(42 days)
Scented, Scented Deodorant and Unscented menstrual tampons for absorption of menstrual fluid: Part 21 C. F. R., Section 884.5460 and Section 884.5470 respectively.
Scented or scented deodorant and unscented menstrual tampons for the absorption of menstrual fluid.
The provided document is a 510(k) summary for Playtex Tampons, seeking substantial equivalence to previously cleared devices. It describes the device, its intended use, and the nonclinical testing performed. However, it does not contain the detailed information necessary to complete a table of acceptance criteria, reported device performance, or elaborate on a specific study as requested.
Here's a breakdown of why the requested information cannot be fully provided from the text:
- Acceptance Criteria & Device Performance: The document states that the new Playtex tampons are "substantially equivalent" to predicate devices. This implies that the performance of the new tampons is expected to be comparable to the predicate devices and meet established safety standards. However, it does not explicitly list specific acceptance criteria (e.g., absorbency rates, leakage rates, or specific irritation scores) nor does it provide quantified reported device performance metrics against those criteria. The "nonclinical testing" listed (human sensitization, dermal irritation, acute oral toxicity, subacute vaginal irritations, agar diffusion and TSST-1 toxin testing) are the types of tests conducted, but not the results or the thresholds for acceptance.
- Study Details (Sample size, data provenance, experts, adjudication, MRMC, Standalone, Ground Truth, Training Set): The document focuses on regulatory submission and a declaration of substantial equivalence based on nonclinical testing referenced. It does not describe a clinical study with a detailed methodology, sample sizes, ground truth establishment, or expert involvement in the way a diagnostic device study would. The "study" here refers to the overall assessment of the device's characteristics against known safety and performance data for similar devices.
Given the limitations of the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: | |
| No significant human sensitization at levels beyond predicate | "Substantially equivalent" to predicate devices in terms of safety |
| No significant dermal irritation at levels beyond predicate | "Substantially equivalent" to predicate devices in terms of safety |
| No significant acute oral toxicity at levels beyond predicate | "Substantially equivalent" to predicate devices in terms of safety |
| No significant subacute vaginal irritations beyond predicate | "Substantially equivalent" to predicate devices in terms of safety |
| No significant agar diffusion effects beyond predicate | "Substantially equivalent" to predicate devices in terms of safety |
| TSST-1 Toxin expression comparable to or less than predicate | "Substantially equivalent" to predicate devices in terms of safety |
| Effectiveness: | |
| Absorption of menstrual fluid comparable to predicate tampons | "Substantially equivalent" to predicate devices in terms of effectiveness |
| Same mode of action as predicate devices | Device has the "same mode of action" as predicate |
| Materials in contact with vaginal wall same or same mode of action | Materials are "the same or have the same mode of action" as predicate |
Note: The performance is reported as "substantially equivalent" to predicate devices, rather than specific quantitative metrics. The acceptance criteria are inferred from the types of nonclinical tests performed and the claim of substantial equivalence to previously cleared devices.
2. Sample sized used for the test set and the data provenance
- Sample Size: Not specified in the document. The nonclinical tests listed typically involve in-vitro assays or animal studies, and potentially human patch tests for sensitization/irritation, but the sample sizes for these are not provided.
- Data Provenance: Not explicitly stated. The tests are general nonclinical tests. It's likely these were conducted in a controlled lab environment. The country of origin of the data is not mentioned, but the submitting company is Playtex Products Inc., based in Paramus, New Jersey, USA. The studies are retrospective in the sense that they are supporting a premarket notification for a device that is compared to existing predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. For nonclinical tests like those listed, "ground truth" typically refers to established scientific methodologies and thresholds in toxicology and material science, rather than expert consensus on diagnostic images or clinical outcomes. The studies are likely interpreted by relevant toxicologists, microbiologists, and material scientists within the company or at contracted labs.
4. Adjudication method for the test set
- Not applicable/not specified. Adjudication methods like "2+1" are relevant for clinical studies, especially those involving multiple readers interpreting data where consensus or tie-breaking is needed. For the nonclinical tests mentioned, results are typically objective measurements against a standard.
