(128 days)
Playtex® unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.
The subject devices, which are modified from the predicate devices, are unscented menstrual tampons consisting of a tampon (pledget with string) and an applicator. The tampons are made of rayon fiber and have absorbency ranges: regular (6-9 grams) and super (9-12 grams). The applicators are made of polyethylene and polypropylene and have four color versions.
The provided text is a 510(k) Summary for the Playtex Stella™ Tampons. It details the device, its intended use, comparison to a predicate device, and the non-clinical performance testing conducted. However, it does not contain the specific acceptance criteria or the full study details that you requested.
Here's what I can extract and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance
The document mentions "color leaching studies" and their analysis using "Tolerable Intake (TI) analysis of each component in the colorant formulation using ISO 10993-17:2002." This implies that the acceptance criteria for these studies would be that any leached components are within tolerable intake levels as defined by ISO 10993-17:2002. However, the specific quantitative acceptance criteria (e.g., maximum allowable concentration of a leached substance) and the actual reported performance (e.g., the measured concentrations) are not provided in this document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: The document states "The color leaching studies were conducted for new applicators." It does not specify the number of applicators or samples tested.
- Data provenance: Not specified.
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 section is not applicable as the studies described are non-clinical (chemical analysis for leaching, biocompatibility leverage) and do not involve human expert interpretation of data like medical imaging would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable as the studies described are non-clinical, involving chemical analysis rather than human interpretation requiring adjudication.
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 section is not applicable. The device is a menstrual tampon, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a menstrual tampon, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the color leaching studies, the "ground truth" would be the established Tolerable Intake (TI) levels for each component, as defined by ISO 10993-17:2002. For the biocompatibility, the ground truth is based on historical data from the predicate device (K132819) which presumably met biocompatibility standards.
8. The sample size for the training set
This section is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This section is not applicable. There is no mention of a "training set."
In summary:
The provided document describes non-clinical testing (color leaching and leveraging biocompatibility data) for a physical medical device (menstrual tampon). It mentions the methodology used (LC-MS, GC-MS, ISO 10993-17:2002 for tolerance) but lacks specific quantitative acceptance criteria or detailed study results and sample sizes that would typically be found in a full study report. The request for information related to AI or expert adjudication is not relevant to this type of device and submission.
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May 30, 2018
Playtex Manufacturing, Inc. % Danielle Vitale Manager, Global Product Safety Edgewell Personal Care 75 Commerce Drive Allendale, NJ 07401
Re: K180167
Trade/Device Name: Playtex Stella™ Tampons Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB Dated: April 27, 2018 Received: April 30, 2018
Dear Danielle Vitale:
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.
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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 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joyce M. Whang -S
Benjamin R. Fisher, Ph.D. for Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use |
| Form Approved: OMB No. 0910-0120 | |
|---|---|
| Expiration Date: 06/30/2020 | |
| See PRA Statement below. |
| 510(k) Number (if known) | K180167 |
|---|---|
| Device Name | Playtex Stella™ Tampons |
| Indications for Use (Describe) | Playtex® unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid. |
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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| FORM FDA 3881 (7/17) | Page 1 of 1 |
|---|---|
| PSC Publishing Services (301) 443-6740 | |
| EF |
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510(k) Summary (K180167)
1. Submitter Information
| Submitter: | Playtex Manufacturing, Inc.804 Walker RoadDover, DE 19904 |
|---|---|
| Contact Person: | Danielle Vitale,Manager, Global Product SafetyPhone: 201-785-8080Fax: 201-785-8202Email: Danielle.Vitale@edgewell.com |
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- Date Prepared May 29, 2018
3. Device Information
| Trade Name: | Playtex Stella™ Tampons |
|---|---|
| Common Name: | Unscented Menstrual Tampon |
| Regulation Number: | 21 CFR §884.5470 |
| Regulation Name: | Unscented Menstrual Tampon |
| Product Code: | HEB (Tampon, Menstrual, Unscented) |
| Regulatory Class: | II |
4. Predicate Device:
Playtex® (Scented and Unscented) Sport Fresh Balance™ Tampons (K132819) manufactured by Playtex® Manufacturing. Inc. The predicate device has not been subject to any design related recalls.
5. Device Description:
The subject devices, which are modified from the predicate devices, are unscented menstrual tampons consisting of a tampon (pledget with string) and an applicator. The tampons are made of rayon fiber and have absorbency ranges: regular (6-9 grams) and super (9-12 grams). The applicators are made of polyethylene and polypropylene and have four color versions.
6. Indications for Use
Playtex® unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.
7. Comparison of Intended Use and Technological Characteristics of the Subject Device and Predicate Device
The subject and predicate devices have the same intended use – to absorb menstrual fluid. The subject and predicate devices have the same tampons, but the subject devices have additional color versions
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for the applicator. This difference in technological characteristics does not raise different questions of safety and effectiveness and can be evaluated by color safety studies.
8. Summary of Non-Clinical Performance Testing
The color leaching studies were conducted for new applicators using liquid chromatography-mass spectrometry (LC-MS) and gas chromatography-mass spectrometry (GC-MS). The results were analyzed along with Tolerable Intake (TI) analysis of each component in the colorant formulation using ISO 10993-17:2002.
In addition, the biocompatibility information provided in the predicate devices (K132819) was leveraged in the current submission to support substantial equivalence to the predicate device.
9. Conclusion
The subject and predicate devices have the same intended use and fundamental technological characteristics. The difference in technological characteristics between subject and predicate devices does not raise different questions of safety and effectiveness. The performance data demonstrate that the subject devices are substantially equivalent to the predicate device.
§ 884.5470 Unscented menstrual tampon.
(a)
Identification. An unscented 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. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).