(287 days)
No
The summary describes a mechanical device for drug transfer and does not mention any AI or ML components or functionalities.
No
The device is a closed system drug transfer device (CSTD) designed to prevent exposure to hazardous drugs and maintain sterility, not to treat or diagnose a disease or condition in a patient.
No
This device is a closed system drug transfer device (CSTD) designed to prevent contamination and exposure to hazardous drugs, not to diagnose medical conditions.
No
The device description clearly indicates it is a physical, mechanical device (closed system drug transfer device) and the performance studies are bench testing and other physical/material tests.
Based on the provided information, the NEOSHIELD System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a closed system drug transfer device (CSTD) designed to minimize exposure to hazardous drugs. This is a drug delivery and safety function, not a diagnostic function.
- Device Description: The description reinforces its function as a CSTD for preventing contamination and drug escape. It mentions preventing microbial ingress, which is related to maintaining the sterility of the drug, not diagnosing a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers of disease, or providing information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on bench testing related to the device's physical properties (leakage, sterility, compatibility) and safety (pyrogenicity, biocompatibility), not on diagnostic accuracy or performance.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. The NEOSHIELD System's function is entirely focused on the safe handling and transfer of drugs.
N/A
Intended Use / Indications for Use
The NEOSHIELD System is an airtight and leak proof closed system drug transfer device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills.
The NEOSHIELD system also prevents microbial ingress for 3 days.
Product codes (comma separated list FDA assigned to the subject device)
ONB
Device Description
NeoShield is a needle free closed system drug transfer device (CSTD). Neoshield prevents transfer of environmental contaminants into the system and also prevents the escape of drug or vapor from the system.
The ability to prevent microbial ingress for up to 3 days should not be interpreted as modifying, extending, or superseding a manufacturer labeling recommendations for the storage and expiration dating. Refer to drug manufacturer's recommendations and USP compounding guidelines for shelf life and sterility information.
Device components:
NEOSHIELD Transfer: NEOSHIELD Transfer is used to transfer a solution from a vial container to another container such as an IV bag. It has a female connector, bag adaptor connector, and vial connector. It also has a stopcock to change the direction of flow. Depending on the stopcock's position it can open the flow from female connector to/from NEOSHIELD Bag Adaptor or from female connector to/from vial. During usage, the NEOSHIELD Transfer keeps aerosol and liquid from being exposed to the outer environment to keep a closed system.
NEOSHIELD Bag Adaptor: NEOSHIELD Bag Adaptor is connected to a liquid container such as IV bags for injection or extraction of liquid. The spike is used for the connection to liquid container and the injection port is used for injection or extraction of liquid in/out of container without leakage maintaining closed system.
NEOSHIELD Infusion Set: The NEOSHIELD Infusion Set is used for infusion of drug solution into a patient.
NEOSHIELD plug: The NEOSHIELD Plug is an optional accessory that can be connected with a female connector (such as one from NEOSHIELD Infusion Set) to inject/ extract solution without using needle in a closed system environment. The slit septum of the NEOSHIELD Plug opens upon connection with NEOSHIELD Lever Lock and the flow path opens. The slit septum of NEOSHIELD plug and the flow path closes once male portion of the NEOSHIELD Lever Lock is removed to keep a closed system.
NEOSHIELD Lever Lock: The NEOSHIELD Lever Lock is used for injecting/extracting solution in a closed system by connecting a device such as syringe to the female connector.
NEOSHIELD Vial Cover: NEOSHIELD Vial Cover is attached to drug vials in order to prevent leakage during extraction. The NEOSHIELD Vial Cover keeps the system closed to outer environment
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Non-Clinical Performance Data (bench testing):
- NeoShield Transfer: Pass
- NeoShield Bag Adaptor (Also includes tests from ISO 8536-4 : 2010): Pass
- NeoShield Infusion Set (Also includes tests from ISO 8536-4 : 2010): Pass
- NeoShield Plug: Pass
- NeoShield Lever Lock: Pass
- NeoShield Vial Cover: Pass
Other tests:
- Leaking Pressure of Pre-Slit Septum: No leak
- Pressure Resistant Test (Liquid Tightness): No leak
- Pressure Resistant Test (Air tightness): No leak
- Pressure Resistant Test (Connecting Part of Closed System): Not leak
- Airtight Connection: No leak
- Leakproof Connections: No leak
- Microbial Ingress Testing: No ingress for 3 days
- Pyrogen test: Non-pyrogenic
- Crack Test for drug compatibility with: N, N-dimethylacetamide Polyethylene Glycol benzyl alcohol polysorbate 80 polyoxyethylene castor oil NaOH CH3COOH: No cracks except for N, N-dimethylacetamide
- Sterility Testing (EO) ISO 11135: Sterile
- Shelf Life Testing: Sterility kept for 3 years
- Biocompatibility Testing: Cytotoxicity Sensitization Irritation or Intracutaneous Reactivity Systematic Toxicity (Acute) Haemocompatibility Pyrogen Particulate Matter: All materials are biocompatible
- Package Testing: Seal Strength/dye penetration testing: Pass/Pass
Note: Based on the crack test for drug compatibility results, DO NOT use NEOSHIELD system with anticancer drug or any solution that contains the plasticizer N, N-dimethylacetamide.
