(241 days)
The skin test applicator is used for conventional administration (percutaneous application of allergenic extracts directly onto the surface of the skin) of diagnostic allergen extracts for performing allergy skin tests on the typical sites (the back and the volar surfaces of the forearms) for hypersensitivity reactions in individuals suspected of having allergies.
The test tray is intended to hold allergenic extracts in a convenient arrangement for storage and use by the clinician.
The AllergiEnd allergy skin testing products are supplied sterile and consist of two (2) devices:
- Test Applicator
- Test Tray
The MedScience AllergiEnd Applicator and Tray are used together 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 AllergiEnd ST-9 Applicator has nine (9) test heads arranged in an asymmetrical design two (2) rows of four (4) test heads and a distal ninth test head. The test heads are labeled 1 through 9.
Each of the 9 test heads has a "leg." At the tip of each leg is an array of nine (9) 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.
The test heads are designed to fit into the matching asymmetrical well design of the AllergiEnd ST-9 Test Tray. The applicator loads the allergen from each well in the tray on to each test head. The wells are numbered 1 to 9 to match the numbering on the applicator.
When properly applied to the skin, the applicator will leave visible indentations in the patient's skin corresponding to the 9 test heads of each applicator is not intended to pierce the skin.
The asymmetric design of the wells allows for only one possible orientation for the applicator to be placed in the tray. It is believed that the asymmetric design may help reduce the potential for operator error inherent in a symmetrical design and may also help the clinician avoid misreading of the skin reactions to the applied allergens.
The tray is configured to hold either 36 or 72 test allergens in individual wells. The groups of wells, either 4 groups for 36 test wells or 8 groups for 72 test wells, determine the tray configuration. The clinician's testing preferences will determine which tray configuration to consider.
The AllergiEnd ST-9 Multiple Well Test Tray is intended to hold small quantities of allergenic extracts in a convenient arrangement for storage and use. The Test Tray is not preloaded with allergens. The allergens are separately sourced and loaded by the clinician. Regardless of the number of wells, the test tray does not come in direct contact with the patient.
The individual wells are numbered with an easily readable alpha-numeric system to facilitate recording reactions to specific allergens. By including an alpha-numeric numbering system in the AllergiEnd ST-9 Multiple Well Test Tray the test administrator has a clear organizational structure for locating each allergen and tracking the patient's response and for correctly documenting in the patient's medical records.
The AllergiEnd ST-9 Multiple Well Test Tray also includes a locking lid that engages with a flexible seal. The locking/sealing cover protects the physician-filled allergenic material from contamination and evaporation. Additionally, the locking feature provides for secure handling. The locking feature does not affect the medical procedure, nor does it have any direct interaction with any of the allergenic extracts.
This document describes the AllergiEnd® ST-9 Multiple Skin Test Applicator and Multiple Well Test Tray. The device is intended for the conventional percutaneous application of diagnostic allergen extracts for allergy skin tests.
Here's a breakdown of the acceptance criteria and supporting studies:
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criterion Reported Device Performance Effectiveness: Ability to administer allergenic extract percutaneously to elicit reactions comparable to the predicate device. Mean wheal diameters of histamine and control (glycerin saline) showed no statistically significant differences between the subject device and the predicate device. Safety: Producing a comparable (or lower) sensation/pain rating as the predicate applicator when used to administer allergenic extract percutaneously. The average pain rating for the AllergiEnd ST-9 Applicator was 1.54, which was comparable to the predicate device's pain rating of 1.55 (using the Wong-Baker FACES Pain Rating). Biocompatibility: Acceptable biocompatibility for limited duration skin contact. Cytotoxicity, sensitization, and irritation tests demonstrated acceptable biocompatibility. Sterility: Sterility Assurance Level (SAL) of 10⁻⁶. Sterilization validation (overkill approach, half-cycle method) achieved acceptance criteria. Inspection: AQL level 1.0 sampling size. Each lot is inspected at AQL level 1.0 sampling size. (While stated, no specific performance metrics provided for this criterion beyond compliance with inspection.) -
Sample size used for the test set and the data provenance:
- Sample Size: 14 patients.
- Data Provenance: Prospective, single-site clinical study. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, implying a U.S.-based study or one compliant with U.S. regulatory standards.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document implies that the ground truth for "effectiveness" (wheal diameters) and "safety" (pain ratings) was established through direct measurement and patient reporting during a clinical study. It does not mention the use of external experts to establish a "ground truth" for the test set in the way one might for diagnostic accuracy; rather, it compares the device's performance to a predicate device and patient self-reported pain. Therefore, the concept of "experts" to establish ground truth in this context is not directly applicable as it would be for image interpretation tasks. The measurements (wheal diameter) are objective, and pain is subjective (patient-reported).
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Adjudication method for the test set:
- The document does not describe an explicit adjudication method (like 2+1 or 3+1 consensus) for the clinical study. The effectiveness relied on comparing mean wheal diameters and pain ratings, which are quantitative measures rather than qualitative assessments requiring adjudication.
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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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is an applicator system for allergy testing, not an AI-assisted diagnostic tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, this is a medical device, not an algorithm, and the performance is evaluated in direct user interaction for applying substances to the skin.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Effectiveness: The ground truth for effectiveness was established by measuring the mean wheal diameters resulting from the application of histamine and control solutions, compared directly to the predicate device's performance. This is an objective, physiological response.
- Safety: The ground truth for safety was established through patient self-reported pain ratings using the Wong-Baker FACES Pain Rating Scale.
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The sample size for the training set:
- Not applicable. This device is a physical medical instrument, not an AI/ML algorithm requiring a training set.
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How the ground truth for the training set was established:
- Not applicable, as it's not an AI/ML algorithm.
§ 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).