PLAYTEX DEODORANT TAMPONS, MODEL 34902

• K Number: K020201
• Device Name: PLAYTEX DEODORANT TAMPONS, MODEL 34902
• Manufacturer: PLAYTEX PRODUCTS, INC.
• Date Cleared: 2002-03-12 ( 49 days)
• Product Code: HIL
• Regulation Number: 884.5460
• Type: Traditional
• Panel: Obstetrics/Gynecology
• Reference & Predicate Devices: N/A
• Predicate For: K060981 , K070745

Intended Use

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

Device Description

Scented, deodorized menstrual tampons for the absorption of menstrual fluid.

AI/ML Overview

This document describes the 510(k) summary for Playtex Tampons, specifically scented, deodorized menstrual tampons. The submission aims to demonstrate substantial equivalence to previously cleared Playtex tampon models.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. A table of acceptance criteria and the reported device performance:

   Acceptance Criteria	Reported Device Performance
   Substantial equivalence to predicate devices regarding safety and effectiveness.	Playtex tampons are reported to be substantially equivalent to the predicate devices (Playtex Deodorant Gentle Glide®, Playtex Deodorant Portables®, Playtex Deodorant Gentle Glide Multipack, and Deodorant Slimfits®) in terms of safety and effectiveness. This determination is based on a review of referenced nonclinical testing data. The new tampon has the same technological characteristics as the predicate devices, with the fiber, string, and materials in contact with the vaginal wall being the same or having the same mode of action. The device is intended for the same use: scented, deodorized menstrual tampons for the absorption of menstrual fluid.
   Nonclinical testing (Human sensitization, dermal irritation, acute oral toxicity, subacute vaginal irritations, agar diffusion, and TSST-1 toxin testing) to support safety.	Nonclinical testing referenced for the determination of substantial equivalence includes: Human sensitization, dermal irritation, acute oral toxicity, subacute vaginal irritations, agar diffusion, and TSST-1 toxin testing. (Specific results or thresholds for these tests are not provided in the summary, only that they were referenced and support substantial equivalence.)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   The document does not specify a "test set" in the context of a clinical study with human subjects. The supporting data for substantial equivalence is based on nonclinical testing. Therefore, information regarding sample size, data provenance (country of origin, retrospective/prospective) for a clinical test set is not applicable or not provided in this 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   As the data relies on nonclinical testing rather than human subject data requiring ground truth established by experts (like radiologists for imaging devices), this information is not applicable to this submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   Given that the supporting data is from nonclinical laboratory tests instead of a clinical test set, an adjudication method for a test set is not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   This submission is for a medical device (tampons) and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC comparative effectiveness study is not applicable.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   This submission is for a medical device (tampons) and does not involve an algorithm. Therefore, a standalone performance study is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   For this device, the "ground truth" for demonstrating safety and effectiveness stems from the results of the nonclinical laboratory tests (human sensitization, dermal irritation, acute oral toxicity, subacute vaginal irritations, agar diffusion, and TSST-1 toxin testing) in comparison to the same tests performed on the predicate devices. The "ground truth" is that the new device performs equivalently in these specific tests to the predicate devices, which are already considered safe and effective.

8. The sample size for the training set:

   This submission does not involve an algorithm or an AI system that requires a "training set." Therefore, this information is not applicable.

9. How the ground truth for the training set was established:

   Given that no training set for an algorithm is involved, this information is not applicable.

Summary of Device and Acceptance Criteria Fulfilment:

The core of this 510(k) submission is to demonstrate substantial equivalence to existing, legally marketed predicate devices. The acceptance criteria relate to showing that the new Playtex Tampons have the "same technological characteristics" and achieve equivalent safety and effectiveness based on nonclinical testing. The study supporting this is a comparison of these nonclinical tests between the new device and the predicate devices. The summary states that these tests were "referenced" and support the conclusion of substantial equivalence. No clinical studies in human subjects with specific performance metrics (like sensitivity, specificity, accuracy) were provided or required for this type of device and submission pathway.

Summary

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

Koaaoi

9. 510(k) SUMMARY

MAR 1 2 2002

SUMMARY OF SAFETY AND EFFECTIVENESS A.

1.	COMPANY NAME	-	Playtex Products Inc.
	ADDRESS	-	75 Commerce DriveAllendale, New Jersey 07401
	TELEPHONE	-	201-785-8000
	CONTACT PERSON	-	M. RosengartenDirector, Regulatory, Safety &International Development
	DATE OF SUMMARY	-	January 18, 2002
2.	DEVICE NAME	-	Playtex Tampons
	CLASSIFICATION NAME	-	Scented, Deodorized MenstrualTampons

• 3. The new Playtex tampons are substantially equivalent to the following tampons that have been previously cleared:
  • a. Playtex Deodorant Gentle Glide® in Regular, Super and Super Plus absorbencies
  • Playtex Deodorant Portables® in Regular and Super absorbencies ف
  • Playtex Deodorant Gentle Glide Multipack in Regular and Super C. absorbencies
  • d. Deodorant Slimfits® in Regular absorbency
• 4. The device description is: Scented, deodorized menstrual tampons for the absorption of menstrual fluid.
• న. Playtex tampons are intended to be used as scented, deodorized menstrual tampons for the absorption of menstrual fluid.
• 6. The new tampon has the same technological characteristics as the predicate device. The fiber, string and materials in contact with the vaginal wall are the same or have the same mode of action.
• B. 1. Nonclinical testing referenced for the determination of substantial equivalence includes:

Human sensitization, dermal irritation, acute oral toxicity, subacute vaginal irritations, agar diffusion and TSST-1 toxin testing.

• 2. Based on the review of the data referenced in this "510(k) Summary," the Playtex tampons are substantially equivalent to the predicate device in terms of safety and effectiveness.

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

mar 1 2 2002

Mr. Mark Rosengarten Director, Safety & International & International Development Playtex Products, Inc. Technical Center, 75 Commerce Dr. ALLENDALE NJ 07401-1600

Re: K020201

Trade/Device Name: Playtex Deodorant Tampons # 34902

Regulation Number: 21 CFR 884.5460 Regulation Name: Scented or scented deodorized menstrual tampon

Regulatory Class: II Product Code: 85 HIL Dated: January 18, 2002 Received: January 22, 2002

Dear Mr. Rosengarden:

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 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.

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.

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

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nredicate 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 11 you toon office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[phone]

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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

Enclosure

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

STATEMENT OF INDICATIONS OF USE PAGE

Page 1 of _1

510(k) Number (if known): KOJOAO

Device Name: Playtex Deodorant Gentle Glide, Playtex Deodorant Portables®, Playtex Deodorant Gentle Glide® Multipack and Playtex Deodorant Slimfits® Tampons Model #34902

Indications For Usc:

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

(Optional Format 1-2-96)

Over-The-Counter Use

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).