(62 days)
Not Found
No
The device description and performance studies indicate a conventional mechanical device without any mention of AI or ML.
No
The device is described as an unscented menstrual tampon used to absorb menstrual fluid, which is a hygiene product, not a therapeutic device designed to treat or alleviate a medical condition.
No
Explanation: The device description clearly states that TAMPAX® Tampons are used to "absorb menstrual fluid." There is no mention of the device being used to identify, monitor, or examine a disease or health condition. Its function is purely absorptive, not diagnostic.
No
The device description clearly states it is a physical tampon with an applicator, made of cotton and rayon fibers, which are hardware components.
Based on the provided information, 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 within the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a physical product designed for absorption and insertion, not a reagent, instrument, or system intended for the diagnosis of disease or other conditions.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like blood, urine, or tissue), detecting biomarkers, or providing information for diagnosis.
- Regulatory Compliance: The mention of compliance with 21 CFR §801.430 relates to absorbency requirements for tampons, not regulations specific to IVDs.
IVDs are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This description clearly does not fit that definition.
N/A
Intended Use / Indications for Use
TAMPAX® Tampons are unscented menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
Product codes
HEB
Device Description
The device is a conventional unscented menstrual tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The absorbent pledget consists of a pad of cotton and/or rayon fibers overwrapped with a non-woven fabric. A cotton withdrawal cord is sewn to the pad, and the pad is compressed into a traditional bullet-shaped pledget. The formed pledget is inserted into a flushable paper applicator consisting of an inner pusher tube and an outer insertion tube with an open distal end. Each tampon is wrapped in an individual wrapper and packaged in sealed multi-unit containers for retail sale.
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)
The device complies with the syngyna absorbency requirements of 21 CFR §801.430. Therefore, additional testing of these tampons is not necessary to establish their equivalence to the predicate device in terms of effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
K06 1486
510(K) SUMMARY FOR TAMPAX® TAMPONS 5.0 SUMMARY OF SAFETY AND EFFECTIVENESS
| Submission Date: | May 30, 2006 | |
|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Applicant Information:
| Company Name: | The Procter & Gamble Company |
|---|---|
| Company Address: | 6110 Center Hill Avenue |
| Cincinnati, OH 45224 | |
| Contact Person: | Philip J. Phillips, MBA |
| Director, Medical Device Practice | |
| Becker & Associates Consulting, Inc. | |
| (202) 822-1854 (voice) | |
| (202) 822-1859 (fax) | |
| Device Information: | |
| Trade Name: | TAMPAX® Tampons |
| Common Name: | Unscented Menstrual Tampon |
| Classification Name: | Unscented Menstrual Tampon (per 21 CFR |
| §884.5470) | |
| Device Class: | II |
| Predicate Device: | TAMPAX® Tampons, |
| The Procter & Gamble Company, K040999 | |
| Device Description: | The device is a conventional unscented menstrual |
| tampon consisting of an absorbent pledget, a | |
| withdrawal cord, and an applicator. | |
| The absorbent pledget consists of a pad of cotton | |
| and/or rayon fibers overwrapped with a non-woven | |
| fabric. A cotton withdrawal cord is sewn to the | |
| pad, and the pad is compressed into a traditional | |
| bullet-shaped pledget. The formed pledget is inserted into a flushable | |
| paper applicator consisting of an inner pusher |
0018
1
tube and an outer insertion tube with an open distal end.
- Each tampon is wrapped in an individual wrapper . and packaged in sealed multi-unit containers for retail sale.
Intended Use: The device is intended to be inserted into the vagina to absorb menstrual fluid.
Comparison to Predicate Device:
Technological Characteristics: The device is similar to the predicate device in terms of component materials, overall design, and labeling. It differs from the predicate device in the design of the applicator grip.
Safety Assessment: The same materials are used in both the predicate device and this device. Therefore, the in vitro and biocompatibility testing performed on the predicate device apply to this device as well. The results of these safety tests support the conclusion that this device is safe for use.
Effectiveness: The device complies with the syngyna absorbency requirements of 21 CFR §801.430. Therefore, additional testing of these tampons is not necessary to establish their equivalence to the predicate device in terms of effectiveness.
- The results of evaluations of this device (TAMPAX® Conclusions: Tampons) support the conclusions that it is safe for its intended use and that it is substantially equivalent to the cited predicate device with regards to safety and effectiveness.
0019
ﮩﺎ
2
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 stylized eagle with three lines extending from its back, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
AUG 0 1 2006
The Procter & Gamble Company c/o Philip J. Phillips, M.B.A. Director, Medical Device Practice Becker & Associates Consulting, Inc. 2001 Pennsylvania Avenue, N.W., Suite 575 WASHINGTON DC 20006
Re: K061486
Trade/Device Name: TAMPAX® Tampons Regulation Number: 21 CFR §884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: May 30, 2006 Received: May 31, 2006
Dear Mr. Phillips:
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 ass mated in 28, 1976, the enactment date of the Medical Device Amendments, or to devices that prov to thay 20, 177 de 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 Applerial), it they of bally of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Protecting and Promoting Public Health
3
Page 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 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/edrh/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
4
4.0 Statement of Indications for Use
| 510(k) Number (if known): | K061486 |
|---|---|
| Device Name: | TAMPAX ® Tampons |
Indications for Use:
TAMPAX® Tampons are unscented menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
Prescription Use (Part 21 CFR 801 Supbart D) AND/OR
Over-The-Counter Use -__X (21 CFR Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Dev 510(k) Number J
0017