The MR Syringes for Solaris Injectors (65mL and 115mL syringe) falls into the Cardiovascular Devices Category and are classified as Angiographic Syringes within the classification of Angiographic Injectors and Syringes. The syringe is intended for use with Medrad Spectris® Solaris™ MR Injection System to inject diagnostic fluids (such as contrast media and saline) into a patient. The MR Syringe Dual Pack for Solaris Injectors will be sold as a Dual Pack. The following configurations may be offered:
i. C853-2201 65mL and 115mL Syringe with 96" Coiled extension YLine and Fill Spikes
ii. C853-2202 65mL and 115mL Syringe with 96" Coiled extension Y-Line and Contrast and Saline Spikes
iii. C853-2203 65mL and 115mL Syringe with 96" Coiled extension YLine, Prime Tube, and Fill Spikes
iv. C853-2204 65mL and 115mL Syringe with 96" Coiled extension YLine, Prime Tube, and Contrast and Saline Spikes
v. C853-2205 ~ 65mL and 115mL Syringe with 96" Coiled Extension YLine and Fill Tube
vi. C853-2206 65mL and 115mL Syringe with 96" Coiled Extension Y~Line, Prime Tube, and Fill Tube

AI/ML Overview

This document is a 510(k) summary for the MR Syringe Dual Pack for Solaris Injectors (K161471), a medical device. It does not describe an AI or algorithm-driven device, but rather a physical syringe product. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable.

Here's the information extracted from the document that aligns with your request, with "NA" (Not Applicable) for categories that don't fit this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test Performed)	Reported Device Performance
Visual Verification (Conformance to visual requirements)	Product inspected for conformance to visual requirements. (Implied: Passed)
Dimensional Evaluation
- ISO 594-2:1998 Evaluation	Evaluation to applicable requirements of the ISO 594 standard. (Implied: Passed)
- Injector Fit (Medrad Spectris® Solaris™ MR Injection System)	Evaluation of fit and function. (Implied: Passed)
- Volume Accuracy	Evaluation of volume accuracy. (Implied: Passed)
Functional Verification
- Pressure Testing (Syringe at 350psi for 10s)	Syringe held at 350psi for 10 seconds. (Implied: Passed without failure)
- Pressure Testing (Extension Line at 400psi for 2.5 min)	Extension Line held at 400psi for 2.5 minutes. (Implied: Passed without failure)
- Failure Testing (post-pressure)	Syringes and Extension Lines pressurized under increasing pressure until failure. (Implied: Demonstrated acceptable failure characteristics)
Age Verification (Based on packaging/component material)	Leveraged 1-year expiration from currently marketed devices using same materials. (Implied: 1-year shelf life accepted)
Biocompatibility	Made of same materials in fluid path as cleared devices (K971712 and K051799) with no added chemicals. (Implied: Biocompatible)

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

Sample Size: Not explicitly stated as a number of devices. The document implies that "the product," "syringes and Extension Lines," and individual units were subjected to these tests without specifying the quantity.
Data Provenance: Not specified, but this is a physical medical device. The testing would have been conducted by the manufacturer (Coeur, Inc.) in a lab setting. It is not patient or case data.

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

NA, as this is not an AI or diagnostic imaging device requiring expert interpretation for ground truth. The ground truth for physical properties (e.g., pressure resistance, dimensions) is based on engineering specifications and international standards.

4. Adjudication Method for the Test Set

NA, no adjudication method is mentioned as there are no expert readings or interpretations to adjudicate for this type of device.

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

NA, this is not an AI device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

NA, this is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is based on engineering specifications, material properties, and established international standards (e.g., ISO 594-2:1998) for physical medical devices.

8. The sample size for the training set

NA, this is a physical medical device, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established

NA, this is a physical medical device, not an AI algorithm.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract human figures, possibly representing individuals or families, with flowing lines suggesting movement or connection.

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

October 6, 2016

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

Re: K161471

Trade/Device Name: MR Syringe Dual Pack for Solaris Injectors Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: DXT Dated: September 2, 2016 Received: September 6, 2016

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

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,

Image /page/1/Picture/7 description: The image shows the name "Brian D. Pullin -S" in a clear, sans-serif font. The text is horizontally aligned and appears to be part of a document or label. The background is plain, which makes the text stand out.

