(24 days)
Not Found
No
The summary describes a menstrual tampon and does not mention any AI or ML components or functionalities.
No
The device is described as absorbing menstrual fluid, which is a supportive rather than a therapeutic function. It is not intended to treat, mitigate, or cure any disease or condition.
No
Explanation: The device description states its intended use is to absorb menstrual fluid, which is a therapeutic or hygienic function, not a diagnostic one. There is no mention of identifying or detecting any medical conditions.
No
The device description clearly states it is a physical product (tampons) intended for insertion into the vagina, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "absorb menstrual fluid" by being inserted into the vagina. This is a physical function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description confirms it's a menstrual tampon for absorption.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like blood, urine, or tissue), detecting biomarkers, or providing diagnostic information about a patient's health condition.
- Safety Evaluation: The performance studies focus on safety evaluations (microbiological, biocompatibility, extraction testing), which are typical for medical devices that come into contact with the body, but not specifically for IVDs.
IVDs are devices used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The TAMPAX® Pearl Plastic™ unscented and scented Tampons are intended to be inserted into the vagina to absorb menstrual fluid.
Product codes (comma separated list FDA assigned to the subject device)
HIL
Device Description
Scented or scented deodorized, unscented menstrual tampons for absorption of menstrual fluid.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Safety Assessment: A battery of safety evaluations were conducted, including in vitro microbiological testing, biocompatibility evaluation and extraction testing, to evaluate the safety profile of the 510(k) device. The results of these safety tests support the conclusion that the 510(k) device is equally as safe as the predicate devices.
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
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JUN 2 7 2008
Section 5: 510(k) Summary
| Submitted by: | The Procter & Gamble Company
6110 Center Hill Avenue
Cincinnati, OH 45224 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lenore Faulhaber, Ph.D., M.B.A.
Regulatory Affairs Manager
(513) 634-2466 (voice)
(513) 634-7364 (FAX) |
| Date Summary Prepared: | June 2, 2008 |
| Trade Name: | TAMPAX® Pearl Tampons, unscented and scented |
| Common Name: | Unscented Tampon and Scented Tampon |
| Classification Name: | Unscented menstrual tampon (21 CFR 884.5470)
Scented or scented deodorized menstrual tampon
(21 CFR 884.5460) |
| Predicate Devices: | TAMPAX Pearl Tampons® unscented and scented
K011996; K040312; K051290 |
| Device Description: | Scented or scented deodorized, unscented menstrual
tampons for absorption of menstrual fluid. |
| Intended Use: | TAMPAX Pearl Tampons® unscented and scented are
intended to be inserted into the vagina to absorb menstrual
fluid |
Technological Characteristics: The device is similar to the predicate devices in terms of basic component materials, overall design and labeling. The device is designed to acquire and hold menstrual fluids similar to the fluid handling capabilities of the predicate devices.
Safety Assessment: A battery of safety evaluations were conducted, including in vitro microbiological testing, biocompatibility evaluation and extraction testing, to evaluate the safety profile of the 510(k) device. The results of these safety tests support the conclusion that the 510(k) device is equally as safe as the predicate devices.
Conclusions: The results of evaluations for this device support the conclusions that it is safe for its intended use and substantially equivalent to the cited predicate devices.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 7 2008
Lenore Faulhaber, Ph.D., M.B.A. Regulatory Affairs Manager The Proctor & Gamble Company 6110 Center Hill Avenue CINCINNATI OH 45224
Re: K081555
Trade Name: TAMPAX® Pearl Plastic Tampons (Scented and Unscented) Regulation Number: 884.5460, 884.5470 Regulation Name: Menstrual Tampons (scented, unscented) Regulatory Class: II Product Code: HIL Dated: June 2, 2008 Received: June 3, 2008
Dear Dr. Faulhaber:
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.
2
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/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
3
Indications for Use Statement
| 510(k) Number (if known) | K081555 |
|---|---|
| Device Name | TAMPAX® Pearl Plastic™ Tampons |
| Indications for Use | The TAMPAX® Pearl Plastic™ unscented and scented Tampons are intended to be inserted into the vagina to absorb menstrual fluid. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801. 109) OR
Over-The-Counter Use
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Hulut lener
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K081555