PLAYTEX TAMPONS #03498 by PLAYTEX, INC.

This document describes a 510(k) submission for Playtex Tampons (K980478), focusing on safety and effectiveness tests rather than AI/machine learning device performance. Therefore, many of the requested categories related to AI models, such as sample size for test sets, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, and training set information, are not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Dioxin Analysis	Not explicitly stated as "passing" or "failing"; implies compliance as part of the overall acceptance.
Primary Dermal Irritation (Rabbits)	Non-Irritating
Acute Oral Toxicity (Rats)	Non-Toxic
Subacute Vaginal Irritation (Rabbits)	Non-Irritating
Agar Diffusion Study	No zones of inhibition were detected
TSST-1, Toxin Testing	Results in the range of values of commercially sold tampons (previously conducted on the same rayon pledget submitted in K971174)
Human Repeat Insult Patch Test (200 persons)	Implies no significant safety issues, as it contributed to the overall substantial equivalence finding.

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

Sample Size:
- Primary Dermal Irritation: Not specified, but "Rabbits" plural implies more than one.
- Acute Oral Toxicity: Not specified, but "Rats" plural implies more than one.
- Subacute Vaginal Irritation: Not specified, but "Rabbits" plural implies more than one.
- Human Repeat Insult Patch Test: 200 persons.
Data Provenance: Not specified, but assumed to be internal laboratory testing or contract research organization testing for the manufacturer (Playtex). Retrospective or prospective is not clearly stated but typical in vivo/in vitro testing for device clearance is prospective.

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

Not applicable. The "ground truth" for these types of tests (e.g., irritation, toxicity) is based on standard biological and chemical assays and established scientific protocols, not expert consensus interpreting results. The experts involved would be laboratory scientists and toxicologists.

4. Adjudication Method for the Test Set

Not applicable. Results are based on objective measurements and established protocols for biological and chemical assays.

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

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

7. The Type of Ground Truth Used

The ground truth is based on:

In vitro/In vivo biological assays: For irritation, toxicity, and inhibition studies, ground truth is determined by the direct observed biological response or lack thereof according to established scientific methodologies and endpoints.
Chemical analysis: For Dioxin analysis, ground truth is determined by chemical quantification against established limits.
Toxin quantification: For TSST-1, ground truth is determined by laboratory methods to measure toxin levels.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device.

9. How the Ground Truth for the Training Set was Established

Not applicable. This is not an AI/machine learning device.

Summary

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K 980478

SUMMARY OF SAFETY AND EFFECTIVENESS 9.

1171

Dioxin Analysis ♪
Primary Dermal Irritation in Rabbits Non-Irritating ♪
APR 3 1998
♪ Acute Oral Toxicity in Rats - Non-Toxic
Subacute Vaginal Irritation in Rabbits Non-Irritating ♪
Agar Diffusion Study No zones of inhibition were detected ♪
TSST-1, Toxin testing was previously conducted on the same rayon pledget ♪ submitted in K971174; results are in the range of values of commercially sold tampons.
200 person Human Repeat Insult Patch Test. ♪

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 1999

Mr. Mark E. Rosengarten Director, Regulatory Affairs 215 College Road P.O. Box 728 Paramus, NJ 07652

Re: K980478

Playtex Tampons #03498 (Unscented) Dated: February 3, 1998 Received: February 6, 1998 Regulatory Class: II 21 CFR 887.5470/Procode: 85 HEB

Dear Mr. Rosengarten:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 Comments Act (Act). You may, therefore, narket 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Feleval Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Proctice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 predication 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmam.html".

Sincerely yours

Lillian Yin, Ph.D.

Director, Division of Reproducti Abdominal, Ear, Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS OF USE PAGE

Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _ Playtex Gentle Glide®, Soft Comfort™ and Slimits ™ Tampons

Indications For Use:

Unscented menstrual tampons for 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)

Robert Matting
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number K980478

Prescription Use. (Per 21 CFR 801.109)

ﻤﻌﺘﻤ

Over-The-Counter Use_

(Optional Format 1-2-96)

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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).