UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR

K962476 · Tambrands, Inc. · HEB · Aug 13, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K962476
• Device Name: UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR
• Applicant: Tambrands, Inc.
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Aug 13, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5470
• Device Class: Class 2

Indications for Use

TAMPAX Tampons, Plastic Applicator are unscented menstrual tampons used to absorb menstrual fluid.

Device Story

Unscented menstrual tampon; consists of rayon fibers, overwrap, cotton withdrawal cord, and colored plastic applicator. Available in regular, super, and super plus absorbencies. Used by women during menstruation to absorb fluid. Device functions via physical absorption; applicator facilitates insertion. Safety of colorants in plastic applicator verified via biocompatibility and clinical testing.

Clinical Evidence

Clinical study (n=57 women) evaluated safety and comfort of colored applicator tampons versus control tampons during intermenstrual use. Primary endpoint: prevalence of product-related irritation. Results showed no significant differences in irritation or comfort; no unexpected adverse events.

Technological Characteristics

Materials: rayon fibers, overwrap, cotton withdrawal cord, colored plastic applicator. Form factor: tampon with applicator in three absorbencies (regular, super, super plus). Non-sterile (implied).

Indications for Use

Indicated for use by women for the absorption of menstrual fluid.

Regulatory Classification

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.

Predicate Devices

• TAMPAX Tampons, Plastic Applicator (K962476)

Submission Summary (Full Text)

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K962476

AUG 13 1996

# 510(k) Summary

as required by 21 CFR 807.92

**Device Name:** Unscented Menstrual Tampon

**Manufacturer:** Tambrands Inc.
Bridge & Springfield Streets
Palmer, MA 01069

**Contact Person:** Jerome B. Wainick
Vice President, Research and Development
Phone: [phone]
FAX: [phone]

**Date Summary Prepared:** June 17, 1996

## Device Names:

**Trade Name:** TAMPAX Tampons, Plastic Applicator
**Common Name:** TAMPAX Tampons
**Classification Name:** Unscented Menstrual Tampons (21 CFR 884.5470)

**Legally Marketed Device:** TAMPAX Tampons, Plastic Applicator

**Device Description:** TAMPAX Tampons, Plastic Applicator will be provided in three absorbencies, regular, super and super plus. TAMPAX Tampons, Plastic Applicator have a colored plastic applicator. TAMPAX Tampons, Plastic Applicator are made of rayon fibers and overwrap, a cotton withdrawal cord, and a colored plastic applicator.

**Intended Use:** TAMPAX Tampons, Plastic Applicator are unscented menstrual tampons used to absorb menstrual fluid.

**How Product Differs from Predicate Device:** The new device has a colored applicator. Except for the color of the applicator, TAMPAX Tampons, Plastic Applicator are identical to the predicate product. The colorants used in the colored applicator have been adequately characterized and evaluated using scientifically valid safety tests.

## Assessment of Performance Data:

**Non-clinical Testing:** Biocompatibility testing of the colorants and the colored applicator used in TAMPAX Tampons, Plastic Applicator was conducted. In addition to the review of existing literature and toxicological data, the following tests were conducted related to the safety of TAMPAX Tampons, Plastic Applicator:

- Irritation and sensitization testing
- Cytotoxicity testing
- Extraction assay

The results of these tests demonstrate that TAMPAX Tampons, Plastic Applicator are equivalent in terms of their safety and effectiveness to legally marketed tampons.

summary.doc

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K962476

Clinical Testing: A clinical study was done to evaluate the safety of TAMPAX Tampons, Plastic Applicator and to compare its safety to its predicates. The study compared insertion of TAMPAX Tampons, Plastic Applicator to insertion of control tampons during intermenstrual use in 57 women. Safety was evaluated by comparing the prevalence of product related irritation after tampon insertion.

The study results showed no differences in product related irritation or comfort between TAMPAX Tampons, Plastic Applicator and the control product. No significant or unexpected adverse events were observed during the study.

Conclusions: Results of the non-clinical and clinical tests showed that the addition of colorant to the Plastic Applicator does not alter the safety or effectiveness of the device and that TAMPAX Tampons, Plastic Applicator are as safe and as effective as predicate, legally marketed tampons. Further, the results demonstrated that TAMPAX Tampons, Plastic Applicator are substantially equivalent to other legally marketed tampons.

summary.doc