The DyeVert™ Contrast Modulation System is to be used for the controlled infusion of radiopague contrast media for angiographic procedures with the following agents: Iodixanol 320 mg/mL and Iopanidol 370 mg/l mL.

Device Description

The Osprey Medical DyeVert™ Contrast Modulation System (DyeVert System) allows for manual, physician-modulated contrast media injection during coronary or peripheral angiographic imaging. The Dyevert System consists of a sterile, single-use, fully-disposable apparatus which provides a secondary fluid (contrast) pathway with a flow resistance feature to divert and store a portion of contrast in the reservoir chamber away from the patient. The source contrast container is connected to the reservoir chamber which has one tube directing contrast (through the manifold) to refill the injection syringe upon aspiration with preference to the diverted contrast volume prior to aspiration from the contrast source.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the DyeVert™ Contrast Modulation System. This application is for a medical device that aims to modulate contrast media injection, not an AI or imaging device, therefore many of the typical AI/ML acceptance criteria sections are not applicable.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with specific quantitative thresholds alongside reported device performance for each criterion. Instead, it states that "All testing passed and demonstrated product performance met all prior established acceptance criteria." This general statement is common for medical device submissions where the specific metrics are typically internal company documents.

However, based on the text, we can infer the types of performance criteria tested:

Acceptance Criteria Category	Reported Device Performance
Device Performance
Flow rate	Passed / Met established acceptance criteria
Peak pressure	Passed / Met established acceptance criteria
Leak testing	Passed / Met established acceptance criteria
Contrast diversion	Passed / Met established acceptance criteria
Mechanical cycle testing	Passed / Met established acceptance criteria
Visual verifications	Passed / Met established acceptance criteria
Sterilization
Sterility Assurance Level	10^-6 (Validated per ISO 11135-1:2007)
Packaging & Shelf Life
Distribution testing (visual inspection)	Passed / Met established acceptance criteria
Distribution testing (cycle test)	Passed / Met established acceptance criteria
Distribution testing (dye leak test)	Passed / Met established acceptance criteria
Distribution testing (seal strength test)	Passed / Met established acceptance criteria
Distribution testing (functional testing)	Passed / Met established acceptance criteria
Biocompatibility
Cytotoxicity	Passed / Met established acceptance criteria
Sensitization	Passed / Met established acceptance criteria
Irritation	Passed / Met established acceptance criteria
Systemic toxicity	Passed / Met established acceptance criteria
Hemocompatibility	Passed / Met established acceptance criteria
Simulated Use (Usability)
Ease of use	Passed / Met established acceptance criteria
System setup	Passed / Met established acceptance criteria
Device priming ability	Passed / Met established acceptance criteria
Injection pressure testing	Passed / Met established acceptance criteria
Contrast diversion testing	Passed / Met established acceptance criteria
Image analysis testing	Passed / Met established acceptance criteria

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

The document does not specify sample sizes for any of the bench tests mentioned. It only states that "Bench testing was performed."

Data Provenance: The data provenance is from "Bench testing" and "Simulated Use (Cath Lab) and Design Validation," indicating in-vitro and simulated environment testing. There is no mention of country of origin for this testing, nor is it categorized as retrospective or prospective since it is not clinical data.

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

The document does not mention the use of experts to establish "ground truth" for the test set. The testing described (flow rate, pressure, leak, mechanical cycle, sterilization, packaging, biocompatibility) are objective, engineering, and laboratory-based tests that do not typically require expert interpretation for ground truth establishment in the way an AI/ML diagnostic device would.

For "Simulated Use (Cath Lab) and Design Validation," it mentions an "assessment of the ease of use, system set up and device priming ability (usability)." While this implies involvement of individuals who would typically use such a device (e.g., cath lab personnel or physicians), their number, specific qualifications, or their role in establishing "ground truth" (as in expert consensus for a diagnostic finding) are not detailed.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective bench or lab tests, not subjective interpretations requiring adjudication.

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

Not applicable. This is not an AI/ML device, and no MRMC study was performed. The device is a mechanical system for modulating contrast media.

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

Not applicable. This is not an AI/ML device with an algorithm. It is a mechanical device that is operated by a human.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the various bench and lab tests, the "ground truth" would be established by predefined engineering specifications, standardized testing protocols (e.g., ISO, ASTM standards), and objective measurements. For simulated use/usability, it would likely be based on pre-defined functional requirements and user feedback. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth, as these are typically associated with diagnostic or therapeutic devices where clinical outcomes or interpretations are central.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for a training set.

