(233 days)
Not Found
No
The device description and performance studies focus on the physical properties and biological interactions of menstrual tampons, with no mention of AI or ML.
No.
The tampons are intended for absorption of menstrual fluid, which is a hygienic and fluid management function, not a therapeutic one to treat or cure a disease or condition.
No
The device description clearly states its purpose is to "absorb menstrual fluid" and the intended use confirms it is to be "inserted into the vagina and used to absorb menstrual fluid." There is no mention of diagnosing conditions or diseases. The studies described are for safety, absorbency, and equivalence, not for diagnostic performance.
No
The device description and performance studies clearly indicate a physical product (menstrual tampons) and not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to absorb menstrual fluid, which is a physical function within the body. IVDs are used to examine specimens from the body (like blood, urine, tissue) to provide information about a person's health or condition.
- Device Description: The description focuses on the physical characteristics of the tampon for absorption.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose, monitor, or screen for any disease or condition.
- Performance Studies: The performance studies focus on safety (biocompatibility, irritation, sensitization) and functional performance (absorbency, odor absorption), not on diagnostic accuracy or the analysis of biological samples.
This device is a medical device, but it falls under a different classification than IVDs. It's a device intended for physical use within the body for a non-diagnostic purpose.
N/A
Intended Use / Indications for Use
Playtex scented or scented deodorized menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid; Playtex unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.
Absorbency Ranges:
Absorbs menstrual flow 6-9 grams (Regular)
Absorbs menstrual flow 9-12 grams (Super)
Absorbs menstrual flow 12-15 grams (Super Plus)
Product codes (comma separated list FDA assigned to the subject device)
HIL, HEB
Device Description
Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility and microbiological studies were conducted in accordance with the FDA guidance and applicable standards on the subject tampons.
Testing included:
Cytotoxicity - ISO Agar Overlay
Sensitization - Human Repeat Insult Patch Test
Irritation - Human Vaginal Irritation Study
Acute Systemic Toxicity - Human Vaginal Irritation Study
The test articles, polar and non-polar extracts of the subject tampons were evaluated for sensitization potential under occlusion using, a nine patch induction phase over a period of three weeks, two week rest and challenge; The response to challenge was monitored post patch over a 72 hour period.
Both scented and unscented tampons were provided to a panel of women of appropriate age over 2 menstrual cycles in randomized double-blind study. Expert assessments were made at baseline, midpoint and termination of study by colposcopy.
Microbiology Tests:
Zone of Inhibition
TSST-1 Testing
Odor Absorption Testing:
Testing included expert panel assessment on OdorShield™ Technology and later validated in consumer testing.
Syngyna Testing:
Syngyna testing was conducted in accordance to 21 CFR 801.430(f)(2) to verify that the subject tampons met absorbency ranges as specified in the regulation.
Conclusion: Results of performance testing indicate that the subject tampon is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
FEB - 3 2012
·
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/Regulatory Affairs | |||
| Research & Development | |||
| Playtex Products, LLC | |||
| 75 Commerce Drive | |||
| Allendale, NJ 07401 | |||
| Telephone: 201-785-8070 | |||
| Facsimile: 201-785-8202 | |||
| Date Submitted: | June 15, 2011 | ||
| Submission #: | K111684 | ||
| Reason for Submission: | The submission was filed to clear changes to the tampon treatment to include the | ||
| OdorShield™ technology and show substantial equivalence of the subject tampon | |||
| to the predicate devices. | |||
| Name of Device | |||
| Trade Name | Playtex Sport (Unscented) Tampons with OdorShield™; | ||
| Playtex Sport (Scented) Tampons with OdorShield™ | |||
| Common Name | Menstrual Tampon, Scented and Unscented | ||
| Tampon, Menstrual Scented and Unscented | |||
| Classification Name | Tampon | ||
| Regulation Number | § 884.5460 | ||
| § 884.5470 | |||
| Product Code | HIL, HEB | ||
| Predicate Devices | Playtex® Non-deodorant Sport (unscented), Playtex Deodorant Sport (fresh scent) | ||