Clinical Performance Data: Not applicable as no clinical tests were referenced in this submission.
Conclusion: The device is equivalent to the predicate device K123213. Through non-clinical performance testing the subject devices have demonstrated that they are substantially equivalent to the predicate 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.
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
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
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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 and 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.
June 1, 2018
JMS North America Corporation % Yolanda Smith Smith Associates 1468 Harwell Ave Crofton, Maryland 21114
Re: K172499
Trade/Device Name: NEOSHIELD Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB Dated: April 30, 2018 Received: May 2, 2018
Dear Yolanda Smith:
We have reviewed vour 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.
1
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 (QS) 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 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,
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
2
Indications for Use
510(k) Number (if known) K172499
Device Name
NEOSHIELD
Indications for Use (Describe)
The NEOSHIELD System is an airtight and leak proof closed system drug transfer device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills.
The NEOSHIELD system also prevents microbial ingress for 3 days.
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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Image /page/3/Picture/0 description: The image shows the logo for JMS North America Corporation. The logo is in blue and features the letters JMS in a stylized font. Below the letters is the text "North America Corporation".
MAIN OFFICE 22320 Foothill Blvd. Suite 350 Hayward, CA 94541 Tel. (510) 888-9090 Fax (510) 888-9099
SALES OFFICE 480 Sawgrass Corp. Pkwy. Suite 120 Sunrise, FL 33325 Tel. (954) 689-9280 Fax (954) 689-9289
K172499 Section 05: 510(k) Summary [807.92(c)]
Owner [807.92(a)1]:
| Company Name: | JMS North America Corp. |
|---|---|
| Company Address: | 22320 Foothill Blvd., Suite 350 |
| Hayward, CA 94541 | |
| Telephone: | 510-888-9090 |
| Fax: | 510-888-9099 |
Contact Person: Sho Hosoki Summary Preparation Date: 06/01/2018
Device of Submission [807.92(a)(2)]
| Classification Name: | Intravascular Administration Set |
|---|---|
| Common/Usual Name: | Closed Antineoplastic and Hazardous Drug |
| Reconstitution and Transfer System | |
| Proprietary Name: | NEOSHIELD |
| Classification: | Class II |
| Product Code: | ONB |
| Code of Federal Regulations: | 21 CFR 880.5440 |
Predicate Device [807.92(a)(3)]
| K Number | Product | Company |
|---|---|---|
| K123213 | ||
| (Primary | ||
| Predicate) | BD PhaSeal Closed System Drug Transfer Device | |
| Protector, injector, Luer connector | Becton Dickinson & Co. |
Reference Device
| K965027 | Vented IV Set | JMS Co., Ltd |
|---|---|---|
| --------- | --------------- | -------------- |
Device Description [807.92(a)(4)]
NeoShield is a needle free closed system drug transfer device (CSTD). Neoshield prevents transfer of environmental contaminants into the system and also prevents the escape of drug or vapor from the system.
The ability to prevent microbial ingress for up to 3 days should not be interpreted as modifying, extending, or superseding a manufacturer labeling recommendations for the storage and expiration dating. Refer to drug manufacturer's recommendations and USP compounding guidelines for shelf life and sterility information.
4
Image /page/4/Picture/0 description: The image shows the logo for JMS North America Corporation. The logo is blue and features the letters JMS in a stylized font. Below the letters is the text "North America Corporation" in a smaller font, also in blue. The logo is simple and professional.
