DyeVert™ Plus Contrast Reduction System
Smart Monitor
The device consists of a Smart Monitor 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 influsion of radiopaque contrast media.
DyeVert Plus Disposable Kit
The DyeVert™ Plus Contrast Reduction System consists of a Monitor and DyeVert Plus 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, lohexol 300 or 350 mg/mL and Iopamidol 370 mg/l mL.
DyeVert™ Plus EZ Contrast Reduction System
Smart Monitor
The device consists of a Smart Monitor 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.
DyeVert Plus EZ Disposable Kit
The DyeVert™ Plus EZ Contrast Reduction System consists of a Monitor 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 mgI/mL and Iopamidol 370 mgI/mL.
DyeTect™ Contrast Monitoring System
Smart Monitor
The device consists of a Smart Monitor 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 influsion of radiopaque contrast media.
DyeTect Contrast Monitoring Disposable Kit
The DyeTect Contrast Monitoring Disposable Kit consists of a Smart Syringe and Pressure Module to be used with the Monitor during angiographic or CT procedures requiring controlled infusion of radiopaque contrast media.

Device Description

The Osprey Medical DyeVert™ Plus 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. The DyeVert" Plus Contrast Reduction System consists of a non-sterile monitor and EO sterilized disposable kit.
The DyeTect™ Contrast Monitoring Disposable Kit consists of EO sterilized Smart Syringe and Pressure Module. The system allows for real-time, wireless, monitoring and display of manually injected contrast volumes. Volumes are displayed and compared to a physician entered contrast usage threshold during angiographic procedures. The system provides a visual and audible indication of when the cumulated volume injected into the patient is approaching a physician determined contrast volume threshold.
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. The DyeVert" Plus EZ Contrast Reduction System consists of a non-sterile monitor and EO sterilized disposable kit.

AI/ML Overview

Based on the provided text, the document is a 510(k) Premarket Notification from the FDA regarding Osprey Medical Inc.'s DyeVert Plus, DyeVert Plus EZ Contrast Reduction Systems, and DyeTect Contrast Monitoring System.

This document clearly states that NO CLINICAL TESTING WAS PERFORMED to support this 510(k) Premarket Notification. Therefore, the device performance is not proven through a clinical study as requested in the prompt. The "acceptance criteria" discussed are related to non-clinical bench testing and regulatory compliance, not performance metrics derived from patient data or AI algorithm evaluation.

Since no clinical study was performed, I cannot fill in the requested information points related to clinical performance, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance.

Here's what can be extracted regarding the non-clinical testing, tailored to address the prompt where possible, and explicitly stating where information is unavailable due to the lack of clinical testing:

Device: DyeVert™ Plus Contrast Reduction System, DyeVert™ Plus EZ Contrast Reduction System, DyeTect™ Contrast Monitoring System (Specifically the Smart Monitor component, as the disposable kits are unchanged from predicates).

1. A table of acceptance criteria and the reported device performance

As no clinical testing was performed, there are no performance metrics related to diagnostic accuracy, sensitivity, specificity, or inter-reader agreement. The "performance" here refers to meeting engineering and regulatory standards in non-clinical bench testing.

Acceptance Criterion (Non-Clinical)	Reported Device Performance (Non-Clinical)
Software development in accordance with IEC 62304:2006	Software development process conducted in accordance with IEC 62304:2006; all software requirement specifications verified.
Electrical Safety per IEC 60601-1	Tested and complies.
EMC compatibility per IEC 60601-1-2	Tested and complies.
Wireless communication complies with FCC Rule part 15	Complies.
Cumulative volume accuracy (with DyeVert Plus EZ and DyeTect Disposable kits)	Successfully completed.
Pause/resume of system with Module pause	Successfully completed.
Pause/resume of system based on stopcock position (DyeVert Plus only)	Successfully completed.
System resume with pressure transducer	Successfully completed.
No count of injection if contrast is sent back to contrast source	Successfully completed.
Distribution testing after environmental conditioning per ASTM D4169-16 and ISTA P2A	Successfully completed.
Human Factors testing in accordance with FDA guidance (Feb 2016), BS EN 62366-1:2015, AAMI/ANSI HE75:2009/(R)2013	Successfully performed.
Cybersecurity evaluation in accordance with FDA guidance (Oct 2014)	Successfully performed.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable as no clinical test set/patient data was used for performance evaluation. Non-clinical testing involved various engineering and simulated tests.
Data Provenance: Not applicable for clinical data. The changes assessed were to the Smart Monitor component (software, memory, connectivity) compared to its predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable. No clinical expert review was performed as there was no clinical study.
Qualifications of Experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. No clinical test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No. No clinical study or human reader component was involved in this 510(k) submission. This device is not an AI algorithm for image interpretation that would assist human readers in a diagnostic task. Its function is for contrast volume management and monitoring.
Effect Size: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable in the context of an "AI algorithm only" evaluation. The device (Smart Monitor) is a hardware component with software for real-time monitoring and display of manually injected contrast volumes. It doesn't perform diagnostic interpretation or AI-driven tasks that would have standalone algorithmic performance metrics. The performance evaluated was its accurate measurement and display of contrast volumes during manual injection, as detailed in the non-clinical bench testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: Not applicable for clinical ground truth. For the non-clinical bench testing, the "ground truth" was established by engineering specifications, calibrated measurement tools, and defined test protocols to verify the device's functional performance (e.g., volume accuracy, electrical safety standards).

