(241 days)
Not Found
No
The device description and performance studies focus on the mechanical aspects of allergen application and do not mention any computational or data-driven components indicative of AI/ML.
No.
This device is used for diagnostic purposes (performing allergy skin tests), not for treating or alleviating a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "conventional administration... of diagnostic allergen extracts for performing allergy skin tests... for hypersensitivity reactions in individuals suspected of having allergies." The purpose of an allergy skin test is to diagnose allergies.
No
The device description clearly outlines physical components (Test Applicator and Test Tray) with specific mechanical features (test heads, tines, wells, locking lid, seal) designed for the physical application and storage of allergenic extracts. There is no mention of any software component.
Based on the provided text, the device described is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed outside of the living organism.
- Device Function: The described device (skin test applicator and tray) is used for the percutaneous application of allergenic extracts directly onto the surface of the skin. This is an in vivo procedure, meaning it is performed within the living organism (the patient's skin).
- Intended Use: The intended use is to perform allergy skin tests for hypersensitivity reactions in individuals. This involves observing a reaction on the patient's skin, not analyzing a sample taken from the patient.
While the device uses diagnostic allergen extracts, the method of diagnosis is through an in vivo skin reaction, not an in vitro analysis of a bodily sample.
N/A
Intended Use / Indications for Use
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 for storage and use by the clinician.
Product codes (comma separated list FDA assigned to the subject device)
SCL, LDH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
the back and the volar surfaces of the forearms
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals in a clinical setting.
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)
Clinical testing of the AllergiEnd® ST-9 Multiple Skin Test Applicator and Multiple Well Test Tray was conducted to establish equivalence to the predicate device through side-by-side testing.
Comparative Device Study
The study included 14 patients at a single site. The test locations on the body were divided into right and left sides of the test subject. The AllergiEnd ST-9 applicators were applied on the left side of the subject. The predicate applicators were applied on the right side of the subject. Eight applicators were used for each test subject. The AllergiEnd ST-9 (a 9-head applicator) had a total of four applications in each test; two using histamine applied to each test head, for a total of 18 locations tested with histamine and 2 using the glycerin saline solution applied to each test head, for a total of 18 locations tested with the control glycerin saline. The Greer Skintestor OMNI (a 10-head applicator) also had a total of four applications in each test; two using histamine applied to each test head, for a total of 20 locations tested with histamine and 2 using the glycerin saline solution applied to each test head, for a total of 20 locations tested with the control glycerin saline solution.
Primary effectiveness endpoint:
The subject device is able to administer allergenic extract percutaneously to elicit reactions comparable to predicate.
Primary safety endpoint:
The applicator of the subject device produces a comparable (or lower) sensation/pain rating as the predicate applicator when used to administer allergenic extract percutaneously.
Effectiveness:
Mean wheal diameters of the histamine and the control, glycerin saline were compared. In comparing the subject and predicate devices, there were no statistically significant differences.
Safety:
The average pain reading for AllergiEnd ST-9 Applicator, using the Wong-Baker FACES Pain Rating, was 1.54, which was comparable to the predicate device's Pain Rating of 1.55.
Summary
Mean wheal diameters were compared showing no statistically significant differences of allergen delivery between subject and predicate devices. Pain assessment, using the Wong-Baker FACES Pain Rating Scale, showed no significant differences between ST-9 and Greer applicators. The data supports the clinical use of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
MedScience Science Research Group, Inc. % Audrey Swearingen Director, Regulatory Affairs Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746
November 1, 2024
Re: K172062
Trade/Device Name: AllergiEnd® ST-9 Multiple Skin Test Applicator. AllergiEnd® ST-9 Multiple Well Test Tray Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: SCL
Dear Audrey Swearingen:
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 March 5, 2018. 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The full name of the agency is "U.S. Food & Drug Administration".
March 5, 2018
MedScience Science Research Group, Inc. % Audrey Swearingen Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746
Re: K172062
Trade/Device Name: AllergiEnd® ST-9 Multiple Skin Test Applicator, AllergiEnd® ST-9 Multiple Well Test Tray Regulatory Class: Unclassified Product Code: LDH Dated: January 26, 2018 Received: January 29, 2018
Dear Audrey Swearingen:
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. 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.
2
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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.
