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 300 or 370 mgI/mL.

Device Description

The Osprey Medical AVERT™ Contrast Modulation System allows for the modulation of contrast media during manual injections in coronary or peripheral imaging procedures. The AVERT System consists of a reusable, non-sterile apparatus (contrast modulator), which 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 document describes the AVERT™ Contrast Modulation System, for which Osprey Medical, Inc. submitted a 510(k) premarket notification (K150485). The document indicates that this submission is for a minor modification to an already cleared predicate device (K140425).

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criterion / Test Performed	Reported Device Performance
Device Performance Testing	- Flow rate	"All testing passed and demonstrated product performance met all prior established acceptance criteria." (indicating acceptable flow rate, peak pressure reduction, contrast diversion, and flow rate adjustability)
	- Peak pressure reduction
	- Contrast diversion
	- Flow rate adjustability
	- Mechanical cycle testing (leveraged from predicate)	"All testing passed and demonstrated product performance met all prior established acceptance criteria."
	- Image analysis (leveraged from predicate)	"All testing passed and demonstrated product performance met all prior established acceptance criteria."
	- Compatibility to Osprey Medical Contrast Monitoring System (leveraged from predicate)	"All testing passed and demonstrated product performance met all prior established acceptance criteria."
Sterilization Validation	- Sterilization conditions validated to achieve Sterility Assurance Level (SAL) of 10-6 in accordance with ISO 11135-1:2007 (leveraged from predicate)	"All testing passed."
Simulated Use (Animal) & Post-market Design Validation	- Assessment of injection pressure (leveraged from predicate)	"Testing demonstrated no new or different question of safety or effectiveness were raised." (indicating acceptable injection pressure, contrast diversion, and image analysis results in animal models)
	- Contrast diversion (leveraged from predicate)
	- Image analysis (leveraged from predicate)
Shelf-Life & Distribution Testing	- Visual inspection, cycle testing, dye leak test, seal strength test, and functional testing per ASTM D4169 (leveraged from predicate)	"All testing passed and demonstrated product performance met all prior established acceptance criteria."
Biocompatibility Testing	- Cytotoxicity, sensitization, irritation (intracutaneous reactivity), systemic toxicity, hemocompatibility, genotoxicity, chemical characterization in accordance with ISO 10993-1:2009 (leveraged from predicate)	"All testing passed and meet prior established acceptance criteria."
Overall	Compliance with established performance criteria and performance as intended.	"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." and "no new or different questions of safety or effectiveness are raised with the proposed modification."

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

The document does not specify the exact sample sizes for each test set. However, it indicates that testing was performed and/or leveraged from the predicate (K140425). The tests are described as "Bench testing," "Simulated use (animal)," and "Shelf-life, distribution and shipping testing." There is no mention of human clinical test sets, as the submission explicitly states "No clinical testing was performed."

The data provenance is largely retrospective in the sense that much of the data was already generated and validated for the predicate device. For the specific modification (new spring component in model RMS-ISOV-300-C), new bench testing was performed. The origin of the simulated use (animal) data is not specified beyond "animal."

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

This information is not provided in the document. Given that the testing primarily involved bench, animal, and physical performance tests, the "ground truth" would likely be objective measurements against predefined engineering and biological specifications, rather than expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods are typically relevant for clinical studies involving subjective interpretations, which were not performed for this submission.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it applicable. The AVERT™ Contrast Modulation System is an angiographic injector and syringe system, a medical device for controlled infusion of contrast media. It is not an AI-powered diagnostic or assistive tool for human readers, so MRMC studies and "AI assistance" effect sizes are irrelevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The AVERT™ Contrast Modulation System is a hardware device that modulates contrast media during manual injections. It is not an algorithm or software that operates in a standalone capacity.

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

The ground truth for the various tests was based on:

Established product specifications and performance requirements for bench testing (flow rate, pressure, diversion, adjustability).
Validated standards for sterilization (ISO 11135-1:2007) and biocompatibility (ISO 10993-1:2009).
Standardized testing methods for shelf-life and distribution (ASTM D4169).
Assessment of safety and effectiveness in simulated use (animal) models against expected physiological responses.

In essence, the ground truth was primarily based on objective engineering and biological performance metrics and compliance with recognized standards, rather than clinical expert consensus, pathology, or outcomes data, as no clinical studies were performed.

