(35 days)
K29696
Not Found
No
The summary describes performance studies related to material safety and toxicity, typical for a physical medical device like a tampon, and lacks any mention of software, algorithms, image processing, or AI/ML terms.
No
The provided text describes various toxicity and irritation tests conducted on Playtex Tampons #29696, comparing them to a predicate device and commercially sold tampons. These tests (TSST-I, Dioxin Analysis, Primary Dermal Irritation, Acute Oral Toxicity, Subacute Vaginal Irritation, Human Repeat Insult Patch Test, Agar Diffusion Study) are focused on product safety and biological compatibility, not on treating or diagnosing a medical condition. Tampons are personal hygiene products, not therapeutic devices.
No
The provided text describes different types of safety testing (e.g., toxicity, irritation, diffusion) for a product, specifically tampons. These tests assess the product's safety and bio-compatibility, not its ability to diagnose a medical condition.
No
The provided text describes performance studies related to physical testing (toxin testing, irritation studies, etc.) of a product, strongly suggesting it is a physical device (likely a tampon based on the study types) and not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Lack of IVD characteristics: The description focuses on testing related to the safety and biological effects of a product (likely a tampon, given the "TSST-I, Toxin testing" and "Vaginal Irritation" mentions). IVDs are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- No mention of diagnostic use: The "Intended Use / Indications for Use" is "Not Found," but the performance studies described are related to safety and irritation, not diagnostic purposes.
- Testing methods are not typical for IVDs: The tests mentioned (TSST-I, Dioxin Analysis, Dermal Irritation, Oral Toxicity, Vaginal Irritation, Patch Test, Agar Diffusion) are standard safety and biocompatibility tests for medical devices or consumer products that come into contact with the body. They are not methods used to diagnose a disease or condition.
Therefore, the information strongly suggests this device is a product that undergoes safety testing, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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
Not Found
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
TSST-I, Toxin testing was conducted; results are in the range of values of commercially sold tampons and there are no significant differences between Playtex Tampons #29696 and the predicate device
Dioxin Analysis
Primary Dermal Irritation in Rabbits Non-Irritating
Acute Oral Toxicity in Rats - Non-Toxic
Subacute Vaginal Irritation in Rabbits - Non-Irritating
Human Repeat Insult Patch Test Non-Irritating and not a Sensitizer
Agar Diffusion Study No zones of inhibitation were detected
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.5460 Scented or scented deodorized menstrual tampon.
(a)
Identification. A scented or scented deodorized 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. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual tampon) or for deodorizing purposes (scented deodorized menstrual tampon). This generic type of device does not include menstrual tampons treated with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).
0
NOV 2 9 1996
SUMMARY OF SAFETY AND EFFECTIVENESS ರು
- TSST-I, Toxin testing was conducted; results are in the range of values of ♪ commercially sold tampons and there are no significant differences between Playtex Tampons #29696 and the predicate device
- ♪ Dioxin Analysis
- Primary Dermal Irritation in Rabbits Non-Irritating ♪
- ♪ Acute Oral Toxicity in Rats - Non-Toxic
-
Subacute Vaginal Irritation in Rabbits - Non-Irritating
- Human Repeat Insult Patch Test Non-Irritating and not a Sensitizer >
- Agar Diffusion Study No zones of inhibitation were detected ♪