As defined by 21 CFR 870.1650, 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. The Coeur adapter is a unit designed to install onto legally marketed power injectors to enable use of the Coeur syringe with such injectors. It includes a component that affixes to the ram of the power injector to adapt it to fit the plunger of the Coeur syringe. It also includes a plastic lever component that allows the injector to be used more like the existing Mallinckrodt injector and will also be sold separately as a replacement part for that injector.

AI/ML Overview

The provided 510(k) summary for the K070798 device, "Coeur, Inc. Adapters for CT and/or Angiographic Power Injectors," outlines the performance criteria and the testing conducted to demonstrate substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Adapter can be properly installed	Installation was successfully completed.
Syringe will properly load into the injector	Loading of the syringe was successfully completed.
Syringe can be filled and used to inject contrast, saline, or other diagnostic fluids into the patient without affecting the function of the power injectors	Injection was successfully completed, and the equipment performed as intended (i.e., did not affect the function of the power injectors).

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

The document describes "Non-clinical Tests Submitted" that involved functional performance verification. It does not explicitly state a numerical sample size (e.g., number of adapters or injection cycles tested).

The data provenance is non-clinical testing performed by the manufacturer, Coeur Medical. The country of origin is not explicitly stated but can be inferred to be the United States, given the submitter's address and the FDA's jurisdiction. The testing was prospective as it was conducted to demonstrate the functional performance of the device for this submission.

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

This information is not provided in the 510(k) summary. The "Non-clinical Tests Submitted" section implies internal engineering or quality assurance testing rather than a study involving expert panels to establish ground truth in the context of clinical interpretation or diagnosis. The ground truth for this device's performance is its ability to physically connect and function with existing power injectors and syringes.

4. Adjudication Method for the Test Set:

An adjudication method is not applicable and therefore not described. The testing focused on functional verification (installation, loading, injection) against pre-defined success criteria, which are objective and do not require expert adjudication in the same way clinical image interpretation might.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The device is an adapter, not an interpretative AI tool or a diagnostic imaging system that would benefit from such a study. The purpose of the testing was to demonstrate the safe and effective mechanical function of the adapter.

6. If a Standalone Performance (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, the described "Non-clinical Tests Submitted" can be considered standalone performance testing. The focus was solely on the physical function of the adapter and its interaction with the injector and syringe, without involving human interpretation of results or requiring human interaction beyond operating the equipment to confirm functionality.

7. The Type of Ground Truth Used:

The ground truth used for this device is objective functional performance and successful mechanical integration. This means confirming that:

The adapter physically fits and can be installed.
The syringe loads correctly.
Contrast/saline can be injected without issues, and the power injector's function is not compromised.
This is not "expert consensus," "pathology," or "outcomes data" in the typical sense, but rather a verification of intended mechanical and operational behavior.

8. The Sample Size for the Training Set:

This information is not applicable and therefore not provided. The Coeur, Inc. Adapters are a mechanical device, not an AI or machine learning algorithm that requires a training set. The development of the adapter would involve design, prototyping, and engineering validation, but not "training data" in the computational sense.

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

This information is not applicable as there is no training set for a mechanical adapter. The "ground truth" during the design and development phase would have been engineering specifications, design requirements, and prior knowledge of the power injectors and syringes the adapter is designed for.

Summary

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K070798

് 2007 OCI A

Coeur, Inc.

Coeur Medical, a division of Coeur, Inc. Adapters for CT and/or Angiographic Power Injectors

510(k) Summary

1.	Submitter:	Name:	Coeur Medical, a division of Coeur, Inc.
		Address:	209 Creekside DriveWashington, NC 27889
		Phone:	(615) 547-7923 (Corporate Office)
		Fax:	(615) 547-7937 (Corporate Fax)
		Contact:	Debra F. Manning, VP, Q & RA
		Date:	October 2, 2007

Device: Trade/Proprietary Name: Coeur, Inc. Adapters for CT and/or Angiographic Power Injectors Common/Usual Name: Adapter for Power Injectors Classification Name: Accessory, Injector and Syringe, Angiographic

3. Legally Marketed Devices to which Substantial Equivalence is claimed:

Coeur Front Load Injector Retrofit Kit (K965214) - Coeur

Front Load Injector Turret and 200ml Front Load Syringe (K960965) - Coeur

CT 8000 Digital Injection System (K912944) - Mallinckrodt Group, Inc.

