VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS by PARAGON TRADE BRANDS, INC.

Paragon Menstrual Tampons are a plug made of cellulosic or synthetic material that is inserted into the vaginal and used to absorb menstrual or other vaginal discharge.

Device Description

Paragon Trade Brands Tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided with 3 absorbencies, regular, super and super plus. These Paragon Trade Brands Tampons are made from rayon and cotton and cotton cord. The material used in Paragon Trade Brand tampons are similar to those used in other legally marketed tampons.

AI/ML Overview

The provided text describes a 510(k) summary for "Paragon Trade Brand Tampons" (K981953), which are menstrual tampons used to absorb menstrual fluid. The submission focuses on demonstrating substantial equivalence to legally marketed Tampax tampons with applicators rather than establishing novel acceptance criteria through a specific clinical study with a device performance table.

Therefore, many of the requested elements for describing a study proving the device meets acceptance criteria are not directly applicable or explicitly stated in the provided text. However, I can extract the relevant information and indicate where data is not available from the text.

Here's an analysis based on the provided documents:

Acceptance Criteria and Device Performance

The core of this submission is substantial equivalence to a predicate device (Tampax tampons with applicators), not a new set of numerical performance acceptance criteria. The "acceptance criteria" are implicitly met if the device is found to be substantially equivalent in terms of safety and effectiveness to the predicate.

Acceptance Criteria Category	Reported Device Performance (Paragon Trade Brand Tampons)
Material Composition	Made from rayon and cotton and cotton cord. Similar to materials used in other legally marketed tampons.
Intended Use	Inserted into the vagina to absorb menstrual fluid. Identical to predicate device.
Biocompatibility	Components demonstrated equivalence to legally marketed tampons in terms of safety and effectiveness.
Irritation (O-Irritation)	Tested (result implied to be acceptable for substantial equivalence).
Sensitization (O-Sensitization)	Tested (result implied to be acceptable for substantial equivalence).
Acute Oral Toxicity (O-Acute Oral Toxicity)	Tested (result implied to be acceptable for substantial equivalence).
Eye Irritation (O-Eye Irritation)	Tested (result implied to be acceptable for substantial equivalence).
Cytotoxicity (O-Cytotoxicity)	Tested (result implied to be acceptable for substantial equivalence).
Dioxins and Furans Analysis	Tested (result implied to be acceptable for substantial equivalence).
Absorbency (Syngyna Testing)	Confirmed absorbency. Implied to be comparable/equivalent to predicate device for each of the three absorbencies (regular, super, super plus).

Study Details (Based on available information in the 510(k) Summary)

The "study" described is a non-clinical testing program to support substantial equivalence.

Sample size used for the test set and the data provenance:
- Sample Size: Not specified for individual tests. The text mentions "Biocompatibility testing of the Paragon Trade Brands Tampons components" and "Standard Syngyna testing confirmed the absorbency of these Tampons." The number of samples or items tested for each specific biocompatability assay (irritation, sensitization, etc.) or Syngyna absorbency is not provided.
- Data Provenance: Not explicitly stated, but typically non-clinical testing like this would be conducted in a laboratory setting, likely within the US or by a contracted lab. It is retrospective in the sense that the testing was performed on the completed device design.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this 510(k) submission. The "ground truth" for non-clinical testing like biocompatibility or absorbency is established by the standardized test methods themselves and the quantitative or qualitative results obtained from those tests, not by expert consensus on interpretations of complex data like medical images. For instance, Syngyna testing has a defined protocol for measuring absorbency.
Adjudication method for the test set:
- Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for clinical studies involving multiple expert readers interpreting subjective data (like medical images) to establish a consensus ground truth. This submission describes non-clinical laboratory testing. The results of tests like biocompatibility or absorbency are typically numerical or based on predefined pass/fail criteria, not subjective expert judgment requiring adjudication.
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:
- This is not applicable. This device is a menstrual tampon, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and AI performance metrics are irrelevant to this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. As stated above, this device is not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For biocompatibility tests (irritation, sensitization, toxicity, cytotoxicity, dioxins/furans), the "ground truth" is established by the standardized test methodologies and their direct results (e.g., specific cellular reactions, chemical levels, lack of observed adverse effects). These results are then compared to established safety profiles for similar materials or predicate devices.
- For absorbency, the "ground truth" is established by the quantitative measurement obtained through standard Syngyna testing.
The sample size for the training set:
- This is not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.
How the ground truth for the training set was established:
- This is not applicable as there is no training set for this device.

Summary

{0}------------------------------------------------

AUG 1 8 1998

VII

510K SUMMARY

K98/953

P191

Device Name: Paragon Trade Brand Tampons

Legally marketed device: These Tampons are substantially equivalent to legally marketed Tampax tampons with applicators.

Device description: Paragon Trade Brands Tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided with 3 absorbencies, regular, super and super plus.

These Paragon Trade Brands Tampons are made from rayon and cotton and cotton cord.

The material used in Paragon Trade Brand tampons are similar to those used in other legally marketed tampons.

Intended Use: Paragon Trade Brands tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.

Assessment of Performance Standards: Not Applicable

Non-Clinical Testing: Biocompatability testing of the Paragon Trade Brands Tampons components was carried out. The results of these tests demonstrate that these Tampons are equivalent in terms of safety and effectiveness to legally marketed tampons. Standard Syngyna testing confirmed the absorbency of these Tampons. In addition to the review of existing toxicological data in the public literature, the following tests were conducted relevant to the safety of Paragon Trade Brand tampons.

0 irritation testing
0 sensitization testing
0 acute oral toxicity
0 eve irritation testing
0 cytotoxicity testing
dioxins and furans analysis 0

{1}------------------------------------------------

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular pattern around the eagle.

AUG 1 8 1998

Paragon Trade Brands, Inc. c/o Robert J. Staab, Ph.D. President Regulatory and Technical Associates 73 Franklin Turnpike Allendale, NJ 07401

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K981953 Paragon Menstrual Tampons Dated: June 1, 1998 Received: June 3, 1998 Regulatory Class: II 21 CFR 884.5470/Procode: 85 HEB

Dear Dr. Staab:

We have reviewed your Section 510(k) notification of intent to market the device 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, parket 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 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 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other. Federal laws of 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 clagnostic 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 vours

Sincerely yours,

Lillian Yin, Ph.D.

Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

510(k) Number (if know):

95
2981159/3

Device Name: Paragon Menstrual Tampons

Indications For Use:

Paragon Menstrual Tampons are a plug made of cellulosic or synthetic material
. In the strual production and tracks and manatrual or other vaginal Paragon Menstrual Tampons are a prag made or over and or other vaginal
that is inserted into the vaginal and used to absorb menstrual or other vaginal discharge.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert R. Sathing /
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96) ·

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).