MAIN OFFICE 22320 Foothill Blvd. Suite 350 Hayward, CA 94541 Tel. (510) 888-9090 Fax (510) 888-9099
SALES OFFICE 480 Sawgrass Corp. Pkwy. Suite 120 Sunrise, FL 33325 Tel. (954) 689-9280 Fax (954) 689-9289
Device components:
| Name of Component | General Description |
|---|---|
| NEOSHIELD Transfer | NEOSHIELD Transfer is used to transfer a solution from a vial container to another container such as an IV bag. It has a female connector, bag adaptor connector, and vial connector. It also has a stopcock to change the direction of flow |
Depending on the stopcock's position it can open the flow from female connector to/from NEOSHIELD Bag Adaptor or from female connector to/from vial. During usage, the NEOSHIELD Transfer keeps aerosol and liquid from being exposed to the outer environment to keep a closed system. |
| NEOSHIELD Bag Adaptor | NEOSHIELD Bag Adaptor is connected to a liquid container such as IV bags for injection or extraction of liquid. The spike is used for the connection to liquid container and the injection port is used for injection or extraction of liquid in/out of container without leakage maintaining closed system. |
| NEOSHIELD Infusion Set | The NEOSHIELD Infusion Set is used for infusion of drug solution
into a patient. |
| NEOSHIELD plug | The NEOSHIELD Plug is an optional accessory that can be connected with a female connector (such as one from NEOSHIELD Infusion Set) to inject/ extract solution without using needle in a closed system environment. The slit septum of the NEOSHIELD Plug opens upon connection with NEOSHIELD Lever Lock and the flow path opens. The slit septum of NEOSHIELD plug and the flow path closes once male portion of the NEOSHIELD Lever Lock is removed to keep a closed system. |
| NEOSHIELD Lever Lock | The NEOSHIELD Lever Lock is used for injecting/extracting solution in a closed system by connecting a device such as syringe to the female connector. |
| NEOSHIELD Vial Cover | NEOSHIELD Vial Cover is attached to drug vials in order to prevent leakage during extraction. The NEOSHIELD Vial Cover keeps the system closed to outer environment |
Intended Use [807.92(a)(5)]
The NEOSHIELD System is an airtight and leak proof closed system drug transfer device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills.
5
Image /page/5/Picture/0 description: The image shows the logo for JMS North America Corporation. The logo is blue and features the letters "JMS" stacked on top of each other. There are three horizontal lines going through the letters. Below the letters is the text "North America Corporation".
MAIN OFFICE 22320 Foothill Blvd. Suite 350 Hayward, CA 94541 Tel. (510) 888-9090 Fax (510) 888-9099
SALES OFFICE 480 Sawgrass Corp. Pkwy. Suite 120 Sunrise, FL 33325 Tel. (954) 689-9280 Fax (954) 689-9289
The NEOSHIELD system also prevents microbial ingress for 3 days.
Predicate Comparison [807.92(a)(6)]
| Device | Modified Device | Currently Legally Marketed Predicate Device
(Primary Predicate) |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NeoShield | BD PhaSeal Closed System Transfer Device |
| Manufacture | JMS Co., Ltd / JMS Singapore Pte Ltd | Becton Dickinson & Co. |
| 510(K) # | ---- | K123213 |
| Classification | Class II | Class II |
| Product Code | ONB | ONB |
| Intended Use | The Neoshield System is an airtight and
leak proof closed system drug transfer
device (CSTD) that mechanically prohibits
the transfer of environmental
contaminants into the system and the
escape of drug or vapor concentrations
outside the system, thereby minimizing
individual and environmental exposure to
drug vapor, aerosols and spills.
The NEOSHIELD system also prevents
microbial ingress for 3 days. | The PhaSeal System is an airtight and leak proof
closed system drug transfer device (CSTD) that
mechanically prohibits the transfer of
environmental contaminants into the system and
the escape of drug or vapor concentrations
outside the system, thereby minimizing individual
and environmental exposure to drug vapor,
aerosols and spills.
The PhaSeal system also prevents microbial
ingress. |
| Equalizes Vial
Pressure
when
Accessed | Yes | Yes |
| Prevents
Escape of
Drug or Vapor
Concentration | Yes | Yes |
| Closed Drug
Transfer
Mechanism | Elastomeric double membrane(non-ISO) | Elastomeric double membrane(non-ISO) |
| Activation
Mechanism | Push-to connect
(Non-ISO) | Push-to connect
with bayonet lock (Non-ISO) |
| Needle Free | Needle free | 18G needle with safety sleeve and /or steal spike |
| Connection to
External
Equipment | Standard ISO Luer Connections and Vial Spikes | Standard ISO Luer Connections and Vial Spikes |
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Image /page/6/Picture/0 description: The image shows the logo for JMS North America Corporation. The logo is in blue and features the letters "JMS" stacked on top of the words "North America Corporation". The letters "JMS" are stylized and bolded. The words "North America Corporation" are in a smaller font size.