Medrad Envision CT Injection System (K993728) - Medrad

Coeur Injector Adapter/Pressure Jacket (K032920) - Coeur

Medrad MCT, MCT Plus Injector/Medrad Front Load (K924116) - Medrad

4. Device Description:

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injector to adapt it to fit the plunger of the Coeur syringe. It also includes a plastic lever component that allows the injector to be used more like the existing Mallinckrodt injector and will also be sold separately as a replacement part for that injector.

1. Intended Use of Device: The Coeur, Inc. Adapters are for use in adapting CT and/or Angiographic power injectors for use with Coeur syringes.

TechnologicalCharacteristics	Proposed Device	CoeurDevices	MedradDevices	Mallinckrodt(LF) Device	Rationale for ApplicableDifferences
Intended Use	For use in adaptingpower injectors for usewith Coeur syringes toenable the intendeduse of the powerinjectors (injection ofcontrast, saline, orother diagnostic fluidsinto a patient) to beaccomplished usingCoeur syringes.	Same	Syringe basedfluid deliverysystems forinjectingcontrast intopatient.	Injects contrastinto vascularsystem forangiographicor CT asprescribed.	NA - The proposed device doesnot alter the intended use (injectingcontrast, saline, or other diagnosticfluid into patient) of the powerinjectors upon which it will beinstalled.
Sterile	No	No	No	No	NA - The disposable syringe issterile, not the adapters/powerinjectors with which they are used.
Components	Combinations of steeland anodizedaluminum, o-rings andplastic componentsincluding levers withmagnets.	Steel andanodizedaluminumand o-ringsor plastic	Injector systemincludeshardware andsoftware	Injector systemincludinghardware andsoftware	The proposed device incorporatesa plastic lever to enable use of thesyringe system similar to a featureavailable with some Mallinckrodtequipment. Otherwise, thedifferences are not applicable asthe components are durable fortheir intended use.
ConnectionMethod	Mechanically affixedto injector in a securemanner (i.e., affixedwith bolts, screws,and/or dowel and rollpins.).	Same	NA	NA	NA
Function	Holds disposablesyringe in positionin front of injectorram.	Same	Same	Same	NA

Summary of Technological Characteristics As Compared to Predicate Devices: 6.

If Substantial Equivalence was based on an Assessment of Performance Data, the following information is also provided:

1. Non-clinical Tests Submitted: Verification of functional performance has been performed to ensure that the adapter can be properly installed, the syringe will properly load into the injector, and that the syringe can be filled and used to inject contrast, saline, or other diagnostic fluids into the patient without affecting the function of the power injectors.

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The installation, the loading, and the injection were all successfully completed. The equipment performed as intended.

Clinical Tests Submitted: NA 2.

Conclusions Drawn from Non-clinical and Clinical Tests Submitted: The 3. primary difference between the proposed Coeur devices and the currently marketed Coeur devices is that the proposed device will be used upon injectors for which it is designed to fit - the form and function will not be significantly different. The proposed design will also allow components that may be used with other power injectors, including, for example, the incorporation of a lever that allows the system with the Coeur syringe to use a "Used Syringe Alarm" feature available with the Mallinckrodt system. The lever will also be available for sale separately as a replacement component. Coeur has expanded its business to include the offering of service for power injectors in its new service division and replacement components are needed for this division. This lever is one such replacement component.
The primary difference between the proposed devices and legally marketed power injectors is that it works in conjunction with the power injectors without changing their intended use, to allow use of the Coeur syringes.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Coeur Medical a division of Coeur, Inc. c/o Ms. Debra F. Manning Vice President, Quality & Regulatory Affairs 209 Creekside Drive Washington, NC 27889

2007

Re: K070798

Trade/Device Name: Coeur, Inc. Adapters/Pressure Jackets for CT and/or Angiographic Power Injectors Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: DXT Dated: August 31, 2007 Received: September 4, 2007

Dear Ms. Manning:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Ms. Debra F. Manning

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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): K070798

Coeur, Inc. Adapters/Pressure Jackets for CT and/or Angiographic Device Name: Power Injectors

Indications For Use:

for use in adapting CT and/or Angiographic power injectors for use with Coeur Syringes

Prescription Use _ V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 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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Division Slan-C

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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.