(233 days)
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.
Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
This document describes the regulatory submission for Playtex Sport Tampons with OdorShield™, not a medical device that uses artificial intelligence or requires a clinical study with image data. Therefore, many of the requested categories for AI/clinical study information are not applicable.
Here's an analysis based on the provided text:
Device: Playtex Sport (Unscented/Scented) Tampons with OdorShield™
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | - Cytotoxicity: ISO Agar Overlay | - Evaluated according to FDA guidance and applicable standards. Results indicate compliance. |
| - Sensitization: Human Repeat Insult Patch Test | - Test articles (polar and non-polar extracts) evaluated for sensitization potential under occlusion (9 patch induction, 2-week rest, challenge, 72-hour monitoring) on a panel of women. Results indicate compliance. | |
| - Irritation & Acute Systemic Toxicity: Human Vaginal Irritation Study | - Both scented and unscented tampons provided to a panel of women over 2 menstrual cycles in a randomized double-blind study. Expert assessments (colposcopy) made at baseline, midpoint, and termination indicated compliance. | |
| Microbiology | - Zone of Inhibition | - Testing conducted. Results indicate compliance. |
| - TSST-1 Testing | - Results indicate compliance. | |
| Odor Absorption | - Testing to demonstrate effectiveness of OdorShield™ Technology | - Expert panel assessment on OdorShield™ Technology performed. |
| - Validated in consumer testing. (Specific quantitative results not provided in the summary, but implied to meet acceptance.) | ||
| Absorbency (Syngyna Testing per 21 CFR 801.430(f)(2)) | - Regular: Absorbs 6-9 grams of menstrual flow | - Syngyna testing conducted. Playtex Sport Regular tampons met the absorbency range of 6-9 grams. The tampons are labeled in accordance with these ranges. |
| - Super: Absorbs 9-12 grams of menstrual flow | - Syngyna testing conducted. Playtex Sport Super tampons met the absorbency range of 9-12 grams. The tampons are labeled in accordance with these ranges. | |
| - Super Plus: Absorbs 12-15 grams of menstrual flow | - Syngyna testing conducted. Playtex Sport Super Plus tampons met the absorbency range of 12-15 grams. The tampons are labeled in accordance with these ranges. | |
| Overall Substantial Equivalence | - The new tampon has the same technological characteristics as the predicate device (K060981) and the odor absorbing technology is already used in a currently marketed device (K070745). The only difference is the modified use of the odor absorbing technology. | - "Results of performance testing indicate that the subject tampon is substantially equivalent to the predicate devices." (Implied that all characteristics, including the modified odor absorbing technology, demonstrate equivalence or acceptable performance for safe and effective use.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Biocompatibility (Sensitization): A panel of women was used for the Human Repeat Insult Patch Test. Specific number not provided, but the description implies a prospective study involving human subjects.
- Biocompatibility (Irritation & Acute Systemic Toxicity): A panel of women of appropriate age was provided with tampons over 2 menstrual cycles. Specific number not provided. This was a randomized double-blind study, indicating a prospective design.
- Odor Absorption: An "expert panel" was used, followed by "consumer testing." Specific sample sizes for both are not provided. The study design (expert panel, consumer testing) suggests prospective data collection.
- Syngyna Testing: This is an in vitro laboratory test, not involving human subjects. The sample size would refer to the number of tampons tested, which is not specified. Data provenance would be laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Biocompatibility (Irritation & Acute Systemic Toxicity): "Expert assessments were made at baseline, midpoint and termination of study by colposcopy." The number of experts is not specified, but they are implied to be medical professionals capable of performing and interpreting colposcopic exams.
- Odor Absorption: An "expert panel" was used for assessment. The number of experts and their specific qualifications are not provided beyond being an "expert panel."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any specific adjudication method like 2+1 or 3+1 for resolving discrepancies in expert assessments. It only mentions "expert assessments" and "expert panel assessment."
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
Not Applicable. This is a physical product (tampon) and not an AI-powered diagnostic or assistive device. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical product and does not involve any algorithms or standalone AI performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Biocompatibility:
- Sensitization: Human physiological response (skin reaction/sensitization).
- Irritation & Acute Systemic Toxicity: Medical expert (colposcopy) assessment of vaginal health, and implied absence of acute systemic toxicity symptoms.
- Microbiology: Laboratory results (Zone of Inhibition, TSST-1 detection thresholds).
- Odor Absorption: Expert panel consensus and consumer perception.
- Absorbency (Syngyna): Gravimetric measurements of liquid absorption against established regulatory standards.
8. The sample size for the training set
Not Applicable. This is a physical product, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
Not Applicable. As there is no training set, this question is not relevant.
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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 DriveAllendale, 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 theOdorShield™ technology and show substantial equivalence of the subject tamponto 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 UnscentedTampon, 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 ofmenstrual fluid. |
:
K WI684 Page リム
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| Intended Use | Playtex scented or scented deodorized menstrual tampons are intended to beinserted into the vagina and used to absorb menstrual fluid; |
|---|---|
| Playtex unscented menstrual tampons are intended to be inserted into the vagina andused to absorb menstrual fluid. | |
| TechnologicalCharacteristics | 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 thesame or have the same mode of action. The only difference is the modified use ofthe odor absorbing technology which is already used in the currently marketedPlaytex Gentle Glide devices (K070745). |
| Biocompatibility Tests | Biocompatibility and microbiological studies were conducted in accordance withthe FDA guidance and applicable standards on the subject tampons. The testingincluded:Cytotoxicity - ISO Agar OverlaySensitization - Human Repeat Insult Patch TestIrritation - Human Vaginal Irritation StudyAcute Systemic Toxicity - Human Vaginal Irritation Study |
| The test articles, polar and non-polar extracts of the subject tampons wereevaluated for sensitization potential under occlusion using, a nine patch inductionphase over a period of three weeks, two week rest and challenge; The response tochallenge was monitored post patch over a 72 hour period. | |
| Both scented and unscented tampons were provided to a panel of women ofappropriate age over 2 menstrual cycles in randomized double-blind study. Expertassessments were made at baseline, midpoint and termination of study bycolposcopy. | |
| Microbiology Tests | Zone of InhibitionTSST-1 Testing |
| Odor AbsorptionTesting | Testing included expert panel assessment on OdorShield™ Technology andlater validated in consumer testing. |
| Syngyna Testing: | Syngyna testing was conducted in accordance to 21 CFR 801.430(f)(2) toverify that the subject tampons met absorbency ranges as specified in theregulation.• 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 issubstantially equivalent to the predicate devices |
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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
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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/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
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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
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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 |
|---|---|
| --------------- | --------- |
CONFIDENTIAL
§ 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).