(146 days)
Playtex® Gentle Glide Scented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.
Playtex® Gentle Glide Unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.
Absorbency Ranges:
Absorbs menstrual flow < 6 grams (Slender Light)
Absorbs menstrual flow 6-9 grams (Slender Regular, Regular)
Absorbs menstrual flow 9-12 grams (Super)
Absorbs menstrual flow 12-15 grams (Super Plus)
Absorbs menstrual flow 15-18 grams (Ultra)
Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
The Playtex® Gentle Glide Scented and Unscented Tampons (K120245) have specific acceptance criteria related to absorbency, which were verified through performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Absorbency Range per 21 CFR §801.430(f)(2)) | Reported Device Performance (Absorbency Grams) |
|---|---|
| Slender Light | < 6 grams (Absorbs menstrual flow) |
| Slender Regular, Regular | 6-9 grams (Absorbs menstrual flow) |
| Super | 9-12 grams (Absorbs menstrual flow) |
| Super Plus | 12-15 grams (Absorbs menstrual flow) |
| Ultra | 15-18 grams (Absorbs menstrual flow) |
The device meets these acceptance criteria, as stated in the performance testing section: "Syngyna testing was conducted in accordance to 21 CFR §801.430(f)(2) to verify that the modified tampons met absorbency ranges as specified in the regulation."
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size for the "Syngyna testing" (absorbency testing) or the biocompatibility tests. It only mentions that these tests were "conducted." The data provenance (e.g., country of origin, retrospective/prospective) is also not specified for these tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since this device is a menstrual tampon and the primary performance testing involves absorbency measurements, there isn't a "ground truth" derived from expert consensus in the same way it would be for a diagnostic AI device. The ground truth for absorbency is established by the standardized Syngyna testing method itself, as defined by 21 CFR §801.430(f)(2).
For the biocompatibility tests (preclinical and clinical), these are standard in vitro and in vivo tests that would be conducted by trained laboratory personnel, but not "experts" in the sense of clinicians establishing ground truth for a diagnostic outcome.
4. Adjudication Method for the Test Set
Not applicable. The absorbency tests are objective measurements, and biocompatibility tests involve standardized protocols and observations. There is no mention of an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
Not applicable. This is a medical device (menstrual tampon), not a diagnostic AI software. Therefore, an MRMC comparative effectiveness study involving human readers with or without AI assistance is not relevant to this submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
The ground truth for the absorbency performance is based on objective measurements obtained through the standardized Syngyna testing method, as mandated by federal regulation (21 CFR §801.430(f)(2)).
For the biocompatibility tests, the ground truth is established through standard laboratory test results (e.g., cytotoxicity, irritation, sensitization, TSS).
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device. There is no concept of a "training set" in the context of its development and testing as described in this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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JUN 2 1 2012
| 510(k) Summary | |
|---|---|
| Name of 510(k) Sponsor | Playtex Products, LLC6 Research DriveShelton, CT 06484 |
| Contact Information | Pushpa Rao, Ph.D., D.A.B.T., R.A.C.Senior Manager, Product Safety/North American Regulatory AffairsResearch & DevelopmentPlaytex Products, LLC75 Commerce DriveAllendale, NJ 07401Telephone: 201-785-8070Facsimile: 201-785-8202 |
| Summary prepared on | January 25, 2012 |
| Pre-Market Notification # | |
| Reason for Submission | Changes to the applicator colorant, fragrance and pledget designcompared to predicate tampons. Pre-clinical and clinical testingconfirmed that these changes did not affect the safety of the modifiedtampon. These changes were not expected to affect efficacy, and thiswas verified by performance testing. The results of these tests areincluded in this 510(k) pre-market notification. |
