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

Device Description

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

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Playtex tampons (K022882):

It is important to note that this 510(k) summary is for a modification to an existing device (Playtex tampons). The change is specifically the "composition of the colorants incorporated into the polyethylene resin used to manufacture the applicator barrel and plunger." Therefore, the studies focus on confirming that these colorant changes do not negatively impact the safety and performance of the tampons, rather than establishing primary efficacy for menstrual fluid absorption.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Requirement	Reported Device Performance	Notes
Biocompatibility	Human sensitization	Meets "all device input requirements"	This suggests that the modified tampons did not induce sensitization in human subjects. The specific threshold or method for "meeting requirements" is not detailed, but generally involves assessing the absence of allergic reactions.
Biocompatibility	Dermal irritation	Meets "all device input requirements"	This indicates the modified tampons did not cause significant skin irritation.
Biocompatibility	Acute oral toxicity	Meets "all device input requirements"	This is typically assessed to ensure that if accidental ingestion of components occurs, it does not lead to acute toxic effects. Given the product's use, this is likely a safety assessment of any leachables from the colorants.
Biocompatibility	Subacute vaginal irritation	Meets "all device input requirements"	This is a crucial test for a vaginal device, confirming the new colorants do not cause irritation to vaginal tissues over a subacute exposure period.
Cytotoxicity	Cytotoxicity	Meets "all device input requirements"	This test assesses whether the device materials are harmful to cells. "Meeting requirements" implies no significant cytotoxic effects were observed.
Material Safety	Extraction (of colorants/components)	Meets "all device input requirements"	This likely refers to testing the migration or leaching of components (especially the new colorants) from the applicator material into surrounding media, simulating conditions of use, to ensure they remain below safety thresholds.
Toxic Shock Syndrome	TSST-1 toxin testing	Meets "all device input requirements"	This is a critical safety test for tampons. It evaluates whether the modified device's materials promote the production of Toxic Shock Syndrome Toxin-1 (TSST-1) by Staphylococcus aureus, which is a known risk associated with tampon use. "Meeting requirements" implies it did not increase TSST-1 production compared to acceptable levels or the predicate device.
Technological Equivalence	Fiber, string, materials in contact with vaginal wall	Same or have the same mode of action as cleared tampon	This explicitly states that the core functional components of the tampon (absorbent material, string) were not changed, and their performance is presumed to be equivalent to the predicate device.
Technological Equivalence	Applicator barrel and plunger material composition	Difference only in the composition of colorants incorporated into the polyethylene resin	This is the only stated difference from the predicate, confirming that only the non-functional colorants in the applicator changed.

Study Information Summary

Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes for each of the performance tests (human sensitization, dermal irritation, etc.).
- Data Provenance: Not explicitly stated as retrospective or prospective, nor is the country of origin mentioned. However, these types of in vitro and in vivo (animal/human) safety tests are typically prospective studies conducted in a controlled laboratory setting.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. These tests are laboratory-based scientific assays (e.g., cell cultures for cytotoxicity, animal models for irritation, analytical chemistry for extraction, microbiological assays for TSST-1). "Ground truth" in this context is established by the assay's results against predetermined safety thresholds, not by expert consensus on clinical findings.
Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjective evaluations (e.g., image interpretation). These are objective laboratory tests with pre-defined criteria.
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:
- Not applicable. This is a safety and technological equivalence study for a medical device (tampons), not an AI-assisted diagnostic tool. No human readers or AI are involved in the "interpretation" of results in the way an MRMC study would apply.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm-based device.
The type of ground truth used:
- The "ground truth" for these studies is based on pre-established scientific safety standards and thresholds for various biological and chemical endpoints (e.g., acceptable levels of irritation, cytotoxicity, extractables, or TSST-1 production). In some cases, it would also involve comparison to the performance of the predicate device.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary

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K022882

510(k) SUMMARY

Playtex Products, Inc.

Name of 510(k) sponsor:

Address:

75 Commerce Drive Allendale, NJ 07401-1600 Telephone: 201.785.8100 201.785.8242 Facsimile:

Dr. Paul A. Siracusa Contact information: Telephone: 201.785.8101 Facsimile: 201.785.8242

August 28, 2002 Date summary prepared:

Playtex Gentle Glide®, Playtex Portables®, Playtex Gentle Proprietary name of device: Glide® Multipack, and Playtex Slimfits® tampons

Scented and Unscented Menstrual Tampons Generic/classification name:

respectively).

Product code (classification):

Legally Marketed (Unmodified) Devices:

Playtex Non-deodorant, Deodorant & Odor-absorbing Gentle Glide® Playtex Non-deodorant & Deodorant Portables® Playtex Non-deodorant & Deodorant Slimfits® Playtex Non-deodorant & Deodorant Gentle Glide® Multipack Tampons

Scented or scented deodorized menstrual tampons and

(HIL, 21 C.F.R. § 884.5460 and HEB, § 884.5470,

unscented menstrual tampons are Class II medical devices

K020200–K020202; K993794; K961870; K830966

Device Description:

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

Intended Use:

Playtex tampons are intended to be used as scented, unscented menstrual tampons for the absorption of menstrual fluid.

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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 difference in the modified tampons from the cleared devices listed above is the composition of the colorants incorporated into the polyethylene resin used to manufacture the applicator barrel and plunger.

Performance Data:

Human sensitization, dermal irritation, acute oral toxicity, subacute vaginal irritation, cytotoxicity, extraction, and TSST-1 toxin testing indicate that the modified device meets all device input requirements.

Conclusions:

The modified Playtex tampons are substantially equivalent to the predicate tampons.

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Image /page/2/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol is a representation of a human figure, with three wavy lines forming the profile of a person's head and shoulders.

SEP 1 6 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Paul A. Siracusa, D. En. Sc. Senior Vice President, Research & Development Playtex Products, Inc. Technical Center, 75 Commerce Dr. ALLENDALE NJ 07401-1600

Re: K022882

Trade/Device Name: Playtex Non-Deodorant, Deodorant & Odor-absorbing Gentle Glide®: Non-Deodorant & Deodorant Portables®: Slimfits®: Gentle Glide® 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: 85 HIL and HEB Dated: August 29, 2002 Received: August 30, 2002

Dear Mr. Siracusa:

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.

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Page 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 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:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrls/dsmamain.html.

Sincerely yours,

Nancy C. Brigdon

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

Enclosure

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INDICATIONS FOR USE STATEMENT

Applicant:	Playtex Products, Inc.
510(k) Number:	K022882
Device Name:	Playtex Non-deodorant, Deodorant and Odor-absorbing GentleGlide®, Playtex Non-deodorant and Deodorant Portables®, PlaytexNon-deodorant and Deodorant Slimfits®, and Playtex Non-deodorant and Deodorant Gentle Glide® Multipack Tampons(#24002)
Indications for Use:	Scented or scented, deodorized menstrual tampon for theabsorption of menstrual fluid; unscented menstrual tampon for theabsorption of menstrual fluid.

(PLEASE DO NOT WRITE BELOW THIS LINE)

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	K022882

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).