CAREFREE PANTYLINERS

K961119 · Personal Products Co. · HHL · Apr 17, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K961119
• Device Name: CAREFREE PANTYLINERS
• Applicant: Personal Products Co.
• Product Code: HHL · Obstetrics/Gynecology
• Decision Date: Apr 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5425
• Device Class: Class 2

Indications for Use

The modified device and the pre-amendments device are both used to absorb small amounts of menstrual or other vaginal discharge.

Device Story

Device is an ultrathin, beltless, absorbent feminine napkin (pantyliner) containing fragrance for aesthetic purposes. Used by individuals for absorption of vaginal discharge. Composed of nonwoven cover, repellent barrier, perfume, adhesive, and release paper. No electronic, software, or mechanical components.

Clinical Evidence

Clinical evidence consists of a Repeated Insult Patch Test (RIPT) in humans to evaluate dermal irritation and sensitization potential of the added perfumes. Results indicated no potential for dermal irritation or sensitization under study conditions. Pre-clinical testing included acute oral toxicity (rats), CHO mammalian cell cytotoxicity, guinea pig sensitization (Magnusson-Kligman), primary dermal irritation (rabbits), and primary eye irritation (rabbits).

Technological Characteristics

Ultrathin, beltless feminine napkin. Materials: nonwoven cover, repellent barrier, perfume, adhesive, release paper. No energy source, connectivity, or software.

Indications for Use

Indicated for individuals requiring absorption of small amounts of menstrual or other vaginal discharge.

Regulatory Classification

Identification

A scented or scented deodorized menstrual pad is a device that is a pad made of cellulosic or synthetic material which is used to absorb menstrual or other vaginal discharge. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual pad) or for deodorizing purposes (scented deodorized menstrual pad). This generic type of device includes sterile scented menstrual pads used for medically indicated conditions, but does not include menstrual pads treated with added antimicrobial agents or other drugs.

Special Controls

*Classification.* (1) Class I (general controls) for menstrual pads made of common cellulosic and synthetic material with an established safety profile. The devices subject to this paragraph (b)(1) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9. This exemption does not include the intralabial pads and reusable menstrual pads.(2) Class II (special controls) for scented or scented deodorized menstrual pads made of materials not described in paragraph (b)(1). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

Predicate Devices

• CAREFREE® Panty Shield (Pre-Amendments device)

Submission Summary (Full Text)

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# K961119

## 510(k) Summary

### 1. Summary

Summarized below is the safety and effectiveness information compiled in support of claims of substantial equivalence (as defined in the FD&C Act).

### 2. Submitter:

Personal Products Company
199 Grandview Road
Skillman, New Jersey 08558

**Contact Person:**

Ms. Lorna-Jane Bremer
Senior Regulatory Affairs Associate
Johnson & Johnson Worldwide Absorbent Products and Materials Research
199 Grandview Road
Skillman, New Jersey 08558
Phone: [phone]
Fax: [phone]

**Date of Submission:** March 15, 1996

**Device trade name:** CAREFREE® Scented Pantyliner
CAREFREE® Lightly Scented Pantyliner

**Device common name:** Panty Shield

**Device classification:** Scented or scented deodorized menstrual pad
(Ref. 21 CFR 884.5425)

4. The modified device is substantially equivalent to CAREFREE® Panty Shield, a Pre-Amendments device what was on the market prior to May 28, 1976.

5. **Description:** The modified device and the Pre-amendments device are both ultrathin, beltless, absorbent feminine napkins made of absorbent material. A fragrance is added for aesthetic purposes.

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## 510(k) Summary (continued)

6. **Intended Use**: The modified device and the pre-amendments device are both used to absorb small amounts of menstrual or other vaginal discharge.

7. **Technological Characteristics**
The modified device and the pre-amendments device are both comprised of a nonwoven cover, repellent barrier, perfume, adhesive, and release paper. They are available as lightly scented and scented products.

8. **Performance Data**
Johnson & Johnson Worldwide Absorbent Products and Materials Research has conducted a thorough program to evaluate the safety of the Modified Device. This program consisted of the following:

### Pre-Clinical Testing

1. **Acute Exposure Oral Toxicity - Rats**
The purpose of this study was to evaluate the single dose oral toxicity of the two perfumes using a single exposure and a 14-day post-exposure observation period. The acute oral $\mathrm{LD}_{50}$ for the two perfumes was found to be greater than $5\,\mathrm{mL/kg}$ of a $1.1\%$ solution.

2. **CHO Mammalian Cell Cytotoxicity Assay**
The purpose of this study was to assess the biocompatibility of the two perfumes by measuring their cytotoxicity in the CHO-K1-BH4 mammalian cell line. Results showed a reduction in viability of the hamster ovary cells for both perfumes.

3. **Guinea Pig Sensitization Maximization Test (Magnusson-Kligman)**
The purpose of this study was to determine the contact dermal sensitization potential of the two perfumes in guinea pigs. Two studies were performed. In the first study, exaggerated levels of both perfumes were used. Results of this study showed that under these conditions, both perfumes caused weak to moderate sensitization in guinea pigs.

In the second study, the concentrations of the perfumes tested were close to actual perfume levels in the pad. The results of this second study indicate that under the conditions of the test and at the concentrations tested, neither perfume caused sensitization in guinea pigs.

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## 510(k) Summary (continued)

### Pre-Clinical Testing (continued)

#### 4. Primary Dermal Irritation Study - Rabbits

The purpose of this study was to determine the potential irritant and/or corrosive effects of the perfumes on the skin of rabbits. The Dermal Irritation Toxicity Category for both perfumes was considered to be Class IV - Mild or Slight Irritation at 72 Hours. The Primary Dermal Irritation Index for both fragrances was considered "slight"

#### 5. Primary Eye Irritation Study - Rabbits

The purpose of this study was to evaluate the potential eye irritation and/or corrosive effects produced by the two perfumes. Both perfumes were found to be non-irritating at the concentrations tested.

### Clinical Testing

#### 6. Repeated Insult Patch Test (RIPT) - Humans

The purpose of this study was to demonstrate, by epidermal contact, the primary or cumulative irritation and/or sensitization potential of the perfumes. Under the conditions of this study, neither perfume indicated a potential for dermal irritation and/or sensitization

#### 9. Conclusions

The modification to this device does not raise new types of safety or effectiveness questions. Accepted scientific methods were utilized to assess the effects of the modification. On the basis of the testing information we conclude that the data provided demonstrate that the Modified Device is safe for its intended use.

Based on the 510(k) Substantial Equivalence Decision-Making Process review as shown and the testing information provided, we believe that the Modified Device is substantially equivalent to the Pre-Amendments Device.

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