The 125mL CT Syringe will be sold as a single syringe. The following configurations may also be offered:
i. 125mL Syringe and Fill Tube
ii. 125mL Syringe with Coiled Line and Spike
iii. 2 125mL Syringes with 2 Spikes
iv. 125mL Syringe and Coiled Extension Line
v. 2 125mL Syringes with Extension Y-Line and 2 Spikes

AI/ML Overview

The provided text is a 510(k) summary for the Coeur 125mL CT Syringe, which aims to demonstrate substantial equivalence to a legally marketed predicate device. This type of regulatory submission focuses on engineering and performance characteristics of a medical device, rather than the performance of an AI algorithm or a diagnostic tool. Therefore, the information requested about AI performance, multi-reader multi-case studies, ground truth establishment for AI, and similar metrics are not applicable to this document.

However, I can extract the relevant acceptance criteria and study information provided for the device itself.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test Performed)	Reported Device Performance/Verification Approach
Visual Conformance	Inspection of the product for conformance to visual requirements. (Passed)
Dimensional Accuracy (ISO 594-2:1998)	Syringe evaluation to dimensional requirements of ISO 594-2 using go/no go gage. (Passed)
Injector Fit (Optivantage DH Injector)	Evaluation of product for fit and function with the Optivantage DH Injector. (Passed)
Injector Fit (CT 9000ADV Injector)	Evaluation of product for fit and function with the CT 9000ADV Injector. (Passed)
Volume Accuracy	Evaluation for volume accuracy when used with injectors. (Passed)
Dynamic Pressure (min. 330 psi)	Syringe tested at a minimum of 330psi in simulated injections. (Passed)
Failure Pressure	Failure testing following dynamic testing, where syringes are pressurized under increasing pressures until failure is observed. (Performed, no specific pass/fail defined, but likely within acceptable engineering limits)
ISO 594-2:1998 (Overall Syringe Requirements)	Syringe evaluation to requirements of the ISO 594-2 standard. (Passed)
ISO 7886-2:1996 (Syringe Requirements)	Syringe evaluation to applicable requirements of the ISO 7886 standard. (Passed)
Shelf Life (2 years)	Age Verification: Based on packaging and testing of accelerated aged samples. (Supported an initial 2-year expiration)
Biocompatibility	Biocompatibility testing conducted on the device (though materials were noted as identical to cleared predicate). (Passed)

Note: The document only indicates that these tests were performed and the conclusions drawn were that the device is "substantially equivalent." Specific quantitative performance values are not typically included in these summary documents, but rather reported in full test reports submitted to the FDA.

The following information is not applicable to this 510(k) submission as it pertains to a physical medical device (syringe) and not an AI or diagnostic algorithm:

Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Adjudication method for the test set
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
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The sample size for the training set
How the ground truth for the training set was established

This document outlines the engineering and material equivalence of a syringe to a previously approved device, not the performance of a diagnostic or AI-powered system.

Summary

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

April 1, 2015

Coeur, Inc. Ms. Erin Rheinscheld Regulatory Analyst 100 Physicians Way Suite 200 Lebanon. Tennessee 37090

Re: K142745

Trade/Device Name: 125ml CT Syringe Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: DXT Dated: February 12, 2015 Received: February 18, 2015

Dear Ms. Rheinscheld.

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

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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" (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 vours.

M.R. Hilleman

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): K142745

Device Name: 125mL CT Syringe

Indications For Use:

For use with the Liebel-Flarsheim Optivantage and Liebel-Flarsheim CT 9000 ADV Injectors for the injection of contrast media or saline.

Prescription Use _√ (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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Coeur, Inc.

125mL CT Syringe

510(k) Summary

1.	Submitter:	Name:	Coeur, Inc.
		Address:	100 Physicians Way, Suite 200Lebanon, TN 37090
		Owner/Operator Number:	9038672
		Phone:	(615) 547-7923 (Corporate Office)
		Fax:	(615) 547-7937 (Corporate Fax)
		Contact:	Erin Rheinscheld, Regulatory Analyst
		Date:	March 23, 2015
2.	Device:	Trade/Proprietary Name:	125mL CT Syringe
		Common/Usual Name:	125mL CT Syringe
		Classification Name:	Accessory, Injector and Syringe

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

Coeur 130mL Syringe, K971712

1. Device Description: The 125mL CT Syringe will be sold as a single syringe. The following configurations may also be offered:
- i. 125mL Syringe and Fill Tube
- ii. 125mL Syringe with Coiled Line and Spike
- iii. 2 125mL Syringes with 2 Spikes
- iv. 125mL Syringe and Coiled Extension Line
- v. 2 125mL Syringes with Extension Y-Line and 2 Spikes

Angiographic

1. Intended Use of Device: For use with the Liebel-Flarsheim Optivantage and Liebel-Flarsheim CT 9000 ADV Injectors for the injection of contrast media or saline.
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 legallymarketed device. The components (accessories) are also the same as legallymarketed devices.

If 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:

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Visual Verification of the Products Inspection of the product for a. conformance to visual requirements.
Dimensional Evaluation of the Products Inspection of the product to b. verify dimensional acceptance.
- i. ISO 594-2:1998 Syringe evaluation to dimensional requirements of the ISO 594-2 standard using go/no go gage.
- ii. Injector Fit :
  - 1. Evaluation of product for fit and function with the Optivantage DH Injector.
  - 1. Evaluation of product for fit and function with the CT 9000ADV Injector.
- iii. Volume Evaluation for volume accuracy when used with injectors.

c. Functional Verification of the Products:

i. Dynamic testing where the syringe is tested at a minimum of 330psi in simulated injections.
ii. Failure testing follow dynamic testing, where syringes are pressurized under increasing pressures until failure is observed.
d. Other
- i. ISO 594-2:1998 Syringe evaluation to requirements of the ISO 594-2 standard
- ii. ISO 7886-2:1996 Syringe evaluation to applicable requirements of the ISO 7886 standard.
e. Age Verification Based on the packaging and testing of accelerated aged samples, the initial expiration of the device is 2 years. The methods and testing used to support new shelf life claims will be the same as those defined to support the 2-year shelf life identified in the submission
f. Biocompatibility - While the proposed device is made of the same materials in contact with the fluid path as that cleared under K971712, biocompatibility testing was conducted on the device. Other accessories are identical to previously marketed accessories or biocompatibility testing was also conducted.

2. Clinical Tests Submitted: NA

1. Conclusions Drawn from Nonclinical and Clinical Tests Submitted: The conclusions drawn from the nonclinical tests demonstrate that the device is substantially equivalent to the predicate devices identified.

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.