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 comparative effectiveness study was not done. This type of study (MRMC, AI assistance) is completely irrelevant to the context of a menstrual tampon and a 510(k) submission based on substantial equivalence through nonclinical testing. This category of study is specific to diagnostic imaging devices or AI-powered clinical decision support systems.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, this is not applicable. The device is a physical product (menstrual tampon), not an algorithm or AI system.
7. The type of ground truth used
- The "ground truth" for the nonclinical tests is based on established scientific standards, toxicological profiles, and material science specifications for analogous predicate devices and general safety requirements for medical devices. For example, a "dermal irritation" test would have an objective scoring system based on visual assessment by trained personnel (e.g., Draize scale) or instrumental measurements, compared against predefined thresholds for what constitutes an acceptable level of irritation. Similarly, TSST-1 toxin testing would involve laboratory culture methods and quantitative analysis against recognized safety limits.
8. The sample size for the training set
- Not applicable. The concept of a "training set" is relevant for machine learning algorithms. For a physical medical device submitted via 510(k), testing (nonclinical) is performed to demonstrate substantial equivalence to predicate devices, not to "train" an algorithm.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set" in this context.
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AUG 1 9 1998
f191
510(k) SUMMAR Y 9.
SUMMARY OF SAFETY AND EFFECTIVENESS A.
| 1. | COMPANY NAME | - | Playtex Products Inc. |
|---|---|---|---|
| ADDRESS | - | 215 College RoadP. O. Box 728Paramus, New Jersey 07652 | |
| TELEPHONE | - | 201-265-8000 | |
| CONTACT PERSON | - | M. RosengartenDirector of Regulatory & BiomedicalAffairs | |
| DATE OF SUMMARY | - | July 7, 1998 | |
| 2. | DEVICE NAME | - | Playtex Tampons |
CLASSIFICATION NAME - - Unscented Menstrual Tampons
-
- The new Playtex tampons are substantially equivalent to previously cleared Playtex Gentle Glide®, Slimfits™ and Soft Comfort™ Tampons, Regular, Super and Super Plus.
- The device description is: Scented or scented deodorant and unscented 4. menstrual tampons for the absorption of menstrual fluid.
- Playtex tampons are intended to be used as scented, scented deodorant and న్. unscented menstrual tampons for the absorption of menstrual fluid.
-
- The new tampon has the same technological characteristics as the predicate device and has the same mode of action. The fiber, string and materials in contact with the vaginal wall are the same or have the same mode of action.
- Nonclinical testing referenced for the determination of substantial equivalence B. 1. includes:
Human sensitization, dermal irritation, acute oral toxicity, subacute vaginal irritations, agar diffusion and TSST-1 toxin testing.
- Based on the review of the data referenced in this "510(k) Summary," the Playtex Tampons are substantially equivalent to the predicate device in terms of safety and effectiveness.
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Image /page/1/Picture/0 description: The image shows a partial view of a seal or emblem, likely from a government or organizational entity. The visible portion includes the stylized silhouette of an eagle or similar bird with outstretched wings, a common symbol of authority or freedom. The text "DEPARTMENT OF HEALTH & HUM" is partially visible, suggesting the emblem belongs to a Department of Health and Human Services or a similar agency.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K982383
Playtex Tampons #18898, Gentle Glide®, Silk Glide® Slimfits™, Soft Comfort™, and Portables® Dated: July 7, 1998 Received: July 8, 1998 Regulatory Class: II 21 CFR 884.5460/Procode: 85 HIL 21 CFR 884.5470/Procode: 85 HEB
Dear Mr. Rosengarten:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 practive, 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 device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrb/dsmaldsmamain.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
AUG / 9 1998
Mr. Mark Rosengarten Director, Regulatory & Biomedical Affairs Research & Development 215 College Road P.O. Box 728 Paramus, NJ 07652
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STATEMENT OF INDICATIONS OF USE PAGE
Page _ 1 _ of __ 1
510(k) Number (if known): _ K 982383
Device Name: Playtex Gentle Glide®, Silk Glide®, Slimfits™ Soft Comfort™ and Portable® Tampons
Indications For Use:
Scented, Scented Deodorant and Unscented menstrual tampons for absorption of menstrual fluid: Part 21 C. F. R., Section 884.5460 and Section 884.5470 respectively.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Retherford
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K982383
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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).