(25 days)
Scented or scented deodorized menstrual tampon for the absorption of menstrual fluid; unscented menstrual tampon for the absorption of menstrual fluid.
Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
This 510(k) submission (K070745) for the Playtex Gentle Glide Plastic and Multipack Tampons is for a medical device modification, not a novel AI/medical imaging device. Therefore, the questions related to AI performance, such as MRMC studies, standalone algorithm performance, and expert ground truth establishment for deep learning models, are not applicable here.
The "acceptance criteria" in this context refer to various safety and performance tests to ensure the modified tampons are substantially equivalent to previously cleared versions.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Cytotoxicity testing | Modified device meets all device input requirements. |
| Acute systemic toxicity testing | Modified device meets all device input requirements. |
| Vaginal irritation testing | Modified device meets all device input requirements. |
| Dermal irritation | Modified device meets all device input requirements. |
| Allergic contact sensitization tests | Modified device meets all device input requirements. |
| Microbial agar diffusion | Modified device meets all device input requirements. |
| Toxic shock syndrome toxin-1 (TSST-1) testing | Modified device meets all device input requirements. |
| Technological characteristics (fiber, string, materials) | Same as cleared tampon or same mode of action. |
| Shape of final formed pledget (for each absorbency) | Essentially identical to the predicate devices. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample sizes used for each of the performance tests (e.g., cytotoxicity, irritation, TSST-1). These are laboratory-based tests on materials and devices, not studies involving human subjects in the sense of clinical trials for imaging. The data provenance is not explicitly stated in terms of country of origin, but it would be expected that these tests were conducted by Playtex Products, Inc. or their contracted laboratories, likely in the US given the submission to the FDA. These are prospective tests conducted on the modified device to demonstrate its safety and performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable to this type of device modification submission. The "ground truth" for these performance tests is based on established scientific methodologies and standards for cytotoxicity, toxicity, irritation, and microbial testing, rather than expert consensus on diagnostic images. The performance is measured against established biological safety limits.
4. Adjudication Method for the Test Set
Not applicable. The "adjudication method" usually refers to the process of resolving discrepancies among multiple human readers in an imaging study. For laboratory tests, results are typically determined by scientific protocols and analyses, not by adjudication among experts in that fashion.
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 submission for a tampon modification, not an AI-powered device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a submission for a tampon modification, not an AI-powered device.
7. The Type of Ground Truth Used
The "ground truth" here is based on the results of established biological safety and material compatibility tests against recognized standards and limits. For example, cytotoxicity testing would compare cell viability to a control, and irritation tests would assess tissue response against a baseline or a known irritant/non-irritant. The "ground truth" for the physical characteristics like pledget shape is visual or dimensional comparison to the predicate device.
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" for this type of device modification. This is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
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510(k) SUMMARY
| Name of 510(k) sponsor: | Playtex Products, Inc. | APR 13 2007 |
|---|---|---|
| Address: | Playtex Products, Inc.804 Walker Rd.Dover, DE 19904Telephone: 302.678.6880Facsimile: 302.678.6540 | |
| Contact information: | Mr. Keith EdgettVice PresidentResearch and DevelopmentPlaytex Products, Inc.Telephone: 302.678.6880Facsimile: 302.678.6540 | |
| Date summary prepared: | March 15, 2007 | |
| Proprietary name of device: | Playtex Gentle Glide Plastic, Playtex Gentle Glide PlasticMultipack Tampons | |
| Generic/classification name: | Scented and Unscented Menstrual Tampons | |
| Product code (classification): | Scented or scented deodorized menstrual tampons andunscented menstrual tampons are Class II medical devices(HIL, 21 C.F.R. § 884.5460 and HEB, § 884.5470,respectively). |
Legally Marketed (Unmodified) Devices:
Playtex Non-deodorant & Deodorant Gentle Glide Playtex Non-deodorant & Deodorant Gentle Glide Multipack Tampons
Device Description:
Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
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Intended Use:
Playtex tampons are intended to be used as scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
Technological Characteristics:
The new tampon has the same technological characteristics as the cleared tampon. The fiber, string, and materials in contact with the vaginal wall are the same or have the same mode of action. The only differences in the modified tampons from the predicate devices are: the composition of the colorants incorporated into the polyethylene resin used to manufacture the applicator barrel and plunger; and the dimensions of the unformed pledget pads. The shape of the final formed pledget for each absorbency is essentially identical to the predicate devices.
Performance Data:
Cytotoxicity testing, acute systemic toxicity testing, vaginal irritation testing, dermal irritation, allergic contact sensitization tests, microbial agar diffusion and toxic shock syndrome toxin-1 (TSST-1) testing indicate that the modified device meets all device input requirements.
Conclusions:
The modified Playtex tampons are substantially equivalent to the predicate tampons.
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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 caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR 1 3 2007
Mr. Keith Edgett Vice President Playtex Products, Inc. 804 Walker Rd. DOVER DE 19904
Re: K070745
Trade/Device Name: Playtex Gentle Glide Plastic and Playtex Gentle Glide Plastic Multipack Tampons Regulation Number: 21 CFR 884.5460 Regulation Name: Scented or scented deodorized menstrual tampon Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HIL and HEB Dated: March 15, 2007 Received: March 19, 2007
Dear Mr. Edgett:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/2/Picture/10 description: The image is a black and white circular seal. The seal contains the text "1806-1906" at the top, and the letters "PA" in a large, bold font in the center. Below the letters, the word "Centennial" is written in a smaller font. There are four stars below the word "Centennial". The text "History of the County" is written along the bottom edge of the seal.
Protecting and Promoting Public Health
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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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
| Applicant: | Playtex Products, Inc. |
|---|---|
| 510(k) Number: | K070745 |
| Device Name: | Playtex Gentle Glide Plastic and Playtex Gentle Glide PlasticMultipack Tampons |
| Indications for Use: | Scented or scented deodorized menstrual tampon for the absorptionof menstrual fluid; unscented menstrual tampon for the absorptionof menstrual fluid. |
(PLEASE DO NOT WRITE BELOW THIS LINE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-the Counter Use
David A. Henderson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number
1-WA/2548871.3
§ 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).