The Disposable High Pressure Injection Lines with and without Rotating Adapters are a combination of connectors and tubing bonded together for injection of radiopaque dye, saline, or other diagnostic fluids during a coronary angiography procedure. The device is designed, like other legally marketed devices, for one end to connect to the fluid source (such as an angiographic syringe) and the other end to connect to the catheter. The contrast, saline, or other diagnostic fluid is then injected from the syringe, through the high pressure line, into the catheter. The materials and properties of the device are tabled in Item 6, below.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided document:

This document is a 510(k) premarket notification for a medical device (Disposable High Pressure Injection Lines with and without Rotating Adapters). The purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to conduct a comprehensive study on a new or innovative technology. Therefore, many of the typical acceptance criteria and study characteristics you'd expect for AI/software-as-a-medical-device (SaMD) are not applicable here.

Device: Coeur Medical, a division of Coeur, Inc. Disposable High Pressure Injection Lines with and without Rotating Adapters

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Functional Performance)	Reported Device Performance
Pressure Rating	500 to 1200 psi
Pressure Test at "worst case" (1200psi)	Acceptable performance
Sterility Assurance Level (SAL)	10⁻⁶

Note: The document states that the primary difference is the manufacturer assembling components and sterilizing the devices, and that the proposed devices will offer a "more flexible device that meets the needs of the high pressure market." However, quantitative metrics for "flexibility" or how it "meets the needs" beyond the pressure rating are not provided as acceptance criteria or performance metrics directly in this summary.

2. Sample size used for the test set and data provenance

Sample Size: Not explicitly stated as a number of units. The document mentions "pressure testing was conducted at 1200psi to verify acceptable performance of the 'worst case' challenge," implying at least one or more units were tested.
Data Provenance: Not applicable. These are nonclinical (bench) tests for a physical medical device, not data from patients or medical imaging.

3. Number of experts used to establish the ground truth for the test set and their qualifications

Not applicable. This relates to nonclinical physical testing, not expert-based ground truth for diagnostic accuracy.

4. Adjudication method for the test set

Not applicable. This relates to nonclinical physical testing, not expert review or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done

No. This is a 510(k) premarket notification for a physical medical device, not an AI/SaMD product. MRMC studies are not relevant here.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

Bench test results/Engineering specifications: The "ground truth" for the device's performance is against its own design specifications and functional requirements (e.g., ability to withstand 1200psi without failure, achieving a specific SAL).

8. The sample size for the training set

Not applicable. There is no "training set" for this physical device.

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

Not applicable. There is no "training set" for this physical device.

Summary of the Study:

The "study" described in the 510(k) summary is based on nonclinical tests to verify the functional performance of the Disposable High Pressure Injection Lines.

Nonclinical Tests Submitted: "Verification of functional performance has been performed."
- Pressure Testing: Conducted at 1200psi to verify acceptable performance, as this is the greatest pressure for which the device is developed ("worst case" challenge).
- Sterilization Cycle Verification: The Coeur sterilization cycle is stated to be able to sterilize the proposed device with an SAL of 10⁻⁶, based on a comparison to products tested for inclusion in the Coeur cycle. This implies a validation of the sterilization process itself.
Clinical Tests Submitted: "NA" (None)
Conclusions: The testing verifies that the proposed devices are suitable for their intended use. The primary basis for substantial equivalence is that the device has similar technological characteristics (materials, intended use, sterilization method, components, pressure rating) to legally marketed predicate devices, and the nonclinical testing demonstrates equivalent performance where applicable.

Summary

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Coeur, Inc.

K071196 page lof 3

SEP - 6 2007

Coeur Medical, a division of Coeur, Inc. Disposable High Pressure Injection Lines with and without Rotating Adapters

510(k) Summary

Name:	Coeur Medical, a division of Coeur, Inc.
Address:	209 Creekside Drive
		Washington, NC 27889
Phone:	(615) 547-7923 (Corporate Office)
Fax:	(615) 547-7937 (Corporate Fax)
Contact:	Debra F. Manning, VP, Q & RA
Date:	April 27, 2007

2.	Device: Trade/Proprietary Name:	Disposable High Pressure Injection Lineswith and without Rotating Adapters
	Common/Usual Name:	High Pressure Lines
	Classification Name:	Diagnostic Intravascular Catheter(21 CFR 870.1200, Product Code DQO)

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

Medrad High Pressure Connecting Tube (K810924) - Medrad

Advance Pressure Monitor/High Pressure Lines (K911884) -Advance Medical Designs, Inc.

