The MR Syringe is a pack that includes two 60ml MR Syringes, a 96" coiled Y-Line, and two Lateral Flow Needle Spikes. The alternate configuration of the MR Syringe is a pack that includes one 60mL MR Syringe, a 60" Coiled Line, and one Lateral Flow Needle Spike. Each of the components to be used in the proposed device has been cleared for marketing under previous 510(k) submissions.

AI/ML Overview

The MR Syringe Dual Pack is intended for use with the LF OptiStar Injector for injection of contrast media or saline. The device was deemed substantially equivalent to predicate devices based on non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance:

Test Category	Acceptance Criteria	Reported Device Performance
Visual Evaluation	Verification of visual acceptance (e.g., presence of all components).	Products inspected to verify visual acceptance. (Implied: Met acceptance criteria as no issues reported and substantial equivalence was determined).
Dimensional Evaluation	Verification of dimensional acceptance (e.g., ISO 594 luer compliance).	Products inspected to verify dimensional acceptance. (Implied: Met acceptance criteria as no issues reported and substantial equivalence was determined).
Functional Verification (Dynamic)	Appropriate function when injection was simulated at higher flow rates, challenging the injector's maximum pressure capability (150psi).	Syringe, spike, and Y-Line were tested using higher flow rates, ensuring appropriate function when injection was simulated at the maximum pressure capability of the injector (150psi). (Implied: Met acceptance criteria as no issues reported and substantial equivalence was determined, demonstrating the device can withstand the maximum pressure and flow conditions).
Functional Verification (Static)	Syringe held at the maximum capability of the injector for an extended period.	Static testing was conducted where the syringe was held at the maximum capability of the injector for an extended period of time. (Implied: Met acceptance criteria as no issues reported and substantial equivalence was determined, demonstrating the device's ability to maintain integrity under sustained pressure).
Age Verification	Expiration of 3 years based on packaging and components, leveraging previous 510(k) clearances.	The expiration of 3 years is leveraged under the 510k submissions and labeling of products as previously cleared and/or marketed based on the packaging and components used in the proposed device. (Implied: Met acceptance criteria, confirming the established shelf life).
Biocompatibility (Overall)	Meets requirements of ISO 10993 for an external communicating, indirect contact, less than 24-hour duration device.	The components of the kit met the requirements for such a device. Results: Cytotoxicity: Pass, Kligman Maximization Test: Pass, Intracutaneous Injection Test: Pass, Systemic Injection Test: Pass, Hemolysis: Pass, In Vitro Hemocompatibility Assay: Pass, Rabbit Pyrogen Test: Pass, Inactivated Partial Thromboplastin: Pass, Complement Activation Assay: Pass. (Met all specific biocompatibility acceptance criteria, indicating material safety for intended use).
Cytotoxicity	Pass	Pass (March 13, 2014)
Kligman Maximization Test	Pass	Pass (April 10, 2014)
Intracutaneous Injection Test	Pass	Pass (March 11, 2014)
Systemic Injection Test	Pass	Pass (March 10, 2014)
Hemolysis	Pass	Pass (March 11, 2014)
In Vitro Hemocompatibility Assay	Pass	Pass (April 10, 2014)
Rabbit Pyrogen Test	Pass	Pass (March 6, 2014)
Inactivated Partial Thromboplastin	Pass	Pass (March 6, 2014)
Complement Activation Assay	Pass	Pass (March 9, 2014)

2. Sample size used for the test set and the data provenance:
The document does not explicitly state the specific sample sizes for each non-clinical test (visual, dimensional, functional, age verification, biocompatibility). It references "testing used to verify substantial equivalence" and "inspection of the product" for visual and dimensional. For functional tests, it mentions "the syringe, spike and Y-Line were tested." Biocompatibility tests were conducted on "the kit."

The data provenance is from non-clinical tests conducted by or for Coeur, Inc. The dates provided for the biocompatibility tests (e.g., March-April 2014) suggest these were prospective tests specifically performed for this 510(k) submission. There is no indication of country of origin for the data, but the submitter is based in Lebanon, TN, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the study involved non-clinical performance and biocompatibility testing of a medical device, not a diagnostic or AI algorithm requiring expert ground truth establishment. The "ground truth" for these tests would be the established scientific and engineering standards (e.g., ISO 594, ISO 10993) and the objective measurements confirming compliance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as the study did not involve human interpretation or adjudication processes typical of diagnostic studies. The results of the non-clinical tests are objective measurements against predefined acceptance criteria.

