(25 days)
Not Found
No
The device description and intended use clearly describe a menstrual tampon, a mechanical device for fluid absorption. There is no mention of any computational or analytical capabilities that would suggest the use of AI/ML. The performance studies listed are standard biocompatibility and safety tests for this type of device.
No.
The intended use is for the absorption of menstrual fluid, and the performance studies focus on safety and biocompatibility, not on treating or preventing a disease or condition. The device is a menstrual tampon, which is a common feminine hygiene product.
No
The device is described as a menstrual tampon for the absorption of menstrual fluid. Its intended use and device description do not mention any diagnostic capabilities, such as detecting, monitoring, or diagnosing a medical condition. Performance studies focus on safety (cytotoxicity, irritation, TSST-1 testing) rather than diagnostic accuracy.
No
The device description and intended use clearly describe a physical product (menstrual tampons) and the performance studies relate to biological and chemical testing of this physical product, 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 for the "absorption of menstrual fluid," which is a physical function within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The description reinforces the function of absorption.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, or tissue), detecting biomarkers, or providing diagnostic information about a disease or condition.
- Performance Studies: The performance studies focus on safety and biocompatibility (cytotoxicity, irritation, toxicity, microbial testing), which are relevant for a medical device intended for internal use, but not for an IVD.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Scented or scented deodorized menstrual tampon for the absorption of menstrual fluid; unscented menstrual tampon for the absorption of 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
Not Found
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)
Cytotoxicity testing, acute systemic toxicity testing, vaginal irritation testing, dermal irritation, allergic contact sensitization tests, microbial agar diffusion and toxic shock syndrome toxin-1 (TSST-1) testing indicate that the modified device meets all device input requirements.
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.
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.
Not Found
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
§ 884.5460 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
510(k) SUMMARY
| Name of 510(k) sponsor: | Playtex Products, Inc. | APR 13 2007 |
|---|---|---|
| Address: | Playtex Products, Inc. | |
| 804 Walker Rd. | ||
| Dover, DE 19904 | ||
| Telephone: 302.678.6880 | ||
| Facsimile: 302.678.6540 | ||
| Contact information: | Mr. Keith Edgett | |
| Vice President | ||
| Research and Development | ||
| Playtex Products, Inc. | ||
| Telephone: 302.678.6880 | ||
| Facsimile: 302.678.6540 | ||
| Date summary prepared: | March 15, 2007 | |
| Proprietary name of device: | Playtex Gentle Glide Plastic, Playtex Gentle Glide Plastic | |
| Multipack Tampons | ||
| Generic/classification name: | Scented and Unscented Menstrual Tampons | |
| Product code (classification): | Scented or scented deodorized menstrual tampons and | |
| unscented menstrual tampons are Class II medical devices | ||
| (HIL, 21 C.F.R. § 884.5460 and HEB, § 884.5470, | ||
| respectively). |
Legally Marketed (Unmodified) Devices:
Playtex Non-deodorant & Deodorant Gentle Glide Playtex Non-deodorant & Deodorant Gentle Glide Multipack Tampons
Device Description:
Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
1
Intended Use:
Playtex tampons are intended to be used as scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
Technological Characteristics:
The new tampon has the same technological characteristics as the cleared tampon. The fiber, string, 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 devices are: the composition of the colorants incorporated into the polyethylene resin used to manufacture the applicator barrel and plunger; and the dimensions of the unformed pledget pads. The shape of the final formed pledget for each absorbency is essentially identical to the predicate devices.
Performance Data:
Cytotoxicity testing, acute systemic toxicity testing, vaginal irritation testing, dermal irritation, allergic contact sensitization tests, microbial agar diffusion and toxic shock syndrome toxin-1 (TSST-1) testing indicate that the modified device meets all device input requirements.
Conclusions:
The modified Playtex tampons are substantially equivalent to the predicate tampons.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR 1 3 2007
Mr. Keith Edgett Vice President Playtex Products, Inc. 804 Walker Rd. DOVER DE 19904
Re: K070745
Trade/Device Name: Playtex Gentle Glide Plastic and Playtex Gentle Glide Plastic Multipack Tampons Regulation Number: 21 CFR 884.5460 Regulation Name: Scented or scented deodorized menstrual tampon Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HIL and HEB Dated: March 15, 2007 Received: March 19, 2007
Dear Mr. Edgett:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image is a black and white circular seal. The seal contains the text "1806-1906" at the top, and the letters "PA" in a large, bold font in the center. Below the letters, the word "Centennial" is written in a smaller font. There are four stars below the word "Centennial". The text "History of the County" is written along the bottom edge of the seal.
Protecting and Promoting Public Health
3
Page 2 --
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
| Applicant: | Playtex Products, Inc. |
|---|---|
| 510(k) Number: | K070745 |
| Device Name: | Playtex Gentle Glide Plastic and Playtex Gentle Glide Plastic |
| Multipack Tampons | |
| Indications for Use: | Scented or scented deodorized menstrual tampon for the absorption |
| of menstrual fluid; unscented menstrual tampon for the absorption | |
| of menstrual fluid. |
(PLEASE DO NOT WRITE BELOW THIS LINE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-the Counter Use
David A. Henderson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number
1-WA/2548871.3