(128 days)
No
The summary describes a physical medical device (menstrual tampons) and its materials, absorbency, and applicator. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The performance studies focus on material safety and biocompatibility, not algorithmic performance.
No
A therapeutic device is one that treats, mitigates, cures, or prevents a disease or condition. This device is for absorption of menstrual fluid, which is a normal bodily function, not a disease or condition that requires therapy.
No
Explanation: The device is a menstrual tampon intended for absorbing menstrual fluid, which is a therapeutic or hygiene function, not a diagnostic one. It does not identify, assess, or monitor a medical condition.
No
The device description explicitly states it consists of a tampon (pledget with string) and an applicator, which are physical hardware components.
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 device is a physical product (tampon and applicator) for insertion into the vagina. IVDs are typically reagents, instruments, or systems used to perform tests on specimens.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose, monitor, or screen for any disease or condition. Its sole purpose is absorption.
- Performance Studies: The performance studies focus on color leaching and biocompatibility, which are relevant to the safety and physical properties of the device, not its ability to provide diagnostic information.
In summary, the Playtex® unscented menstrual tampon is a medical device, but it falls under a different classification than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Playtex® unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.
Product codes
HEB
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.
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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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.
1
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 Road
Dover, DE 19904 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Danielle Vitale,
Manager, Global Product Safety
Phone: 201-785-8080
Fax: 201-785-8202
Email: Danielle.Vitale@edgewell.com |
-
- 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
4
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.