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K161471

Device Name

MR Syringe Dual Pack for Solaris Injectors

Indications for Use (Describe)

For use with the Medrad Spectris® Solaris™ MR Injection of contrast media or saline to the vascular system for diagnostic purposes.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X 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."

{3}------------------------------------------------

Coeur, Inc.

MR Syringes for Solaris Injectors

K161471 510(k) Summary

1.	Submitter:	Name:	Coeur, Inc.
		Address:	100 Physicians Way, Suite 200Lebanon, TN 37090Owner/Operator Number: 9038672
		Phone:	(615) 547-7923 (Corporate Office)
		Fax:	(615) 547-7937 (Corporate Fax)
		Contact:	Priscilla Clinner, Regulatory Analyst
		Date:	October 5, 2016
2.	Device:	Trade/Proprietary Name:	MR Syringe Dual Pack for Solaris Injectors
		Common/Usual Name:	MR Syringe Dual Pack for Solaris Injectors

Accessory, Injector and Syringe,

Angiographic

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

Primary Predicate Device

Medrad: Syringe Included in Spectris Solaris MR Injection System (K033247)

Referenced Devices

Coeur:

Coeur 130mL Syringe (K971712) ●
Coeur Syringes for Nemoto Injectors (K051799)
Coeur 330psi Extension Lines (K120892) ●

Classification Name:

Coeur MR Syringe Dual Pack (K140469) ●
E-Z-EM Empower MR Injector System and Fastload MR Syringe Pack ● (K062449)
Device Description: The MR Syringes for Solaris Injectors (65mL and 115mL 4. syringe) falls into the Cardiovascular Devices Category and are classified as Angiographic Syringes within the classification of Angiographic Injectors and Syringes. The syringe is intended for use with Medrad Spectris® Solaris™ MR Injection System to inject diagnostic fluids (such as contrast media and saline) into a patient. The MR Syringe Dual Pack for Solaris Injectors will be sold as a Dual Pack. The following configurations may be offered:
- i. C853-2201 65mL and 115mL Syringe with 96" Coiled extension Y~Line and Fill Spikes
- ii. C853-2202 65mL and 115mL Syringe with 96" Coiled extension Y-Line and Contrast and Saline Spikes
- iii. C853-2203 65mL and 115mL Syringe with 96" Coiled extension Y~Line, Prime Tube, and Fill Spikes
- iv. C853-2204 65mL and 115mL Syringe with 96" Coiled extension Y~Line, Prime Tube, and Contrast and Saline Spikes

{4}------------------------------------------------

v. C853-2205 ~ 65mL and 115mL Syringe with 96" Coiled Extension Y~Line and Fill Tube
vi. C853-2206 65mL and 115mL Syringe with 96" Coiled Extension Y~Line, Prime Tube, and Fill Tube
1. Indications for Use of Device: For use with the Medrad Spectris® Solaris™ MR Injection System 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 for diagnostic purposes), the method of use (pressure injection with power injectors), and the fluid path materials (PET barrel, synthetic rubber jacket, extension lines, fill tubes, and spikes) of the proposed device are the same as the legally-marketed 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:
- a. Visual Verification of the Products Inspection of the product for conformance 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.
  - ii. Injector Fit –Evaluation of fit and function with the Medrad Spectris® Solaris™ MR Injection System.
  - iii. Volume -Evaluation of volume accuracy.
- c. Functional Verification of the Products:
  - i. Pressure testing was conducted where the syringe was held at 350psi for 10 seconds and the Extension Line was held at 400psi for 2.5 minutes.
  - ii. Failure testing followed pressure testing, where syringes and Extension Lines are pressurized under increasing pressure until failure is observed.
- 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.
- e. Biocompatibility The proposed device is made of the same materials in contact with the fluid path as that cleared under K971712 and 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.).
- 1. Clinical Tests Submitted: NA
- Conclusions Drawn from Nonclinical and Clinical Tests Submitted: The 3. 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.