(242 days)
Not Found
No
The 510(k) summary describes a physical guiding catheter and dilator system used for accessing renal arteries. There is no mention of software, algorithms, AI, or ML capabilities in the device description, intended use, or performance studies.
No
The device is a guiding catheter system intended to facilitate the introduction of other diagnostic and interventional devices into the renal arterial vasculature, rather than directly treating a condition itself.
No
Explanation: The device is described as a "Renal Guiding Catheter system" whose "Intended Use / Indications for Use" is to "facilitate a pathway to introduce interventional and diagnostic devices into the renal arterial vasculature." This indicates it is a pathway device for other tools, not a diagnostic device itself.
No
The device description clearly outlines physical components like a catheter assembly, dilator, hub, and tubing, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate a pathway to introduce interventional and diagnostic devices into the renal arterial vasculature." This describes a device used in vivo (within the body) for accessing a specific anatomical location.
- Device Description: The description details a catheter designed for insertion into blood vessels, with features like a usable length, outside diameter, distal tip, hub, and dilator. These are characteristics of a medical device used for accessing and navigating within the body.
- Anatomical Site: The device is intended for the "Renal arterial vasculature," which is a part of the circulatory system within the body.
- Input Imaging Modality: The mention of "Fluoroscopy" indicates the device is used in conjunction with imaging techniques to visualize its placement within the body.
- Performance Studies: The performance studies involve "bench and animal testing," which are typical for in vivo medical devices.
- Predicate Device: The predicate device is a "Guide Catheter," which is also an in vivo medical device used for accessing blood vessels.
In Vitro Diagnostic (IVD) devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
DQY
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
renal arterial vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Summary of the bench and performance testing conducted is listed below:
Device performance:
- 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
- Pyrogenicity
Hemocompatibility - Hemolysis
- Partial Thromboplastin Time
- Complement Activation
- In vivo Thromboresistance
Chemical Characterization - Gas Chromatography with Mass Spectrometry (GC/MS) Static and Dynamic
- Inductively Coupled Plasma Spectroscopy (ICP)
- Fourier Transform Infrared Spectroscopy (FTIR)
- Physicochemical – Non Volatile Residue (NVR)
Sterilization/Microbiology:
- Sterilization
- Ethylene Oxide Residuals
- Bioburden
- LAL endotoxin
Packaging:
- Bubble Leak Test
- Visual Inspection
- Pouch Seal Strength
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
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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p. 2 of 5
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
2
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
3
Performance Testing Summary
| Item | Tests |
|---|---|
| Device | |
| performance | - 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
- Pyrogenicity
Hemocompatibility - Hemolysis
- Partial Thromboplastin Time
- Complement Activation
- In vivo Thromboresistance
Chemical
Characterization - Gas Chromatography with Mass
Spectrometry (GC/MS) Static and
Dynamic - Inductively Coupled Plasma
Spectroscopy (ICP) - Fourier Transform Infrared
Spectroscopy (FTIR) - Physicochemical – Non Volatile
Residue (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 |
·
4
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.
5
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
6
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
7
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)
Image /page/7/Picture/13 description: The image shows the name "Kenneth J. Cavanaugh -S" in a bold, sans-serif font. The name is written in black ink on a white background. The letters are evenly spaced and the name is easy to read. The text appears to be a signature or a nameplate.
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