K Number

Device Name

CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip

Manufacturer

Coeur, Inc.

Date Cleared

2017-08-18

(186 days)

Product Code

DXT

Regulation Number

870.1650

Intended Use

For use with the Medrad® Stellant® CT Injection System equipped with the appropriate Coeur Fascia and Ram Tip for the injection of contrast media or saline to the vascular system for diagnostic purposes.

Device Description

The 200mL Syringe for Stellant Injectors are syringes / kits intended for use with the Medrad® Stellant® CT Injection System equipped with the appropriate Coeur Fascia and Ram Tip for the injection of contrast media or saline to the vascular system for diagnostic purposes. Each configuration is listed below in the "Models"section and provided sterile. To further define the device, the kits may include (depending on package configuration) extension lines, fill tubes, prime tubes, and spikes. The extension lines are used to connect the svringe to a patient's IV. The prime tube is used for catching fluid while purging air from the extension line. The fill tubes and spikes are used to connect the syringe to contrast media or saline containers for filling. The Fascia (installed on the surface of the injector case and through which the ram/ram tip moves) and the RamTip (connected to the injector ram and to which the syringe is connected), used in adapting the Medrad* Stellant* Injector for use with the Coeur 200mL Syringe for Stellant Injectors are not sterile, and after installation onto the injector, remain installed as long as the Coeur 200mL Syringe for Stellant Injectors is used with the injector. (Cleaning instructions for the Fascia and Ram Tip are provided in the IFU.) Principle of operation- The syringe plunger is engaged by the equipment ram and moved forward and back for filling and injection purposes.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K051799, K960965, K070798, K161471, K063090

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a syringe and related accessories for a CT injection system. The principle of operation is purely mechanical (plunger movement). There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies focus on physical and functional characteristics of the syringe and accessories.

Therapeutic

No
This device is for the injection of contrast media or saline for diagnostic purposes, not for therapeutic treatment.

Diagnostic

The device, a 200mL Syringe for Stellant Injectors, is used for the "injection of contrast media or saline to the vascular system for diagnostic purposes." It facilitates the diagnostic process by delivering substances but does not perform the diagnosis itself.

SaMD (Software as a Medical Device)

The device description clearly outlines physical components such as syringes, extension lines, fill tubes, prime tubes, spikes, fascia, and ram tip. The principle of operation describes the mechanical movement of a syringe plunger. The performance studies detail testing of physical attributes like dimensions, fit, pressure, and pull strength. These are all characteristics of a hardware medical device, not a software-only device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the injection of contrast media or saline into the vascular system for diagnostic purposes. This involves introducing a substance into the body to enhance imaging, which is an in vivo (within the living body) process, not an in vitro (outside the living body) process.
Device Description: The device is a syringe and associated components used for delivering substances into the patient's bloodstream. This is a delivery system, not a device that analyzes samples taken from the body.
Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or any reagents used for such analysis.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device facilitates a diagnostic procedure performed on the patient, not on a sample from the patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

DXT

Device Description

Principle of operation- The syringe plunger is engaged by the equipment ram and moved forward and back for filling and injection purposes.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Vascular system

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Nonclinical Tests Submitted: Testing used to verify substantial equivalence including an assessment of Performance Data for the proposed device, including:

