(63 days)
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No
The summary describes performance studies related to biocompatibility and physical properties of an epoxy coating, not the functionality of a software or imaging device that would typically incorporate AI/ML.
No.
The description provided details various toxicity and irritation tests performed on an aqueous extract from an epoxy-coated applicator, but does not provide any information about the device's function or intended use to suggest it is a therapeutic device. The tests performed are generally for material biocompatibility and safety, not therapeutic efficacy.
No
The provided text details biocompatibility and safety tests for an epoxy coating on an applicator, not performance metrics related to diagnosing a condition.
No
The summary describes performance studies related to an epoxy-coated applicator and its biological compatibility, indicating a physical device component, not a software-only device.
Based on the provided information, it is highly unlikely that this device is an IVD (In Vitro Diagnostic). Here's why:
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Lack of IVD-specific information: The document is completely devoid of any information typically associated with IVDs, such as:
- Intended Use/Indications for Use: This is a crucial section for IVDs, describing what the device is used to measure or detect in a biological sample.
- Device Description: IVD descriptions would detail the reagents, instruments, or kits used to perform the test.
- Input Imaging Modality/Anatomical Site: These are irrelevant for most IVDs, which analyze biological samples.
- Training/Test Set Descriptions: While performance studies are mentioned, the lack of detail about training and test sets for an algorithm or model suggests it's not an AI/ML-based IVD.
- Key Metrics: IVDs are typically evaluated using metrics like sensitivity, specificity, and accuracy, which are not mentioned here.
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Focus on Biocompatibility and Safety Testing: The "Summary of Performance Studies" section details tests related to the biocompatibility and safety of an epoxy-coated applicator. These tests (dermal irritation, oral toxicity, vaginal irritation, agar diffusion, toxin study, patch test, dioxin analysis, lamination bond integrity, cytotoxicity) are characteristic of devices that come into contact with the body, not devices that perform diagnostic tests on biological samples.
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Mention of an "applicator": The description of testing on an "epoxy coated applicator" further suggests a device used for delivery or application, not for in vitro diagnostic testing.
In summary, the provided information strongly indicates that this device is a medical device intended for contact with the body, and the testing described is related to its safety and biocompatibility, not its ability to perform an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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Device Description
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests have been completed on an aqueous extract from the RAD-KOTE K261 epoxy coated applicator covered by this 510(k). - Primary Dermal Irritation in Rabbits Not a primary irritant 1. - 2. Oral Toxicity in Rats - Non-toxic - Subacute Vaginal Irritation in Rabbits Non-irritating ם 3. - Agar Diffusion Study No zones of inhibition were seen (Exhibit 6). 4. - ेंड. Toxin Study - Results were in the range of values of commercially sold tampons (Exhibit 7). - 6. Repeat Insult Patch Test in Humans - No irritation or sensitization reported - Dioxin Analysis Not detectable at limits of detection of HRGG/HRMS Method *7. 8290 (Triangle Labs, North Carolina) (Exhibit 8) - **8. Lamination Bond Integrity Test - No delamination reported (Exhibit 9) - Cytotoxicity Test No evidence of cell lysis or toxicity was reported. - 9 * Tests conducted on applicator, pledget and string. ** Tests conducted on applicator only.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
JUN 18 1996
1961456
SUMMARY OF SAFETY AND EFFECTIVENESS
The following tests have been completed on an aqueous extract from the RAD-KOTE K261 epoxy coated applicator covered by this 510(k).
- Primary Dermal Irritation in Rabbits Not a primary irritant 1.
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- Oral Toxicity in Rats - Non-toxic
- Subacute Vaginal Irritation in Rabbits Non-irritating ം 3.
- Agar Diffusion Study No zones of inhibition were seen (Exhibit 6). 4.
- ેન્ડ. Toxin Study - Results were in the range of values of commercially sold tampons (Exhibit 7).
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- Repeat Insult Patch Test in Humans - No irritation or sensitization reported
- Dioxin Analysis Not detectable at limits of detection of HRGG/HRMS Method *7. 8290 (Triangle Labs, North Carolina) (Exhibit 8)
- **8. Lamination Bond Integrity Test - No delamination reported (Exhibit 9)
- Cytotoxicity Test No evidence of cell lysis or toxicity was reported. - 9
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- Tests conducted on applicator, pledget and string.
- ** Tests conducted on applicator only.