(30 days)
Playtex scented (or scented deodorized) and unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.
Absorbency Ranges:
Absorbs menstrual flow < 6 grams (Light)
Absorbs menstrual flow 6-9 grams (Regular)
Absorbs menstrual flow 9-12 grams (Super)
Absorbs menstrual flow 12-15 grams (Super Plus)
Scented (or scented deodorized) and unscented menstrual tampons for the absorption of menstrual fluid. The tampon consists of a pledget, string and applicator (barrel and plunger).
The provided text is related to a 510(k) submission for menstrual tampons, specifically regarding a change in the applicator color. It is not an AI/ML device, and therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance is not applicable.
However, I can extract the relevant "acceptance criteria" and the "study" that proves the device meets them from the document in the context of this specific regulatory submission.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit from Submission Goal) | Reported Device Performance/Conclusion |
|---|---|
| Safety: No adverse impact on safety due to applicator color change. | Risk Assessment & Leaching Studies: "As confirmed by our risk assessment and leaching studies, the proposed modification on the applicator colorant has no impact on the safety... of the device." (Conclusion) Additionally, "Biocompatibility Tests: Deemed not applicable for the modified device based on the results of the Leaching Studies. Biocompatibility testing was performed on the predicate device to confirm the tampon material safety." |
| Efficacy: No adverse impact on efficacy (absorbency) due to applicator color change. | Syngyna Testing: "No changes were made to the tampon pledget. Syngyna testing was performed and the results confirmed that the absorbance ranges are the same as the predicate device and comply with 21 CFR §801.430(f)(2)." (Performance Testing) "As confirmed by our risk assessment... the proposed modification on the applicator colorant has no impact on the... efficacy of the device." (Conclusion) |
| Substantial Equivalence: Device remains substantially equivalent to the predicate device. | Conclusion: "The proposed device is substantially equivalent to the predicate device." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this is a regulatory submission for a physical medical device (menstrual tampon) with a minor change (applicator color), not an AI/ML device relying on test sets of data. The "tests" mentioned are laboratory tests (Leaching Studies, Syngyna testing) performed on the device itself or its materials, not on a data set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. Ground truth, in the context of expert consensus, is relevant for AI/ML diagnostic or measurement devices. For this physical device, "ground truth" refers to established scientific/regulatory standards for material safety and absorbency, measured through laboratory methods, not expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in clinical trials or studies for AI/ML devices or human reader performance. The studies performed here are laboratory tests.
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
This information is not applicable. MRMC studies are specific to evaluating the impact of AI on human reader performance, which is not relevant for a menstrual tampon.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. There is no algorithm involved in the performance or evaluation of this menstrual tampon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is based on established regulatory standards and scientific methodologies for biocompatibility (evaluated through leaching studies, indirectly confirming safety) and absorbency (Syngyna testing against 21 CFR §801.430(f)(2)). It's not based on expert consensus, pathology, or outcomes data in the way these terms are used for AI/ML devices.
8. The sample size for the training set
This information is not applicable. There is no AI/ML algorithm requiring a training set for this device.
9. How the ground truth for the training set was established
This information is not applicable. Since there is no training set, there's no ground truth to establish for it.
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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 America Regulatory AffairsResearch & DevelopmentPlaytex Products, LLC75 Commerce DriveAllendale, NJ 07401Telephone: 201-785-8070Facsimile: 201-785-8202 |
| Summary prepared on | September 5, 2013 |
| Pre-Market Notification # | |
| Reason for Submission | Changes were made to the applicator color compared to the predicate device.These changes do not affect the intended use or alter the fundamental scientifictechnology of the device. In addition, the efficacy of the device has not beenaffected as there were no changes made to the tampon pledget and absorbencyranges. A risk assessment is provided in this Special 510(k) pre-marketnotification and confirms that these changes do not raise any safety concernsfor the proposed device. |
| Name of Device | |
| Trade Name | Playtex® (Scented) Sport Fresh Balance™ TamponsPlaytex® (Unscented) Sport Fresh Balance™ Tampons |
| Common Name | Menstrual Tampon, Scented and Unscented |
| Classification Name | Scented or scented deodorized menstrual tampon and Unscented menstrualtampon |
| Classification Code | HIL, HEB |
| Predicate Devices | Playtex® Sport (Scented) Tampons with Odorshield ™ and Playtex® Sport(Unscented) Tampons with Odorshield™ (K111684) |
| Device Description | Scented (or scented deodorized) and unscented menstrual tampons for theabsorption of menstrual fluid. The tampon consists of a pledget, string andapplicator (barrel and plunger). |
| Intended Use | Playtex scented and unscented menstrual tampons are intended to be insertedinto the vagina and used to absorb menstrual fluid. |
| TechnologicalCharacteristics | The modified tampons have the same technological characteristics as thepredicate devices (K111684) as they have the same design, absorbency and |
| mode of action. The fiber and materials in contact with the vaginal wall arealso the same. The only difference in the modified tampons from the predicatetampons is the composition of the colorants incorporated into the polyethyleneresin used to manufacture the applicator. | |
| Biocompatibility Tests | Deemed not applicable for the modified device based on the results of theLeaching Studies. Biocompatibility testing was performed on the predicatedevice to confirm the tampon material safety. |
| Performance Testing | No changes were made to the tampon pledget. Syngyna testing was performedand the results confirmed that the absorbance ranges are the same as thepredicate device and comply with 21 CFR §801.430(f)(2). |
| Conclusion | As confirmed by our risk assessment and leaching studies, the proposedmodification on the applicator colorant has no impact on the safety or efficacyof the device. The proposed device is substantially equivalent to the predicatedevice. |
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-C Silver Spring, MD 20993-0002
October 9, 2013
Playtex Manufacturing, Inc. Playtex Products, LLC % Pushpa Rao, Ph.D., D.A.B.T, R.A.C Senior Manager, Product Safety/North America Regulatory Affairs 75 Commerce Drive Allendale, NJ 07401
Re: K132819
Trade/Device Name: Playtex® (Scented) Sport Fresh Balance™ Tampons Playtex® (Unscented) Sport Fresh Balance™ Tampons Regulation Number: 21 CFR§ 884.5460 Regulation Name: Scented or scented deodorized menstrual tampon Regulatory Class: 11 Product Code: HIL, HEB Dated: September 5, 2013 Received: September 9, 2013
Dear Pushpa 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 mislcading.
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.
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Page 2 - Pushps Rao, Ph.D., D.A.B.T., R.A.C.
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
for
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: K132819
Playtex® (Scented) Sport Fresh Balance™ Tampons Playtex® (Unscented) Sport Fresh Balance™ Tampons
Indications For Use:
Playtex scented (or scented deodorized) and unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.
Absorbency Ranges:
Absorbs menstrual flow < 6 grams (Light)
Absorbs menstrual flow 6-9 grams (Regular)
Absorbs menstrual flow 9-12 grams (Super)
Absorbs menstrual flow 12-15 grams (Super Plus)
Prescription Use Over-The-Counter Use X AND/OR . (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH), Office of Device Evaluation (ODE)
Herbert P. Lerner 2013.10.09 14:26:00 -04'00'
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§ 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).