Tina Kiang
-s
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) K172062
Device Name
AllergiEnd® ST-9 Multiple Skin Test Applicator and AllergiEnd® ST-9 Multiple Well Test Tray
Indications for Use (Describe)
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 for storage and use by the clinician.
| 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
510(k) Summary
K172062
1. Submission Sponsor
MedScience Research Group, Inc. 16469 Bridlewood Circle Delray Beach, Florida, 33445 USA
Marvin Smollar Co-president Email: marvin.smollar@medscienceinc.com Phone: 561-499-0411
2. Submission Correspondent
Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 USA
Office Phone: (512) 327-9997
Contact: Audrey Swearingen, RAC Title: Director, Regulatory Affairs
3. Date Prepared
01/25/2018
4. Device Identification
| Trade/Proprietary Name: | AllergiEnd® ST-9 Multiple Skin Test Applicato
AllergiEnd® ST-9 Multiple Well Test Tray |
|-------------------------|-------------------------------------------------------------------------------------------|
| Common/Usual Name: | System, delivery, allergen and vaccine |
| Regulation Number: | None: Pre-Amendment |
| Product Code: | LDH |
| Device Class: | Unclassified |
| Classification Panel: | General Hospital |
5
5. Legally Marketed Predicate Device(s)
K003195, Greertrack Skin Testing System, currently marked by Greer under the brand name Skintestor OMNI™.
6. Indication for Use Statement
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.
7. Device Description
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.
6
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.
8. Substantial Equivalence Discussion
The following table compares the Allergy skin testing device to the predicate device with respect to indications for use, principles of operation, technological characteristics, and materials. The subject devices do not raise any new issues of safety or effectiveness based on the similarities to the predicate device.
| Manufacturer | MedScience | Greer Laboratories | Device Comparison |
|---|---|---|---|
| Trade Name | AllergiEnd ST-9 Applicator | ||
| and Tray | Greertrack Skin Testing | ||
| System | |||
| Applicator - Model 1000 | |||
| Tray - Models 1001-36 and 1001 | Models: GT-IT, GT-IC | ||
| 510(k) Number | TBD | K003195 | N/A |
| Product Code | LDH | Same | Same |
| Regulation | |||
| Number | None: Pre-Amendment | Same | Same |
| Regulation Name | System, delivery, allergen | ||
| and vaccine | Same | Same | |
| Manufacturer | MedScience | Greer Laboratories | |
| Trade Name | AllergiEnd ST-9 Applicator | ||
| and Tray | |||
| Applicator - Model 1000 | |||
| Tray - Models 1001-36 and 1001 | Greertrack Skin Testing | ||
| System | |||
| Models: GT-IT, GT-IC | Device Comparison | ||
| Indications for Use | 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 device system is for use | ||
| in the prick/puncture | |||
| application of allergen | |||
| extracts to the epicutaneous | |||
| layer of the skin in the | |||
| performance of skin testing | |||
| for immediate type | |||
| hypersensitivity reactions in | |||
| those individuals suspected | |||
| of having allergies. | The proposed | ||
| Indications for Use is | |||
| more descriptive. | |||
| Does not raise any | |||
| additional questions | |||
| of safety or | |||
| effectiveness. | |||
| Allergens | Not supplied: added by | ||
| clinician | Same | Same | |
| Target Population | The device is intended for | ||
| use by medical | |||
| professionals in a clinical | |||
| setting. | Same | Same | |
| Applicator | |||
| General Use | Application of doctor | ||
| provided allergenic extracts | |||
| used for skin testing | Same | Same | |
| Method for | |||
| loading the | |||
| allergenic material | Capillary action | Same | Same |
| Anatomical | |||
| site/Location | Back and volar surface of | ||
| forearms | Same | Same | |
| Manufacturer | MedScience | Greer Laboratories | |
| Trade Name | AllergiEnd ST-9 Applicator | ||
| and Tray | |||
| Applicator - Model 1000 | |||
| Tray - Models 1001-36 and 1001 | Greertrack Skin Testing | ||
| System | |||
| Models: GT-IT, GT-IC | Device Comparison | ||
| Material | Applicator is molded from | ||
| Dupont Delrin® | |||
| (polyoxymethylene) | |||
| 100P NC010. | Per spectral analysis, the | ||
| applicator is molded from a | |||
| thermoplastic polymer | |||
| identified as | |||
| polyoxymethylene or | |||
| polyacetal. | Both are made of | ||
| polyoxymethylene. | |||
| Any minor differences | |||
| in material does not | |||
| raise any additional | |||
| questions of safety or | |||
| effectiveness as the | |||
| proposed material | |||
