(396 days)
TAMPAX® Pearl Plastic Applicator Unscented Tampons are 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, an overwrap, a withdrawal cord, an absorbent braid, and an applicator.
This document provides a 510(k) summary for the TAMPAX® Pearl Plastic Applicator Unscented Tampons. The purpose of this summary is to demonstrate the device's substantial equivalence to predicate devices, focusing on safety and effectiveness.
Here’s an analysis of the provided information, framed by your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Description of Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety - Toxicology | Compliance with FDA guidance and applicable standards for irritation testing, sensitization testing, acute toxicity, and cytotoxicity. | Favorable safety outcomes reported from preclinical toxicology testing. Specific results (e.g., irritation score thresholds) are not provided, but the conclusion is that the device met the safety requirements in these areas. |
| Safety - Microbiology | No impact on the growth of Staphylococcus aureus; no impact on normal vaginal microflora; no increase in the production of TSST-1 (Toxic Shock Syndrome Toxin-1). | Preclinical microbiology testing confirmed that the device "does not impact the growth of Staphylococcus aureus or the normal vaginal microflora, nor does it increase the production of TSST-1." |
| Safety - Clinical Adverse Events | Absence of adverse events related to the test products during clinical trials. | "In the clinical trials that were performed, no adverse events related to the test products were reported." |
| Effectiveness - Absorbency | Compliance with the syngyna absorbency requirements of 21 CFR 801.430. This regulation defines the standard laboratory test for determining the absorbency of menstrual tampons. | "TAMPAX® Pearl Plastic Applicator Unscented Tampons comply with the syngyna absorbency requirements of 21 CFR 801.430." The report explicitly states, "Therefore, additional testing of these tampons is not necessary to establish their equivalence to the predicate tampons in terms of effectiveness." This indicates that the device met the regulatory absorbency standard. |
| Substantial Equivalence (Overall) | The device is equally as safe and effective as the predicate devices in terms of component materials, overall design, intended use, labeling, and performance. The primary change in the 510(k) device is the incorporation of a process aid to decrease microwave setting time for the pledget, which should not affect safety or effectiveness. | The submission concludes that "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 devices with regard to safety and effectiveness." The FDA's 510(k) clearance letter confirms this substantial equivalence determination. |
Since this is a 510(k) summary for a menstrual tampon, the "AI" related questions are not applicable to this type of medical device submission. The device described does not involve AI, image analysis, or expert-driven diagnostic interpretations. Therefore, sections 2-6 and 8-9 are specifically tailored to human-read diagnostic studies or AI-driven medical devices and cannot be fully answered or are entirely irrelevant for this tampon submission.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Clinical Trials): The exact sample size for the clinical trials is not specified in the provided text. The document states "In the clinical trials that were performed..." but does not give numerical details about participants.
- Data Provenance: The document does not specify the country of origin of the data. It implies prospective clinical evaluations ("clinical trials that were performed").
- Preclinical Testing: No sample sizes are provided for the preclinical toxicology or microbiology testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This is a physical medical device (tampon), not a diagnostic device requiring expert interpretation or ground truth establishment in the traditional sense of image analysis or diagnostic studies. The safety and effectiveness are assessed through laboratory tests and clinical observations rather than expert consensus on a diagnostic output.
4. Adjudication Method for the Test Set
- Not Applicable. As above, this is not a diagnostic study requiring adjudication of expert opinions. Clinical observations were made during trials, and laboratory tests were conducted, but an adjudication method for a "test set" in the context of interpretation is not relevant here.
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 not a diagnostic device, and therefore neither an MRMC study nor AI assistance is relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, "ground truth" is established through:
- Standardized Laboratory Testing: For absorbency, the syngyna absorbency test (21 CFR 801.430) serves as the defined standard. For toxicology and microbiology, standard methods are used to determine parameters like irritation, sensitization, and microbial growth/toxin production. These are objective measures against predefined criteria.
- Clinical Observation: Absence of adverse events in clinical trials serves as "ground truth" for clinical safety, relying on participant reporting and investigator observation.
- Comparison to Predicate: The ultimate "ground truth" for substantial equivalence is that the new device performs equivalently to the legally marketed predicate devices, as demonstrated by the above tests.
8. The sample size for the training set
- Not Applicable. This device does not involve an algorithm or AI, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. This device does not involve an algorithm or AI, so there is no "training set" and therefore no ground truth established for it.
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Section 5: 510(k) Summary
| Submitted by: | The Procter & Gamble Company6110 Center Hill AvenueCincinnati, OH 45224 | |
|---|---|---|
| Contact Person: | Kimberly A Nemeth, Ph.D.Regulatory Affairs Manager(513) 634-3768 (voice)(513) 277-7085 (fax) | JUN - 1 2010 |
| Date Summary Prepared: | May 27, 2010 | |
| Trade Name: | TAMPAX® Pearl Plastic Applicator UnscentedTampons | |
| Common Name: | Unscented Menstrual Tampon | |
| Classification Name: | Unscented Menstrual Tampon (21 CFR 884.5470) | |
| Predicate Devices: | TAMPAX® Pearl Plastic Applicator UnscentedTampons - Light, Regular, Super, and Super Plus(K011996) | |
| TAMPAX® Pearl Plastic Applicator UnscentedTampons - Ultra (K051290) |
- Device Description: The device is a conventional unscented menstrual tampon consisting of an absorbent pledget, an overwrap, a withdrawal cord, an absorbent braid, and an applicator.
- Intended Use: This device is intended to be inserted into the vagina to absorb menstrual fluid.
- Technological Characteristics: This device is similar to the predicate devices in terms of component materials, overall design, intended use, and labeling. The 510(k) device incorporates a process aid to substantially decrease the microwave time needed to set the pledget.
- Non-Clinical and Clinical Testing: Preclinical toxicology information was gathered and evaluated in accordance with FDA guidance and applicable standards, including irritation testing, sensitization testing, acute toxicity and cytotoxicity testing. In the clinical trials that were performed, no adverse events related to the test products were reported.
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Preclinical microbiology testing confirmed that the 510(k) device does not impact the growth of Staphylococcus aureus or the normal vaginal microflora, nor does it increase the production of TSST-1.
The favorable safety outcomes associated with the preclinical toxicology testing, preclinical microbiology testing, and clinical evaluations support the conclusion that this 510(k) device is equally as safe as the predicate devices.
- Effectiveness: TAMPAX® Pearl Plastic Applicator Unscented Tampons comply 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 tampons 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 devices with regard to safety and effectiveness.
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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002.
Kimberly A. Nemeth, Ph.D. Regulatory Affairs Manager Proctor & Gamble Co. 6110 Center Hill Ave CINCINNATI OH 45224
JUN - 1 2010
Re: K091281
Trade Name: Tampax Pearl Unscented Menstrual Tampons Regulation Number: 21 CFR §884.5460 Regulation Name: Scented or scented deodorized menstrual tampon Regulatory Class: II Product Code: HFB Dated: May 21, 2010 Received: May 21, 2010
Dear Dr. Nemeth:
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
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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,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4: Indications for Use Statement
510(k) Number (if known): K09 | 28 |
Device Name: TAMPAX® Pearl Plastic Applicator Unscented Tampons
Indications for Use:
TAMPAX® Pearl Plastic Applicator Unscented Tampons are 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)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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§ 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).