(22 days)
Not Found
No
The device description and intended use clearly define a menstrual tampon, a physical product for fluid absorption. There is no mention of software, data processing, or any technology that would typically incorporate AI/ML. The performance studies are focused on biocompatibility and safety, not algorithmic performance.
No.
The device is described as a menstrual tampon for the absorption of menstrual fluid, which is a hygiene product, not a therapeutic device.
No
The device, a menstrual tampon, is intended for the absorption of menstrual fluid, which is a therapeutic or supportive function, not a diagnostic one. No diagnostic claims or performance metrics (like sensitivity or specificity) are mentioned.
No
The device description explicitly states it is a "menstrual tampon," which is a physical, hardware device. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "absorption of menstrual fluid." This is a physical function within the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description reinforces the function of absorption.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening of a disease or condition.
- Performance Studies: The performance studies listed (cytotoxicity, toxicity, irritation, sensitization, microbial, TSST-1) are related to the safety and biocompatibility of the device for its intended use within the body, not diagnostic performance.
Therefore, this device is a medical device, but specifically a menstrual tampon, which is not classified as an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Scented or scented deodorized menstrual tampon for the absorption of menstrual fluid; unscented menstrual tampon for the absorption of menstrual fluid.
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
Not Found
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)
Cytotoxicity testing, acute systemic toxicity testing, vaginal irritation testing, 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.
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
510(k) SUMMARY
| Name of 510(k) sponsor: | Playtex Products, Inc. |
|---|---|
| Address: | Playtex Products, Inc. |
| 804 Walker Rd. | |
| Dover, DE 19904 | |
| Telephone: 302.678.6880 | |
| Facsimile: 302.678.6540 | |
| JAN 17 2008 | |
| Contact information: | Mr. Keith Edgett |
| Vice President | |
| Research and Development | |
| Playtex Products, Inc. | |
| Telephone: 302.678.6880 | |
| Facsimile: 302.678.6540 | |
| Date summary prepared | December 21, 2007 |
| Proprietary name of device: | Playtex Gentle Glide, Playtex Gentle Glide Multipack |
| Tampons | |
| Generic/classification name: | Scented and Unscented Menstrual Tampons |
| Product code (classification): | Scented or scented deodorized menstrual tampons and |
| unscented 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 (K961870) Playtex Non-deodorant & Deodorant Gentle Glide Multipack Tampons (K070745)
Device Description:
Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
1
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 tampon from the predicate devices are the absorbency (lower), the dimensions of the unformed pledget pads, and the dimensions of the final formed pledget.
Performance Data:
Cytotoxicity testing, acute systemic toxicity testing, vaginal irritation testing, 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 tampon is substantially equivalent to the predicate tampons.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a series of waving lines, representing health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 17 2008
Mr. Keith Edgett Vice President, Research and Development Playtex Products, Inc. 804 Walker Rd. DOVER DE 19904
Re: K073662
Trade/Device Name: Playtex Gentle Glide and Playtex Multipack Tampons Regulation Number: 21 CFR 884.5460 Regulation Name. Scented or scented deodorized menstrual tampon Regulatory Class: II Product Code: HIL and HEB Dated: December 21, 2007 Received: December 26, 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 (PMA), 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.
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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.html.
Sincerely yours.
Nancy C Brogdon
Nancy C. Brogdon Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE STATEMENT
| Applicant: | Playtex Products, Inc. |
|---|---|
| 510(k) Number: | K073662 |
| Device Name: | Playtex Gentle Glide and Playtex Gentle Glide Multipack Tampons |
| Indications for Use: | Scented or scented deodorized menstrual tampon for the absorption of menstrual fluid; unscented menstrual tampon for the absorption of menstrual fluid. |
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | or | Over-the Counter Use ✓ |
|---|---|---|
| ------------------ | ---- | ------------------------------------------------------------------------ |
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K073662 |
|---|---|
| --------------- | --------- |