The provided text describes a 510(k) submission for Playtex Tampons, specifically addressing their substantial equivalence to previously cleared Playtex Gentle Glide Tampons. It does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested.

The document states:

Device Name: Playtex Tampons (Unscented Menstrual Tampons)
Predicate Device: Previously cleared Playtex Gentle Glide Tampons, Regular, Super and Super Plus.
Intended Use: Unscented menstrual tampons for the absorption of menstrual fluid.
Technological Characteristics: The new tampon has the same technological characteristics as the predicate device (fiber, string, materials in contact with the vaginal wall, and mode of action are the same).
Nonclinical Testing: Dioxin analysis, dermal irritation, acute oral toxicity, subacute vaginal irritations, agar diffusion, and TSST-1 toxin testing.
Conclusion: The Playtex Tampons are substantially equivalent to the predicate device in terms of safety and effectiveness based on the review of the data.

Therefore, I cannot populate the table or provide information for the specific points you requested, as the document focuses on demonstrating substantial equivalence rather than reporting on specific performance acceptance criteria from a study.

The document indicates that the determination of safety and effectiveness was based on the nonclinical testing mentioned above and a comparison to the predicate device. It does not describe a clinical study with a test set, ground truth, or statistical analysis of performance metrics against predefined acceptance criteria for the new device.

Summary

{0}------------------------------------------------

5100x) SUMMARY 11 9.

יסרש 2 - 1 מני "

1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -

MAY 2 | 1997

1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SUMMARY OF SAFETY AND EFFECTIVENESS A.

K971174

Playtex Products Inc. -COMPANY NAME 215 College Road - ADDRESS P. O. Box 728 Paramus, New Jersey 07652 201-265-8000 TELEPHONE • M. Rosengarten CONTACT PERSON .
Director of Regulatory Affairs

May 19, 1997 DATE OF SUMMARY -

Playtex Tampons -2. DEVICE NAME
Unscented Menstrual Tampons CLASSIFICATION NAME -
The new Playtex tampons are substantially equivalent to previously 3. cleared Playtex Gentle Glide Tampons, Regular, Super and Super Plus.
The device description is: Unscented menstrual tampons for the absorption 4. of menstrual fluid.
Playtex Gentle Glide Tampons are intended to be used as unscented menstrual ડ. tampons for the absorption of menstrual fluid.
The new tampon has the same technological characteristics as the predicate ఈ device. The fiber, string and materials in contact with the vaginal wall are the same and have the same mode of action.
Nonclinical testing referenced for the determination of substantial equivalence B. 1. includes:

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

Based on the review of the data referenced in this "510(k) Summary," the 3. Playtex Tampons are substantially equivalent to the predicate device in terms of safety and effectiveness.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular pattern around the left side of the eagle. The letters "GSA" are located on the upper right side of the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 1 1997

Irwin Butensky, Ph.D. Senior Vice President of R&D ... ... ... ... ... ... Playtex Products, Inc. 215 College Road, P.O. Box 728 Paramus, New Jersey 07652

Re: K971174

Playtex Tampons #08597 ... ... ...... ....... ........................................................ Dated: March 26, 1997 Received: March 31, 1997 Regulatory class: II 21 CFR §884.5470/Product code: 85 HEB

Dear Dr. Butensky:

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 Cosmetic Act (Act). 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. 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/dsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat/ and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

STATEMENT OF INDICATIONS OF USE PAGE

Page 1 of _1

ﻨﺘﻬﺎ

510(k) Number (if known): 上旬 2 l 7 4 - - -

Device Name: _ Playtex Gentle Glide Tampon

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 D. Sather/
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number - 1971122

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use_ T

(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).