The provided 510(k) summary (K060981) for Playtex Sport Plastic Tampons does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

The 510(k) submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (Playtex Non-deodorant & Deodorant Gentle Glide Playtex Non-deodorant & Deodorant Gentle Glide Multipack Tampons, K830966, K020201, K912002). This means the manufacturer is asserting that the new device has the same technological characteristics and intended use as the previously cleared device, and therefore does not raise new questions of safety and effectiveness.

Instead of presenting specific performance acceptance criteria and a study demonstrating the device meets those criteria, the submission states:

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 differences in the modified tampons from the predicate devices are: the composition of the colorants incorporated into the polyethylene resin used to manufacture the applicator barrel and plunger; a new fragrance; and the contoured shape of the applicator and pledget."

Performance Data:
"Cytotoxicity testing, acute systemic toxicity testing, vaginal irritation testing, dermal irritation, allergic contact sensitization tests, microbial agar diffusion and toxic shock syndrome toxin-1 (TSST-1) testing indicate that the modified device meets all device input requirements."

Conclusions:
"The modified Playtex tampons are substantially equivalent to the predicate tampons."

Here's a breakdown of the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified in document	Meets all device input requirements based on cytotoxicity, acute systemic toxicity, vaginal irritation, dermal irritation, allergic contact sensitization, microbial agar diffusion, and TSST-1 testing.
Substantial Equivalence to predicate device (Playtex Non-deodorant & Deodorant Gentle Glide Playtex Non-deodorant & Deodorant Gentle Glide Multipack Tampons)	Concluded to be substantially equivalent.

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

The document mentions "Cytotoxicity testing, acute systemic toxicity testing, vaginal irritation testing, dermal irritation, allergic contact sensitization tests, microbial agar diffusion and toxic shock syndrome toxin-1 (TSST-1) testing." However, it does not provide details on the sample sizes used for these tests or the data provenance (e.g., country of origin, retrospective/prospective). These tests are generally laboratory or animal studies, not human clinical trials in this context.

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

Not applicable. This submission focuses on chemical and biological safety testing and substantial equivalence, not on interpreting images or patient data that would require expert consensus for ground truth.

4. Adjudication Method for the Test Set:

Not applicable. See point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. An MRMC study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret results, and the device aims to assist or replace human interpretation. This submission is for a menstrual tampon.

6. Standalone (Algorithm Only) Performance:

Not applicable. This device is not an algorithm or AI system.

7. Type of Ground Truth Used:

The "ground truth" used for this type of submission generally refers to established scientific/regulatory standards for biocompatibility and safety. The performance data mentioned (cytotoxicity, systemic toxicity, irritation, sensitization, microbial, TSST-1) are established methods to assess these safety aspects. There is no "ground truth" in the sense of expert consensus, pathology, or outcomes data for clinical accuracy as would be found in diagnostic device submissions.

8. Sample Size for the Training Set:

Not applicable. This submission does not involve machine learning or AI, and therefore, there is no training set.

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

Not applicable. See point 8.

Summary

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K06098i

and the contraction of the consisted on the consisted on the comments of the comments of the province of the province

510(k) SUMMARY

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Name of 510(k) sponsor:	Playtex Products, Inc.
Address:	75 Commerce DriveAllendale, NJ 07401-1600Telephone:	201.785.8101Facsimile:201.785.8242
Contact information:	Mr. Keith EdgettPlaytex Products, Inc.Telephone:Facsimile:	302.678.6880302.678.6540
Date summary prepared:	April 7, 2006
Proprietary name of device:	Playtex Sport Plastic, Playtex Sport Plastic MultipackTampons
Generic/classification name:	Scented and Unscented Menstrual Tampons
Product code (classification):	Scented or scented deodorized menstrual tampons andunscented menstrual tampons are Class II medical devices(HIL, 21 C.F.R. § 884.5460 and HEB, § 884.5470,respectively).

Legally Marketed (Unmodified) Devices:

Playtex Non-deodorant & Deodorant Gentle Glide Playtex Non-deodorant & Deodorant Gentle Glide Multipack Tampons

K830966, K020201, K912002

Device Description:

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

Intended Use:

Playtex tampons are intended to be used as scented or scented deodorized, 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 differences in the modified tampons from the predicate devices are: the composition of the colorants incorporated into the polyethylene resin used to manufacture the applicator barrel and plunger; a new fragrance; and the contoured shape of the applicator and pledget.

Performance Data:

Cytotoxicity testing, acute systemic toxicity testing, vaginal irritation testing, dermal irritation, allergic contact sensitization tests, microbial agar diffusion and toxic shock syndrome toxin-1 (TSST-1) 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAY - 9 2006

Mr. Keith Edgett Vice President Playtex Products, Inc. 75 Commerce Drive ALLENDALE NJ 07401

Re: K060981

Trade/Device Name: Playtex Sport Plastic Tampons, Unscented and Playtex Sport Plastic Tampons, Fresh Scent

Regulation Number: 21 CFR 884.5460 Regulation Name: Scented or scented deodorized menstrual tampon Regulatory Class: II Product Code: HIL Dated: April 7, 2006 Received: April 11, 2006

Dear Mr. Edgett:

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/11 description: The image shows the FDA Centennial logo. The logo is circular and contains the letters "FDA" in bold, black font. The words "Centennial" are written below the letters "FDA". The years "1906-2006" are written at the top of the circle.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FIEAS or advised that I DA's Issuance of a saceannal of the requirements of the Act or any FDA has made a decemination that your devices. You courses. You must comply with all
Federal statutes and regulations administered by other Federal agencies. CON CEP Re-1 807 Federal statutes and regulations administered of Ourse to registration and listing (21 CFR Part 807); the Act s requirements, mending, vat not mined to very career equirements as set forth in the quality labeling (21 CFR Part 001), good manalastians Fapplicable, the electronic product radiation in control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin marketing of substantial equivalence of your device to a legally premarket notification: "The PDA midnig of backannal vour 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 If you desire specific advice for your correst on the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 Also, please note the regulation other general information on your responsibilities under the Act from CI N 601.97). Tod may obtain outs. Beternational 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/industry/support/index.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

KO60981

510(k) Number (if known):

Playtex Products, Inc.

Device Name:

Indications For Use:

Playlex Sport Plastic Tampons, unscented Playtex Sport Plastic Tampons, fresh scent

Playtex Sport Plastic Tampons (unscented/fresh scent) for the absorption of menstrual fluid.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Brogdon

(Division Sign-Off) / Division of Reproductive, Abdominal, and Radiological Dev 510(k) Number

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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).