(30 days)
Not Found
No
The device description and performance studies focus on the physical properties and absorbency of menstrual tampons, with no mention of AI or ML technology.
No
The device, a menstrual tampon, is intended for absorbing menstrual fluid, which is a hygienic function and not a medical treatment or therapy for a disease or condition.
No
This device is described as a menstrual tampon used to absorb fluid, not to diagnose any condition or disease.
No
The device description clearly states it is a physical product (tampons) consisting of a pledget, string, and applicator. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "absorb menstrual fluid" by being "inserted into the vagina." This is a physical function within the body, not a test performed on a sample taken from the body to diagnose a condition or provide information about a physiological state.
- Device Description: The description details the physical components of a tampon (pledget, string, applicator). It doesn't describe any components or processes related to analyzing biological samples.
- Lack of Diagnostic Function: The device's function is purely absorptive. It doesn't measure, detect, or analyze any substances in the menstrual fluid for diagnostic purposes.
- Performance Studies: The performance studies focus on absorbency, which is a physical characteristic, not a diagnostic metric. The reference to 21 CFR §801.430(f)(2) relates to tampon absorbency standards, not IVD regulations.
IVDs are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This description clearly indicates a device for physical absorption within the body.
N/A
Intended Use / Indications for Use
Playtex® (Scented) Sport Fresh Balance™ Tampons Playtex® (Unscented) Sport Fresh Balance™ Tampons
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
§ 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).
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510(k) Summary
| Name of 510(k) Sponsor | Playtex Products, LLC
6 Research Drive
Shelton, CT 06484 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information | Pushpa Rao, Ph.D., D.A.B.T., R.A.C.
Senior Manager, Product Safety/North America Regulatory Affairs
Research & Development
Playtex Products, LLC
75 Commerce Drive
Allendale, NJ 07401
Telephone: 201-785-8070
Facsimile: 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 scientific
technology of the device. In addition, the efficacy of the device has not been
affected as there were no changes made to the tampon pledget and absorbency
ranges. A risk assessment is provided in this Special 510(k) pre-market
notification and confirms that these changes do not raise any safety concerns
for the proposed device. |
| Name of Device | |
| Trade Name | Playtex® (Scented) Sport Fresh Balance™ Tampons
Playtex® (Unscented) Sport Fresh Balance™ Tampons |
| Common Name | Menstrual Tampon, Scented and Unscented |
| Classification Name | Scented or scented deodorized menstrual tampon and Unscented menstrual
tampon |
| 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 the
absorption of menstrual fluid. The tampon consists of a pledget, string and
applicator (barrel and plunger). |
| Intended Use | Playtex scented and unscented menstrual tampons are intended to be inserted
into the vagina and used to absorb menstrual fluid. |
| Technological
Characteristics | The modified tampons have the same technological characteristics as the
predicate devices (K111684) as they have the same design, absorbency and |
| | mode of action. The fiber and materials in contact with the vaginal wall are
also the same. The only difference in the modified tampons from the predicate
tampons is the composition of the colorants incorporated into the polyethylene
resin used to manufacture the applicator. |
| 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. |
| Performance 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). |
| Conclusion | As confirmed by our risk assessment and leaching studies, the proposed
modification on the applicator colorant has no impact on the safety or efficacy
of the device. The proposed device is substantially equivalent to the predicate
device. |
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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