MAIN OFFICE 22320 Foothill Blvd. Suite 350 Hayward, CA 94541 Tel. (510) 888-9090 Fax (510) 888-9099
SALES OFFICE 480 Sawgrass Corp. Pkwy. Suite 120 Sunrise, FL 33325 Tel. (954) 689-9280
Fax (954) 689-9289
| Single Use | yes | yes |
|---|---|---|
| Sterilization | ||
| Method | EO | EO |
| Open or | ||
| Closed | ||
| System | closed system | |
| Following tests were conducted: | ||
| Leaking Pressure of Pre-Slit Septum | ||
| Pressure Resistant Test (Liquid Tightness) | ||
| Pressure Resistant Test (Air tightness) | ||
| Pressure Resistant Test (Connecting Part of | ||
| Closed System) | ||
| Airtight Connection | ||
| Leakproof Connections | ||
| Microbial Ingress Testing | closed system | |
| Filter | PTFE (NeoShield Transfer) | PTFE (Protector) |
| Material | Contains plastics, elastomeric double | |
| membrane, PTFE filter | Plastics, elastomeric double membrane, PTFE | |
| filter, stainless steel | ||
| Performance | ||
| testing | Leak proof connections | |
| Airtight connections | ||
| Microbial Ingress | Leak proof connections | |
| Airtight connections | ||
| Microbial Ingress |
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Image /page/7/Picture/0 description: The image contains the logo for JMS North America Corporation. The logo is blue and features the letters "JMS" in a stylized font with horizontal lines above the letters. Below the letters is the text "North America Corporation" in a smaller font.
MAIN OFFICE 22320 Foothill Blvd. Suite 350 Hayward, CA 94541 Tel. (510) 888-9090 Fax (510) 888-9099
SALES OFFICE 480 Sawgrass Corp. Pkwy. Suite 120 Sunrise, FL 33325 Tel. (954) 689-9280 Fax (954) 689-9289
Non-Clinical Performance Data [807.92(b)(1)]
The following non-clinical tests were conducted:
Performance test (bench testing)
| Name of device | Result |
|---|---|
| NeoShield Transfer | Pass |
| NeoShield Bag Adaptor (Also includes tests | |
| from ISO 8536-4 : 2010) | Pass |
| NeoShield Infusion Set (Also includes tests | |
| from ISO 8536-4 : 2010) | Pass |
| NeoShield Plug | Pass |
| NeoShield Lever Lock | Pass |
| NeoShield Vial Cover | Pass |
| Name of Test | Result |
|---|---|
| Leaking Pressure of Pre-Slit Septum | No leak |
| Pressure Resistant Test (Liquid Tightness) | No leak |
| Pressure Resistant Test (Air tightness) | No leak |
| Pressure Resistant Test (Connecting Part of Closed System) | No leak |
| Airtight Connection | No leak |
| Leakproof Connections | No leak |
| Microbial Ingress Testing | No ingress for 3 days |
Other tests
| Name of Test | Result |
|---|---|
| Pyrogen test | Non-pyrogenic |
| Crack Test for drug compatibility with: | |
| N, N-dimethylacetamide Polyethylene Glycol benzyl alcohol polysorbate 80 polyoxyethylene castor oil NaOH CH3COOH | No cracks except for |
| N, N-dimethylacetamide |
8
Image /page/8/Picture/0 description: The image shows the logo for JMS North America Corporation. The logo is blue and features the letters JMS stacked on top of each other. There are also horizontal lines above the letters. The words "North America Corporation" are written below the letters.
MAIN OFFICE 22320 Foothill Blvd. Suite 350 Hayward, CA 94541 Tel. (510) 888-9090 Fax (510) 888-9099
SALES OFFICE 480 Sawgrass Corp. Pkwy. Suite 120 Sunrise, FL 33325 Tel. (954) 689-9280 Fax (954) 689-9289
| Sterility Testing (EO)
| ISO 11135 | Sterile |
|---|---|
| Shelf Life Testing | Sterility kept for 3 years |
| Biocompatibility Testing: | |
| Cytotoxicity Sensitization Irritation or Intracutaneous Reactivity Systematic Toxicity (Acute) Haemocompatibility Pyrogen Particulate Matter | All materials are biocompatible |
| Package Testing: Seal Strength/dye | |
| penetration testing | Pass/Pass |
Note: Based on the crack test for drug compatibility results, DO NOT use NEOSHIELD system with anticancer drug or any solution that contains the plasticizer N, N-dimethylacetamide.
Clinical Performance Data [807.92(b)(2)]
Not applicable as no clinical tests were referenced in this submission
Conclusion [807.92(b)(3)]
The device is equivalent to the predicate device K123213.
Through non-clinical performance testing the subject devices have demonstrated that they are substantially equivalent to the predicate device.