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Oryum and Ovem Epidermal Skin Prick Test Applicator is used for the percutaneous administration of diagnostic allergenic extracts.

Oryum and Ovem Epidermal Skin Prick Test Applicator is a sterile, disposable, multiple test head applicator used to administer skin test substances to the surface of the skin. The Oryum and Ovem Epidermal Skin Prick Test Applicator are used for the conventional percutaneous application of substance directly onto the surface of the skin of diagnostic allergen extracts for performing skin tests for hypersensitivity reactions in individuals suspected of having allergies. The Oryum and Ovem Epidermal Skin Prick Test Applicator is offered in several configurations with 1 to 12 test heads arranged in an asymmetrical design. Each of the test heads have a "leg." At the tip of each leg is an array of protruding test points (tines). The tines utilize capillary action to hold the allergenic material for percutaneous delivery when the applicator is applied to the skin. This is an industry wide standard design. The test heads are designed to fit into the matching asymmetrical well design of a dipwell tray. The applicator loads the allergen from each well in the tray on to each test head. When properly applied to the skin, the applicator will leave visible indentations in the patient's skin corresponding to the test heads of each applicator is not intended to pierce the skin.

This is an FDA 510(k) summary for the Oryum and Ovem Epidermal Skin Prick Test Applicator. The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its absolute safety and effectiveness through clinical trials. Therefore, the information provided focuses on comparative performance rather than extensive clinical efficacy studies with specific acceptance criteria as might be seen for novel devices.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of acceptance criteria and reported device performance:

The document doesn't explicitly state "acceptance criteria" in the format of a clinical study endpoint with a pre-defined threshold. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device by comparing various technological characteristics and non-clinical performance aspects. The "performance" is implicitly deemed acceptable if it is comparable to the predicate device and meets recognized standards.

2. Sample size used for the test set and the data provenance:

• Biocompatibility Tests: The specific sample sizes for in vitro (cytotoxicity) and in vivo (sensitization, irritation, systemic toxicity) biocompatibility tests are not disclosed in this summary. These are typically performed on a sufficient number of samples as required by the ISO 10993 standards.
• Sterility Validation: The sample size for sterility validation (ISO 11737-2) is not specified. This involves a statistically significant number of units to demonstrate a SAL of $10^{-6}$.
• Shelf-Life Validation: The sample size is not specified. This typically involves real-time or accelerated aging studies on multiple samples.
• Shipping Performance: The sample size for ASTM D4169 is not specified but would involve a predefined number of packed devices.
• Performance Comparison with Predicate: The summary states "Internal method" for the comparison of allergen collection and delivery ability. No sample size (e.g., number of tests, patients, or trials) is reported for this internal performance comparison.
• Data Provenance: The document does not specify the country of origin of the data for these non-clinical tests, nor whether they were prospective or retrospective. Given they are laboratory and bench tests, "prospective" or "retrospective" typically isn't applicable in the same way as clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is typically not applicable or not provided in the context of a 510(k) submission focused on non-clinical comparative performance. The "ground truth" for the non-clinical tests (like biocompatibility, sterility) is established by the test methods themselves and their adherence to international standards (e.g., ISO 10993, ISO 11737). The interpretation of results against these standards is usually performed by qualified laboratory personnel, but not typically "experts establishing ground truth" in the sense of clinical consensus.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly those involving subjective interpretation of data (e.g., image reading), to establish a consensus "ground truth." The tests reported here are objective bench and lab tests based on standardized protocols where an adjudication process as described is not typically employed.

5. 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 an epidermal skin prick test applicator, a physical medical device, not an AI-powered diagnostic tool. Therefore, MRMC studies or human-in-the-loop performance with AI assistance are not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable, as this is a physical medical device and not an algorithm.

7. The type of ground truth used:

The "ground truth" for each non-clinical test reported is based on:

• International Standards: For biocompatibility (ISO 10993), sterility (ISO 11737), and shipping (ASTM D4169), the ground truth is defined by the objective pass/fail criteria stipulated within these respective standards.
• Predicate Device Comparison: For the "Performance comparison with predicate device" regarding allergen collection and delivery, the ground truth is established by the performance of the legally marketed predicate device (Multi-Test II K961918) as a benchmark.

8. The sample size for the training set:

Not applicable. This is a 510(k) for a physical medical device, not a machine learning or AI algorithm, so there is no "training set."

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this device.

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eVENT™ Allergen Barriers have been designed exclusively for allergy sufferers wishing to reduce their exposure to house dust mite allergens in mattresses, pillows and duvel/comforters.

eVENT™ Allergen Barriers consist of mattress, pillow and duvet/comforter encasings. The products consist of an expanded PTFE membrane laminated to a synthetic or synthetic/natural combination fabric. The expanded PTFE membrane provides a moisture-vapor & air permeable ("breathable") barrier with pores too small to allow passage to either house dust mites or their allergen containing fecal droppings. The fabric component provides a strong, easily maintained support for the ePTFE membrane. EVENT™ Allergen Barrlers are soft, comfortable and easy to clean; They are simply damp-dusted when the bed sheets are changed. Allergydirect.com's membrane manufacturing process is sufficiently controlled to ensure uniform nominal pore sizes too small to permit the Allergen Barners provide high levels of protection from house dust mite allergens. The membrane's vapor permeable characteristics help promote sleeping comfort. Thus, eVENT™ Allergen Barriers serve as an effective barrier between a patient and a cause of their allergies; this results in a healthier, more comfortable sleeping environment.

The acceptance criteria and study proving meeting those criteria for the eVENT™ Allergen Barriers are described below, based on the provided FDA 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a specific numerical sample size for the test set. It mentions "Laboratory tests" and "Additional testing" without detailing the number of units tested.

The data provenance is not explicitly stated. Given that the submission is to the FDA for a US market, it is likely the testing was conducted in a controlled laboratory environment. The nature of the tests (material properties) suggests these were likely prospective, controlled laboratory tests rather than retrospective or prospective clinical data from human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The tests described are primarily material property tests (e.g., breathability, pore size inference, strength), which typically rely on standardized laboratory methods rather than expert consensus on interpretation.

4. Adjudication Method for the Test Set

This information is not provided in the document. As mentioned above, the tests are primarily objective material property measurements, not requiring adjudication of subjective interpretations.

5. 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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an allergen barrier, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improving with AI vs. without AI assistance" is not applicable.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a physical product (allergen barrier), not an algorithm or software.

7. The Type of Ground Truth Used

The ground truth used for demonstrating device performance appears to be:

• Direct measurement of material properties: For "breathability," the "Modified Desiccant Method (MDM) dry method" was used.
• Inferred physiological effect based on physical properties: The barrier effectiveness against dust mites and their fecal matter is based on the controlled manufacturing process to ensure "uniform nominal pore sizes too small to permit the Allergen Barners provide high levels of protection from house dust mite allergens." This implies physical measurement of pore size or validation that the pore size effectively blocks the allergens.
• Performance against established standards/comparable devices: The breathability was compared directly to "comparable Allergy Control Products' ACb™ Elite and over 4 times more 'breathable' than Allergy Control Products' ACb™ Sheer."
• Qualitative assessment of physical characteristics: Softness, comfort, and ease of cleaning were likely assessed through testing that demonstrated these attributes, although specific methods are not detailed.

8. The Sample Size for the Training Set

This is not applicable as the device is a physical product, not a machine learning model requiring a training set.

9. How the Ground Truth for the Training Set was Established

This is not applicable as the device is a physical product, not a machine learning model.

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