ENLIGHTN RENAL GUIDE CATHETER

K131592 · St. Jude Medical, Inc. · DQY · Jan 31, 2014 · Cardiovascular

Device Facts

• Record ID: K131592
• Device Name: ENLIGHTN RENAL GUIDE CATHETER
• Applicant: St. Jude Medical, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Jan 31, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The EnligHTN Renal Guiding Catheter system is indicated for percutaneous use through an introducer sheath to facilitate a pathway to introduce interventional and diagnostic devices into the renal arterial vasculature.

Device Story

EnligHTN Renal Guiding Catheter facilitates access to renal arterial vasculature; used by physicians in clinical settings. System comprises 55cm guiding catheter with RDC-1 distal curve, radiopaque marker band, and molded hub with hemostasis valve; includes compatible dilator for support during vascular advancement. Device provides pathway for interventional/diagnostic instruments. Operates under fluoroscopic guidance; physician manipulates catheter to engage renal ostium. Benefits include stable access to renal arteries for therapeutic or diagnostic procedures.

Clinical Evidence

Bench and animal testing only. Bench testing included catheter dimensions, kink resistance, torque strength, air leak, seal manipulation, hemostasis performance, tensile testing, and corrosion resistance. Biocompatibility testing (cytotoxicity, sensitization, reactivity, toxicity, pyrogenicity, hemocompatibility) and chemical characterization (GC/MS, ICP, FTIR) were performed. Animal testing evaluated dilator/catheter fit, visualization, engagement, seal performance, and withdrawal. No human clinical data provided.

Technological Characteristics

8F (2.7mm) OD catheter; 0.089" distal ID; 55cm usable length. Features RDC-1 curve, radiopaque marker band, hemostasis valve, and 3-way stopcock. Compatible with 0.035" guidewires. Ethylene oxide (EO) sterilized. Single-use. No software or energy source.

Indications for Use

Indicated for percutaneous use in patients requiring interventional or diagnostic device access to the renal arterial vasculature via an introducer sheath.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Vista Brite Tip IG Guide Catheter (K971572)

Submission Summary (Full Text)

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### p. 1 of 5 St. Jude Medical

# 510(K) SUMMARY

JAN 3 1 2014

#### Administrative Information 1.

St. Jude Medical

Name: Address:

Phone: Fax: Contact Person:

Date:

5050 Nathan Lane North Plymouth, MN 55442 651-756-2706 651-756-5355 Blair Schwartz Regulatory Affairs Specialist II April 01, 2013

#### Device Information 2.

| Name of Device: | EnligHTN Renal Guide Catheter |
|----------------------|-----------------------------------|
| Common Name: | Guide Support Catheter |
| Classification Name: | Catheter, Percutaneous (870.1250) |
| Product Code: | DQY |

#### 3. Predicate Device Information

1) Vista Brite Tip IG Guide Catheter (Cordis) - K971572 cleared July 1997

#### Device Description 4.

The EnligHTN Renal Guiding Catheter consists of two primary components, the guiding catheter assembly and the dilator. The guide catheter assembly is the renal access device and has a usable length of 55cm. The outside diameter (OD) of the catheter shaft is 8F (2.7mm) with a distal tip inner diameter (ID) of 0.089 inches. The device is single use and packaged sterile via Ethylene oxide (EO) sterilization. The dilator fits inside the guiding catheter providing support during advancement through the vasculature and placement near the renal ostia. At the proximal end of the guiding catheter is a molded hub equipped with a hemostasis valve that is secured by an ultrasonically welded cap. The hub has a side port feature with an extension tubing and stopcock assembly attached. The distal end of the guiding catheter is formed to match the RDC-1 curve common to the industry and incorporates a radiopaque marker band. The dilator lumen is designed to accommodate a guidewire with an outside diameter of 0.035" or less.

> Page 1 of 5 EnligHTN Renal Guiding Catheter 510(k) Premarket Notification

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ST. JUDE MEDICAL

#### 5. Intended Use

The EnligHTN Renal Guiding Catheter system is indicated for percutaneous use through an introducer sheath to facilitate a pathway to introduce interventional and diagnostic devices into the renal arterial vasculature.

#### Technological Characteristics 6.

The EnligHTN Renal Guiding Catheter is substantially equivalent to the Cordis Guide Catheter (K971572. July 14. 1997). The EnligHTN Renal Guiding Catheter has substantially equivalent indication for use, principles of operation and materials of construction as the Cordis Guide Catheter.

