The Osprey Medical AVERT™ System allows for controlled infusion and contrast volume reduction during manual injection of radiopaque contrast media. The AVERT™ System is to be used for angiographic coronary and peripheral procedures with the following agents: Iodixanol 270 or 320 mgUml, Iohexol 300 or 350 mgI/ml, and Iopamidol 300 or 370 mgI/ml.

Device Description

The Osprey Medical AVERT™ Contrast Modulation System provides a second fluid pathway that modifies the overall system resistance as experienced during the physician's manual injection and allows for excess (i.e. contrast that is not needed for diagnostic or therapeutic purposes) contrast media to be diverted into a reservoir and away from the patient during the manual injection of contrast media while maintaining adequate image quality. Excess contrast is typically a result of refluxed contrast within the patient's vasculature retrograde to the desired image area. The AVERT™ System allows for the modulated reduction of contrast media during manual injections in coronary or peripheral imaging procedures. The AVERT™ System is a device for physician utilization during efforts to minimize total patient contrast volumes.

The AVERT™ System consists of a reusable, non-sterile apparatus (contrast modulator), which applies a force to a disposable sterile modulation reservoir with a standard, off-the-shelf 4-way stopcock and extension line. The contrast modulator utilizes an internal mechanism to apply a force to the modulation reservoir; allowing for modulated diversion of manual contrast injections. The force can be easily and quickly adjusted by moving the location of the pin as identified on the outer housing of the system, thereby increasing or decreasing the amount of force applied to the modulation reservoir. The contrast modulator is attached to a wheeled stand and is positioned near the patient, outside of the sterile field.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a comprehensive study report with all the requested information for the AVERT Contrast Modulation System. The document is an FDA 510(k) summary and approval letter, which primarily focuses on establishing substantial equivalence to a predicate device.

However, based on the Summary of Non-Clinical Testing section and the Clinical Testing section, I can extract some relevant information and identify what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Implied)	Reported Device Performance
Non-Clinical Testing
Flow rate	Meets product specification and performance requirements	All testing passed and demonstrated product performance met all prior established acceptance criteria.
Peak pressure reduction	Meets product specification and performance requirements	All testing passed and demonstrated product performance met all prior established acceptance criteria.
Contrast diversion	Meets product specification and performance requirements	All testing passed and demonstrated product performance met all prior established acceptance criteria.
Flow rate adjustability	Meets product specification and performance requirements	All testing passed and demonstrated product performance met all prior established acceptance criteria.
Mechanical cycle testing	Meets product specification and performance requirements	All testing passed and demonstrated product performance met all prior established acceptance criteria.
Image analysis (non-clinical)	Adequate image quality maintained	All testing passed and demonstrated product performance met all prior established acceptance criteria. (Also mentioned in simulated use: "included assessment of injection pressure, contrast diversion, image analysis. All testing passed...")
Compatibility with Osprey Medical Contrast Monitoring System	Meets product specification and performance requirements	All testing passed and demonstrated product performance met all prior established acceptance criteria.
Sterility Assurance Level (SAL)	10⁻⁶	Validated in accordance with ISO 11135-1:2007. All testing passed to provide a Sterility Assurance Level of 10⁻⁶.
Biocompatibility	Meet prior established acceptance criteria	Cytotoxicity, sensitization, irritation (intracutaneous reactivity), systemic toxicity, hemocompatibility, genotoxicity, chemical characterization testing passed and met prior established acceptance criteria.
Clinical Testing
Contrast Volume Reduction	Pre-specified level of statistical significance	"The study demonstrated a mean difference in contrast volume between the AVERT and control groups, achieving the pre-specified level of statistical significance, while maintaining adequate image quality." and "This reduction in contrast was achieved without device-related adverse events."
Image Quality (Clinical)	Adequate image quality maintained	"The study demonstrated a mean difference in contrast volume between the AVERT and control groups, achieving the pre-specified level of statistical significance, while maintaining adequate image quality."
Device-related Adverse Events	No device-related adverse events	"This reduction in contrast was achieved without device-related adverse events."

