The device consists of a display to be used with the DyeVert Plus Disposable Kit, DyeVert Plus EZ Disposable Kit or the DyeTect Contrast Monitoring Disposable Kit during angiographic or CT procedures requiring controlled infusion of radiopaque contrast media.

The DyeVert™ Plus EZ Contrast Reduction System consists of a Display and DyeVert Plus EZ Disposable Kit. The system is to be used for contrast volume reduction and for the monitoring of radiopaque contrast media during angiographic or CT procedures with the following agents: Iodixanol 270 or 320 mg/mL, Iohexol 300 or 350 mg/mL and Iopamidol 370 mgI/mL.

Device Description

The Osprey Medical DyeVert™ Plus EZ Contrast Reduction System is a compatible device to manual contrast injections and provides fluid pathway resistance modulation such that excess contrast volume (i.e. contrast that is not needed for diagnostic or therapeutic purposes) is minimized in the patient's vasculature and total contrast agent volume reduction occurs; while maintaining adequate image quality. Age, diabetes, moderate and severe chronic kidney disease and heart failure on presentation are leading factors for when to consider renal protection measures such as contrast minimization tools and processes.

The DyeVert Plus EZ Contrast Reduction System consists of the:

Contrast Monitoring Display (provided separately) and
DyeVert Plus EZ Disposable Kit.

The DyeVert Plus EZ Disposable Kit consists of the Smart Syringe and DyeVert Plus EZ Module. The DyeVert Plus EZ Disposable Kit is intended to be used with the Contrast Monitoring Display to allow monitoring and display of contrast volumes manually injected. Volumes are displayed and compared to physician entered contrast usage thresholds during angiographic procedures.

The DyeVert Plus EZ Module has been designed for use with standard injection syringes and manifolds with Luer fittings that have been demonstrated to comply with ISO 594 "Conical fittings with a 6% luer taper for syringes, needles and certain other medical equipment"; and the catheter configurations listed below. Utilization of catheters beyond those listed has not been substantiated.

AI/ML Overview

This document describes the DyeVert™ PLUS EZ Contrast Reduction System, a medical device designed for contrast volume reduction and monitoring during angiographic or CT procedures. The submission is a 510(k) premarket notification (K181936), indicating a claim of substantial equivalence to a legally marketed predicate device.

It's important to note that the provided text focuses on the device's technical specifications, non-clinical bench testing, and comparison to its predicate. No clinical testing was performed or reported in this submission to demonstrate the device's performance in humans or improvement in human reader performance.

Therefore, the following information will be extracted primarily from the non-clinical testing sections, as clinical study data for device performance or human reader improvement is explicitly stated as not performed.

Acceptance Criteria and Reported Device Performance

Since no clinical study demonstrating human-in-the-loop performance or specific clinical outcomes was conducted, the acceptance criteria and reported performance relate to bench testing of the device's functional and safety characteristics.

Acceptance Criteria	Reported Device Performance
Contrast Diversion (System meets performance specification)	All testing results passed, meeting the acceptance criteria.
Accuracy Testing (DyeVert Plus EZ System measures contrast accounting with an accuracy of +/- 10%)	All results passed.
Air Aspiration Verification (Confirm device integrity under vacuum based on ISO 10555-1)	All tests passed.
Simulated Use Design Validation (Acceptance criterion met with participants performing entire cath lab procedure and providing feedback)	The results demonstrated that the acceptance criterion was met.
Environmental Conditioning and Distribution Simulation (Visual inspection of packaging/labeling, functional testing of Disposable Kit components and Display, package integrity/seal strength)	All testing results met the acceptance criteria.
Pressure Leak Test (Leveraged from predicate; module assembly components and bonding process are nearly identical, pressure joints are identical)	Not explicitly stated "passed" for the NEW device, but implied by leveraging predicate data where it "passed".
Software Verification (Software development process in accordance with IEC 62304:2006; verification of software requirement specifications)	All testing passed.
Sterilization Adoption (EO sterilized using same cycle as predicate, supported by AAMI TIR28)	Not explicitly stated "passed", but implied by leveraging predicate data and assessment.
Biocompatibility Testing (In accordance with ISO 10993-1)	All testing passed and met prior established acceptance criteria.