Visual Verification of the Products Inspection of the product for conformance to visual requirements.
Dimensional Evaluation of the Products Inspection of the product to verify dimensional acceptance.
- ISO 594-2:1998 Evaluation to applicable requirements of the ISO 594 standard, including liquid leakage, air leakage, separation force, ease of assembly, resistance to overriding, and stress cracking.
- ISO 7886-2 Evaluation to applicable requirements of the ISO 7886-2 standard, including cleanliness, limits for acidity and alkalinity, limits for extractable metals, lubricant, tolerance on graduated capacity, graduated scale, piston plunger assembly, and nozzle.
- Dimensional Evaluation of product to conform to Coeur drawing specifications using gauging and measuring.
- Injector Fit Evaluation of syringe, fascia and ram tip for fit with the Medrad® Stellant® Injector.
- Volume Evaluation of volume accuracy.
Functional Verification of the Products:
- Functional Testing was conducted to evaluate the syringe, fascia, and ram tip to function with the Medrad® Stellant® Injector
- Pressure testing was conducted where the syringe was held at 400psi for 10 seconds and the Extension Line was held at 400psi for 2.5 minutes.
- Failure testing followed pressure testing, where syringes and Extension Lines are pressurized under increasing pressure until failure is observed (for reference only).
- Pull testing was conducted on the Extension Lines to verify correct assembly and bonding process during the manufacturing.
- Functional testing was conducted on the spike to evaluate the ability of the spike to connect to syringe, bottle port, and bag and allow fluid to flow into svringe.
Age Verification Based on use of the same packaging and component material as used in currently marketed devices, the expiration of 1 year is leveraged for the proposed device. Aging study is included and was included in the 510k for predicate device cleared under K051799.
Biocompatibility The proposed device is made of the same materials (including, PET, PVC, PC, PE, and ABS) in contact with the fluid path as that cleared under K051799 in formulation, processing, and sterilization, and no other chemicals have been added (e.g. plasticizers, fillers, color additives, cleaning agents, mold release agents, etc.). Further, biocompatibility testing, in accordance with FDA's guidance document titled "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", has been conducted on the proposed device. All test results indicate the suitability of the materials used in the device for the intended purposes: externally communicating, indirect blood path,

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.

Summary

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the edge. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

August 18, 2017

Coeur, Inc. Priscilla Clinner Regulatory Specialist 100 Physicians Way Lebanon, Tennessee 37090

Re: K170431

Trade/Device Name: 200mL Syringe for Stellant Injectors Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: Class II Product Code: DXT Dated: July 17, 2017 Received: July 18, 2017

Dear Priscilla Clinner:

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 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 (DICE) 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 (DICE) 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,

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K170431

Device Name

200mL Syringe for Stellant Injectors

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

Page 1 of 1

Services (301) 443-6740 . Ef PSC Publ

K170431

Coeur, Inc.

200mL Syringe for Stellant Injectors

510(k) Summary

1.	Submitter:	Name:	Coeur, Inc.
		Address:	100 Physicians Way, Suite 200
			Lebanon, TN 37090
			Owner/Operator Number: 9038672
		Phone:	(615) 547-7923 (Corporate Office)
		Fax:	(615) 547-7937 (Corporate Fax)
		Contact:	Priscilla Clinner, Regulatory Specialist
		Date:	February 10, 2017

1. Device: Trade/Proprietary Name: 200mL Syringe for Stellant Injectors Common/Usual Name: 200mL Svringe for Stellant Injectors Classification Name: Accessory, Injector and Syringe, Angiographic

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

Coeur Syringes for Nemoto Injectors (K051799) (Primary Predicate Device)
Coeur Front Load Injector Turret & 200mL Front Load Syringe (K960965) (Secondary Predicate Device)
Coeur Adapters for CT, Angiographic, and/or MRI Power Injectors (K070798) ● (Secondary Predicate Device)
Coeur MR Syringe Dual Pack for Solaris Injectors (K161471) (Secondary Predicate Device)

Medrad:

Syringe included in Medrad® Stellant® CT Injector System with XDS Accessorv ● (K063090) (Secondary Predicate Device)

4. Device Description:

Principle of operation- The syringe plunger is engaged by the equipment ram and moved forward and back for filling and injection purposes.

. Proposed conditions of use – The proposed devices are intended to be sterile for use with the Medrad® Stellant® CT Injection System equipped with the

appropriate Coeur Fascia and Ram Tip for the injection of contrast media or saline to the vascular system for diagnostic purposes. The devices include ISO-594 compatible components for connection with the ISO 594 compatible syringe luer or other components that otherwise press-fit the syringe. All devices included with the syringes are sterilized.