Ultra High Pressure Injector Lines (K023591) - DeRoyal Industries, Inc.

flexcil® Contrast Injection Lines (K822100) - NAMIC

High Pressure Lines (K963749) - Maxxim Medical, Inc.

4. Device Description:

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K071196 Page 2 of 3

1. Intended Use of Device: The Disposable High Pressure Injection Line with and without Rotating Adapter is for use during coronary angiography procedures as a connecting line for the injection of radiopaque dye, saline, or other diagnostic fluids. As the table in Item 6 demonstrates, this is consistent with other legally marketed devices.

TechnologicalCharacteristics	Proposed Device	Other LegallyMarketed Devices	Rationale forApplicable Differences
Intended Use	For use duringcoronary angiographyprocedures as aconnecting line for theinjection of radiopaquedye, saline, or otherdiagnostic fluids.	Medrad: To connectan angiographiccatheter for needleto an automaticpower injector.De Royal: For useduring coronaryangiographyprocedures andconnecting line forthe injection ofradiopaque dye orsaline.NAMIC: Intended tobe used in thedelivery of contrastmedia.	NA: There are nosignificant differencesin the intended uses.
Connector Tube	Multiple lengths ofbraided or unbraided,flexible, clear or tinted,plastic polymers	Multiple lengths,plastic polymers,PVC, braided andunbraided, varyinglevels of flexibility	The same basicmaterials will be usedin the proposeddevices as are used inlegally marketeddevices. Coeur intendsto offer a more flexibledevice that meets theneeds of the highpressure market.
Sterility	Sterile and Non-Sterile	Same	NA
SterilizationMethod (ForSterile Product)	EtO	Same	NA
Components	Combinations of maleand female luers(including rotatingmale luers), with andwithout dust caps	Same	NA
Packaging ofSterile Product	Sealed Tyvek-liddedpackage or included ascomponent in trays orkits. Products may bewrapped with a bandto facilitate packaging.	Same	NA
Pressure Rating	500 to 1200psi	Same	NA

Summary of Technological Characteristics As Compared to Predicate Devices: 6.

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

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K671196 page 3 of 3

1. Nonclinical Tests Submitted: Verification of functional performance has been performed. As 1200psi is the greatest pressure for which the device is developed. pressure testing was conducted at 1200psi to verify acceptable performance of the "worst case" challenge. The Coeur sterilization cycle is able to sterilize the proposed device with an SAL of 106, based on a comparison to products tested for inclusion into the Coeur cycle. (A product analysis, compliant with AAMI/ANS/ISO 11135/EN 550, will be performed and appropriate actions will be taken accordingly.)
Clinical Tests Submitted: 2. NA
1. Conclusions Drawn from Nonclinical and Clinical Tests Submitted: The primary difference between the proposed Coeur devices and other legally marketed predicate devices is that Coeur, who has experience in the production of tubing extension products and has the facilities and equipment for assembly of the proposed devices, will assemble the components to make the proposed devices which will be sterilized in Coeur's sterilization cycle. Coeur intends to offer a variety of high pressure lines, including a more flexible device that meets the needs of the high pressure market. The results of the testing verify the proposed devices are suitable for their intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with flowing lines, representing the department's mission of health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is presented in black and white.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 6 2007

Coeur, Inc. c/o Ms. Debra F. Manning V.P. of Quality and Regulatory Affairs 704 Cadet Court Lebanon, TN 370787

Re: K071196 Trade/Device Name: Disposable High Pressure Injection Lines with and without Rotating Adapters Regulation Number: 21 CFR 870.1200 Regulation Name: Catheter, Intravascular, Diagnostic Regulatory Class: Class II Product Code: DQO Dated: August 10, 2007 Received: August 13, 2007

Dear Ms. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 -- Ms. Debra F. Manning

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Blymmermon 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): K07119 (v

Coeur, Inc. Disposable High Pressure Injection Lines with and Device Name: without Rotating Adapters

Indications For Use:

for use during coronary angiography procedures as a connecting line for the injection of radiopaque dye, saline or other diagnostic fluids.

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)

B. Benveniste
(Division Sign-Off)

(Division/sign-On)
Division of Cardiovascular Devices
510(k) Number K071196

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Page 1 of 1

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).