| Tampons (K060981) | |||
| Playtex Gentle Glide Tampons (K070745) | |||
| Device Description | Scented or scented deodorized, unscented menstrual tampons for the absorption of | ||
| menstrual fluid. |
:
K WI684 Page リム
1
| Intended Use | Playtex scented or scented deodorized menstrual tampons are intended to be
inserted into the vagina and used to absorb menstrual fluid; |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Playtex unscented menstrual tampons are intended to be inserted into the vagina and
used to absorb menstrual fluid. |
| Technological
Characteristics | The new tampon has the same technological characteristics as the predicate device
(K060981). The fiber, string and materials in contact with the vaginal wall are the
same or have the same mode of action. The only difference is the modified use of
the odor absorbing technology which is already used in the currently marketed
Playtex Gentle Glide devices (K070745). |
| Biocompatibility Tests | Biocompatibility and microbiological studies were conducted in accordance with
the FDA guidance and applicable standards on the subject tampons. The testing
included:
Cytotoxicity - ISO Agar Overlay
Sensitization - Human Repeat Insult Patch Test
Irritation - Human Vaginal Irritation Study
Acute Systemic Toxicity - Human Vaginal Irritation Study |
| | The test articles, polar and non-polar extracts of the subject tampons were
evaluated for sensitization potential under occlusion using, a nine patch induction
phase over a period of three weeks, two week rest and challenge; The response to
challenge was monitored post patch over a 72 hour period. |
| | Both scented and unscented tampons were provided to a panel of women of
appropriate age over 2 menstrual cycles in randomized double-blind study. Expert
assessments were made at baseline, midpoint and termination of study by
colposcopy. |
| Microbiology Tests | Zone of Inhibition
TSST-1 Testing |
| Odor Absorption
Testing | Testing included expert panel assessment on OdorShield™ Technology and
later validated in consumer testing. |
| Syngyna Testing: | Syngyna testing was conducted in accordance to 21 CFR 801.430(f)(2) to
verify that the subject tampons met absorbency ranges as specified in the
regulation.
• Absorbs menstrual flow 6-9 grams (Regular)
• Absorbs menstrual flow 9-12 grams (Super)
• Absorbs menstrual flow 12-15 grams (Super Plus)
The tampons are labeled in accordance to these ranges. |
| Conclusion | Results of performance testing indicate that the subject tampon is
substantially equivalent to the predicate devices |
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Pushpa Rao, Ph.D. Global Manager Product Safety/Regulatory Affairs Playtex Manufacturing Inc. 75 Commerce Drive ALLENDALE NJ 07401
FEB - 3 2012
Re: K111684
Trade/Device Name: Playtex Sport (Scented) with OdorShield™ Regulation Number: 21 CFR§ 884.5460 Regulation Name: Scented or scented deodorized menstrual tampon Regulatory Class: II Product Code: HIL Dated: January 26, 2012 Received: January 27, 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
3
Page 2 -
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/CDRH0ffices/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,
Benjamin K. Ticho
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
4
Indications for Use
510(k) Number (if known):
Device Name:
Playtex Sport (Unscented) with OdorShield™
Indications for Use:
Playtex Unscented deodorized menstrual tampon are intended to be inserted into the vagina and used to absorb menstrual fluid.
Absorbency Ranges:
Absorbs menstrual flow 6-9 grams (Regular)
Absorbs menstrual flow 9-12 grams (Super)
Absorbs menstrual flow 12-15 grams (Super Plus)
Over-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helen Glenn
CONFIDENTIAL 510
5
Indications for Use
510(k) Number (if known):
Device Name:
Playtex Sport (Scented) with OdorShield™
Indications for Use:
Playtex Scented or scented deodorized menstrual tampon are intended to be inserted into the vagina and used to absorb menstrual fluid.
Absorbency Ranges:
Absorbs menstrual flow 6-9 grams (Regular)
Absorbs menstrual flow 9-12 grams (Super)
| Prescription
| (Part 21 CFR 801 Subpart D) | Use |
|---|---|
| --------------------------------------------- | ----- |
AND/OR
| Over-The-Counter
| (21 CFR 801 Subpart C) | Use X |
|---|---|
| -------------------------------------------- | --------- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
(Division Sign-Off)
Concurrence of CDRH, Office of Division of Reproductive (ODE), Gastro-Renal, and Urological Devices
| 510(k) Number | K111684 |
|---|---|
| --------------- | --------- |