The DyeVert™ NG Contrast Modulation System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

The DyeVert™ NG Contrast Modulation System is to be used for the controlled infusion and contrast volume reduction of radiopaque contrast media for angiographic procedures with the following agents: Iodixanol 270 or 320 mgI/mL, Iohexol 300 or 350 mgI/mL and Iopamidol 370 mgI/mL.

Device Description

The Osprey Medical DyeVert™ NG Contrast Modulation System (DyeVert 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 System consists of a disposable, single-use sterile device including a Reservoir and Diversion Valve. The device is positioned between a manual injection control syringe and an injection manifold via the DyeVert stopcock. The diversion valve responds to the contrast injection pressure administered by the physician manually and modulates the amount of contrast diverted to the reservoir.

The DyeVert System 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". The DyeVert System is designed for use with contrast media and catheter configurations as listed in the Instructions for Use.

AI/ML Overview

The document provided is a 510(k) premarket notification for the DyeVert NG Contrast Modulation System. It describes the device, its intended use, and compares it to a predicate device. This is a submission for a modified device, and the review explicitly states "No clinical testing was performed to support this Special 510(k) Premarket Notification." This means that the device was approved based on its similarity to a previously cleared device (predicate device) and extensive bench testing, rather than a clinical study demonstrating its performance against specific acceptance criteria in human subjects.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them (especially in a clinical context with human readers, ground truth, and sample sizes) cannot be fully provided from this document as no clinical study was conducted.

However, I can extract the information related to bench testing and how its results demonstrated the device met pre-established acceptance criteria, even though those specific criteria aren't enumerated in detail.

Here's the breakdown of the available information:

No clinical study was performed for the DyeVert NG Contrast Modulation System.

The device's substantial equivalence was established through a comparison to a predicate device and extensive non-clinical (bench) testing. Therefore, many of the requested categories related to clinical study design and outcomes are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states:

"Device performance testing was performed and leveraged for flow rate, peak pressure reduction, contrast diversion, mechanical cycle testing and visual verification to design specifications for specific contrasts and catheter configurations."
"Confirmation testing was conducted for priming, high pressure simulation, leak testing, reservoir capacity and tensile strength."
"All testing passed and demonstrated product performance met all prior established acceptance criteria."
"Biocompatible testing was leveraged from the predicate in accordance with ISO 10993-1:2009... All testing passed and meet prior established acceptance criteria."
"Shelf-life, shipping and distribution testing... All testing passed and demonstrated product performance met all prior established acceptance criteria."

Specific Acceptance Criteria (Not explicitly detailed in the document):

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Flow Rate	Met established design specifications	Passed
Peak Pressure Reduction	Met established design specifications	Passed
Contrast Diversion	Met established design specifications	Passed
Mechanical Cycle Testing	Met established design specifications	Passed
Visual Verification	Met established design specifications	Passed
Priming Performance	Met prior established acceptance criteria	Passed
High Pressure Simulation	Met prior established acceptance criteria	Passed
Leak Testing	Met prior established acceptance criteria	Passed
Reservoir Capacity	Met prior established acceptance criteria	Passed
Tensile Strength	Met prior established acceptance criteria	Passed
Sterility Assurance Level (SAL)	10^-6 (per ISO 11135-1:2007)	Passed
Packaging Integrity (Seal Strength)	Per ASTM F88-09 acceptance	Passed
Packaging Integrity (Dye Penetration)	Per ASTM F1886-09 acceptance	Passed
Biocompatibility	Met ISO 10993-1:2009 acceptance (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemocompatibility)	Passed
Shelf-life	Met prior established acceptance criteria	Passed
Shipping & Distribution Testing	Per ASTM D4169:2009, met acceptance criteria (visual, cycle, dye leak, seal, functional)	Passed

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not specified in the document for the non-clinical tests.
Data Provenance: Non-clinical (bench) testing performed by Osprey Medical. The country of origin for this bench testing data is not specified, but the company is based in Minnetonka, Minnesota, USA. The testing is retrospective in the sense that it's performed on the finalized device design.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not applicable. No clinical study was performed that would require expert-established ground truth for a test set. Bench testing relies on objective measurements against pre-defined engineering and material specifications.

4. Adjudication Method for the Test Set:

Not applicable. No clinical study involving human assessment was performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. No MRMC study was performed. The device is for contrast modulation, not for diagnostic interpretation by human readers.

6. Standalone Performance Study (Algorithm Only):

Not applicable. This is a mechanical device, not an AI or algorithm-driven system. Its "performance" is mechanical and fluid dynamic, evaluated through bench tests.

7. Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" was the established design specifications, engineering standards (e.g., ISO, ASTM), and chemical/biological safety standards (e.g., ISO 10993). For instance, a flow rate measurement would be compared to a target flow rate specification.

8. Sample Size for the Training Set:

Not applicable. This refers to a supervised learning algorithm context, which is not relevant for this device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

In summary, the K161505 submission for the DyeVert NG Contrast Modulation System is a "Special 510(k)" for a modified device. Approval was based on demonstrating substantial equivalence to a predicate device and comprehensive bench testing, which confirmed the device met all prior established performance, material, and safety acceptance criteria. No new clinical trials were conducted to support this specific submission.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.

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

August 3, 2016

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

Re: K161505

Trade/Device Name: DyeVert NG Contrast Modulation System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: DXT Dated: June 30, 2016 Received: July 5, 2016

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 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.

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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 vours.

Mude Jellman
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) TBD K161505

Device Name DyeVert NG Contrast Modulation System

Indications for Use (Describe)

The DyeVert™ NG Contrast Modulation System is to be used for the controlled infusion and contrast volume reduction of radiopaque contrast media for angiographic procedures with the following agents: Iodixanol 270 or 320 mgIlmL. Iohexol 300 or 350 mgI/mL and Iopamidol 370 mgI/mL.

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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510(k) Summary

510(k) Summary As required by 21CFR 807.92(c)

510(k) Number: K161505

Date Prepared:

May 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™ NG Contrast Modulation System
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:

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the DyeVert stopcock. The diversion valve responds to the contrast injection pressure administered by the physician manually and modulates the amount of contrast diverted to the reservoir.

Intended Use:

The DyeVert™ NG Contrast Modulation System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

Indications for Use:

Predicate Device:

Trade Name/Proprietary Name:	DyeVert™ Contrast Modulation System
Common Name:	Injector and Syringe, Angiographic
Classification Registration:	21 CFR § 870.1650
Product Code:	DXT
510(k) number(s)	K153141

Reference Predicate Device(s):
Trade Name/Proprietary Name:	AVERT™ Contrast Modulation System
Manufacturer:	Osprey Medical Inc.
Product Code:	DXT
510(k) number(s)	K151300
Trade Name/Proprietary Name:	Medallion (VACLOK)™ Syringe
Manufacturer:	Merit Medical Systems, Inc.
Product Code:	FMF

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510(k) Summary

K994253

Comparison to the Predicate Device:

The DyeVert™ NG System is substantially equivalent and unchanged from the predicate DyeVert™ System in that they are identical systems with the exception of the minor design modification to the reservoir and tubing inner diameter modification of the reservoir from a balloon style to a plunger style does not change the primary function of the reservoir as a passive component which temporarily holds diverted contrast until physician directed aspiration. There is no change to the diversion valve assembly mechanism for the diversion of excess contrast to the passive reservoir. No changes have been made to the product performance specifications, materials, sterilization process, directions for use, manufacturing processes or risk assessment. The intended use, indications for use and fundamental scientific technology remains unchanged. No new or different questions of safety or effectiveness were raised with the modification.

Summary of Non-Clinical Testing:

Bench testing was performed or leveraged from the predicate to support the DyeVert System and results demonstrate the DyeVert System meets all product specification and performance requirements. The following testing was successfully completed:

Device performance testing was performed and leveraged for flow rate, peak pressure reduction, . contrast diversion, mechanical cycle testing and visual verification to design specifications for specific contrasts and catheter configurations. Confirmation testing was conducted for priming, high pressure simulation, leak testing, reservoir capacity and tensile strength. All testing passed and demonstrated product performance met all prior established acceptance criteria.
Sterilization conditions have been validated and leveraged from the predicate in accordance with ● ISO 11135-1:2007, 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.
Shelf-life, shipping and distribution testing was performed and leveraged. Distribution testing was . conducted per ASTM D4169:2009 Standard Practice for Performance Testing of Shipping Containers and Systems. Testing visual inspection, cycle testing, dye leak 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. Seal strength testing was

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performed per ASTM F88-09 and seal integrity by dye penetration was performed per ASTM F1886-09. All testing passed.

. Biocompatible testing was leveraged from the predicate in accordance with ISO 10993-1:2009 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing. Testing included cytotoxicity, sensitization, irritation (intracutaneous reactivity), systemic toxicity and hemocompatibility. All testing passed and meet 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 Special 510(k) Premarket Notification.

Statement of Equivalence:

The DyeVert System with the proposed modifications is substantially equivalent in intended use, indications for use and method of operation to the predicate DyeVert System. Based on the substantially equivalent assessment and data collected 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 14971:2012 Risk management for medical devices, the DyeVert System has 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.