Summary

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

October 9, 2015

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

Re: K151746

Trade/Device Name: DyeVert™ Contrast Modulation System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector And Syringe Regulatory Class: Class II Product Code: DXT Dated: September 4, 2015 Received: September 8, 2015

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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

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 yours,

M.A. Hillebrand

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) K151746

Device Name

DyeVert(tm) Contrast Modulation System

Indications for Use (Describe)

The DyeVert™ Contrast Modulation System is to be used for the controlled infusion of radiopague contrast media for angiographic procedures with the following agents: lodixanol 320 mg/mL and Iopanidol 370 mg/l 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 - K151746

This summary of 510(k) information is submitted in accordance with 21 CFR 807.92(c)

510(k) Number: K151746 Date Prepared: Applicant Information:

June 26, 2015 Osprey Medical 5600 Rowland Road Suite 250 Minnetonka, MN 55343 Phone: 952-955-8230 Fax: 952-955-8171

Contact Person:

Melanie Hess Vice President, Regulatory Affairs Phone: 952-955-8252 Fax: 952-955-8171 Mhess@ospreymed.com

Device Information:

Trade Name/Proprietary Name:	DyeVert™ Contrast Modulation System
Common/Classification Name:	Angiographic Injector
Classification:	II
Classification Registration:	21 CFR § 870.1650
Product Code:	DXT
FDA Center/Branch:	CDRH/Interventional Cardiology Devices Branch (ICDB)

Device Description:

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fluid (contrast) pathway with a flow resistance feature to divert and store a portion of contrast in the reservoir chamber away from the patient. The source contrast container is connected to the reservoir chamber which has one tube directing contrast (through the manifold) to refill the injection syringe upon aspiration with preference to the diverted contrast volume prior to aspiration from the contrast source.

Intended Use:

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

Indications for Use:

The DyeVert™ Contrast Modulation System is to be used for the controlled infusion of radiopaque contrast media for angiographic procedures with the following agents: Iodixanol 320 mg1/mL, Iohexol 350 mgI/mL and Iopamidol 370 mgI/mL.

Predicate Device:

Trade Name/Proprietary Name:	AVERT™ Contrast Modulation System
Common/Classification Name:	Angiographic Injector
Classification:	II
Classification Registration:	21 CFR § 870.1650
Product Code:	DXT
510(k) number(s)	K140425

Predicate Indications for Use:

The AVERT™ Contrast Modulation System is intended to be used for the controlled infusion 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.

Comparison to the Predicate Device:

The proposed DyeVert™ Contrast Modulation System is substantially equivalent in intended use, indication for use, method of operation, performance specifications and technical aspects to the predicate device, Osprey Medical AVERT™ Contrast Modulation System (K140425). The method of operation (mechanism of action) is entirely mechanical for both devices divert and temporarily store

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excess radiopaque contrast media away from the patient; and both function to reduce the users hand fatigue during routine angiographic procedures.

Summary of Non-Clinical Testing:

Bench testing was performed and results demonstrate the DyeVert System materials, design considerations and manufacturing processes meet product specifications and performance requirements. The following testing was successfully completed:

. Device performance testing included flow rate, peak pressure, leak testing, contrast diversion, mechanical cycle testing and visual verifications to design specific contrasts and catheter configurations. All testing passed and demonstrated product performance met all prior established acceptance criteria.
. Sterilization conditions have been validated and leveraged 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.
. Packaging, shelf life and distribution testing was performed or leveraged. Distribution testing was conducted per ASTM D4169:2009 Standard Practice for Performance Testing of Shipping Containers and Systems. Testing included 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.
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 (intracutaneous reactivity), systemic toxicity and hemocompatibility. All testing passed and met prior established acceptance criteria.
Simulated Use (Cath Lab) and Design Validation was performed and leveraged for injection . pressure, contrast diversion and image analysis testing. Testing included an assessment of the ease of use, system set up and device priming ability (usability). All testing passed and met prior established acceptance criteria.

Clinical Testing:

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

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Statement of Equivalence:

The DyeVert System has a substantially equivalent intended use, indications for use statement, performance specifications and fundamental scientific technology as the predicate device. Based on this equivalence and the data collected in accordance with Osprey Medical Quality System Procedures in compliance with BS EN ISO 13485: 2012 Medical Devices - Quality management systems requirements for regulatory purposes and EN ISO 14791:2012 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.