(81 days)
Not Found
No
The device description and performance studies describe a conventional menstrual tampon with no mention of AI or ML technology.
No
The device is used to absorb menstrual fluid, which is a supportive function and not a treatment for a disease or condition.
No
The device is a menstrual tampon designed to absorb fluid, not to diagnose a medical condition.
No
The device description clearly outlines a physical product (tampon with applicator) made of cotton, rayon, and paper, with no mention of software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- Device Function: The description clearly states that TAMPAX® Tampons are inserted into the vagina to absorb menstrual fluid. Their function is purely mechanical absorption within the body, not the analysis of a specimen outside the body.
- Intended Use: The intended use is for absorbing menstrual fluid, not for diagnosing any condition or providing information about a person's health through laboratory testing.
The information provided about the device's safety and effectiveness relates to its physical properties and performance as a menstrual product, not as a diagnostic tool.
N/A
Intended Use / Indications for Use
The device is intended to be inserted into the vagina to absorb menstrual fluid.
TAMPAX® Tampons are unscented menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
Product codes (comma separated list FDA assigned to the subject device)
78 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)
Safety Assessment: This safety assessment of the 510(k) device was based on a battery of safety tests, including in vitro testing and biocompatibility testing. The results of these safety tests support the conclusion that this 510(k) device is equally as safe as the predicate device.
Effectiveness The TAMPAX® Tampons 510(k) device complies with the syngyna absorbency requirements of 21 CFR 801.430. Therefore, additional syngyna ubberbeno, is not necessary to establish their equivalence to the predicate tampon in terms of effectiveness.
Conclusions: The results of evaluations of this device support the conclusions that it is safe for its intended use and that it is substantially equivalent to the cited predicate device with regard to safety and effectiveness.
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
§ 884.5470 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
JUL - 9 2004
| 4. 510(k) Summary | K040999 |
|---|---|
| Submitted by: | The Procter & Gamble Company |
| 6110 Center Hill Avenue | |
| Cincinnati, OH 45224 | |
| Contact Person: | Mark M. Anderson, Regulatory Affairs Manager |
| (513) 634-5196 (voice) (513) 634-7364 (FAX) | |
| Date Summary Prepared: | April 15, 2004 |
| Trade Name: | TAMPAX® Tampons |
| Common Name: | Unscented Menstrual Tampon |
| Classification Name: | Unscented Menstrual Tampon (per 21 CFR |
| 884.5470) | |
| Predicate Device: | TAMPAX® Tampons, |
| Procter & Gamble, K002096 |
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.
Intended Uses: The device is intended to be inserted into the vagina to absorb menstrual fluid.
- 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 composition of the non-woven pledget overwrap material.
Safety Assessment: This safety assessment of the 510(k) device was based on a battery of safety tests, including in vitro testing and biocompatibility testing.
Page 1 of 2
1
K040999
Page 2 of 2
The results of these safety tests support the conclusion that this 510(k) device is equally as safe as the predicate device.
- Effectiveness The TAMPAX® Tampons 510(k) device complies with the syngyna absorbency requirements of 21 CFR 801.430. Therefore, additional syngyna ubberbeno, is not necessary to establish their equivalence to the predicate tampon in terms of effectiveness.
- Conclusions: The results of evaluations of this device support the conclusions that it is safe for its intended use and that it is substantially equivalent to the cited predicate device with regard to safety and effectiveness.
2
Image /page/2/Picture/1 description: The image shows a logo with a stylized bird in the center. The bird is composed of three curved lines, suggesting movement or flight. The bird is encircled by text that follows the curve of the circle. The text is small and difficult to read, but it appears to be a phrase or title associated with the logo. The overall design is simple and symbolic, likely representing an organization or concept related to nature, freedom, or health.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 9 2004
Mark M. Anderson, Ph.D. Regulatory Affairs Manager The Procter & Gamble Company Feminine Care Global Business Unit 6110 Center Hill Avenue CINCINNATI OH 45224
Re: K040999
Trade/Device Name: TAMPAX® Tampons – (Junior, Regular, Super and Super Plus Absorbencies) Regulation Number: 21 CFR §884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: 78 HEB Dated: April 15, 2004 Received: April 19, 2004
Dear Dr. Anderson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becaon 310(t) pe device is substantially equivalent (for the indications ferenced above and nave use notemined in marketed predicate devices marketed in interstate for use stated in the enclosure) to regars and ment date of the Medical Device Amendments, or to Commerce prior & may 20, 1978, the econdance with the provisions of the Federal Food, Drug, devices that have occh recuire approval of a premarket approval application (PMA). alle Cosment Act (Free) market the device, subject to the general controls provisions of the Act. The r ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of use incentificans against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), IT your device is elassified (600 a00 regulations affecting your device can be It hay be subject to additional controllars, 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 I Teast of advised that I Dr i a sounds syour device complies with other requirements of the Act that I Dri has made a decommance. and regulations administered by other Federal agencies. You must of any I ederal statutes and regulatelly including, but not limited to: registration and listing Compry with an the Ace Frequirements, as a 11. 8.
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 807), labeming (21 OFR Part 820); and if applicable, the electronic forth in the quanty bystems (QB) reggions 531-542 of the Act); 21 CFR 1000-1050.
3
: :
This letter will allow you to begin marketing your device as described in your Section 100(k) This letter will allow you to begin marketing of substantial equivalence of your device to a lexally premarket nothication - The FDA inding of assistention 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 CFK Part 801), phease If you desire specific advice for your decise on our of the following numbers, based on the regulation number at the top of the letter.
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the promotion can and the regulation entitled, "Misbranding
Office of Compliance at (301) 594-4639. Also, please note the contract of the one Othice of Compliance at (301) 374-1057. This, production of a Pinisce of Since general by reference to premarket notification (Dr. St Free may be obtained from the Division of Small information on your responsionalites and consumer Assistance at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its tolds (demo Manufacturers, International and Collisation in Collisantes
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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
3. Statement of Indications for Use
510(k) Number (if known) _KO40999
TAMPAX® Tampons Device Name:
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 _________________________________________________________________________________________________________________________________________________________ (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)
Samue Morris Spencer
(Division Sign-Off)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number