FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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.

AI/ML Overview

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.

Acceptance Criteria (Inferred from comparison to predicate and standards)	Reported Device Performance
Biocompatibility: No adverse tissue reactions (cytotoxicity, skin sensitization, skin irritation, acute systemic toxicity)	In Vitro Cytotoxicity Test (ISO10993-5:2009): Passed
Skin Sensitization Test (ISO10993-10:2010): Passed
Skin Irritation Test (ISO10993-10:2010): Passed
Acute Systemic Toxicity Test (ISO10993-11:2017): Passed
Sterility: Sterility Assurance Level (SAL) of $10^{-6}$	Sterilization of Medical Devices (ISO11737-2:2009; ISO 11737-2:1998): Met (SAL $10^{-6}$)
Shelf-Life: Maintenance of sterility and functionality over declared shelf-life	Sterilization of Medical Devices (ISO 11737-2:2009): 3 years shelf life validated
Shipping Performance: Integrity of packaging and device during transit	Standard Practice for Performance Testing of Shipping Containers and Systems (ASTM D4169): Passed
Performance in Allergen Delivery: Ability to collect sufficient allergen extract and deliver it to the patient.	Comparison of ability to collect sufficient allergen extract from dipwell and deliver to the patient (Internal method): Found comparable to predicate device.
Physical Dimensions (for comparison): Prick size	Prick Size: 1.2-1.6mm (vs. 2.0mm for predicate) - Difference noted but likely deemed non-critical given overall substantial equivalence claim.
Physical Dimensions (for comparison): Lancet Intervals	Lancet Intervals: 2.0-2.5cm (vs. 2.0-2.4cm for predicate) - Difference noted but likely deemed non-critical given overall substantial equivalence claim.
Material: Acrylic Polymer Construction	Acrylic Polymer Construction: YES (identical to predicate)
Sterilization Method: Ethylene Oxide (applicator)	Sterilization Method: Ethylene Oxide (applicator) (consistent with predicate, though predicate also noted Gamma Radiation for tray)
Packaging: Sterilization Pouch, PET Plastic	Packaging: Sterilization Pouch, PET Plastic (identical to predicate)

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.

Summary

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).