(85 days)
No
The document describes a menstrual tampon and its performance testing, with no mention of AI or ML technology.
No.
The tampons are intended to absorb menstrual fluid, which is a supportive function and does not provide therapy (treatment or prevention of a disease/condition).
No
The device, TAMPAX® C Plastic™ Tampons, is intended to absorb menstrual fluid, which is a therapeutic rather than a diagnostic function.
No
The device description and performance studies clearly indicate this is a physical medical device (tampons) and not software.
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 within the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description confirms it's a "menstrual tampon for absorption of menstrual fluid."
- Lack of Diagnostic Elements: There is no mention of analyzing a sample (like blood, urine, or tissue), detecting a substance, or providing information for diagnosis.
- Performance Studies: The performance studies focus on material safety, applicator function, and packaging integrity, which are relevant to a medical device for absorption, not a diagnostic device.
IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
N/A
Intended Use / Indications for Use
TAMPAX® C PlasticTM Tampons, unscented, are intended to be inserted into the vagina to absorb menstrual fluid
The TAMPAX® C Plastic™ Tampons, unscented, are intended to be inserted into the vagina to absorb menstrual fluid.
Product codes
HEB
Device Description
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)
Nonclinical Testing: Tampon material safety and design have been established in 510(k) submission K081555. Extractions of the 510(k) device plastic applicators were performed under exaggerated conditions to confirm negligible or no tampon pledget exposure to the applicator components. Tests of the 510(k) tampon applicator expulsion force showed that the force is within acceptable limits. Tests of the seal strength (Thwing-Albert measurement) and peel strength (Instron measurement) of the 510(k) modified wrapper showed that the seal and peel strength of the wrapper is within specified limits. The results of these 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)
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
K110669
pg. 1 of 2
JUN - 2 2011
Section 5: 510(k) Summary
| Submitted by: | The Procter & Gamble Company
6110 Center Hill Avenue
Cincinnati, OH 45224 |
|------------------------|---------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kathleen Blieszner, Ph.D.
Regulatory Affairs Manager
(513) 634-3168 (voice)
(513) 277-2931 (FAX) |
| Date Summary Prepared: | 1 June 2011 |
| Trade Name: | TAMPAX® C PlasticTM Tampons, unscented |
| Common Name: | Unscented Tampon |
| Classification Name: | Unscented menstrual tampon (21 CFR 884.5470) |
| Predicate Devices: | TAMPAX® Pearl Tampons, unscented
K081555 |
| Device Description: | Unscented menstrual tampons for absorption of
menstrual fluid |
| Intended Use: | TAMPAX® C PlasticTM Tampons, unscented, 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. A pigment has been added to the applicator, the applicator shape and the wrapper have been modified.
- Nonclinical Testing: Tampon material safety and design have been established in 510(k) submission K081555. Extractions of the 510(k) device plastic applicators were performed under exaggerated conditions to confirm negligible or no tampon pledget exposure to the applicator components. Tests of the 510(k) tampon applicator expulsion force showed that the force is within acceptable limits. Tests of the seal strength (Thwing-Albert measurement) and peel strength (Instron measurement) of the 510(k) modified wrapper showed that the seal and peel strength of the wrapper is within specified limits. The results of these tests support the conclusion that the 510(k) device is equally as safe as the predicate devices.
- Conclusions: The tampon pledget design was not changed from the predicate device. Extracts of the proposed and predicate device applicators show similar results. The modified applicator has similar expulsion force as the current applicator. The seal strength and peel strength results show that the modified wrapper has similar
1
K110669
Pg. 2 of 2
integrity to the current wrapper. The results of the extraction testing and seal and peel strength testing for this device support the conclusion that it is safe for its intended use and is substantially equivalent to the cited predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Kathleen Blieszner, Ph.D. Regulatory Affairs Manager The Procter and Gamble Company 6110 Center Hill Avenue CINCINNATI OH 45224
JUN - 2 2011
Re: K110669
Trade Name: TAMPAX® C Plastic™ Tampons. unscented Regulation Number: 21 CFR 8884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: May 3, 2011 Received: May 4, 2011
Dear Dr. Blieszner:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting of medical device-related
3
adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301)-796-7100-or-at-its-Internet-address-
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Hicker Lemur MD
erbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
| 510(k) Number (if known) | K110669 |
|---|---|
| Device Name | TAMPAX® C Plastic™ Tampons, unscented |
| Indications for Use | The TAMPAX® C Plastic™ Tampons, unscented, 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) Over-The-Counter Use
Signature
OR
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number