TAMPAX TAMPONS (JUNIOR, REGULAR, SUPER AND SUPER PLUS ABSORBENCIES) by PROCTER & GAMBLE CO.

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.

AI/ML Overview

The provided text describes a 510(k) submission for TAMPAX® Tampons, which is a conventional unscented menstrual tampon. The submission asserts that the device is substantially equivalent to a predicate device (TAMPAX® Tampons, K002096). The acceptance criteria and supporting study details for this type of medical device clearance are generally different from those for AI/ML-powered software devices.

Based on the provided documents, here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this conventional medical device are primarily focused on safety and effectiveness as defined by regulatory standards for menstrual tampons.

Acceptance Criteria	Reported Device Performance
Safety:	The results of these safety tests support the conclusion that this 510(k) device is equally as safe as the predicate device.
- Biocompatibility	Conducted. (Implicitly met as part of the safety assessment.)
- In vitro testing	Conducted. (Implicitly met as part of the safety assessment.)
Effectiveness:	The TAMPAX® Tampons 510(k) device complies with the syngyna absorbency requirements of 21 CFR 801.430. Therefore, additional syngyna absorbency testing is not necessary to establish their equivalence to the predicate tampon in terms of effectiveness.
- Syngyna absorbency (compliance with 21 CFR 801.430)	Complies with 21 CFR 801.430.
Substantial Equivalence (Overall):	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. 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.

Study Details (Based on the provided text, many details specific to AI/ML or complex clinical studies are not applicable or not provided)

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not explicitly stated for specific tests. The safety assessment involved a "battery of safety tests," but the number of units or samples tested for each is not detailed.
Data Provenance: Not specified. Given the nature of in vitro and biocompatibility testing for a medical device like a tampon, the data would likely originate from laboratory settings rather than human subjects/patients or specific geographical regions in the way clinical studies often do. This would be prospective testing done on the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable in the context typically seen for AI/ML diagnostic devices. "Ground truth" for a tampon's safety and absorbency is established by standardized laboratory methods (e.g., syngyna testing, biocompatibility assays), not expert consensus on interpretations. The evaluation of test results would be performed by qualified laboratory personnel following established protocols.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review in diagnostic imaging or similar scenarios where subjective interpretation might need resolution. For laboratory tests on a physical device, results are typically quantitative and assessed against predefined specifications without this type of adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. An MRMC study is not relevant for this device. This type of study is specifically for evaluating the impact of AI on human readers' diagnostic performance in fields like radiology. This device is a physical product (a tampon), not an AI/ML diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This device is a physical tampon, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For safety: Compliance with established biocompatibility standards and material safety profiles. This is based on validated laboratory test methods.
For effectiveness: Compliance with the syngyna absorbency requirements defined in 21 CFR 801.430. This is a standardized, objective laboratory test.

8. The sample size for the training set:

Not applicable. This is a conventional medical device; there is no "training set" in the machine learning sense. Device design and material selection are based on engineering principles and regulatory requirements, not machine learning training.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this device.

Summary

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JUL - 9 2004

4. 510(k) Summary	K040999
Submitted by:	The Procter & Gamble Company6110 Center Hill AvenueCincinnati, 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 CFR884.5470)
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

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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.

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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.

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: :

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

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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

Regulation Number and Section

§ 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).