Unscented menstrual tampons for the absorption of menstrual fluid. The new tampon has the same technological characteristics as the predicate device. The fiber, string and materials in contact with the vaginat wall are the same or have the same mode of action.

AI/ML Overview

This 510(k) summary describes a new menstrual tampon and compares it to a legally marketed predicate device. The information provided is not about an AI/ML powered device, and therefore, many of the requested fields are not applicable.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (N/A for AI/ML)	Reported Device Performance and Results
Safety - Sensitization	Implied criterion: Device materials should not cause skin sensitization.	Testing conducted. Device is substantially equivalent to predicate.
Safety - Acute Oral Toxicity	Implied criterion: Device materials should not pose acute oral toxicity hazards.	Testing conducted. Device is substantially equivalent to predicate.
Safety - Subacute Vaginal Irritation	Implied criterion: Device should not cause subacute vaginal irritation.	Testing conducted. Device is substantially equivalent to predicate.
Safety - Agar Diffusion	Implied criterion: Device materials should not show cytotoxic effects in agar diffusion tests.	Testing conducted. Device is substantially equivalent to predicate.
Safety - TSST-1 Toxin Testing	Implied criterion: Device should not promote the production of TSST-1 toxin beyond acceptable levels.	Testing conducted. Device is substantially equivalent to predicate.
Effectiveness (Absorption of Menstrual Fluid)	Implied criterion: Device should absorb menstrual fluid effectively.	Based on substantial equivalence to the predicate device, which is already marketed for this purpose. The new tampon has the same technological characteristics, fiber, string, and materials in contact with the vaginal wall.
Substantial Equivalence (Overall)	The new device must be substantially equivalent to the predicate device in terms of safety and effectiveness.	Concluded that the Playtex #13203PV tampons are substantially equivalent to the predicate device (Playtex SilkGlide® Odor-Absorbing Cardboard Applicator Tampons K981760) in terms of safety and effectiveness.

Explanation of N/A for AI/ML criteria: The document describes a physical medical device (a tampon), not an artificial intelligence or machine learning product. Therefore, performance metrics typical for AI/ML devices such as accuracy, sensitivity, specificity, AUC, recall, precision, F1-score, etc., and criteria related to model performance, bias, or generalizability are not relevant or discussed. The acceptance criteria here are based on physicochemical and biological safety testing and a historical comparison to a predicate device for substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not specified in the provided summary. Clinical and nonclinical testing was conducted, but the number of subjects or samples for these tests is not detailed.
Data Provenance: Not explicitly stated, but the testing would have been performed by or for Playtex Products, Inc., likely in their R&D facilities or contracted laboratories. The information does not indicate specific countries of origin for the data (e.g., patient demographics for clinical trials), as this is not a study involving patient data in the typical sense of AI/ML evaluation. The study is prospective in the sense that the testing was performed specifically for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Experts for Ground Truth: Not applicable in the context of an AI/ML device. For a physical device like a tampon, safety and effectiveness are typically assessed through laboratory tests (e.g., agar diffusion, toxicity tests) and potentially human use studies (e.g., irritation studies). The "ground truth" is established by the results of these tests and their interpretation by qualified scientists/toxicologists/clinicians, not through expert consensus on diagnostic imaging or similar AI/ML applications.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. Adjudication methods like "2+1" or "3+1" are used in studies where human readers evaluate cases and their discrepancies need to be resolved for ground truth establishment. This is not relevant to physicochemical and biological testing for a tampon.

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:

MRMC Study: No. This is not an AI/ML device, so an MRMC study comparing human reader performance with and without AI assistance is irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Standalone Performance: No. This is not an algorithm.

7. The Type of Ground Truth Used:

Type of Ground Truth: The "ground truth" for the safety endpoints (sensitization, toxicity, irritation, TSST-1 toxin) is established by the results of standardized laboratory and biological assays (e.g., positive/negative reaction in sensitization tests, specific toxin levels, observed irritation scores). For effectiveness, the ground truth is indirectly supported by the known performance characteristics of the predicate device and the statement that the new device has the "same technological characteristics." There is no "pathology" or "outcomes data" in the sense of disease diagnosis or patient outcomes beyond the general safety profile.

8. The Sample Size for the Training Set:

Sample Size for Training Set: Not applicable. This is not an AI/ML device, so there is no "training set." The materials used for manufacturing are specified, and their safety properties are investigated.

9. How the Ground Truth for the Training Set Was Established:

Ground Truth for Training Set: Not applicable as there is no training set for an AI/ML device. The "ground truth" for the characteristics of the materials used in the manufacturing of the tampon would have been established through material specifications, quality control testing, and adherence to industry standards, not through a "training set" in the AI/ML context.

Summary

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K632636

NOV 1 4 2003

510(k) SUMMARY

Name of 510(k) Sponsor:	Playtex Products, Inc.
Address:	75 Commerce DriveAllendale, New Jersey 07401
Telephone:Fax:	(201) 785-8090(201) 785-8212
Contact Person:	Karen A. Costa, Ph.D.Director, Regulatory, Safety &Biomedical Affairs
Date of Summary:	August 25, 2003
Proprietary Name of Device:	Playtex Tampons #13203 & #13203PV
Generic/Classification Name:	Unscented menstrual tampon

Legally Marketed Predicate Devices:

Playtex SilkGlide® Odor-Absorbing Cardboard Applicator Tampons (K981760).

Device Description and Technological Characteristics:

Intended Use:

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

Testing:

Clinical and nonclinical testing conducted included sensitization, acute oral toxicity, subacute vaginal irritation, agar diffusion and TSST-1 toxin testing. Based on these data, it can be concluded that the Playtex #13203PV tampons are substantially equivalent to the predicate device in terms of safety and effectiveness.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 4 2003

Karen A. Costa, Ph.D. Director, Regulatory & Biomedical Affairs Playtex Products, Inc. Technical Center 75 Commerce Dr. ALLENDALE NJ 07401-1600 Re: K032636

Trade/Device Name: Playtex® Unscented Cardboard Applicator Tampon #13203(colored) and #13203PV(non-colored) Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: 85 HEB Dated: August 25, 2003 Received: August 28, 2003

Dear Dr. Costa:

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.

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 (OS) 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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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 the 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" (21CFR Part 807.97) you may obtain. 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/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

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INDICATIONS FOR USE STATEMENT

Applicant:	Playtex Products, Inc.
510(k) Number (if known):	K032636
Device Name:	Playtex® Unscented Cardboard Applicator Tampon#13203 (colored) and #13203PV (non-colored)
Indications for Use:	unscented tampons for the absorption of menstrual fluid

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)	or	Over-the-Counter Use
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(Division Sign-Off)
Division of Reproductive, Abdominal,and Radiological Devices	Page 18
PROPRIETARY DOCUMENT and information contained herein may not be reproduced, used or disclosed without written permission of Playtex Products, Inc.
510(k) Number	K032636

Regulation Number and Section

§ 884.5470 Unscented menstrual tampon.

(a)
Identification. An unscented 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. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).