(266 days)
No reference devices were used in this submission.
No
The description focuses on the physical construction and mechanical function of a catheter and its accessory, with no mention of data processing, algorithms, or learning capabilities. The performance study is an animal study evaluating physical performance, not algorithmic performance.
No.
This device is designed to facilitate the placement of guidewires for other percutaneous interventions, not to directly treat a medical condition.
No
Explanation: The device is described as a "Micro Guide Catheter ELITE accessory" used to "facilitate the intraluminal placement of conventional guide wires beyond stenotic lesions" and to "provide additional support for the Frontrunner® CTO Catheter." Its function is to aid in the physical navigation and placement of other medical tools (guidewires and catheters) for intervention, rather than to gather information about a patient's medical condition or diagnose a disease. While it uses fluoroscopy for visibility, this is for guidance during a procedural intervention, not for diagnostic imaging.
No
The device description clearly details a physical catheter with various material components (PTFE, stainless steel braid, polymer jacket, hydrophilic coating, molded hub, luer fitting, radiopaque marker band) and features designed for physical manipulation within the vasculature. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Micro Guide Catheter ELITE is a medical device used within the body (in vivo) to facilitate the placement of guidewires in the peripheral vasculature during a medical procedure. It is a tool used by a healthcare professional to aid in diagnosis or treatment, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly describes a procedure performed within the peripheral vasculature.
- Device Description: The description details the physical components and function of a catheter designed for navigation within blood vessels.
- Performance Studies: The performance study described is an animal study evaluating the device's performance and safety during an in-vivo procedure.
Therefore, the Micro Guide Catheter ELITE falls under the category of an in-vivo medical device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Micro Guide Catheter ELITE accessory is to be used with the Frontrumer® CTO Catheter. The Frontrumer® CTO Catheter is intended to facilitate the intraluminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention.
Product codes
PDU
Device Description
The Micro Guide Catheter ELITE is a 6F sheath compatible catheter designed to navigate and place guidewires in the peripheral vasculature and to provide additional support for the Frontrunner® CTO Catheter. The Frontrunner® CTO Catheter is indicated to facilitate the intraluminal placement of conventional guidewires beyond the stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention. The Micro Guide Catheter ELITE is a single lumen torqueable tube containing a PTFE inner liner that is surrounded by a stainless steel braid, which is further encompassed by a polymer jacket, and features a final external hydrophilic coating. The proximal end utilizes a molded hub with a luer fitting for flushing, with winged tabs designed to facilitate maneuvering and torqueing in the vasculature, while the distal tip contains a radiopaque marker band for visibility under fluoroscopy. The Micro Guide Catheter ELITE is available in various configurations and several lengths.
The Micro Guide Catheter ELITE is provided sterile (by EO) and is intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Peripheral 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
Biocompatibility evaluation for the Micro Guide Catheter ELITE (subject device) leveraged the existing biocompatibility test data generated for the Micro Guide Catheter XP (predicate device). Supplemental biocompatibility testing to support the Micro Guide Catheter ELITE was performed on finished and sterilized catheters in compliance with U.S. Food and Drug Administration Good Laboratory Practice (GLP) regulations set forth in 21 CFR Part 58 and per ISO 10993-1:2009/Cor 1:2010 Biological evaluation of medical devices - Part 1. Supplemental Biocompatibility testing included In vitro Cytotoxicity - MEM Elution, In vitro Hemolysis - ASTM Extract & Direct Contact, and USP Containers - Plastics, Physicochemical Tests. Extraction testing was also conducted.
Device Dimensional and Functional Testing included Dimensional, Tensile, Leak, Coating integrity, Lubricity, Stiffness and pushability, Kink, Torque strength and torque transmission, Corrosion resistance, Particulate, and Simulated use.
Packaging and Sterilization tests included Bioburden, EO residuals, and Bacterial Endotoxin.
Cordis conducted a GLP animal study to evaluate the performance of Micro Guide Catheter Elite under simulated conditions in a porcine model. Two animals were utilized for the acute evaluations in the peripheral vasculature. Four devices (2 test articles and 2 control articles) were evaluated in each animal and scored for radiopacity and the ability to rotate, advance and retract the devices. No procedure-related complications or deaths were reported. Evaluation arteries were grossly evaluated in situ, and following excision, they were longitudinally cut and evaluated for signs of damage or trauma. There was no evidence of tissue damage or perforation. This study demonstrated that the angled tip and added stiffness of the Micro Guide Catheter ELITE relative to the predicate device does not increase the risk of vessel damage or perforation.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting a sense of community and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the figure in a circular pattern.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 14, 2014
Cordis Corporation Dr. Michelle Ragozzino Rodgers Sr. Regulatory Affairs Specialist 6500 Paseo Padre Pkwy. Fremont, CA 94555
Re: K140438
Trade/Device Name: Micro Guide Catheter ELITE Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: October 9, 2014 Received: October 10, 2014
Dear Dr. Rodgers.
