(203 days)
Not Found
No
The device description and performance studies focus on mechanical function and biocompatibility, with no mention of AI/ML or data processing.
No
The device is used for the "percutaneous administration of diagnostic allergenic extracts" for "performing skin tests for hypersensitivity reactions," indicating a diagnostic rather than therapeutic purpose.
Yes
Explanation: The device is explicitly stated to be "used for the percutaneous administration of diagnostic allergenic extracts" and for "performing skin tests for hypersensitivity reactions in individuals suspected of having allergies." Administering materials to perform tests for diagnosis directly indicates a diagnostic purpose.
No
The device description clearly details a physical, sterile, disposable applicator with test heads and tines designed for percutaneous administration of substances to the skin. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for diagnostic purposes.
- Device Function: The Oryum and Ovem Epidermal Skin Prick Test Applicator is used for the percutaneous administration of diagnostic allergenic extracts onto the surface of the skin. It facilitates the delivery of a substance to the body, rather than analyzing a specimen taken from the body.
- Intended Use: The intended use clearly states "percutaneous administration of diagnostic allergenic extracts" and "performing skin tests for hypersensitivity reactions." This involves applying a substance to the skin and observing the body's reaction, which is an in vivo (within the living organism) process, not an in vitro (in glass/outside the living organism) process.
- Device Description: The description focuses on the mechanical aspects of applying the allergen to the skin surface and the design for holding and delivering the substance. There is no mention of analyzing a bodily fluid or tissue sample.
Therefore, while the device is used in a diagnostic process (allergy testing), its function is to deliver a diagnostic substance to the body, not to analyze a sample from the body. This places it outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Oryum and Ovem Epidermal Skin Prick Test Applicator is used for the percutaneous administration of diagnostic allergenic extracts.
Product codes
SCL, LDH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin Surface
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Sterility
ISO11737-2:2009; ISO 11737-2:1998 Sterilization of Medical Devices
Sterilization of Medical Devices
Shelf-Life Validation
ISO 11737-2:2009 Sterilization of Medical Devices
Performance Testing of Shipping Containers and Systems
ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems
Performance comparison with predicate device
Internal method Comparison of ability to collect sufficient allergen extract from dipwell and deliver to the patient
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Multi-Test II (K961918)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows 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.
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
1
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
2
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
3
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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4
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, LLC
5018 Expressway Dr. S.
Suite LL5
Ronkonkoma, NY 11779
Establishment Registration: t/b/d |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Yılmaz Medikal Mustafa Nazlier
Budak Mah. Hasirci Sami Bey Cad. No: 12
Sehitkamil, Gaziantep, TURKEY
Ph.: +90 342 321 74 77
E-mail: info@yilmazmedikal.com
Establishment 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 1025
Washington, D.C. 20006
Ph: 202.765.4491
E-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) |
5
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
6
Allergy & Applicator Depot, LLC
Traditional 510k Submission Oryum and OvemEpidermal Skin Prick Test Applicator
| Sterility | ISO11737-2:2009; ISO 11737-
2:1998 Sterilization of Medical
Devices | Sterilization of Medical Devices |
|-----------------------------------------------------------|---------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Shelf-Life Validation | ISO 11737-2:2009 | Sterilization of Medical Devices |
| Performance Testing of Shipping
Containers and Systems | ASTM D4169 | Standard Practice for Performance
Testing of Shipping Containers and
Systems |
| Performance comparison with
predicate device | Internal method | Comparison of ability to collect
sufficient allergen extract from
dipwell 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 Ovem
Epidermal | Multi-Test II (K961918) |
|---------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Product code | LDH | LDH |
| Indications for use | Percutaneous
administration of
diagnostic allergenic
extracts. | Percutaneous administration
of diagnostic allergenic
extracts. |
| Applicator for
Allergenic Extracts | YES | YES |
| Acrylic Polymer
Construction | YES | YES |
| SAL | 10-6 | 10-6 |
| Sterilization Method | Ethylene Oxide
(applicator); AAMI
Guidelines | Ethylene Oxide (applicator);
Gamma Radiation (tray
with 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
7
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.