Scented or scented deodorized menstrual tampon for the absorption of menstrual fluid; unscented menstrual tampon for the absorption of menstrual fluid.

Device Description

Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.

AI/ML Overview

This 510(k) summary is for a menstrual tampon, not a medical device that uses AI or requires complex statistical studies for its approval. Therefore, many of the requested categories regarding acceptance criteria and study design for AI/medical imaging devices are not applicable.

Here's the information that can be extracted and a clear indication of why other sections are not relevant to this specific premarket notification:

Acceptance Criteria and Device Performance for Playtex Gentle Glide Tampons

Acceptance Criteria (from "Performance Data")	Reported Device Performance
Cytotoxicity testing: (Implied: Device must not exhibit cytotoxic effects)	"Cytotoxicity testing...indicate that the modified device meets all device input requirements." (Implies satisfactory performance, absence of cytotoxicity)
Acute systemic toxicity testing: (Implied: Device must not cause acute systemic toxic effects)	"acute systemic toxicity testing...indicate that the modified device meets all device input requirements." (Implies satisfactory performance, absence of acute systemic toxicity)
Vaginal irritation testing: (Implied: Device must not cause vaginal irritation)	"vaginal irritation testing...indicate that the modified device meets all device input requirements." (Implies satisfactory performance, absence of vaginal irritation)
Allergic contact sensitization tests: (Implied: Device must not cause allergic contact sensitization)	"allergic contact sensitization tests...indicate that the modified device meets all device input requirements." (Implies satisfactory performance, absence of allergic contact sensitization)
Microbial agar diffusion: (Implied: Device must not promote microbial growth or conversely, may need to demonstrate inhibitory properties if claimed, though typically it's about biocompatibility)	"microbial agar diffusion...indicate that the modified device meets all device input requirements." (Implies satisfactory performance related to microbial interaction, consistent with safe use)
Toxic Shock Syndrome Toxin-1 (TSST-1) testing: (Implied: Device must meet safety standards regarding TSST-1 production, typically by not enhancing its production or having low/negligible impact. This is a critical safety aspect for tampons.)	"toxic shock syndrome toxin-1 (TSST-1) testing indicate that the modified device meets all device input requirements." (Implies satisfactory performance, consistent with safety standards for TSST-1, which is a key regulatory requirement for tampons.)

Note on "Device Input Requirements": The document states the device "meets all device input requirements." These "input requirements" would be the specific pass/fail criteria for each test (e.g., cytotoxicity score below a certain threshold, no irritation observed, TSST-1 production not significantly increased, etc.). The 510(k) summary only states that these requirements were met, not the specific numerical thresholds themselves.

Non-Applicable Sections and Explanations:

Due to the nature of this device (a menstrual tampon), the following information is not provided and is generally not relevant for this type of medical device submission:

Sample size used for the test set and the data provenance: Not specified for biocompatibility/safety tests. These tests are typically conducted in vitro or on animal models, not on large human "test sets" in the way an AI algorithm is evaluated.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood in AI/imaging studies (e.g., expert radiological reads) is not relevant for tampon safety testing. Biocompatibility tests rely on standardized laboratory protocols and scientific evaluation.
Adjudication method: Not applicable for standard biocompatibility and safety testing. The results are typically objectively measured and interpreted by laboratory personnel.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study assesses how AI impacts human reader performance, which doesn't apply to a physical product like a tampon.
Standalone performance (algorithm only without human-in-the-loop performance): Not applicable, as there is no algorithm or human-in-the-loop component for a tampon.
The type of ground truth used: For these safety tests, the "ground truth" is established via standardized biological and chemical assay results (e.g., cell viability percentages for cytotoxicity, observed tissue reactions for irritation, quantitative measurements for TSST-1). It's not "expert consensus, pathology, or outcomes data" in the context of an AI/imaging device.
The sample size for the training set: Not applicable. There is no AI model or "training set" for a menstrual tampon.
How the ground truth for the training set was established: Not applicable, as there is no training set.

Summary of the Device and Basis for Substantial Equivalence:

The Playtex Gentle Glide and Playtex Gentle Glide Multipack Tampons are seeking substantial equivalence to previously cleared Playtex tampons (K961870 and K070745). The submission emphasizes that the new tampon has the "same technological characteristics" and that "The fiber, string, and materials in contact with the vaginal wall are the same or have the same mode of action." The primary differences are noted as "the absorbency (lower), the dimensions of the unformed pledget pads, and the dimensions of the final formed pledget."

The "Performance Data" section demonstrates that despite these minor changes, the modified device still meets established safety and biocompatibility standards, specifically citing:

Cytotoxicity testing
Acute systemic toxicity testing
Vaginal irritation testing
Allergic contact sensitization tests
Microbial agar diffusion
Toxic Shock Syndrome Toxin-1 (TSST-1) testing

The conclusion is that based on these results, the modified Playtex tampon is substantially equivalent to the predicate tampons, meaning it is as safe and effective as the legally marketed devices.

Summary

{0}------------------------------------------------

510(k) SUMMARY

Name of 510(k) sponsor:	Playtex Products, Inc.
Address:	Playtex Products, Inc.804 Walker Rd.Dover, DE 19904Telephone: 302.678.6880Facsimile: 302.678.6540JAN 17 2008
Contact information:	Mr. Keith EdgettVice PresidentResearch and DevelopmentPlaytex Products, Inc.Telephone: 302.678.6880Facsimile: 302.678.6540
Date summary prepared	December 21, 2007
Proprietary name of device:	Playtex Gentle Glide, Playtex Gentle Glide MultipackTampons
Generic/classification name:	Scented and Unscented Menstrual Tampons
Product code (classification):	Scented or scented deodorized menstrual tampons andunscented 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 (K961870) Playtex Non-deodorant & Deodorant Gentle Glide Multipack Tampons (K070745)

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 tampon from the predicate devices are the absorbency (lower), the dimensions of the unformed pledget pads, and the dimensions of the final formed pledget.

Performance Data:

Cytotoxicity testing, acute systemic toxicity testing, vaginal irritation testing, 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 tampon is substantially equivalent to the predicate tampons.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a series of waving lines, representing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 17 2008

Mr. Keith Edgett Vice President, Research and Development Playtex Products, Inc. 804 Walker Rd. DOVER DE 19904

Re: K073662

Trade/Device Name: Playtex Gentle Glide and Playtex Multipack Tampons Regulation Number: 21 CFR 884.5460 Regulation Name. Scented or scented deodorized menstrual tampon Regulatory Class: II Product Code: HIL and HEB Dated: December 21, 2007 Received: December 26, 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 (PMA), 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.

{3}------------------------------------------------

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.html.

Sincerely yours.

Nancy C Brogdon

Nancy C. Brogdon Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

{4}------------------------------------------------

INDICATIONS FOR USE STATEMENT

Applicant:	Playtex Products, Inc.
510(k) Number:	K073662
Device Name:	Playtex Gentle Glide and Playtex Gentle Glide 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)

A .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	or	Over-the Counter Use ✓
------------------	----	------------------------------------------------------------------------

(Division Sign-Off)

Division of Reproductive, Abdominal,

and Radiological Devices

510(k) Number	K073662
---------------	---------

Regulation Number and Section

§ 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).