EnligHTN and Cordis guide catheters have the similar intended indications. Both of the devices are used for the delivery of interventional and diagnostic devices in the vascular system. The EnligHTN Renal Guiding Catheter's indication is specific to the renal arterial vasculature while the Cordis Guide Catheter intended use encompasses coronary, peripheral and neurovasculature. The EnligHTN Renal Guiding Catheter indications for use falls within the scope of the indications for use of the Cordis Guide Catheter. Specifically, the EnligHTN Renal Guiding Catheter's renal arterial vasculature indication falls within the general peripheral vasculature indication of the Cordis Guide Catheter and therefore substantially equivalent for the purpose of this submission.

The EnligHTN Renal Guiding Catheter also has substantially equivalent materials and technological characteristics to the Cordis Guide Catheter with the exception of the hemostasis seal. St. Jude Medical has no information on the materials of composition for the hemostasis seal of the Cordis Guide Catheter.

Although technologically substantially equivalent, the EnligHTN Renal Guiding Catheter and the Cordis Guide Catheter differ in materials of construction including the radiopaque marker band and dilator, dilator length, and distal tip inner diameter. The minor differences between the two devices outlined in the body of this 510(k) do not raise new questions in safety of effectiveness.

> Page 2 of 5 EnligHTN Renal Guiding Catheter 510(k) Premarket Notification

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# UDE MEDICAL

The EnligHTN Renal Guiding Catheter system includes the following design aspects:

- 55cm Usable Length -
- Renal double curve (RDC-1) at the distal end to assist in engagement of renal ostium
- Radiopaque marker band at the distal tip to aid in visualization under fluoroscopy
- -Hub with hemostasis valve
- -Extension tube with 3-way stopcock
- -Compatible Dilator

#### Summary of Non-clinical Testing 7.

Performance testing of the EnligHTN Renal Guiding Catheter consists of bench and animal testing. Results of the testing demonstrate that the guide catheters design meets product specifications and intended uses and that the device is as safe, as effective, and performs at least as safely and effectively as the Cordis Guide Catheter. A summary of the bench and performance testing conducted is listed below:

> Page 3 of 5 EnligHTN Renal Guiding Catheter 510(k) Premarket Notification

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### Performance Testing Summary

| Item | Tests |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>performance | - Catheter Dimensions<br>- Kink Resistance<br>- Torque manipulation and Strength<br>- Air Leak<br>- Seal Manipulation<br>- Dilator Dimensions<br>- Hemostasis Performance<br>- Renal Double Curve Maintenance<br>- Tensile Test<br>- Corrosion Resistance |
| Biocompatibility | Biological Test<br>- Cytotoxicity<br>- Sensitization<br>- Intracutaneous Reactivity<br>- Acute Systemic Toxicity<br>- Pyrogenicity<br>Hemocompatibility<br>- Hemolysis<br>- Partial Thromboplastin Time<br>- Complement Activation<br>- In vivo Thromboresistance<br>Chemical<br>Characterization<br>- Gas Chromatography with Mass<br>Spectrometry (GC/MS) Static and<br>Dynamic<br>- Inductively Coupled Plasma<br>Spectroscopy (ICP)<br>- Fourier Transform Infrared<br>Spectroscopy (FTIR)<br>- Physicochemical – Non Volatile<br>Residue (NVR) |
| Sterilization/<br>Microbiology | - Sterilization<br>- Ethylene Oxide Residuals<br>- Bioburden<br>- LAL endotoxin |
| Packaging | - Bubble Leak Test<br>- Visual Inspection<br>- Pouch Seal Strength |
| Item | Tests |
| Shelf Life | - 13 Month Accelerated Aging<br>- 13 Month Real Time Aging (In-process) |
| Animal Testing | Fit of the Dilator and Catheter, Visualization, Engagement,<br>Seal Performance, and Withdrawal Performance |

·

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## ST. JUDE MEDICAL

#### Substantial Equivalence Conclusion 8.

The EnligHTN Renal Guiding Catheter is substantially equivalent to the legally marketed device; Cordis Guide Catheter (K971572, July 14, 1997).

The EnligHTN Renal Guiding Catheter is substantially equivalent in indication for use, materials, technological characteristics and principles of operations as the Cordis Guiding Catheter. The minor differences between the two devices do not raise new questions in safety of effectiveness.

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Image /page/5/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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

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

January 31, 2014

St. Jude Medical c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, MN 55313

Re: K131592

Trade/Device Name: EnligHTN™ Renal Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: DQY Dated: December 19, 2013 Received: December 20, 2013

Dear Mr. Job:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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" (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 Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours

**Kenneth J. Cavanaugh -S**

for

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

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EnligHTN™ Renal Guiding Catheter Premarket Notification 510(k)

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### Indications for Use

510(k) Number (if known):

Device Name: EnligHTN™ Renal Guiding Catheter

Indications For Use:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The EnligHTN™ Renal Guiding Catheter system is indicated for percutaneous use through an introducer sheath to facilitate a pathway to introduce interventional and diagnostic devices into the renal arterial vasculature.

Prescription Use X (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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