(62 days)
TAMPAX® Tampons are unscented menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the TAMPAX® Tampons (K061486), structured according to your request.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with syngyna absorbency requirements of 21 CFR §801.430 | The device complies with the syngyna absorbency requirements of 21 CFR §801.430. |
| Safety equivalent to predicate device | "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 equivalent to predicate device | "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." |
| Substantial equivalence to predicate device (K040999) in terms of safety and effectiveness | "The results of evaluations of this device (TAMPAX® 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." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific sample size for a test set as it relies heavily on the equivalence to a predicate device. The primary "test" mentioned is compliance with a regulatory standard (syngyna absorbency), which is a laboratory test, not a clinical study with a human subject test set.
- Sample Size: Not applicable/not explicitly stated for a "test set" in the traditional sense of a clinical trial.
- Data Provenance: Not applicable as it's primarily a regulatory compliance statement and reliance on prior predicate device testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission relies on regulatory standards and previous testing of a predicate device. There is no mention of a ground truth established by human experts for a specific test set within this document.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring expert adjudication is mentioned.
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
Not applicable. This is a medical device submission for tampons, not an AI-powered diagnostic tool. Therefore, an MRMC study is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device (tampon), not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating effectiveness and safety is primarily based on:
- Regulatory Standard Compliance: Specifically, 21 CFR §801.430 for syngyna absorbency. This is a defined, objective test.
- Equivalence to Predicate Device: The safety and effectiveness are established by demonstrating that the new device is "substantially equivalent" to an already approved predicate device (TAMPAX® Tampons, K040999) due to similar materials and intended use, with the only difference being applicator grip design. The ground truth for the predicate device would have been established through its own initial approval process.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set mentioned.
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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 AvenueCincinnati, OH 45224 |
| Contact Person: | Philip J. Phillips, MBADirector, Medical Device PracticeBecker & 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 menstrualtampon consisting of an absorbent pledget, awithdrawal cord, and an applicator.The absorbent pledget consists of a pad of cottonand/or rayon fibers overwrapped with a non-wovenfabric. A cotton withdrawal cord is sewn to thepad, and the pad is compressed into a traditionalbullet-shaped pledget. The formed pledget is inserted into a flushablepaper applicator consisting of an inner pusher |
0018
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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
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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
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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
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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
§ 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).