| was found to be | |||
| biocompatible. | |||
| Applicator design | Rigid center spine that | ||
| incorporates the test heads | |||
| with tines | Same | Same | |
| Number of | |||
| applicator heads | 9 | 10 | Number of applicator |
| heads does not | |||
| provide for a | |||
| functional difference, | |||
| therefore it does not | |||
| raise any additional | |||
| questions of safety or | |||
| effectiveness. | |||
| Applicator Head | |||
| pattern | Asymmetric | ||
| 9 test heads arranged in 2 | |||
| rows of 4 test heads with a | |||
| single test head distally | |||
| located along the center | |||
| line of the applicator. | Symmetric | ||
| 5 rows of 2 heads. | The arrangement of | ||
| applicator heads does | |||
| not provide for a | |||
| functional difference; | |||
| therefore, it does not | |||
| raise any additional | |||
| questions of safety or | |||
| effectiveness. | |||
| Spacing between | |||
| Heads | 20 mm | 18.4 mm | The small increase in |
| the spacing between | |||
| heads does not | |||
| provide for a | |||
| functional difference; | |||
| therefore, it does not | |||
| raise any additional | |||
| questions of safety or | |||
| effectiveness. | |||
| Manufacturer | MedScience | Greer Laboratories | Device Comparison |
| Trade Name | AllergiEnd ST-9 Applicator | ||
| and Tray | |||
| Applicator - Model 1000 | |||
| Tray - Models 1001-36 and 1001 | Greertrack Skin Testing | ||
| System | |||
| Models: GT-IT, GT-IC | Device Comparison | ||
| Number of tines | |||
| on each test head | 9 | 7 | The difference in the |
| number of tines is not | |||
| expected to affect | |||
| performance or | |||
| safety. | |||
| Sterile | Ethylene Oxide (EO) | Same | Same |
| Single-Use | Yes | Same | Same |
| Applicator | |||
| Complies with ISO | |||
| 10993-10 | Yes | USP Class VI | Proposed device was |
| tested per current | |||
| requirements and | |||
| shown to pass. | |||
| Tray | |||
| General Use | Holds small quantities of | ||
| doctor-provided allergenic | |||
| extracts and to allow | |||
| allergens to be applied to | |||
| the applicator used for skin | |||
| testing. | Same | Same | |
| Tray pattern | Matches that of applicator | Same | Same |
| Number of tray | |||
| wells | Catalogue# 1001-36 | ||
| has 36 wells | |||
| Catalogue# 1001 | |||
| has 72 wells | 20 - three trays may be | ||
| combined to have 60 wells | The number of test | ||
| wells does not provide | |||
| for a functional | |||
| difference; therefore, | |||
| it does not raise any | |||
| additional questions | |||
| of safety or | |||
| effectiveness. | |||
| Sterile | Ethylene Oxide (EO) | Same | Same |
| Single Use | No | No | Same |
| Material | |||
| Composition | Rohm Plexiglas® | ||
| Plexiglas SG 10 acrylic | Per spectral analysis, the | ||
| tray is molded from | |||
| Polymethyl methacrylate | |||
| (commonly referred to as | |||
| acrylic). | Difference in material | ||
| does not raise any | |||
| additional questions | |||
| of safety or | |||
| effectiveness as the | |||
| proposed material | |||
| was found to be | |||
| biocompatible. | |||
| Manufacturer | MedScience | Greer Laboratories | |
| Trade Name | AllergiEnd ST-9 Applicator | ||
| and Tray | |||
| Applicator - Model 1000 | |||
| Tray - Models 1001-36 and 1001 | Greertrack Skin Testing | ||
| System | |||
| Models: GT-IT, GT-IC | Device Comparison | ||
| Lid Function | Locking | No Lid | Lid decreases chance |
| for contamination. | |||
| More securely | |||
| integrates the test | |||
| wells with the cover to | |||
| form a sturdier device | |||
| allowing for more | |||
| secure handling. | |||
| Does not raise any | |||
| additional questions | |||
| of safety or | |||
| effectiveness. | |||
| Applicator | |||
| Complies with ISO | |||
| 10993-10 | Yes | USP Class VI | Proposed device was |
| tested per current | |||
| requirements. |
Table 5A – Comparison of Characteristics
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9. Non-Clinical Performance Data
Each lot of the AllergiEnd® ST-9 Multiple Skin Test Applicator and Multiple Well Test Tray are inspected at AQL level 1.0 sampling size.
The following data were provided in support of the substantial equivalence determination:
Biocompatibility Testing
Biocompatibility evaluation of the AllergiEnd® ST-9 Multiple Skin Test Applicator was conducted in accordance with the FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" April 23, 2013, and International Standard ISO 10993-1 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process, as recognized by FDA.
The AllergiEnd® ST-9 Multiple Skin Test Applicator contacts intact skin for limited duration (