Missing Information/Not Provided in the Document:

Specific quantitative values for "product specification and performance requirements" for most non-clinical tests (e.g., what was the acceptance range for flow rate, peak pressure reduction, etc.?).
The exact "pre-specified level of statistical significance" for the clinical study's primary endpoint.

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated for either non-clinical or clinical testing.
- For the non-clinical tests, it simply states "All testing passed."
- For the clinical study, it's described as a "prospective, randomized, multi-center clinical evaluation," but the number of patients/cases is not provided.
Data Provenance:
- Non-Clinical: Performed by Osprey Medical or contracted labs. Location not specified, but likely within the US given the FDA submission.
- Clinical: "Prospective, randomized, multi-center clinical evaluation." The country of origin is not specified, but multi-center implies multiple locations.

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

Non-Clinical: Not applicable in the same way as imaging studies. Acceptance criteria were likely based on engineering specifications and regulatory standards.
Clinical: The document mentions "maintaining adequate image quality" in relation to the clinical study. However, it does not specify how many experts assessed image quality, their qualifications, or how a "ground truth" for image diagnostic adequacy was established for the clinical images.

4. Adjudication Method for the Test Set

Non-Clinical: Not applicable. Testing results either met criteria or did not.
Clinical: No information is provided regarding an adjudication method for image quality or clinical outcomes in the clinical trial.

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted or reported.
- The clinical study was a comparison of the AVERT system (with standard therapy) versus standard therapy alone (peri-procedural hydration), focusing on contrast volume reduction and safety, not on human reader performance or AI assistance. The device is a physical system to modulate contrast delivery, not an AI diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, implicitly. The non-clinical Device performance testing (flow rate, pressure reduction, contrast diversion, etc.) and Simulated use (animal) testing represent standalone performance of the device's mechanical and fluidic functions. The device itself is a mechanical system, not an AI algorithm.
The clinical study evaluates the device's effect in a human-in-the-loop scenario (physician using the device), comparing overall outcomes against standard care.

7. Type of Ground Truth Used

Non-Clinical:
- Engineering Specifications: For flow rates, pressure, cycle testing, etc.
- Regulatory Standards: For sterility (ISO 11135-1:2007) and biocompatibility (ISO 10993-1:2009).
Clinical:
- Measured Contrast Volume: Objective quantitative measurement.
- Clinical Observations/Outcomes: For device-related adverse events.
- Clinical Assessment of Image Quality: This is described qualitatively as "adequate image quality," but the specifics of its establishment are not detailed.

8. Sample Size for the Training Set

Not applicable/Not mentioned. The AVERT system is a mechanical device, not an AI algorithm that requires a training set. The term "training set" is typically used for machine learning models.

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

Not applicable. As above, this is not an AI device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Public Health Service

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

October 16, 2015

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

Re: K151300

Trade/Device Name: Avert Contrast Modulation System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: DXT Dated: September 11, 2015 Received: September 14, 2015

Dear Melanie Hess:

This letter corrects our substantially equivalent letter of October 15, 2015.

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.

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

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 device-related 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.

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" (21CFR 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,

Kenneth J. Cavanaugh -S

for

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

Enclosure

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

510(k) Number: K151300

Device Name: AVERT™ Contrast Modulation System

Indications for Use:

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

Over-The Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Summary

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

510(k) Number: _TBD
Date Prepared:	May 15, 2015
Submitter's Name/Address:	Osprey Medical5600 Rowland Road Suite 250Minnetonka, MN 55343
Contact Person:	Melanie HessVice President, Regulatory AffairsTel: 952-955-8252Fax: 952-955-8171Mhess@ospreymed.com

Device Information:

Trade Name/Proprietary Name:	AVERT™ 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:

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

of contrast media during manual injections in coronary or peripheral imaging procedures. The AVERT™ System is a device for physician utilization during efforts to minimize total patient contrast volumes.

