(29 days)
Not Found
No
The device description and performance studies focus on the material properties and biological compatibility of a menstrual tampon, with no mention of AI/ML or related concepts.
No.
The primary function of tampons is absorption of menstrual fluid, which is a hygienic function and not a medical treatment or therapy.
No
Explanation: This device, a tampon, is intended for the absorption of menstrual fluid, which is a physiological function, not for diagnosing any medical conditions.
No
The device description clearly indicates it is a physical product (tampons) for the absorption of menstrual fluid, with no mention of software components.
No, 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 samples taken from the body.
- Device Description: The description reinforces the physical absorption function.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, or tissue), detecting biomarkers, or providing diagnostic information about a disease or condition.
- Performance Studies: The performance studies focus on safety and biocompatibility (cytotoxicity, irritation, toxicity, TSST-1 testing), which are relevant for a medical device intended for internal use, but not for an IVD.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This description clearly indicates a device for physical absorption, not diagnostic testing.
N/A
Intended Use / Indications for Use
Playtex tampons are intended to be used as scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
Playtex Sport Plastic Tampons (unscented/fresh scent) for the absorption of menstrual fluid.
Product codes (comma separated list FDA assigned to the subject device)
HIL
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, 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.
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
K06098i
and the contraction of the consisted on the consisted on the comments of the comments of the province of the province
510(k) SUMMARY
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| Name of 510(k) sponsor: | Playtex Products, Inc. | |
|---|---|---|
| Address: | 75 Commerce Drive | |
| Allendale, NJ 07401-1600 | ||
| Telephone: | 201.785.8101 | |
| Facsimile: | ||
| 201.785.8242 | ||
| Contact information: | Mr. Keith Edgett | |
| Playtex Products, Inc. | ||
| Telephone: | ||
| Facsimile: | 302.678.6880 | |
| 302.678.6540 | ||
| Date summary prepared: | April 7, 2006 | |
| Proprietary name of device: | Playtex Sport Plastic, Playtex Sport Plastic 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 Playtex Non-deodorant & Deodorant Gentle Glide Multipack Tampons
Device Description:
Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
Intended Use:
Playtex tampons are intended to be used as scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
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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; a new fragrance; and the contoured shape of the applicator and pledget.
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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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAY - 9 2006
Mr. Keith Edgett Vice President Playtex Products, Inc. 75 Commerce Drive ALLENDALE NJ 07401
Re: K060981
Trade/Device Name: Playtex Sport Plastic Tampons, Unscented and Playtex Sport Plastic Tampons, Fresh Scent
Regulation Number: 21 CFR 884.5460 Regulation Name: Scented or scented deodorized menstrual tampon Regulatory Class: II Product Code: HIL Dated: April 7, 2006 Received: April 11, 2006
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/11 description: The image shows the FDA Centennial logo. The logo is circular and contains the letters "FDA" in bold, black font. The words "Centennial" are written below the letters "FDA". The years "1906-2006" are written at the top of the circle.
3
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FIEAS or advised that I DA's Issuance of a saceannal of the requirements of the Act or any FDA has made a decemination that your devices. You courses. You must comply with all
Federal statutes and regulations administered by other Federal agencies. CON CEP Re-1 807 Federal statutes and regulations administered of Ourse to registration and listing (21 CFR Part 807); the Act s requirements, mending, vat not mined to very career equirements as set forth in the quality labeling (21 CFR Part 001), good manalastians Fapplicable, the electronic product radiation in 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) This letter will anow you to begin marketing of substantial equivalence of your device to a legally premarket notification: "The PDA midnig of backannal vour 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 If you desire specific advice for your correst on 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" (21 Also, please note the regulation other general information on your responsibilities under the Act from CI N 601.97). Tod may obtain outs. Beternational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/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
Enclosure
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Indications for Use
KO60981
510(k) Number (if known):
Playtex Products, Inc.
Device Name:
Indications For Use:
Playlex Sport Plastic Tampons, unscented Playtex Sport Plastic Tampons, fresh scent
Playtex Sport Plastic Tampons (unscented/fresh scent) for the absorption of menstrual fluid.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Brogdon
(Division Sign-Off) / Division of Reproductive, Abdominal, and Radiological Dev 510(k) Number
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