List of devices for which clearance is requested - See "Models" section below for a list of product configurations

5. Models:

The 200mL Syringe for Stellant Injectors will be sold as a single syringe and in a dual pack. The following configurations may be offered:

C853-3101, 200mL Syringe for Stellant Injectors and Spike ●
C853-3102, 200mL Syringe for Stellant Injectors with 60" Coiled Extension Line and Spike
C853-3103, 200mL Syringe for Stellant Injectors with 60" Coiled Extension Line, Prime Tube and Spike
C853~3104, 200mL Syringe for Stellant Injectors with Fill Tube ●
C853-3105, 200mL Syringe for Stellant Injectors with 60" Coiled Extension Line and Fill Tube
C853-3106, 200mL Syringe for Stellant Injectors with 60" Coiled Extension Line, ● Prime Tube, and Fill Tube
C853-3201, (2) 200mL Syringes for Stellant Injectors with 60" Coiled Extension Y -Line and Spikes
C853-3202, (2) 200mL Syringes for Stellant Injectors with 60" Coiled Extension Y -● Line, and Contrast and Saline Spike
C853-3203, (2) 200mL Syringes for Stellant Injectors with 60" Coiled Extension Y -Line, Prime Tube and Spikes
C853-3204, (2) 200mL Syringes for Stellant Injectors with 60" Coiled Extension Y -● Line, Prime Tube, and Contrast and Saline Spike
C853-3205, (2) 200mL Syringes for Stellant Injectors with 60" Coiled Extension Y -Line and Fill Tube
C853-3206, (2) 200mL Syringes for Stellant Injectors with 60" Coiled Extension Y ~ Line, Prime Tube, and Fill Tube

The Fascia and RamTip will be sold as a single and a dual Fascia and Ram Tip. The following configurations may be offered:

C859-3100, Single Fascia and Ram Tip for Stellant Injectors
C859-3200. Dual Fascia and Ram Tips for Stellant Injectors .
1. Indications For Use: For use with the Medrad® Stellant® CT Injection System equipped with the appropriate Coeur Fascia and Ram Tip for the injection of contrast media or saline to the vascular system for diagnostic purposes.
1. Summary of Technological Characteristics as Compared to Predicate Devices: The intended use (injection of contrast media or saline), the method of use (pressure), and the fluid path materials of the proposed device are the same as the legally-marketed devices.

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

1. Nonclinical Tests Submitted: Testing used to verify substantial equivalence including an assessment of Performance Data for the proposed device, including:

Visual Verification of the Products Inspection of the product for conformance a. to visual requirements.
b. Dimensional Evaluation of the Products Inspection of the product to verify dimensional acceptance.
- i. ISO 594-2:1998 Evaluation to applicable requirements of the ISO 594 standard, including liquid leakage, air leakage, separation force, ease of assembly, resistance to overriding, and stress cracking.
- ii. ISO 7886-2 Evaluation to applicable requirements of the ISO 7886-2 standard, including cleanliness, limits for acidity and alkalinity, limits for extractable metals, lubricant, tolerance on graduated capacity, graduated scale, piston plunger assembly, and nozzle.
- iii. Dimensional Evaluation of product to conform to Coeur drawing specifications using gauging and measuring.
- iv. Injector Fit Evaluation of syringe, fascia and ram tip for fit with the Medrad® Stellant® Injector.
- v. Volume Evaluation of volume accuracy.

c. Functional Verification of the Products: -

i. Functional Testing was conducted to evaluate the syringe, fascia, and ram tip to function with the Medrad® Stellant® Injector
ii. Pressure testing was conducted where the syringe was held at 400psi for 10 seconds and the Extension Line was held at 400psi for 2.5 minutes.
iii. Failure testing followed pressure testing, where syringes and Extension Lines are pressurized under increasing pressure until failure is observed (for reference only).
iv. Pull testing was conducted on the Extension Lines to verify correct assembly and bonding process during the manufacturing.
v. Functional testing was conducted on the spike to evaluate the ability of the spike to connect to syringe, bottle port, and bag and allow fluid to flow into svringe.
d. Age Verification Based on use of the same packaging and component material as used in currently marketed devices, the expiration of 1 year is leveraged for the proposed device. Aging study is included and was included in the 510k for predicate device cleared under K051799.
Biocompatibility The proposed device is made of the same materials e. (including, PET, PVC, PC, PE, and ABS) in contact with the fluid path as that cleared under K051799 in formulation, processing, and sterilization, and no other chemicals have been added (e.g. plasticizers, fillers, color additives, cleaning agents, mold release agents, etc.). Further, biocompatibility testing, in accordance with FDA's guidance document titled "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", has been conducted on the proposed device. All test results indicate the suitability of the materials used in the device for the intended purposes: externally communicating, indirect blood path,