Intended Use:

Osprey Medical AVERT™ Contrast Modulation System (AVERT System) is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

Indications for Use:

The Osprey Medical AVERT™ System allows for controlled infusion and contrast volume reduction during manual injection of radiopaque contrast media. The AVERT™ System is to be used for angiographic coronary and peripheral procedures with the following agents: Iodixanol 270 or 320 mgVml, Iohexol 300 or 350 mgI/ml, and Iopamidol 300 or 370 mgI/ml.

Predicate Device:

Trade Name/Proprietary Name:	AVERT™ Contrast Modulation System
Common Name:	Injector and Syringe, Angiographic
Classification Registration:	21 CFR § 870.1650
Product Code:	DXT
510(k) number(s):	K140425, K150485

Comparison to the Predicate Device:

The AVERT Contrast Modulation System is substantially equivalent to the previously cleared AVERT Contrast Modulation System, K140425 and K150485, in that they are both designed to control the infusion of radiopaque contrast media for angiographic procedures.

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

The AVERT™ System and predicate AVERT™ System are identical systems with the exception of the modification to the labeling in accordance with clinical trial data. The subject device is identical to the predicate in that:

. The proposed device consists of the same material and technical characteristics; and
No changes have been made to the product performance specifications, sterilization process, . manufacturing processes or risk assessment; and
. The intended use and fundamental scientific technology remains unchanged; and
. No new or different questions of safety or effectiveness are raised with the proposed modification.

Summary of Non-Clinical Testing:

Due to the identical technical characteristics, bench testing was leveraged from the predicate AVERT™ System to support the AVERT™ System. All results demonstrate the AVERT™ System meets product specification and performance requirements. The following testing was successfully completed:

. Device performance testing included flow rate, peak pressure reduction, contrast diversion, flow rate adjustability, mechanical cycle testing, image analysis and compatibility to Osprey Medical Contrast Monitoring System. All testing passed and demonstrated product performance met all prior established acceptance criteria.
Sterilization conditions have been validated 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 106. All testing passed.
Simulated use (animal) and post-market design validation was performed and included . assessment of injection pressure, contrast diversion, image analysis. All testing passed and no new or different question of safety or effectiveness were raised.
Shelf-life, distribution and shipping testing was performed per ASTM D4169. 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.
. Biocompatible testing was performed in accordance with ISO 10993-1:2009 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing included cytotoxicity, sensitization, irritation (intracutaneous reactivity), systemic toxicity, hemocompatibility,

{6}------------------------------------------------

genotoxicity, chemical characterization. All testing passed and meet prior established acceptance criteria.

All test results demonstrate that the materials, manufacturing processes and design of the Osprey Medical AVERT™ Contrast Modulation System meet the established performance criteria and will perform as intended.

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

Clinical Testing:

A prospective, randomized, multi-center clinical evaluation of the Osprey Medical AVERT System was conducted. The study control consisted of standard therapy which is peri-procedural hydration. The treatment included standard therapy plus the AVERT System. The study demonstrated a mean difference in contrast volume between the AVERT and control groups, achieving the pre-specified level of statistical significance, while maintaining adequate image quality. The use of the AVERT System across a range of manual diagnostic and PCI procedures resulted in a significant relative reduction in the volume of contrast delivered during the procedure. This reduction in contrast was achieved without device-related adverse events.

Statement of Equivalence:

The AVERT™ Contrast Modulation System has identical intended use, technological characteristics and fundamental scientific technology as the predicate device. Based on this and data collected in accordance with Osprey Medical Quality System Procedures in compliance with ISO 13485:2003 Medical Devices -Quality management systems - requirements for regulatory purposes and EN ISO 14791:2012 Risk management for medical devices, the AVERT 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.