Study Details

Given that no clinical study was performed, the sections below will reflect the information provided for the non-clinical bench testing.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly quantified as a "sample size" in the conventional sense for patient data. For bench testing, samples of the device components (e.g., DyeVert Plus EZ System, Disposable Kit components) were tested. The number of units tested for each specific test (e.g., how many devices were subjected to contrast diversion testing) is not provided, but the description implies a sufficient number were tested to satisfy the respective acceptance criteria for device performance.
- Data Provenance: The data is from non-clinical bench testing performed by Osprey Medical, Inc. (the manufacturer) and third-party testing certification for electrical safety. The data is prospective in nature, as it was generated specifically for this submission to demonstrate device performance against pre-established engineering and safety specifications. No geographical provenance for the "data" in terms of patient population is relevant here as no patient data was used.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For non-clinical bench testing, "ground truth" is established by engineering specifications, international standards (e.g., ISO 10555-1, IEC 60601-1, IEC 62304), and validated test methods. While engineers and quality assurance professionals with relevant expertise would conduct and interpret these tests, they are not "experts" in the context of establishing medical ground truth for a diagnostic AI model. The "Simulated Use design validation" involved "participants" who performed procedures and provided feedback, but these were likely users/clinicians assessing usability rather than experts establishing clinical ground truth for a specific medical condition.
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 for diagnostic imaging, where multiple experts assess cases and discrepancies are resolved. As this was non-clinical bench testing, such an adjudication method is not relevant.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. The document explicitly states: "No clinical testing was performed to support this 510(k) Premarket Notification." Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or reported.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- While the device contains "software" (Display software), it is an electromechanical system for managing contrast media infusion, not an AI or diagnostic algorithm that operates "stand-alone" in a diagnostic capacity. Its "performance" is based on mechanical and fluid dynamic principles (e.g., contrast diversion efficacy, accuracy of volume measurement) rather than image interpretation. Therefore, the concept of a "standalone" algorithmic performance study in the context of diagnostic AI is not applicable here. The software verification confirmed the software's compliance with IEC 62304:2006.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable in the clinical sense. The "ground truth" for the non-clinical tests was based on engineering specifications, pre-defined acceptance criteria, and compliance with international standards (e.g., ISO, IEC, AAMI). For instance, "accuracy testing" had a ground truth of +/- 10% deviation from a known, actual volume.
The sample size for the training set:
- Not Applicable. This device is not an AI/machine learning model in the conventional sense that requires a "training set" of data for learning patterns. It is an electromechanical device with embedded software.
How the ground truth for the training set was established:
- Not Applicable. As no training set was used, no ground truth needed to be established for it.

Summary

{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.

October 25, 2018

Osprey Medical, Inc. Melanie Hess Vice President, Regulatory Affairs and Compliance 5600 Rowland Rd. Suite 250 Minnetonka, Minnesota 55343

Re: K181936

Trade/Device Name: DyeVert™ PLUS EZ Contrast Reduction System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector And Syringe Regulatory Class: Class II Product Code: DXT Dated: September 21, 2018 Received: September 25, 2018

Dear Melanie Hess:

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/cdrh/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

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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,

Lydia S. Glaw -S 2018.10.25 13:40:54 -04'00'

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K181936

Device Name

DyeVert™ PLUS EZ Contrast Reduction System

Indications for Use (Describe)

Display

DyeVert Plus EZ Disposable Kit

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)	□

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

K181936 510(k) Summary	510(k) Summary As required by 21CFR 807.92(c)
510(k) Number:	K181936
Submission Type:	Special pre-market notification (510(k))
Date Prepared:	17 July 2018
Submitter's Name/Address:	Osprey Medical5600 Rowland Road Suite 250Minnetonka, MN 55343
Contact Person:	Melanie HessVice President, Regulatory Affairs, Compliance and QualityTel: 952-955-8252Fax: 952-955-8171Mhess@ospreymed.com
Device Information:
Trade Name/Proprietary Name:	DyeVert™ Plus EZ Contrast Reduction System
Manufacturer:	Osprey Medical, Inc.

Common Name: Classification Registration: Product Code: FDA Center/Branch:

Injector and Syringe, Angiographic 21 CFR § 870.1650 DXT CDRH/Interventional Cardiology Devices Branch (ICDB)

Device Description:

The DyeVert Plus EZ Contrast Reduction System consists of the:

1. Contrast Monitoring Display (provided separately) and
1. DyeVert Plus EZ Disposable Kit.

{4}------------------------------------------------

Indications for Use:

Display

DyeVert Plus EZ Disposable Kit

The DyeVert™ Plus EZ Contrast Reduction System consists of a Display and DyeVert Plus EZ Disposable Kit. The system is to be used for contrast volume reduction and for the monitoring of radiopague contrast media during angiographic or CT procedures with the following agents: Iodixanol 270 or 320 mg/mL. Iohexol 300 or 350 mgI/mL and Iopamidol 370 mgI/mL.