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
1
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 Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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
Enclosure
2
Indications for Use
510(k) Number (if known) K140438
Device Name Micro Guide Catheter ELITE
Indications for Use (Describe)
The Micro Guide Catheter ELITE accessory is to be used with the Frontrumer® CTO Catheter. The Frontrumer® CTO Catheter is intended to facilitate the intraluminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|
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510(k) SUMMARY
-SUBMITTER
Cordis Corporation, a Johnson & Johnson Company 6500 Paseo Padre Parkway Fremont, CA 94555
Contact Person: Michelle Ragozzino Rodgers, Ph.D. (510) 248-2450 Tel: Fax: (510) 248-2533
Date Prepared: October 9, 2014
II. DEVICE
Name of Device: Micro Guide Catheter ELITE Common Name: Percutaneous catheter Classification Name: Catheter for Crossing Total Occlusions (21 CFR §870.1250) Requlatory Class: Class II Product Code: PDU
III. PREDICATE DEVICE
Micro Guide Catheter XP, previously cleared under K082143 This predicate has not been the subject of a recall.
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
The Micro Guide Catheter ELITE is a 6F sheath compatible catheter designed to navigate and place guidewires in the peripheral vasculature and to provide additional support for the Frontrunner® CTO Catheter. The Frontrunner® CTO Catheter is indicated to facilitate the intraluminal placement of conventional guidewires beyond the stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention. The Micro Guide Catheter ELITE is a single lumen torqueable tube containing a PTFE inner liner that is surrounded by a stainless steel braid, which is further encompassed by a polymer jacket, and features a final external hydrophilic coating. The proximal end utilizes a molded hub with a luer fitting for flushing, with winged tabs designed to facilitate maneuvering and torqueing in the vasculature, while the distal tip contains a radiopaque marker band for visibility under
4
fluoroscopy. The Micro Guide Catheter ELITE is available in various configurations and several lengths.
The Micro Guide Catheter ELITE is provided sterile (by EO) and is intended for single use only.
V. INDICATIONS FOR USE
The Micro Guide Catheter ELITE accessory is to be used with the Frontrunner® CTO Catheter. The Frontrunner® CTO Catheter is intended to facilitate the intraluminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject Micro Guide Catheter ELITE is identical in intended use to the predicate Micro Guide Catheter XP. No change was made to the operating principle or control mechanism. At a high level, the subject and predicate devices are based on the following same technological elements:
- Catheter-Facilitates placement of and provides support to Frontrunner® XP CTO ● Catheter
- Use of marker bands and radiopaque materials for fluoroscopic visualization of catheter . tip
- 6F Sheath compatibility
- Use of hydrophilic coating for distal lubricity to advance through lesion
- Use of a standard male luer fitting for flush port ●
- EO sterilized, single use device ●
The changes to the subject device relative to the predicate are limited to minor modifications to the catheter shaft and tip and an improved packaging design. The following technological differences exist between the subject and the predicate devices:
- . Modified shaft
- Distal tip shape
- Packaging size reduction and associated packaging material change ●
5
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination:
Biocompatibility Testing
Biocompatibility evaluation for the Micro Guide Catheter ELITE (subject device) leveraged the existing biocompatibility test data qenerated for the Micro Guide Catheter XP (predicate device). Supplemental biocompatibility testing to support the Micro Guide Catheter ELITE was performed on finished and sterilized catheters in compliance with U.S. Food and Drug Administration Good Laboratory Practice (GLP) requlations set forth in 21 CFR Part 58 and per ISO 10993-1:2009/Cor 1:2010 Biological evaluation of medical devices - Part 1. Supplemental Biocompatibility testing included the following tests:
- o In vitro Cytotoxicity - MEM Elution
- o In vitro Hemolysis - ASTM Extract & Direct Contact
- o USP Containers - Plastics, Physicochemical Tests
Extraction testing was also conducted on the Micro Guide Catheter ELITE.
Device Dimensional and Functional Testing
- Dimensional
- o Tensile
- o Leak
- Coating integrity
- Lubricity
- Stiffness and pushability o
- Kink
- Torque strength and torque transmission
- Corrosion resistance
- Particulate ●
- o Simulated use
Packaging and Sterilization
- Bioburden
- EO residuals ●
- Bacterial Endotoxin ●
6
Animal Study
Cordis conducted a GLP animal study to evaluate the performance of Micro Guide Catheter Elite under simulated conditions in a porcine model. Two animals were utilized for the acute evaluations in the peripheral vasculature. Four devices (2 test articles and 2 control articles) were evaluated in each animal and scored for radiopacity and the ability to rotate, advance and retract the devices. No procedure-related complications or deaths were reported. Evaluation arteries were grossly evaluated in situ, and following excision, they were longitudinally cut and evaluated for signs of damage or trauma. There was no evidence of tissue damage or perforation. This study demonstrated that the angled tip and added stiffness of the Micro Guide Catheter ELITE relative to the predicate device does not increase the risk of vessel damage or perforation.
VIII. CONCLUSIONS
The subject Micro Guide Catheter ELITE is the same in basic design and identical intended use as the legally marketed predicate, Micro Guide Catheter XP. The minor modifications made to the catheter shaft and tip and improved packaging design for Micro Guide Catheter ELITE product family do not alter the fundamental scientific technology of the device's operating principles, mechanism of action, or the indication for the use of device. The design modifications made to the Micro Guide Catheter ELITE were verified and validated through a series of tests ensuring that the subject catheter meets the specifications and that the performance and functionality are substantially equivalent to the predicate device. The Micro Guide Catheter ELITE continues to meet all previous performance specifications, and none of the critical clinical performance parameters have changed. The modifications do not raise new questions of safety and effectiveness. Micro Guide Catheter ELITE can be used according to its intended use and in an equivalent manner to the predicate device.