The 330psi Extension Y-Line with Dual Check Valve is to be used as an interface between an Angiographic, CT, or MR Syringe and a needle catheter for the purpose of delivering diagnostic fluids (such as contrast media and saline) to the vascular system.

Device Description

The 330psi Extension Y -Lines with Dual Check Valves will be offered in the following configurations:
i. 60" 330psi Extension Y-Line with Dual Check Valve (C405-1569)
ii. Short 330psi Extension Y-Line with Dual Check Valve (C405-2042)
iii. 60" 330psi Extension Y~Line with Dual Check Valve and Linden Adapters (C405-2155)
iv. 96" 330psi Extension Y-Line with Dual Check Valve (C405-2962)

AI/ML Overview

The provided document is a 510(k) summary for a medical device called "330psi Extension Y-Line with Dual Check Valve". This document describes the device, its intended use, and the testing conducted to establish substantial equivalence to a predicate device. It specifically states that no clinical tests were submitted.

Therefore, it is not possible to provide a detailed response to most of the questions as they relate to performance studies, sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance, which are typically associated with software as a medical device (SaMD) or AI/ML-driven devices. This document describes a physical medical device (an extension line) and its acceptance criteria are primarily based on non-clinical engineering and biocompatibility tests.

However, I can extract the acceptance criteria and summarize the study type to the best of what's available in the document.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on non-clinical laboratory testing. The document lists the tests conducted and their respective outcomes (Pass/Fail).

Acceptance Criteria	Reported Device Performance	Study Proving Performance
Dimensional Evaluation	Verified dimensional acceptance.	Inspection of the product.
Crack Pressure and Flow Rate	Not explicitly stated, but implies meeting predefined functional requirements.	Functional Verification.
330psi Pressure Test (Forward and Back)	Not explicitly stated, but implies meeting pressure resistance requirements.	Functional Verification.
Pressurize to Failure Test	Not explicitly stated, but implies meeting failure limits.	Functional Verification.
Pull Test (Bond)	Not explicitly stated, but implies meeting bond strength requirements.	Functional Verification.
Biocompatibility (ISO 10993 requirements for external communicating, indirect contact, less than 24-hour duration device)	Met requirements.	Biocompatibility testing (Cytotoxicity, Kligman Maximization, Intracutaneous Injection, Systemic Injection, Hemolysis, In Vitro Hemocompatibility, Rabbit Pyrogen, Unactivated Partial Thomboplastin, Complement Activation).
- Cytotoxicity	Pass	Biocompatibility Test
- Kligman Maximization Test	Pass	Biocompatibility Test
- Intracutaneous Injection Test	Pass	Biocompatibility Test
- Systemic Injection Test	Pass	Biocompatibility Test
- Hemolysis	Pass	Biocompatibility Test
- In Vitro Hemocompatibility Assay	Pass	Biocompatibility Test
- Rabbit Pyrogen Test	Pass	Biocompatibility Test
- Unactivated Partial Thomboplastin	Pass	Biocompatibility Test
- Complement Activation Assay	Pass	Biocompatibility Test

Studies Proving Device Meets Acceptance Criteria:

The studies conducted were nonclinical laboratory tests to verify the physical and biological characteristics of the device.

Sample size used for the test set and the data provenance: Not explicitly stated for each test, but standard engineering and biocompatibility testing typically uses a representative sample size of manufactured devices. The data provenance is from internal testing conducted by Coeur, Inc. (e.g., test dates provided for biocompatibility).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For engineering and biocompatibility tests, "ground truth" is typically defined by standardized test methods and established scientific principles, not expert consensus on individual cases.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Test results are typically objective (e.g., pressure readings, pass/fail for biological reactions) and do not require expert adjudication in the way clinical image interpretation might.
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: Not applicable. This is a physical medical device, not an AI/ML diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For dimensional and functional tests, the ground truth is against engineering specifications and industry standards. For biocompatibility, the ground truth is against ISO 10993 cytotoxicity, sensitization, irritation, systemic toxicity, and hemocompatibility standards.
The sample size for the training set: Not applicable. This is a physical medical device; there is no "training set" in the context of an algorithm.
How the ground truth for the training set was established: Not applicable.

Summary

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Public Health Service

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

October 22, 2015

Coeur, Inc. Debra F. Manning Director, Quality & Regulatory Affairs 100 Physicians Way Suite 200 Lebanon, Tennessee 37090

Re: K150902

Trade/Device Name: 330psi Extension Y-line With Dual Check Valve Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector And Syringe Regulatory Class: Class II Product Code: DXT Dated: September 18, 2015 Received: September 21, 2015

Dear Debra F. 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. 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

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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 (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 yours,

M.A. Hillebrand

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): K150902

Device Name: 330psi Extension Y-Line with Dual Check Valve

Indications For Use:

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.

K150902

330psi Extension Y-Line with Dual Check Valve

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:	Debra D. F. Manning, Director of Quality Assurance andRegulatory Affairs
		Date:	October 20, 2015
2.	Device:	Trade/Proprietary Name:	330psi Extension Y-Line with Dual Check Valve

2.	Device:	Trade/Proprietary Name:	330psi Extension Y-Line with Dual Check Valve
		Common/Usual Name:	330psi Extension Y-Line with Dual Check Valve
		Classification Name:	Accessory, Injector and Syringe,Angiographic

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

Coeur Disposable 330psi Extension Lines K120892 l
1. Device Description: The 330psi Extension Y -Lines with Dual Check Valves will be offered in the following configurations:
- i. 60" 330psi Extension Y-Line with Dual Check Valve (C405-1569)
- ii. Short 330psi Extension Y-Line with Dual Check Valve (C405-2042)
- iii. 60" 330psi Extension Y~Line with Dual Check Valve and Linden Adapters (C405-2155)
- iv. 96" 330psi Extension Y-Line with Dual Check Valve (C405-2962)
Indications for Use: The 330psi Extension Y-Line with Dual Check Valve is to be used as an 5. interface between an Angiographic, CT, or MR Syringe and a needle catheter for the purpose of delivering diagnostic fluids (such as contrast media and saline) to the vascular system.
Summary of Technological Characteristics as Compared to Predicate Devices: The intended 6. use (injection of contrast media or saline), the method of use (pressure), and the fluid path material types of the proposed device are the same as the legally-marketed device. As compared to the predicate device, the proposed device is essentially combining the Yconnector and 2 check valves (all of which are separate components in the current legallymarketed devices) into a single component (in the proposed device).

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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. Dimensional Evaluation of the Products Inspection of the product to verify dimensional acceptance. (Note: Given no change in the luer connectors, no ISO 594 Testing is required.)
- b. Functional Verification of the Products:
  - i. Crack Pressure and Flow Rate
  - ii. 330psi Pressure Test (Forward and Back)
  - iii. Pressurize to Failure Test
  - iv. Pull Test (Bond)
- c. 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 (February 12, 2015)
  - ii. Kligman Maximization Test Pass (March 18, 2015)
  - iii. Intracutaneous Injection Test Pass (March 23, 2015)
  - iv. Systemic Injection Test Pass (March 11, 2015)
  - v. Hemolysis Pass (February 18, 2015)
  - vi. In Vitro Hemocompatibility Assay Pass (March 10, 2015)
  - vii. Rabbit Pyrogen Test -Pass (February 27, 2015)
  - viii. Unactivated Partial Thomboplastin Pass (March 4, 2015)
  - ix. Complement Activation Assay~ Pass (March 13, 2015)
1. Clinical Tests Submitted: NA
Conclusions Drawn from Nonclinical and Clinical Tests Submitted: The conclusions 3. 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.