The provided text is a 510(k) Summary for a medical device (Playtex Tampons). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include information about acceptance criteria or a study proving that the device meets specific performance criteria in the context of an AI/algorithm-driven device.

The document is a regulatory submission for a physical product (tampons) and focuses on demonstrating substantial equivalence according to FDA regulations existing in 1998. It references nonclinical testing related to biocompatibility and safety (e.g., sensitization, irritation, toxicity, Dioxin analysis, TSST-1 toxin testing) to show that the new tampon has the same technological characteristics and mode of action as previously cleared predicate devices.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving device performance as outlined in your prompt because the provided text does not contain this type of information.

Specifically, it lacks:

A table of acceptance criteria and reported device performance: The document mentions "nonclinical testing" but no specific performance metrics or acceptance criteria for those tests are presented in a table format.
Sample size, data provenance, number of experts, adjudication method for a test set: This information is not relevant to the type of substantial equivalence submission for a physical product like a tampon.
MRMC comparative effectiveness study or standalone algorithm performance: These are concepts related to AI/algorithm performance and are not applicable to the submitted document.
Type of ground truth, training set sample size, how ground truth was established for a training set: Also not applicable to this type of device submission.

The document's purpose is to establish substantial equivalence for a physical medical device, not to present performance data for an AI/algorithm.

Summary

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JUL 22 1998

9. 510(k) SUMMAR Y

K981760

P171

SUMMARY OF SAFETY AND EFFECTIVENESS A.

1.	COMPANY NAME	-	Playtex Products Inc.
	ADDRESS	-	215 College RoadP. O. Box 728Paramus, New Jersey 07652
	TELEPHONE	-	201-265-8000
	CONTACT PERSON	-	M. RosengartenDirector of Regulatory & BiomedicaAffairs
	DATE OF SUMMARY	-	May 15, 1998
2.	DEVICE NAME	-	Playtex Tampons

CLASSIFICATION NAME - Unscented Menstrual Tampons

The new Playtex tampons are substantially equivalent to previously 3. cleared Playtex Gentle Glide® and Silk Glide®Tampons, Regular, Super and Super Plus.
The device description is: Unscented menstrual tampons for the absorption 4. of menstrual fluid.
Playtex tampons are intended to be used as unscented menstrual tampons for న. the absorption of menstrual fluid.
1. 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.
Nonclinical testing referenced for the determination of substantial equivalence B. 1. includes:

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

1. 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.

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Image /page/1/Picture/2 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human figures, stacked on top of each other. The figures are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the figures.

JUL 22 1998

Mr. Mark Rosengarten Director. Regulatory and Biomedical Affairs Research and Development Playtex Products, Inc. 215 College Road, P.O. Box 728 Paramus, NJ 07652

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K981760 Playtex Silk Glide Odor Absorbing Flushable Cardboard Tampons #13598 Dated: May 15, 1998 Received: May 19, 1998 Regulatory Class: II 21 CFR 884.5470/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 revisions of the Federal Food. Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of 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 III (Premarket Approval), 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 895. A substantially equivaliance compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, 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 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 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 deving regulation (21 CFR Part 80) 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/odri/dsmaldsmamain.html".

Sincerely your

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_

جنج

510(k) Number (if known): K 98 l 7 6 o

Device Name: __ Playtex Silk Glide®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 R. Satting/
(Division Sign-Off)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K981760

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use_ }

(Optional Format 1-2-96)

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).