DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS

K071196 · Coeur, Inc. · DQO · Sep 6, 2007 · Cardiovascular

Device Facts

• Record ID: K071196
• Device Name: DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS
• Applicant: Coeur, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Sep 6, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

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.

Device Story

Disposable high pressure injection lines connect fluid sources (e.g., angiographic syringes) to catheters during coronary angiography. Device consists of braided or unbraided plastic polymer tubing with male/female luer connectors (including rotating options). Used in clinical settings by medical professionals to deliver radiopaque dye, saline, or diagnostic fluids. Pressure rating ranges from 500 to 1200 psi. Device facilitates fluid delivery from injector to patient catheter; provides flexible connection to meet clinical needs.

Clinical Evidence

No clinical data. Bench testing only. Functional performance verified via pressure testing at 1200 psi. Sterilization validation performed per AAMI/ANSI/ISO 11135/EN 550 standards to achieve SAL of 10^-6.

Technological Characteristics

Braided or unbraided plastic polymer tubing; male/female luer connectors (rotating/non-rotating); pressure rating 500-1200 psi; sterile (EtO) or non-sterile; packaging includes Tyvek-lidded trays or kits. Sterilization compliant with AAMI/ANSI/ISO 11135/EN 550.

Indications for Use

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

Regulatory Classification

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.

Predicate Devices

• Medrad High Pressure Connecting Tube (K810924)
• Advance Pressure Monitor/High Pressure Lines (K911884)
• Ultra High Pressure Injector Lines (K023591)
• flexcil® Contrast Injection Lines (K822100)
• High Pressure Lines (K963749)

Submission Summary (Full Text)

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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

| 1. | Submitter: | Name: | Coeur Medical, a division of Coeur, Inc. | |
|----|------------|----------|------------------------------------------|----------------------|
| | | Address: | 209 Creekside Drive | |
| | | | | Washington, NC 27889 |
| | | Phone: | [phone] (Corporate Office) | |
| | | Fax: | [phone] (Corporate Fax) | |
| | | Contact: | Debra F. Manning, VP, Q & RA | |
| | | Date: | April 27, 2007 | |

| 2. | Device: Trade/Proprietary Name: | Disposable High Pressure Injection Lines<br>with and without Rotating Adapters |
|----|---------------------------------|--------------------------------------------------------------------------------|
| | Common/Usual Name: | High Pressure Lines |
| | Classification Name: | Diagnostic Intravascular Catheter<br>(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:

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.

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# K071196 Page 2 of 3

- 5. 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.

| Technological<br>Characteristics | Proposed Device | Other Legally<br>Marketed Devices | Rationale for<br>Applicable Differences |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use during<br>coronary angiography<br>procedures as a<br>connecting line for the<br>injection of radiopaque<br>dye, saline, or other<br>diagnostic fluids. | Medrad: To connect<br>an angiographic<br>catheter for needle<br>to an automatic<br>power injector.<br>De Royal: For use<br>during coronary<br>angiography<br>procedures and<br>connecting line for<br>the injection of<br>radiopaque dye or<br>saline.<br>NAMIC: Intended to<br>be used in the<br>delivery of contrast<br>media. | NA: There are no<br>significant differences<br>in the intended uses. |
| Connector Tube | Multiple lengths of<br>braided or unbraided,<br>flexible, clear or tinted,<br>plastic polymers | Multiple lengths,<br>plastic polymers,<br>PVC, braided and<br>unbraided, varying<br>levels of flexibility | The same basic<br>materials will be used<br>in the proposed<br>devices as are used in<br>legally marketed<br>devices. Coeur intends<br>to offer a more flexible<br>device that meets the<br>needs of the high<br>pressure market. |
| Sterility | Sterile and Non-Sterile | Same | NA |
| Sterilization<br>Method (For<br>Sterile Product) | EtO | Same | NA |
| Components | Combinations of male<br>and female luers<br>(including rotating<br>male luers), with and<br>without dust caps | Same | NA |
| Packaging of<br>Sterile Product | Sealed Tyvek-lidded<br>package or included as<br>component in trays or<br>kits. Products may be<br>wrapped with a band<br>to 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
- 3. 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 [phone]. 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 [phone] or [phone] 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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