8. The Sample Size for the Training Set

This question is not applicable. The AVERT™ Contrast Modulation System is a physical device, not an AI/ML algorithm that requires a training set.

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

This question is not applicable as there is no training set for this type of device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three human profiles facing right, with a stylized design above them that resembles an eagle or bird in flight.

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

March 26, 2015

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

Re: K150485

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: February 23, 2015 Received: February 24, 2015

Dear Ms. 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 (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. Hillebrenner

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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510(k) Number: K150485

Device Name: AVERT™ Contrast Modulation System

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 mgl/mL, Iohexol 300 or 350 mgI/mL and Iopamidol 300 or 370 mgI/mL.

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)

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510(k) Summary

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

510(k) Number: K150485

Date Prepared:
February 12, 2015

Submitter's Name/Address:

Osprey Medical 5600 Rowland Road Suite 250 Minnetonka, MN 55343

Contact Person:

Melanie Hess Sr. Director, Regulatory Affairs Tel: 952-955-8252 Fax: 952-955-8171 Mhess @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:

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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.

Indications for Use:

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

Comparison to the Predicate Device:

The AVERT™ System is substantially equivalent and unchanged from the predicate AVERT™ System in that they are identical systems with the exception of the minor modification to include a new AVERT™ System model number, RMS-ISOV-300-C, with a new spring component. No modifications to performance specifications have been made. The subject device is identical to the predicate in that:

. The proposed device consists of the same material; and
. No changes have been made to the product performance specifications, sterilization process, manufacturing processes or risk assessment; and
The intended use, indications for use and fundamental scientific technology remains unchanged. .

The fundamental scientific technology, materials, sterilization process, manufacturing processes and risk assessment are unchanged from the predicate. The intended use and indications for use statement are unchanged from the predicate device. No new or different questions of safety or effectiveness are raised with the proposed modification.

Summary of Non-Clinical Testing:

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

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Device performance testing included flow rate, peak pressure reduction, contrast diversion and . flow rate adjustability. Testing was leveraged from the predicate for 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 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.
Simulated use (animal) and post-market design validation was performed and leveraged from the . predicate. Testing included assessment of injection pressure, contrast diversion, image analysis. Testing demonstrated no new or different question of safety or effectiveness were raised.
Shelf-life, distribution and shipping testing was performed and leveraged from the predicate 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 and 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, hemocompatibility, 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:

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

Statement of Equivalence:

The AVERT™ System with the proposed modification is substantially equivalent in intended use, indications for use and method of operation to the predicate AVERT" System. Based on the substantially

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equivalent assessment and data collected in accordance with Osprey Medical Quality System Procedure in compliance with EN ISO 13485:2003 Medical Devices – Quality management systems – requirements for regulatory purposes and EN ISO 14971: 2012 Risk management for medical devices, the AVERT™ System has been shown to be substantially equivalent under 21 CFR Part 807 subpart E.

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510(k) Summary

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

510(k) Number: K150485

Date Prepared:
February 12, 2015

Submitter's Name/Address:

Osprey Medical 5600 Rowland Road Suite 250 Minnetonka, MN 55343

Contact Person:

Melanie Hess Sr. Director, Regulatory Affairs Tel: 952-955-8252 Fax: 952-955-8171 Mhess @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:

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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.

Indications for Use:

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

Comparison to the Predicate Device:

. The proposed device consists of the same material; and
. No changes have been made to the product performance specifications, sterilization process, manufacturing processes or risk assessment; and
The intended use, indications for use and fundamental scientific technology remains unchanged. .

Summary of Non-Clinical Testing:

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Device performance testing included flow rate, peak pressure reduction, contrast diversion and . flow rate adjustability. Testing was leveraged from the predicate for 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 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.
Simulated use (animal) and post-market design validation was performed and leveraged from the . predicate. Testing included assessment of injection pressure, contrast diversion, image analysis. Testing demonstrated no new or different question of safety or effectiveness were raised.
Shelf-life, distribution and shipping testing was performed and leveraged from the predicate 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 and 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, hemocompatibility, genotoxicity, chemical characterization. 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 AVERT™ System with the proposed modification is substantially equivalent in intended use, indications for use and method of operation to the predicate AVERT" System. Based on the substantially

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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.