented and Unscented menstrual tampons, is intended to absorb menstrual fluid, which is a therapeutic and hygiene function, not a diagnostic one. It does not identify or detect any disease or condition.
No
The device is a physical product (tampons) intended for absorption of menstrual fluid, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissues, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Tampon Function: The intended use of Playtex Gentle Glide tampons is to absorb menstrual fluid within the body (in the vagina). They are not used to examine a specimen outside the body to provide diagnostic information.
- Lack of Diagnostic Purpose: The description and intended use clearly state the purpose is absorption of menstrual fluid, not diagnosis or providing information about a physiological state or disease.
- Testing Focus: The performance studies mentioned focus on safety (biocompatibility, irritation, toxicity) and performance (absorbency), not on diagnostic accuracy or the ability to detect specific substances or conditions in a specimen.
Therefore, based on the provided information, Playtex Gentle Glide tampons are not IVDs. They are considered medical devices, but not in the category of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Playtex scented or scented deodorized menstrual tampons are intended unscented menstrual tampons are inserted into the vagina and used to absorb menstrual fluid.
Product codes (comma separated list FDA assigned to the subject device)
HIL, HEB
Device Description
Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Preclinical:
Cytotoxicity
Vaginal Irritation in Rabbits
Acute Systemic Toxicity
Zone of Inhibition (Vaginal Microflora)
Toxic Shock Syndrome Test
In vitro Vaginal Irritation
Clinical
Human Repeat Insult Patch Test (Sensitization)
Human Vaginal Irritation (Safety In Use)
Performance Testing
Syngyna testing was conducted in accordance to 21 CFR §801.430(f)(2) to verify that the modified tampons met absorbency ranges as specified in the regulation.
● Absorbs menstrual flow
§ 884.5460 Scented or scented deodorized menstrual tampon.
(a)
Identification. A scented or scented deodorized 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. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual tampon) or for deodorizing purposes (scented deodorized menstrual tampon). This generic type of device does not include menstrual tampons treated with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).
0
JUN 2 1 2012
| 510(k) Summary | |
|---|---|
| Name of 510(k) Sponsor | Playtex Products, LLC |
| 6 Research Drive | |
| Shelton, CT 06484 | |
| Contact Information | Pushpa Rao, Ph.D., D.A.B.T., R.A.C. |
| Senior Manager, Product Safety/North American Regulatory Affairs | |
| Research & Development | |
| Playtex Products, LLC | |
| 75 Commerce Drive | |
| Allendale, NJ 07401 | |
| Telephone: 201-785-8070 | |
| Facsimile: 201-785-8202 | |
| Summary prepared on | January 25, 2012 |
| Pre-Market Notification # | |
| Reason for Submission | Changes to the applicator colorant, fragrance and pledget design |
| compared to predicate tampons. Pre-clinical and clinical testing | |
| confirmed that these changes did not affect the safety of the modified | |
| tampon. These changes were not expected to affect efficacy, and this | |
| was verified by performance testing. The results of these tests are | |
| included in this 510(k) pre-market notification. | |
| Name of Device | |
| Trade Name | Playtex® Gentle Glide Scented Tampons |
| Playtex® Gentle Glide Unscented Tampons | |
| Common Name | Menstrual Tampon, Scented and Unscented |
| Classification Name | Tampon, Menstrual Scented and Unscented |
| Classification Code | HIL, HEB |
| Predicate Devices | Playtex® Gentle Glide and Playtex® Gentle Glide Multipack Tampons |
| (K073662) |
Playtex® Gentle Glide Plastic and Playtex® Gentle Glide Plastic
Multipack Tampons (K070745)
Playtex® Non-deodorant Gentle Glide (unscented), Playtex Deodorant
Gentle Glide (Scented) and Playtex Non-deodorant and Deodorant
Multipack Tampons (K072376) |
| Device Description | Scented or scented deodorized, unscented menstrual tampons for the
absorption of menstrual fluid. |
| Intended Use | Playtex scented or scented deodorized menstrual tampons are intended |
| | unscented menstrual tampons are inserted into the vagina and used to
absorb menstrual fluid. |
| Technological
Characteristics | The modified tampons have the same technological characteristics as the
predicate devices (K070745, K072376 and K073662). The fiber and
materials in contact with the vaginal wall are the same or have the same
mode of action. The only differences in the modified tampons from the
predicate tampons are: (1) the composition of the colorants incorporated
into the polyethylene resin used to manufacture the applicator (barrel
and plunger); (2) a new fragrance; (3) a new pledget design. |
| Biocompatibility Tests | Biocompatibility and microbiological studies of the modified tampons
were conducted in accordance with the FDA guidance and applicable
standards. The results demonstrate that the modified Playtex Gentle
Glide tampons are safe and effective for their intended use and are
substantially equivalent to legally marketed predicate tampons. The
testing included: |
| | Preclinical:
Cytotoxicity
Vaginal Irritation in Rabbits
Acute Systemic Toxicity
Zone of Inhibition (Vaginal Microflora)
Toxic Shock Syndrome Test
In vitro Vaginal Irritation |
| | Clinical
Human Repeat Insult Patch Test (Sensitization)
Human Vaginal Irritation (Safety In Use) |
| Performance Testing | Syngyna testing was conducted in accordance to 21 CFR §801.430(f)(2)
to verify that the modified tampons met absorbency ranges as specified
in the regulation. |
| | ● Absorbs menstrual flow