(27 days)
The text identifies the following predicate device(s): CAREFREE® Panty Shield. However, no K/DEN number is provided for this device. Therefore, no K/DEN numbers can be listed.
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No
The device description and performance studies focus on the material properties and safety of a feminine hygiene product, with no mention of AI/ML technology.
No
The device is described as an absorbent feminine napkin used for menstrual or vaginal discharge, which is a hygiene product, not a therapeutic device.
No
The device is a feminine napkin used to absorb menstrual or other vaginal discharge. Its intended use is defined by absorption, not by diagnosing any condition or disease. The performance studies focus on safety (toxicity, irritation, sensitization) rather than diagnostic accuracy.
No
The device description explicitly states it is a physical product ("ultrathin, beltless, absorbent feminine napkins made of absorbent material") and the performance studies focus on the biocompatibility and safety of the materials and fragrance, not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "absorb small amounts of menstrual or other vaginal discharge." This is a physical function for managing bodily fluids, not for diagnosing a condition or providing information about a physiological state.
- Device Description: The device is described as an "ultrathin, beltless, absorbent feminine napkin." This aligns with a personal hygiene product, not a diagnostic tool.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide diagnostic information. The testing described focuses on the safety and biocompatibility of the materials (specifically the fragrance), not on diagnostic performance.
- Predicate Device: The predicate device is a "Panty Shield," which is also a personal hygiene product and not an IVD.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The modified device and the pre-amendments device are both used to 6. absorb small amounts of menstrual or other vaginal discharge.
Product codes
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Device 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
- 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): 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.
- 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 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.
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.
Key Metrics
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Predicate Device(s)
CAREFREE® Panty Shield
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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 Pantyliner |
| CAREFREE® 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.
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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.