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device is not an AI algorithm that undergoes a "training" phase with a dataset.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable.

Summary

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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 & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 17, 2019

Osprey Medical Inc. Melanie Hess VP Regulatory Affairs 5600 Rowland Road Suite 250 Minnetonka, Minnesota 55343

Re: K190102

Trade/Device Name: DyeVert Plus Contrast Reduction System, DyeVert Plus EZ Contrast Reduction System, DyeTect Contrast Monitoring System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: DXT Dated: September 13, 2019 Received: September 16, 2019

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

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190102

Device Name

DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System

Indications for Use (Describe) DyeVert™ Plus Contrast Reduction System

Smart Monitor

The device consists of a Smart Monitor 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 influsion of radiopaque contrast media.

DyeVert Plus Disposable Kit

The DyeVert™ Plus Contrast Reduction System consists of a Monitor and DyeVert Plus 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, lohexol 300 or 350 mg/mL and Iopamidol 370 mg/l mL.

DyeVert™ Plus EZ Contrast Reduction System

Smart Monitor

DyeVert Plus EZ Disposable Kit

The DyeVert™ Plus EZ Contrast Reduction System consists of a Monitor 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.

DyeTect™ Contrast Monitoring System

Smart Monitor

DyeTect Contrast Monitoring Disposable Kit

The DyeTect Contrast Monitoring Disposable Kit consists of a Smart Syringe and Pressure Module to be used with the Monitor during angiographic or CT procedures requiring controlled infusion of radiopaque contrast media.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary As required by 21CFR 807.92(c)
510(k) Number:	K190102
Submission Type:	Traditional pre-market notification (510(k))
Date Prepared:	16 October 2019
Submitter's Name/Address:	Osprey Medical Inc.
	5600 Rowland Road Suite 250
	Minnetonka, MN 55343
Contact Person:	Melanie Hess
	Vice President Regulatory Affairs, Compliance and Quality
	Tel: 952-955-8252
	Fax: 952-955-8171
	Mhess@ospreymed.com
Device Information:
Trade Name/Proprietary Name(s):	DyeVert™ Plus Contrast Reduction System
	DyeTect™ Contrast Monitoring System
	DyeVert™ Plus EZ Contrast Reduction System
Manufacturer:	Osprey Medical Inc.
Common Name:	Injector and Syringe, Angiographic
Regulation Name:	Angiographic injector and syringe
Classification Registration:	21 CFR § 870.1650
Product Code:	DXT

Device Description:

The DyeTect™ Contrast Monitoring Disposable Kit consists of EO sterilized Smart Syringe and Pressure Module. The system allows for real-time, wireless, monitoring and display of manually injected contrast volumes. Volumes are displayed and compared to a physician entered contrast usage threshold during angiographic procedures. The system provides a visual and audible indication of when the cumulated volume injected into the patient is approaching a physician determined contrast volume threshold.

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. The DyeVert" Plus EZ Contrast Reduction System consists of a non-sterile monitor and EO sterilized disposable kit.

Indications for Use:

DyeVert™ Plus Contrast Reduction System

Smart Monitor

DyeVert™ Plus Disposable Kit

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The DyeVert Plus Contrast Reduction System consists of a Monitor and DyeVert Plus 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 mgI/mL and Iopamidol 370 mgI/mL.

DyeVert™ Plus EZ Contrast Reduction System

Smart Monitor

DyeVert™ Plus EZ Disposable Kit

DyeTect™ Contrast Monitoring System

Smart Monitor

Predicate Device:

Trade Name/Proprietary Name:	DyeVert™ Plus Contrast Reduction SystemDyeTect™ Contrast Monitoring System
Manufacturer:	Osprey Medical, Inc.
Common Name:	Injector and Syringe, Angiographic
Classification:	II
Regulation Name:	Angiographic injector and syringe
Regulation:	21 CFR § 870.1650
Product Code:	DXT
510(k) number(s)	K163054
Trade Name/Proprietary Name:	DyeVert™ Plus EZ Contrast Reduction System
Manufacturer:	Osprey Medical, Inc.
Common Name:	Injector and Syringe, Angiographic
Classification:	II
Regulation Name:	Angiographic injector and syringe
Regulation:	21 CFR § 870.1650
Product Code:	DXT
510(k) number(s)	K181936

Comparison to the Predicate Device:

Comparison of Indications for use

The proposed system's Indications for Use are the same.

