(24 days)
The TAMPAX® Pearl Plastic™ unscented and scented Tampons are intended to be inserted into the vagina to absorb menstrual fluid.
Scented or scented deodorized, unscented menstrual tampons for absorption of menstrual fluid.
This document is a 510(k) summary for a medical device (TAMPAX® Pearl Tampons) seeking clearance from the FDA. The information provided focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with detailed acceptance criteria and results.
Therefore, many of the requested sections regarding acceptance criteria, study details, and AI-specific metrics cannot be extracted from the provided text. The document primarily describes the device, its intended use, and a safety assessment, then states conclusions about its safety and substantial equivalence to existing products.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided in the requested format. The document does not describe specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or corresponding quantitative device performance metrics in the way a diagnostic AI study would.
- What is stated: "The results of these safety tests support the conclusion that the 510(k) device is equally as safe as the predicate devices." and "The device is designed to acquire and hold menstrual fluids similar to the fluid handling capabilities of the predicate devices." This indicates a qualitative comparison for safety and functionality rather than quantitative performance against a set of predefined thresholds.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not explicitly stated for a "test set" in the context of device performance. The document mentions "in vitro microbiological testing, biocompatibility evaluation and extraction testing" as part of the safety assessment. However, it does not specify sample sizes or data provenance (country, retrospective/prospective) for these tests in a way that aligns with evaluating a device's diagnostic performance against a ground truth.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not stated. This type of information is relevant for studies validating diagnostic algorithms where expert consensus or pathological analysis establishes ground truth. For a menstrual tampon, the "ground truth" would likely relate to material properties, absorbency, and safety markers, which are evaluated through lab tests, not expert interpretation of outputs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not stated. Adjudication methods are used in studies involving human interpretation or subjective assessments, typically for diagnostic image analysis or similar tasks. This is not described for a tampon.
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 device is a menstrual tampon, not an AI-powered diagnostic tool. Therefore, a multi-reader multi-case comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Implied ground truth for safety and function: The "ground truth" for this device would be established through laboratory testing standards for absorbency, material composition, biocompatibility, and microbiological safety. The document refers to "in vitro microbiological testing, biocompatibility evaluation and extraction testing." These tests have their own established methods and criteria for determining safety and performance, which serve as the "ground truth" for evaluating the tampon's characteristics.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device that requires a training set.
Summary of what the document does provide regarding the device and its assessment:
The document describes the submission of a 510(k) premarket notification for TAMPAX® Pearl Tampons (unscented and scented). The primary goal of this submission is to demonstrate substantial equivalence to predicate devices (TAMPAX Pearl Tampons® unscented and scented: K011996; K040312; K051290).
Key "Acceptance Criteria" (implicit, based on 510(k) process for this device type):
- Safety: The device is as safe as predicate devices.
- Effectiveness/Functionality: The device is designed to acquire and hold menstrual fluids similar to the fluid handling capabilities of the predicate devices.
- Technological Characteristics: The device is similar to the predicate devices in terms of basic component materials, overall design, and labeling.
- Intended Use: Consistent with predicate devices.
Study that proves the device meets the (implicit) acceptance criteria:
- Study Type: A battery of safety evaluations was conducted.
- Specific Tests Mentioned:
- In vitro microbiological testing
- Biocompatibility evaluation
- Extraction testing
- Results/Conclusions:
- "The results of these safety tests support the conclusion that the 510(k) device is equally as safe as the predicate devices."
- "The results of evaluations for this device support the conclusions that it is safe for its intended use and substantially equivalent to the cited predicate devices."
In conclusion, this document describes a traditional medical device submission (a tampon) seeking clearance based on substantial equivalence, not a performance study for an AI-driven diagnostic device. Therefore, the detailed metrics and study design elements typically associated with AI performance evaluation are not present.
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JUN 2 7 2008
Section 5: 510(k) Summary
| Submitted by: | The Procter & Gamble Company6110 Center Hill AvenueCincinnati, OH 45224 |
|---|---|
| Contact Person: | Lenore Faulhaber, Ph.D., M.B.A.Regulatory Affairs Manager(513) 634-2466 (voice)(513) 634-7364 (FAX) |
| Date Summary Prepared: | June 2, 2008 |
| Trade Name: | TAMPAX® Pearl Tampons, unscented and scented |
| Common Name: | Unscented Tampon and Scented Tampon |
| Classification Name: | Unscented menstrual tampon (21 CFR 884.5470)Scented or scented deodorized menstrual tampon(21 CFR 884.5460) |
| Predicate Devices: | TAMPAX Pearl Tampons® unscented and scentedK011996; K040312; K051290 |
| Device Description: | Scented or scented deodorized, unscented menstrualtampons for absorption of menstrual fluid. |
| Intended Use: | TAMPAX Pearl Tampons® unscented and scented areintended to be inserted into the vagina to absorb menstrualfluid |
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.
Safety Assessment: A battery of safety evaluations were conducted, including in vitro microbiological testing, biocompatibility evaluation and extraction testing, to evaluate the safety profile of the 510(k) device. The results of these safety tests support the conclusion that the 510(k) device is equally as safe as the predicate devices.
Conclusions: The results of evaluations for this device support the conclusions that it is safe for its intended use and substantially equivalent to the cited predicate devices.
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Image /page/1/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 stripes representing human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 7 2008
Lenore Faulhaber, Ph.D., M.B.A. Regulatory Affairs Manager The Proctor & Gamble Company 6110 Center Hill Avenue CINCINNATI OH 45224
Re: K081555
Trade Name: TAMPAX® Pearl Plastic Tampons (Scented and Unscented) Regulation Number: 884.5460, 884.5470 Regulation Name: Menstrual Tampons (scented, unscented) Regulatory Class: II Product Code: HIL Dated: June 2, 2008 Received: June 3, 2008
Dear Dr. Faulhaber:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/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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Indications for Use Statement
| 510(k) Number (if known) | K081555 |
|---|---|
| Device Name | TAMPAX® Pearl Plastic™ Tampons |
| Indications for Use | The TAMPAX® Pearl Plastic™ unscented and scented Tampons 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) OR
Over-The-Counter Use
CLAR-HANK AMbil AMbil R-2-11 1-1415 This Charles Child Child Child Child Children Home Mather Home
Hulut lener
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K081555
§ 884.5460 Scented or scented deodorized menstrual tampon.
(a)
Identification. A scented or scented deodorized 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. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual tampon) or for deodorizing purposes (scented deodorized menstrual tampon). This generic type of device does not include menstrual tampons treated with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).