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

DyeVert Plus Disposable Kit: The DyeVert™ Plus Contrast Modulation/Monitoring System consists of a Display 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 mg/mL and Iopamidol 370 mgI/mL.

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

Device Description

The Osprey Medical DyeVert™ Plus Contrast Modulation/Monitoring System is a compatible system to manual contrast injections and provides fluid pathway resistance modulation and/or monitoring such that excess contrast volume (i.e. contrast that is not needed for diagnostic or therapeutic purposes also referred to as 'refluxed contrast') is minimized in the patient's vasculature. This allows for a reduction in total contrast agent volume during coronary or peripheral imaging; while maintaining adequate image quality. The DyeVert Plus Contrast Modulation/Monitoring System consists of the Display and the DyeVert Plus Disposable Kit.

The Contrast Monitoring System is a component of the DyeVert™ Plus Contrast Modulation/Monitoring System and also provided separately. 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. This allows for attentive physician decision-making of total contrast volume use during a patient case while allowing the physician's primary focus to remain on the image and therapeutic need of imaging. When sold separately, the Contrast Monitoring System consists of the Display and the Contrast Monitoring Disposable Kit.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (DyeVert™ Plus Contrast Modulation/Monitoring System, Contrast Monitoring System). It describes the device, its intended use, comparison to predicate devices, and a summary of non-clinical testing. However, it explicitly states: "No clinical testing was performed to support this 510(k) Premarket Notification."

Therefore, I cannot provide information on acceptance criteria and a study proving the device meets those criteria from this document, as there was no clinical study mentioned for this specific 510(k) submission.

Here's an overview of what can be extracted regarding testing and criteria, though it pertains to non-clinical (bench) testing:

Acceptance Criteria and Device Performance (Non-Clinical)

Acceptance Criteria Category	Specific Acceptance Criteria (Implied)	Reported Device Performance
Device Performance	Visual verification to design specifications.	All testing passed, demonstrating product performance met all prior established acceptance criteria.
	Accuracy testing of cumulative and individual injection volume measurement and display verification.	All testing passed, demonstrating product performance met all prior established acceptance criteria.
	Compatibility with disposable kits.	All testing passed, demonstrating product performance met all prior established acceptance criteria.
	Compliance to IEC 60601-1 3.1 edition, electrical safety for medical devices.	Compliance demonstrated through third-party testing certification.
	Compliance to IEC 60601-1-2 (2007) emissions and immunity for non-life supporting equipment.	Compliance demonstrated through third-party testing certification.
	Compatibility with contrast media (flow rate, peak pressure, leak testing, contrast diversion, mechanical cycle testing, visual verifications to design specifications).	All testing passed, demonstrating product performance met all prior established acceptance criteria.
	Compatibility with catheter configurations (flow rate, peak pressure, leak testing, contrast diversion, mechanical cycle testing, visual verifications to design specifications).	All testing passed, demonstrating product performance met all prior established acceptance criteria.
Sterilization	Sterility Assurance Level of 10^-6 (in accordance with ISO 11135-1:2014).	All testing passed. Sterilization conditions validated.
Software	Verification of all software requirement specifications (in accordance with IEC 62304:2006).	All testing passed.
Simulated Use (Bench)	Priming, disposable wireless pairing, ease of use, system set up, device priming ability (usability).	Testing demonstrated no new or different question of safety or effectiveness.
	Injection pressure, contrast diversion, image analysis.	Testing demonstrated no new or different question of safety or effectiveness.
Packaging & Shelf Life	Visual inspection, cycle testing, dye leak/penetration test, seal strength test, functional testing (per ASTM D4169:2016 and ISO 11607 Part 1 and 2:2006).	All testing passed, demonstrating product performance met all prior established acceptance criteria. Packaging deemed in compliance.
Biocompatibility	Cytotoxicity, sensitization, irritation, acute systemic toxicity, hemocompatibility (in accordance with ISO 10993-1:2009).	All testing passed and met prior established acceptance criteria.

