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

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November 1, 2024

Allergy & Applicator Depot, LLC % Marc Sanchez Contract In-House Counsel and Consultants, LLC (FDA Atty) 53516 Bickett Drive Chapel Hill, North Carolina 27517

Re: K182582

Trade/Device Name: Oryum and Ovem Epidermal Skin Prick Test Applicator Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: SCL

Dear Marc Sanchez:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 10, 2019. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code SCL.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact David Wolloscheck, OHT3: Office of GastroRenal, OB-Gyn, General Hospital and Urology Devices, 301-796-1480, David.Wolloscheck(@fda.hhs.gov.

Sincerely,

David Wolloscheck -S

David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices and Human Factors OHT3: Office of GastroRenal, OB-Gyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 10, 2019

Allergy & Applicator Depot, LLC % Marc Sanchez Contract In-House Counsel and Consultants, LLC (FDA Atty) 53516 Bickett Drive Chapel Hill, North Carolina 27517

Re: K182582

Trade/Device Name: Oryum and Ovem Epidermal Skin Prick Test Applicator Regulatory Class: Unclassified Product Code: LDH Dated: March 6, 2019 Received: March 8, 2019

Dear Marc Sanchez:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Geeta K. Pamidimukkala -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182582

Device Name

Oryum and Ovem Epidermal Skin Prick Test Applicator

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Allergy & Applicator Depot, LLC

Traditional 510k Submis sion Oryum and OvemEpidermal Skin Prick Test Applicator

K182582

510(K) Summary

The following information is provided as required by 21 CFR 807.92 for the Oryum and Ovem Epidermal Skin Prick Test Applicator 510(k) premarket notification.

Sponsor:	Allergy & Applicator Depot, LLC5018 Expressway Dr. S.Suite LL5Ronkonkoma, NY 11779Establishment Registration: t/b/d
Manufacturer:	Yılmaz Medikal Mustafa NazlierBudak Mah. Hasirci Sami Bey Cad. No: 12Sehitkamil, Gaziantep, TURKEYPh.: +90 342 321 74 77E-mail: info@yilmazmedikal.comEstablishment Registration: t/b/d
Contact:	Marc C. Sanchez, Esq.Contract In-House Counsel and Consultants, LLC(d/b/a FDA Atty)1717 Pennsylvania Ave. Suite 1025Washington, D.C. 20006Ph: 202.765.4491E-mail: msanchez@fdaatty.com
Date of Submission:	August 23, 2018
Proprietary Name:	Oryum and Ovem Epidermal Skin Prick Test Applicator
Common Name:	System, Delivery, Allergen And Vaccine
Regulation Number:	Pre-Amendment
Regulatory Class:	Unclassified
Product Code:	LDH
Predicate Device(s):	Multi-Test II (K961918)

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Allergy & Applicator Depot. LLC

Traditional 510k Submission Oryum and OvemEpidermal Skin Prick Test Applicator

Device Description: 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.

Intended Use :

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

Summary of Non-Clinical Testing

Oryum and Ovem Epidermal Skin Prick Test Applicator has completed non-clinical tests to identify the substantial equivalence from the predicate device. The tests include the concerning of the biocompatibility, sterility and performance, which are demonstrated in the table below.

Biocompatibility	ISO10993-5:2009	In Vitro Cytotoxicity Test
	ISO10993-10:2010	Skin Sensitization Test
	ISO10993-10:2010	Skin Irritation Test
	ISO10993-11:2017	Acute systemic toxicity

Table 1 Summary of Non-Clinical Performance testing

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Allergy & Applicator Depot, LLC

Traditional 510k Submission Oryum and OvemEpidermal Skin Prick Test Applicator

Sterility	ISO11737-2:2009; ISO 11737-2:1998 Sterilization of MedicalDevices	Sterilization of Medical Devices
Shelf-Life Validation	ISO 11737-2:2009	Sterilization of Medical Devices
Performance Testing of ShippingContainers and Systems	ASTM D4169	Standard Practice for PerformanceTesting of Shipping Containers andSystems
Performance comparison withpredicate device	Internal method	Comparison of ability to collectsufficient allergen extract fromdipwell and deliver to the patient

Summary of Technological Similarities/Differences:

The Oryum and Ovem Epidermal Skin Prick Test Applicator and the predicate are both acrylic plastic model applicators use to load allergenic extracts on the points of the applicator and apply to the skin. They share the same intended use and near identical design. Any differences in technology are minor and do not raise new questions of safety or efficacy.

Parameter/application	Oryum and OvemEpidermal	Multi-Test II (K961918)
Product code	LDH	LDH
Indications for use	Percutaneousadministration ofdiagnostic allergenicextracts.	Percutaneous administrationof diagnostic allergenicextracts.
Applicator forAllergenic Extracts	YES	YES
Acrylic PolymerConstruction	YES	YES
SAL	10-6	10-6
Sterilization Method	Ethylene Oxide(applicator); AAMIGuidelines	Ethylene Oxide (applicator);Gamma Radiation (traywith lid); AAMI Guidelines
Use Area	Skin Surface	Skin Surface
Prick Size	1.2-1.6mm	2.0mm
Lancet Intervals	2.0-2.5cm	2.0-2.4cm
Packaging Method	Sterilization Pouch	Sterilization Pouch
Packaging Materials	PET Plastic	PET Plastic
Shelf Life	3 years	3 years

Table 2 Technological Characteristics

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Allergy & Applicator Depot, LLC

Traditional 510k Submission Oryum and OvemEpidermal Skin Prick Test Applicator

Conclusion

Therefore, taking into consideration Table 1 for Substantial Equivalence, an analysis of safety, indications, intended uses, performance, and technological properties, the Oryum and Ovem Epidermal Skin Prick Test Applicator raises no different questions of safety or effectiveness and has been found to be substantially equivalent to the predicate devices.

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).