(27 days)
The modified device and the pre-amendments device are both used to absorb small amounts of menstrual or other vaginal discharge.
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.
This 510(k) summary describes the safety testing for a Carefree Scented Pantyliner with modified perfumes. The document focuses on demonstrating that the revised perfumes do not introduce new safety or effectiveness concerns, rather than on the performance of the pantyliner itself against specific acceptance criteria for absorption or fit, which would typically be assessed for the device's primary function.
Therefore, the requested information elements cannot be fully populated as they are generally related to the performance of a diagnostic device or a device with measurable clinical outcomes. However, I will extract and present the available information in the spirit of your request, focusing on the safety evaluations.
Here's the breakdown:
Acceptance Criteria and Reported Device Performance (Safety Focus)
| Acceptance Criteria (Safety) | Reported Device Performance (Safety of Perfumes) |
|---|---|
| Acute Oral Toxicity: LD50 > 5 mL/kg (of 1.1% solution) | Acute Oral Toxicity Ruts: LD50 for both perfumes was found to be greater than 5 mL/kg of a 1.1% solution. |
| CHO Mammalian Cell Cytotoxicity Assay: Results showed a reduction in viability of the hamster ovary cells for both perfumes. (Note: While a reduction in viability was observed, the summary does not explicitly state an acceptance threshold for this test, making it difficult to definitively state if it "met" an unstated criterion. It's reported as an observation.) | |
| Guinea Pig Sensitization: No sensitization at actual use concentrations. | Guinea Pig Sensitization Maximization Test (Magnusson-Kligman): In an initial exaggerated study, both perfumes caused weak to moderate sensitization. In a second study with concentrations close to actual levels, neither perfume caused sensitization in guinea pigs. |
| Primary Dermal Irritation (Rabbits): Class IV - Mild or Slight Irritation at 72 Hours. | Primary Dermal Irritation Study 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." |
| Primary Eye Irritation (Rabbits): Non-irritating at tested concentrations. | Primary Eye Irritation Study Rabbits: Both perfumes were found to be non-irritating at the concentrations tested. |
| Repeated Insult Patch Test (Humans): No potential for dermal irritation and/or sensitization. | Repeated Insult Patch Test (RIPT) Humans: Under the conditions of this study, neither perfume indicated a potential for dermal irritation and/or sensitization. |
Study Details (Safety Focus)
Here's a breakdown of the available information regarding the safety studies conducted:
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Acute Oral Toxicity Ruts: "Ruts" (likely a typo for rats) - Number of animals not specified.
- CHO Mammalian Cell Cytotoxicity Assay: "CHO-K1-BH4 mammalian cell line" - In vitro study, not a human or animal test set.
- Guinea Pig Sensitization Maximization Test: "Guinea pigs" - Number of animals not specified.
- Primary Dermal Irritation Study Rabbits: "Rabbits" - Number of animals not specified.
- Primary Eye Irritation Study Rabbits: "Rabbits" - Number of animals not specified.
- Repeated Insult Patch Test (RIPT) Humans: "Humans" - Number of participants not specified.
- Data Provenance: Not explicitly stated, but these are pre-clinical (animal and in vitro) and clinical (human patch test) studies conducted by "Johnson & Johnson Worldwide Absorbent Products and Materials Research." The country of origin is not specified. All studies appear to be prospective for the purpose of this submission.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to these types of pre-clinical and basic clinical safety studies. Ground truth is established by standardized laboratory methods and observations, not by expert consensus on interpretations like in diagnostic imaging. The results are based on objective measures (e.g., LD50, cell viability, irritation scores, sensitization responses).
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. These are laboratory studies with objective endpoints or standardized scoring by trained personnel, not multi-reader adjudication of clinical cases.
-
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 consumer product (panty liner) and the studies are safety assessments of its components (perfumes), not a diagnostic device involving human readers or AI assistance.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device does not involve an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Acute Oral Toxicity: Measured lethality (LD50) in animals.
- CHO Mammalian Cell Cytotoxicity: Measured reduction in cell viability (in vitro).
- Guinea Pig Sensitization: Observed dermal reactions (sensitization) in animals.
- Primary Dermal Irritation: Observed dermal irritation scores in animals.
- Primary Eye Irritation: Observed eye irritation scores in animals.
- Repeated Insult Patch Test: Observed dermal reactions (irritation/sensitization) in human subjects.
- The "ground truth" for these tests is the direct empirical outcome of the standardized assays and observations.
-
The sample size for the training set:
- Not applicable. These are safety studies, not machine learning studies requiring training data. The "training" for such studies would involve standardizing laboratory procedures and personnel expertise.
-
How the ground truth for the training set was established:
- Not applicable. (See #7)
{0}------------------------------------------------
510(k) Summary
Summary 1.
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: 908-874-1216 Fax: 908-874-2751
| Date of Submission: | March 15, 1996 |
|---|---|
| Device trade name: | CAREFREE® Scented PantylinerCAREFREE® Lightly Scented Pantyliner |
| Device common name: | Panty Shield |
| Device classification: | Scented or scented deodorized menstrual pad(Ref. 21 CFR 884.5425) |
- র . The modified device is substantially equivalent to CAREFREE® Panty Shield, a Pre-Amendments device what was on the market prior to May 28, 1976.
- રું 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.
Continued on next page
000 00000
{1}------------------------------------------------
510(k) Symmary (continued)
- Intended Use. The modified device and the pre-amendments device are both used to 6. absorb small amounts of menstrual or other vaginal discharge.
Technological Characteristics 7.
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
-
- Acute Exposure Oral Toxicity Ruts
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 LD50 for the two perfumes was found to be greater than 5 mL/kg of a 1.1% solution.
- Acute Exposure Oral Toxicity Ruts
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-K 1-BH4 mammalian cell line. Results showed a reduction in viability of the hamster ovary cells for both perfumes
Guinea Pig Sensitization Maximization Test (Magnusson-Kligman) 3.
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.
000 0001
{2}------------------------------------------------
296 111 9
510(k) Summary (continued)
Pre-Clinical Testing (continued)
-
- 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"
- Primary Dermal Irritation Study Rabbits
-
- Primary Eye Irritation Study Rahbits
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.
- Primary Eye Irritation Study Rahbits
Clinical Testing
-
- 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
- Repeated Insult Patch Test (RIPT) Humans
ਰੇ. 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
Image /page/2/Picture/14 description: The image shows a series of oval shapes, with three on the left side that are solid black and two in the middle that are outlined. To the right of the ovals is a complex, abstract shape formed by curved lines, resembling a stylized signature or artistic flourish. The overall composition is simple, with a focus on the contrast between the geometric shapes and the free-flowing lines.
§ 884.5425 Scented or scented deodorized menstrual pad.
(a)
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.(b)
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.