Study Details (Based on Non-Clinical Testing Summary)

Since the document explicitly states "No clinical testing was performed to support this 510(k) Premarket Notification," most of the requested fields related to clinical studies and ground truth cannot be answered from the provided text.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable/Not provided for non-clinical bench testing in the detail requested. The "test set" would refer to the various components and conditions evaluated during bench testing. Data provenance is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical study or expert-adjudicated ground truth for a test set is mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no clinical study or expert adjudication is mentioned.
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 MRMC clinical study was performed. The device described is a contrast modulation/monitoring system, not an AI-assisted diagnostic imaging tool with human reader involvement in interpretation.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No standalone clinical performance study was performed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical testing, the "ground truth" would be established by engineering specifications, validated test methods, and industry standards (e.g., ISO, IEC, ASTM standards for materials, software, electrical safety, etc.).
The sample size for the training set:
- Not applicable as no AI/machine learning model requiring a training set is described in the context of clinical performance. The "device performance testing" likely involves internal validation against pre-defined engineering parameters rather than machine learning training.
How the ground truth for the training set was established:
- Not applicable as no AI/machine learning model requiring a training set is described.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 8, 2017

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

Re: K163054

Trade/Device Name: DyeVert™ Plus Contrast Modulation/Monitoring System, Contrast Monitoring System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector And Syringe Regulatory Class: Class II Product Code: DXT Dated: February 3, 2017 Received: February 6, 2017

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Fernando Agnel
Fernando
Aquel-S

for

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

Enclosure

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Indications for Use

510(k) Number (if known) K163054

Device Name

DyeVert™ Plus Contrast Modulation/Monitoring System, Contrast Monitoring System

Indications for Use (Describe)

Display

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

DyeVert Plus Disposable Kit

The DyeVert™ Plus Contrast Modulation/Monitoring System consists of a Display 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 mg/mL and Iopamidol 370 mgI/mL.

Contrast Monitoring Disposable Kit

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

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

Prescription Use (Part 21 CFR 801 Subpart D)	X
Over-The-Counter Use (21 CFR 801 Subpart C)

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K163054

510(k) Summary
510(k) Summary As required by 21CFR 807.92(c)
510(k) Number:	K163054
Date Prepared:	October 31, 2016
Submitter's Name/Address:	Osprey Medical
	5600 Rowland Road Suite 250
	Minnetonka, MN 55343
Contact Person:	Melanie Hess
	Vice President, Regulatory Affairs
	Tel: 952-955-8252
	Fax: 952-955-8171
	Mhess@ospreymed.com
Device Information:
Trade Name/Proprietary Name:	DyeVert™ Plus Contrast Modulation/Monitoring System
Manufacturer:	Osprey Medical, Inc.
Common Name:	Injector and Syringe, Angiographic
Classification Registration:	21 CFR § 870.1650
Product Code:	DXT
FDA Center/Branch:	CDRH/Interventional Cardiology Devices Branch (ICDB)
Trade Name/Proprietary Name:	Contrast Monitoring System
Manufacturer:	Osprey Medical, Inc.
Common Name:	Injector and Syringe, Angiographic
Classification Registration:	21 CFR § 870.1650
Product Code:	DXT
FDA Center/Branch:	CDRH/Interventional Cardiology Devices Branch (ICDB)

Device Description:

Indications for Use:

Display

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DyeVert Plus Disposable Kit

The DyeVert™ Plus Contrast Modulation/Monitoring System consists of a Display and DyeVert Plus 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 mg/mL and Iopamidol 370 mgI/mL.

Contrast Monitoring Disposable Kit

Primary Predicate Device:

Trade Name/Proprietary Name:	DyeVert™ Contrast Modulation 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)	K161505

Secondary Predicate Device:

Trade Name/Proprietary Name:	CMS™ Contrast Monitoring 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)	K142081

Comparison to the Predicate Device:

The proposed devices are substantially equivalent to the previously cleared DyeVert Contrast Modulation Systems (K161505) and CMS Contrast Monitoring System (K142081) respectively, in that they are both designed for use during the controlled infusion of manual injection of radiopaque contrast media for angiographic procedures.

The proposed devices have identical product performance specification processes and benefit risk profiles. The fundamental scientific technology, principle of operation and primary mechanism of action remains unchanged. No new intended use, intended user or different questions of safety or effectiveness are raised with the proposed modifications.