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:
This information is not applicable. The submission relates to a medical device (syringe kit) and does not involve an AI component or any human-in-the-loop performance evaluation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The submission relates to a medical device and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the non-clinical tests was established by predetermined objective standards and specifications. This includes:

Engineering specifications and visual standards for visual and dimensional evaluations.
Mechanical and fluid dynamics principles for functional verification (pressure, flow rate).
Established industry standards such as ISO 594 for luer compliance and ISO 10993 for biocompatibility, specific parts of which define the acceptable limits and methodologies for tests like cytotoxicity, sensitization, systemic toxicity, and hemocompatibility.

8. The sample size for the training set:
This information is not applicable. This is a submission for a medical device (syringe kit) and does not involve an AI algorithm with a training set.

9. How the ground truth for the training set was established:
This information is not applicable as there is no training set for an AI algorithm.

Summary

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Coeur, Inc.

MR Syringe Dual Pack

JUL 2 8 2014 K140469

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:	Erin Rheinscheld, Regulatory Analyst
		Date:	February 20, 2014

1. Device: Trade/Proprietary Name: MR Syringe Dual Pack Common/Usual Name: MR Syringe Kit Classification Name: Accessory, Injector and Syringe, Angiographic

Legally Marketed Devices to which Substantial Equivalence is claimed: 8.

Optistar Injection System, Mallinckrodt, K984088 ﺘ
Disposable CT/MR Syringes for Nemoto Injectors, Coeur, Inc., K051799 ﺳ
Monoject 60cc Syringes, Sherwood Medical, K852580 ﺘ
-ANT Angiographic Syringes, Shenzhen Ant Hi-Tech, K072696
The MR Syringe is a pack that includes two 60ml MR Device Description: 4. Syringes, a 96" coiled Y-Line, and two Lateral Flow Needle Spikes.

· The alternate configuration of the MR Syringe is a pack that includes one 60mL MR Syringe, a 60" Coiled Line, and one Lateral Flow Needle Spike.

Each of the components to be used in the proposed device has been cleared for marketing under previous 510(k) submissions.

Intended Use of Device: For use with the LF OptiStar Injector for injection of 5. contrast media or saline.
Summary of Technological Characteristics As Compared to Predicate Devices: The 6. intended use, the method of use, and the materials of the proposed device are exactly the same as those of legally-marketed devices (as they are the same devices packaged together for sterilization).

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

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1. Nonclinical Tests Submitted: Testing used to verify substantial equivalence including an assessment of Performance Data for the proposed device considering both the original and the alternate configurations, including:
- a. Visual Evaluation of the Products Inspection of the product to verify visual acceptance (such as presence of all components).
- b. Dimensional Evaluation of the Products Inspection of the product to verify dimensional acceptance (such as ISO 594 luer compliance).
- c. Functional Verification of the Products:
  - i. Dynamic testing where the syringe, spike and Y -Line were tested using higher flow rates (which cause higher pressures) to ensure appropriate function when injection was simulated such that the maximum pressure capability of the injector (150psi) was challenged.
  - ii. Static testing was also conducted where the syringe was held at the maximum capability of the injector for an extended period of time.
- d. Age Verification Based on the packaging and the components use in the proposed device, the expiration of 3 years is leveraged under the 510k submissions and labeling of products as previously cleared and/or marketed.
- e. Biocompatibility Biocompatibility testing was conducted on the kit to verify it meets the requirements of ISO 10993 for an external communicating, indirect contact, less than 24 hour duration device. The components of the kit met the requirements for such a device. The results are as follows:
  - i. Cytotoxicity Pass (March 13, 2014)
  - Kligman Maximization Test Pass (April 10, 2014) 11.
  - Intracutaneous Injection Test Pass (March 11, 2014) 111.
  - Systemic Injection Test Pass (March 10, 2014) İV.
  - Hemolysis -- Pass (March 11, 2014) V.
  - vi. In Vitro Hemocompatibility Assay Pass (April 10, 2014)
  - Rabbit Pvrozen Test -Pass (March 6, 2014) vii.
  - I Jnactivated Partial Thomboplastin Pass (March 6, 2014) VIII.
  - ix. Complement Activation Assay Pass (March 9, 2014)
Clinical Tests Submitted: 2. NA
Conclusions Drawn from Nonclinical and Clinical Tests Submitted: 3. The conclusions drawn from the nonclinical tests demonstrate that the device is substantially equivalent to the predicate devices identified.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its wing. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle.

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

July 28, 2014

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

Re: K140469

Trade/Device Name: MR Syringe Dual Pack Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: DXT Dated: June 24, 2014 Received: June 25, 2014

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 I no general over in a 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 or my I vith 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

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Page 2 - Ms. Erin C. Rheinscheld

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.fca.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,

M. A. Stillman

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): K140469

Device Name: MR Syringe Dual Pack

Indications For Use:

For use with the LF OptiStar Injector for injection of contrast media or saline.

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)

MDA

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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.