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 Description

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.

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

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the EnligHTN Renal Guiding Catheter:

Summary of Acceptance Criteria and Device Performance (Assumed from Testing Summary)

The document describes various performance tests conducted to demonstrate that the EnligHTN Renal Guiding Catheter meets product specifications and intended uses, and is as safe and effective as the predicate device (Cordis Guide Catheter). While explicit "acceptance criteria" are not listed with quantitative thresholds, the successful completion of these tests implies that the device met the required performance standards.

Item	Acceptance Criteria (Implied)	Reported Device Performance
Device Performance	Meets product specifications for: Dimensions, Kink Resistance, Torque Manipulation and Strength, Air Leak, Seal Manipulation, Hemostasis Performance, Renal Double Curve Maintenance, Tensile Strength, Corrosion Resistance.	Testing demonstrated that the guide catheter's design meets product specifications and intended uses.
Biocompatibility	Meets biological safety standards for: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogenicity, Hemolysis, Partial Thromboplastin Time, Complement Activation, In Vivo Thromboresistance, and Chemical Characterization (GC/MS, ICP, FTIR, NVR).	All biocompatibility tests were successfully conducted.
Sterilization/Microbiology	Meets standards for: Sterilization, Ethylene Oxide Residuals, Bioburden, LAL Endotoxin.	All sterilization and microbiology tests were successfully conducted.
Packaging	Meets standards for: Bubble Leak Test, Visual Inspection, Pouch Seal Strength.	All packaging tests were successfully conducted.
Shelf Life	Maintains performance over the specified shelf life of 13 months (accelerated and real-time).	13-month accelerated aging and 13-month real-time aging (in-process) were conducted. (Implicitly met criteria).
Animal Testing (In-Vivo Performance)	Demonstrates satisfactory performance for: Fit of the Dilator and Catheter, Visualization, Engagement, Seal Performance, and Withdrawal Performance.	Performed a study to assess fit, visualization, engagement, seal, and withdrawal. (Implicitly met criteria).

1. A table of acceptance criteria and the reported device performance:

(See table above)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size for Test Set: The document does not explicitly state the numerical sample sizes for each specific test (e.g., how many catheters were used for kink resistance, how many animals for animal testing). It lists the types of tests performed.
Data Provenance: Not specified. Standard practice for medical device testing implies that these tests are performed in a controlled laboratory environment. The country of origin of the data is not mentioned and is typically not a requirement for this type of 510(k) submission unless specific clinical trial data from diverse populations is being used. This would be considered prospective bench and animal testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided in the document. For bench and animal testing of this nature, "experts" in the traditional sense of medical specialists establishing ground truth for diagnostic accuracy are not typically involved. The "ground truth" would be defined by engineering specifications and expected physiological responses, assessed by engineers, technicians, and veterinarians.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable to the non-clinical (bench and animal) testing described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly those involving human interpretation of medical images, to resolve discrepancies among expert readers.

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:

No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (catheter), not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with AI assistance is not relevant.

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

No, a standalone algorithm performance study was not done. This device is a medical catheter and does not involve any algorithms or AI.

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

For the non-clinical tests (bench, biocompatibility, sterilization, packaging, shelf life): The "ground truth" is based on engineering specifications, recognized industry standards, and regulatory requirements (e.g., ISO standards for biocompatibility, sterility assurance levels).
For the animal testing: The "ground truth" for performance aspects like fit, visualization, engagement, seal, and withdrawal performance would be based on direct observation and assessment by trained personnel (e.g., veterinarians, researchers) in accordance with study protocols, confirming the device performs as intended within the physiological model.

8. The sample size for the training set:

Not applicable. This document describes the testing of a physical medical device. There is no "training set" in the context of machine learning or AI algorithm development. The device's design is refined through engineering and iterative testing, not through training on a dataset.

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

Not applicable. As there is no training set for an AI algorithm, the concept of establishing ground truth for it does not apply here.

Summary

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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

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

Device Description 4.

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

K131592

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K131592

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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
Deviceperformance	- Catheter Dimensions- Kink Resistance- Torque manipulation and Strength- Air Leak- Seal Manipulation- Dilator Dimensions- Hemostasis Performance- Renal Double Curve Maintenance- Tensile Test- Corrosion Resistance
Biocompatibility	Biological Test- Cytotoxicity- Sensitization- Intracutaneous Reactivity- Acute Systemic Toxicity- PyrogenicityHemocompatibility- Hemolysis- Partial Thromboplastin Time- Complement Activation- In vivo ThromboresistanceChemicalCharacterization- Gas Chromatography with MassSpectrometry (GC/MS) Static andDynamic- Inductively Coupled PlasmaSpectroscopy (ICP)- Fourier Transform InfraredSpectroscopy (FTIR)- Physicochemical – Non VolatileResidue (NVR)
Sterilization/Microbiology	- Sterilization- Ethylene Oxide Residuals- Bioburden- LAL endotoxin
Packaging	- Bubble Leak Test- Visual Inspection- Pouch Seal Strength
Item	Tests
Shelf Life	- 13 Month Accelerated Aging- 13 Month Real Time Aging (In-process)
Animal Testing	Fit of the Dilator and Catheter, Visualization, Engagement,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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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 (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" (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 (800) 638-2041 or (301) 796-7100 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:

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

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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Page 1 of 1

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
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.(b)
Classification. Class II (performance standards).