| Name of Device | |
| Trade Name | Playtex® Gentle Glide Scented TamponsPlaytex® Gentle Glide Unscented Tampons |
| Common Name | Menstrual Tampon, Scented and Unscented |
| Classification Name | Tampon, Menstrual Scented and Unscented |
| Classification Code | HIL, HEB |
| Predicate Devices | Playtex® Gentle Glide and Playtex® Gentle Glide Multipack Tampons(K073662)Playtex® Gentle Glide Plastic and Playtex® Gentle Glide PlasticMultipack Tampons (K070745)Playtex® Non-deodorant Gentle Glide (unscented), Playtex DeodorantGentle Glide (Scented) and Playtex Non-deodorant and DeodorantMultipack Tampons (K072376) |
| Device Description | Scented or scented deodorized, unscented menstrual tampons for theabsorption of menstrual fluid. |
| Intended Use | Playtex scented or scented deodorized menstrual tampons are intended |
| unscented menstrual tampons are inserted into the vagina and used toabsorb menstrual fluid. | |
| TechnologicalCharacteristics | The modified tampons have the same technological characteristics as thepredicate devices (K070745, K072376 and K073662). The fiber andmaterials in contact with the vaginal wall are the same or have the samemode of action. The only differences in the modified tampons from thepredicate tampons are: (1) the composition of the colorants incorporatedinto the polyethylene resin used to manufacture the applicator (barreland plunger); (2) a new fragrance; (3) a new pledget design. |
| Biocompatibility Tests | Biocompatibility and microbiological studies of the modified tamponswere conducted in accordance with the FDA guidance and applicablestandards. The results demonstrate that the modified Playtex GentleGlide tampons are safe and effective for their intended use and aresubstantially equivalent to legally marketed predicate tampons. Thetesting included: |
| Preclinical:CytotoxicityVaginal Irritation in RabbitsAcute Systemic ToxicityZone of Inhibition (Vaginal Microflora)Toxic Shock Syndrome TestIn vitro Vaginal Irritation | |
| ClinicalHuman Repeat Insult Patch Test (Sensitization)Human Vaginal Irritation (Safety In Use) | |
| Performance Testing | Syngyna testing was conducted in accordance to 21 CFR §801.430(f)(2)to verify that the modified tampons met absorbency ranges as specifiedin the regulation. |
| ● Absorbs menstrual flow < 6 grams (Slender Light)● Absorbs menstrual flow 6-9 grams (Slender Regular, Regular)● Absorbs menstrual flow 9-12 grams (Super)● Absorbs menstrual flow 12-15 grams (Super Plus)● Absorbs menstrual flow 15-18 grams (Ultra) | |
| The tampons are labeled in accordance to these absorbency ranges. | |
| Conclusion | The results of the preclinical and clinical testing indicate that themodified tampons are safe and effective for their intended use and whenconsidered in conjunction with the performance testing results are |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
JUN 2 1 2012
Pushpa Rao, Ph.D., D.A.B.T. R.A.C. Senior Manager, Product Safety/North American Regulatory Affairs Playtex, Inc. 75 Commerce Drive ALLENDALE NJ 07401
Re: K120245
Trade/Device Name: Playtex® Gentle Glide Scented & Unscented Tampons Regulation Number: 21 CFR§ 884.5460 Regulation Name: Scented or scented deodorized menstrual tampon Regulatory Class: II Product Code: HIL, HEB Dated: June 11, 2012 Received: June 12, 2012
Dear Dr. Rao:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Benjamin R. Tucker
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
Playtex® Gentle Glide Scented Tampons
Playtex® Gentle Glide Unscented Tampons
Indications For Use:
Playtex® Gentle Glide Scented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.
Playtex® Gentle Glide Unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.
Absorbency Ranges:
Absorbs menstrual flow < 6 grams (Slender Light)
Absorbs menstrual flow 6-9 grams (Slender Regular, Regular)
Absorbs menstrual flow 9-12 grams (Super)
Absorbs menstrual flow 12-15 grams (Super Plus)
Absorbs menstrual flow 15-18 grams (Ultra)
| Prescription Use(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use X(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)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Gastro-Renal, and Urological Devices | |
| 510(k) Number | K120245 |
§ 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).