Technical Characteristic	Proposed Device	Predicate Device
Intended Use	Intended to be used for the controlledinfusion of radiopaque contrast mediafor angiographic procedures.	Intended to be used for the controlledinfusion of radiopaque contrast mediafor angiographic procedures.
	Indications for Use	The system is to be used for contrastvolume reduction and for the monitoringof radiopaque contrast media duringangiographic or CT procedures with thefollowing agents: Iodixanol 270 or 320mgI/mL, Iohexol 300 or 350 mgI/mLand Iopamidol 370 mgI/mL.	The system is to be used for contrastvolume reduction and for themonitoring of radiopaque contrastmedia during angiographic or CTprocedures with the following agents:Iodixanol 270 or 320 mgI/mL, Iohexol300 or 350 mgI/mL and Iopamidol 370mgI/mL.
		Indications for Use(Display/Syringe)	To be used during angiographic or CTprocedures requiring controlled infusionof radiopaque contrast media.
Touchscreen		Capacitive touchscreen, Resolution1280x800	Resistive touchscreen, Resolution800x600

Summary of technical characteristics comparison

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Technical Characteristic	Proposed Device	Predicate Device
User access	Multiple USB, 1 internal user accessible(Osprey User only)	1 external USB
Memory	MicroSD socket with 32GB class 10card	External flash memory using a SPIinterface
Alarms	Variable audio	Limited audio
DyeVert Module	Diversion valve with reservoir; includessensors, electronics, circuit board andpressure transducer to allow wirelesspositioning identification. Compatiblewith Contrast Monitoring Display	Diversion valve with reservoir (doesnot include additional wirelesspositioning components)Not compatible with ContrastMonitoring Display.
Syringe	Contrast injection syringe; includes HallEffect sensors, electronics and circuitboard to allow wireless positioningidentification and communication.	Contrast injection syringe with IR lightsensing positioning identification(does not include additional wirelesscommunication components)
Communication	Bluetooth communications to Display	Hard wire communications to Display
Power	Internal Battery	Hard Wire
Visual Indicators	Blinking and/or solid LED(green/amber) indicates status;additional blinking allowing additionalstatus communication during disposablepairing through Bluetooth.	Solid LED (green/amber) indicatesstatus
Compatible CatheterConfigurations	Diagnostic 4Fr, 5Fr, 6FrGuide 5Fr, 6Fr, 7FrGuide with RX 6Fr, 7FrGuide with OTW 6Fr, 7Fr	Diagnostic 4Fr, 5Fr, 6FrGuide 5Fr, 6Fr, 7FrGuide with RX 6Fr, 7FrGuide with OTW 6Fr, 7Fr
Sterilization	EO sterilization to 10-6	EO sterilization to 10-6

Summary of Non-Clinical Testing:

Bench testing was performed and/or leveraged 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/or leveraged within this submission:

. Device performance testing included visual verifications to design specifications, accuracy testing of cumulative and individual injection volume measurement along with display verification, compatibility with disposable kits and testing demonstrating compliance to IEC 60601-1 3.1 edition, electrical safety for medical devices and IEC 60601-1-2 (2007) emissions and immunity for non-life supporting equipment through third party testing certification. In addition, device performance testing for compatibility with contrast media and catheter configurations was leveraged and included flow rate, peak pressure, leak testing, contrast diversion, mechanical cycle testing and visual verifications to design specifications for specific contrasts and catheter configurations. All testing passed and demonstrated product performance met all prior established acceptance criteria.
. Sterilization - Sterilization conditions have been validated in accordance with ISO 11135-1:2014, Sterilization of health care products - Ethylene Oxide Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices to provide a Sterility Assurance Level of 10-6. All testing passed.
. Software development process was in accordance with IEC 62304:2006 Software life cycle process and testing was performed and included verification of all software requirement specifications. All testing passed.
. Simulated Use (Bench) design validation was performed and included the assessment of priming, disposable wireless pairing and assessment of the ease of use, system set up and device priming ability (usability). In addition, design validation was performed and leveraged for injection pressure, contrast diversion and image analysis testing. Testing demonstrated no new or different question of safety or effectiveness.

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. Packaging, shelf life and distribution testing was performed and leveraged. Distribution testing was conducted per ASTM D4169:2016 Standard Practice for Performance Testing of Shipping Containers and Systems. Testing included visual inspection, cycle testing, dye leak/penetration test, seal strength test and functional testing. All testing passed and demonstrated product performance met all prior established acceptance criteria. Packaging was deemed to be in compliance with ISO 11607 part 1 and 2:2006 Packaging for terminally sterilized medical devices.
. Biocompatibility testing was performed and leveraged in accordance with ISO 10993-1:2009 Biological Evaluation of Medical Devices - Part I: Evaluation and Testing. Testing included cytotoxicity, sensitization, irritation and acute systemic toxicity, and hemocompatibility. 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 subject devices are substantially equivalent in intended use, indications for use statement and fundamental scientific technology as the predicate devices. Based on this and data analyzed in accordance with Osprey Medical Quality System Procedure in compliance with 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.