Predicate Device:

Trade Name/Proprietary Name:	DyeVert™ Plus Contrast Reduction System
Manufacturer:	Osprey Medical, Inc.
Common Name:	Injector and Syringe, Angiographic
Classification:	II
CFR Reference:	21 CFR § 870.1650
Product Code:	DXT
510(k) number(s)K163054

Comparison to the Predicate Device:

The proposed device is substantially equivalent to the previously cleared predicate, in that they are both designed for use during the controlled infusion of manual injection of radiopaque contrast media for angiographic procedures. The proposed device has identical sterilization processes, shelf life and benefitrisk profiles. The subject device has nearly identical performance specifications that do not impact the principle of operation.

The subject device differs from the predicate device by providing ease of priming through a two-way checkvalve and removing the shared fluid pathway between the diversion line and the contrast line.

The fundamental scientific technology and, principle of operation remain unchanged and primary mechanism of action remains unchanged. No new intended user or different questions of safety or effectiveness are raised with the proposed modification.

Summary of Non-Clinical Testing:

Bench testing was previously performed and leveraged to support this submission. Results demonstrate the materials, design considerations and manufacturing processes meet product specifications and performance requirements. The following testing was successfully completed and leveraged within this submission:

Confirmatory device performance testing (design verification) included contrast diversion, accuracy, aspiration verification, functional testing after environmental conditioning and distribution simulation, pressure leak, shelf life, software verification, sterilization adoption, biocompatibility and testing demonstrating compliance to IEC 60601-1, electrical safety for medical devices and IEC 60601-1-2 emissions and immunity for non-life supporting equipment through third party testing certification. T

The subject device use as intended was validated during simulated use validation. All testing passed and demonstrated product performance met all pre-established acceptance criteria.

{5}------------------------------------------------

Contrast Diversion Testing was conducted to verify that the Dye Vert Plus EZ System meets the performance specification. All testing results passed, meeting the acceptance criteria.
. Accuracy Testing was performed to demonstrate the DyeVert Plus EZ System measures contrast accounting with an accuracy of +/- 10%. All results passed.
. Air aspiration verification was performed based on ISO 10555-1 to confirm device integrity under vacuum. All tests passed.
Simulated Use design validation was conducted during simulated use scenarios and following the Instructions for Use. Participants performed the entire cath lab procedure and provided feedback. Data and evaluation results were collected and analyzed. The results demonstrated that the acceptance criterion was met.
. Testing was performed after environmental conditioning and distributions simulation at T=0. Testing included visual inspection of packaging and labeling, functional testing of the Disposable Kit components and the Display. Package integrity and seal strength were testing. All testing results met the acceptance criteria.
. Pressure leak test was leveraged from that conducted with the predicate. The Module assembly components are nearly identical; and the bonding process used for the subject and predicate device is the same. The pressure joints are identical to those previously tested in K163054.
. Software development process was performed in accordance with IEC 62304:2006 Software life cycle process and testing conducted included verification of software requirement specifications rel. All testing passed.
. The subject device shelf life has been leveraged from that reported in the predicate 510(k).
. The DyeVert Plus EZ Disposable kit is EO sterilized using the same cycle as the predicate. The use of the cycle is supported by a sterilization adoption assessment conducted per AAMI TIR28. As such, the sterilization validation has been leveraged and is located in K163054.
. Confirmatory biocompatibility testing was performed in accordance with ISO 10993-1. All testing passed and met prior established acceptance criteria.

No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for angiographic injectors and syringes.

Clinical Testing:

No clinical testing was performed to support this 510(k) Premarket Notification.

Statement of Equivalence:

The proposed DyeVert Plus EZ Module and the updated Display software are substantially equivalent in intended use, indications for use statement and fundamental scientific technology as the predicate device. Based on this and data analyzed in accordance with Osprey Medical Quality System Procedure in compliance with 21 CFR 820, EN ISO 13485:2012 Medical Devices - Quality management systems requirements for regulatory purposes and EN ISO 14791:2012 Risk management for medical devices, the proposed subject devices have been shown to be substantially equivalent under 21 CFR Part 807 subpart E.

Regulation Number and Section

§ 870.1650 Angiographic injector and syringe.

(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.