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Comparison of Technological Characteristics

The disposable kits components of the subject systems have not changed. The Smart Monitor component of the subject systems is the only modification proposed in this submission and a comparison to the predicate is provided below. The monitor is non-patient contacting.

The Smart Monitor, like the predicate (Display) is a multiuse, non-sterile, and non-disposable device that allows for real-time monitoring and display of manually injected contrast volumes when used with the compatible disposable kits. The Smart Monitor has the same intended use as the predicate. Identical to the predicate, the Smart Monitor communicates wirelessly via a Bluetooth connection with the disposables. The Smart Monitor differs from the predicate display in design, materials and software. The Smart Monitor provides additional memory, can receive and execute software updates automatically or manually via WiFi, includes optional voice alerts, and can export de-identifiable case information via WiFi for further analysis.

Device Characteristic	Smart Monitor (Proposed)	CMW Display (PredicateK181936)
Principle of Operation	Real-time wireless monitoringand display of contrast volumesmanually injected.	Real-time wirelessmonitoring and display ofcontrast volumes manuallyinjected.
Product Code/Regulation	DXT / 21 CFR § 870.1650	DXT / 21 CFR § 870.1650
User Interface	Touchscreen, user-presetvolume variables, proactivemonitoring through userindicators, electronic display,audio alarms	Touchscreen, user-presetvolume variables,proactive monitoringthrough user indicators,electronic display, audioalarms
Power Source	AC Power via cable. Built-in19.1 watt hour rechargeablelithium polymer battery asbackup power supply.	AC Power via cable
Screen	7.9 inch backlit capacitivedisplay	10.4 inch LCD backlitcapacitive display
Housing	iPad Mini 4	Polycarbonate/ABShousing
Display Memory	128 GB	32GB
Packaging Materials	Corrugated shipping box,polyurethane ester	C-fluted 275 lb Kraftcolored box with foam
App Framework	QT 5.8.0	QT 5.8.0
Device Characteristic	Smart Monitor (Proposed)	CMW Display (PredicateK181936)
Bluetooth Stack	CoreBluetooth (iOS)	BlueZ (Linux)
Software Updates	Wi-Fi via. Mobile DeviceManagement (MDM)	USB
Video Player	iOS (AVPlayer)	Qt (QtMultimedia 5.8)
Settings Storage	iOS (NSUserDefaults)	Text File
Case Database Format	SQLite File	SQLite File
Shelf Life	No established life expectancylabeled to return to OspreyMedical for repair/servicing	No established lifeexpectancy labeled toreturn to Osprey Medicalfor repair/servicing
Wireless Connections	Wifi, and Bluetooth	Bluetooth
User Settings	Warning Tones, ThresholdWarning %, Tone Selection,Pause Voice Alert, Start inPause Mode, Pause Lock, CaseID & Renal FunctionCheckbox, Case History	Warning Tone, WarningTone Volume, ThresholdWarning %, ToneSelection, ScreenBrightness, Pause Lock,Language, Start in PauseMode, Case History,Date/Time
Case Export	AWS S3	USB

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The differences in technology were assessed during Design Verification bench testing, Software Validation, Electrical Safety, EMC, Cybersecurity and Human Factors testing and the results of the testing demonstrate that the changes do not raise questions of safety and effectiveness.

Summary of Non-Clinical Testing:

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

Software development process was conducted in accordance with IEC 62304:2006 Software life ● cycle process and testing was performed, which included verification of all software requirement specifications.

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The Smart Monitor has been tested for Electrical Safety and EMC compatibility per IEC 60601-● 1, 60601-1-2 and ANSI C63.27.
The wireless communication of the Smart monitor complies with part 15 of the FCC Rule.
. Design verification testing was conducted with the DyeVert Plus EZ, and the DyeTect Disposable kits and which included cumulative volume accuracy, pause/resume of the system with Module pause, pause/resume of the system based on stopcock position (DyeVert Plus only), system resume with pressure transducer and no count of injection if contrast is sent back to the contrast source.
. Distribution testing was conducted after environmental conditioning per ASTM D4169-16 and ISTA P2A.
Human Factors testing was performed in accordance with FDA guidance Applying Human ● Factors and Usability Engineering to Medical Devices, issued February 2016. BS EN 62366-1 Medical Devices - application of usability engineering to medical devices. 2015; and AAMI/ANSI HE75 2009/(R)2013 Human factors engineering - Design of medical devices.
. Cybersecurity evaluation was performed in accordance with FDA guidance, Content of premarket submissions for management of cybersecurity in medical devices, issued October 2014.

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 Contrast Reduction System, DyeVert Plus EZ Contrast Reduction System and DyeTect Contrast Monitoring Systems are substantially equivalent to the predicate devices as they have the same intended use and indications for use. Based on this and data analyzed in accordance with Osprey Medical Quality System Procedure in compliance with 21 CFR 820, EN ISO 13485:2016 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.