Predicate Devices

Medtronic Launcher™ Guide Catheter (6F) K021256, Medtronic Launcher™ Guide Catheter (5F) K030779

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use clearly define a physical medical device (a guiding catheter) used for delivering other devices. There is no mention of software, algorithms, data processing, or any components that would suggest the use of AI or ML. The performance studies focus on physical characteristics and biocompatibility.

Therapeutic

No.
The device description states it is a "Guiding Catheter" designed to "provide a pathway through which therapeutic and diagnostic devices are introduced," which means it facilitates the use of therapeutic devices rather than being one itself. Additionally, its GMDN definition explicitly states it is used for the "passage and placement of guidewires and diagnostic and therapeutic devices."

Diagnostic

No.
The device is a guiding catheter, designed to create a pathway for the introduction of other therapeutic and diagnostic devices, not to perform diagnostics itself. The text explicitly states it facilitates the passage of "diagnostic devices (angiographic catheter, IVUS-catheter)".

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical, flexible plastic tube with various components and a central lumen for introducing other devices. It is a hardware device.

IVD (In Vitro Diagnostic)

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. They are used to provide information for diagnosis, monitoring, or screening.
Device Function: The description clearly states that the guiding catheter is a tool used to introduce other therapeutic and diagnostic devices into the vascular system. It provides a pathway for these other devices. It does not perform any diagnostic testing on a sample taken from the body.
Intended Use: The intended use is to provide a pathway for other devices within the coronary or peripheral vascular system. This is an interventional procedure, not an in vitro diagnostic test.
Device Description: The description focuses on the physical structure and function of the catheter as a conduit. There is no mention of reagents, assays, or analysis of biological samples.
GMDN Code: The GMDN code 17846 and its definition align with a cardiovascular catheter used for introducing devices, not an IVD.

In summary, the guiding catheter is a medical device used in interventional procedures to facilitate the delivery of other devices. It does not perform any diagnostic testing on biological samples, which is the defining characteristic of an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Convey Guiding Catheter is designed to provide a pathway through which therapeutic and diagnostic devices are introduced. The Convey Guiding Catheter is intended to be used in the coronary or peripheral vascular system.

Product codes (comma separated list FDA assigned to the subject device)

DQY, 74 DQY

Device Description

The guiding catheter is a flexible plastic tube featuring a luer hub, a strain relief, a body, an intermediate tip, and a soft tip. The body and the intermediate tip exist of an inner liner (basecoat) and a outer jacket (topcoat) reinforced with a tightly wound stainless steel braid wire in between the layers. The central lumen of the catheter is used for the percutaneous, transluminal passage and placement of guidewires, diagnostic and therapeutic devices within the vascular system. After the catheter is inserted through the skin using a dilator, a sheath (introducer) and a guide wire it is brought into position. Subsequently, a guidewire is advanced through its lumen and tracked over by a diagnostic device (angiographic catheter, IVUS-catheter) and/or a therapeutic device (e.g., balloon dilatation catheter, stent and delivery system, embolization device) to the intended location. The distal section of the catheter has a variety of preformed shapes (e.g., Judkins Left (abbreviated as JL), Judkins Right (JR), Amplatz (AL), Multi-purpose, hockey stick) to facilitate placement of the catheter tip in the desired target vessel. Some catheter models feature two (2) small "in-line" side holes in the intermediate tip section to maintain perfusion of the target vessel. This device is a single-use device (i.e., single patient, single procedure, single purpose use). After finalizing the procedure, the catheter is withdrawn, removed and discarded. The intravascular guiding catheter is a cardiovascular catheter with GMDN-code 17846 (and ECRI-code 17846) with GMDN definition: A flexible tube with a central lumen used for the percutaneous, transluminal passage and placement of guidewires and diagnostic and therapeutic devices within the vascular system. After the tube is inserted in position, a guidewire is advanced through its lumen and tracked over by a diagnostic / therapeutic device (e.g., balloon dilatation catheter, stent and delivery system, or embolization device) to the intended location. The distal section of the tube can have a variety of preformed shapes (e.g., straight, multi- purpose, hockey stick, renal double curve); This is a single-use device. (Reference www.GMDNagency.org).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

coronary or peripheral vascular system

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)

Substantial Equivalence of the Convey™ Guiding Catheter with the predicate devices has been demonstrated via data collected from non-clinical design verification tests and two European clinical post market surveillance (comparison) studies (design validation). Biocompatibility of the device was tested in several biological evaluation tests completed per current ISO 10993-series of standards. Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing.

The following biocompatibility tests were completed on the Convey™ Guiding Catheter considering Categorization per Material Characterization for Medical Application per ISO 10993-1 and USP.
Categorization by Nature of body contact: External Communicating Device: Circulating blood: devices that contact circulating blood
Categorization by Duration of Contact: Limited Exposure (A): devices whose single or multiple use or contact is likely to be up to 24 h.
ISO 10993-4: Haemocompatibility: Hemolysis, In vitro Haemocompatibility, Coagulation Tests Prothrombin Time Assay (PT), Coagulation Unactivated Partial Thromboplastin Time Assay (UPTT).
ISO 10993-5: Cytotoxicity - MEM-elution (USP)
ISO 10993-7: Ethylene Oxide Sterilization Residuals
ISO 10993-10: Sensitization (USP)
ISO 10993-10: Irritation / Intracutaneous Reactivity (USP )
ISO 10993-11: Acute Systemic Toxicity (USP )
ISO 10993-11: Material Mediated Pyrogenicity (USP )
USP : Packaging Plastic Containers Leachables
Additional USP tests conducted:
USP Endotoxin-Mediated Pyrogenicity
USP Particulate testing (light obscuration) (after simulated use)

The following in-vitro performance tests (following simulated use, if applicable) were completed of the Convey™ Guiding Catheter:
Shape Conformance (Shape retention) - Inner Diameter - Outer Diameter - Catheter Usable Length - Coating Length - C-Kink (Bending Kink Diameter) - Euler Kink (Axial Kink Displacement) - Radial Stiffness (Collapse) - Coating Integrity (Visual Inspection) - Outer Friction & Wear (Coating Integrity functional test) - Three Point Bending Test (Bending Stiffness Body) - Pull Force (after simulated use) - Radiopacity - Torque Strength.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Medtronic Launcher™ Guide Catheter (6F) K021256, Medtronic Launcher™ Guide Catheter (5F) K030779

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

K120585

Traditional 510(k) Notification
PendraCare Convey™ Guiding Catheter

AUG 8 2012

510(k) Summary

per 21 CFR §807.92

| Submitter's Name and Address | PendraCare International B.V.
Van der Waalspark 22
9351 VC Leek
The Netherlands |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and Information | Bert Roossien, Ph.D.
Manager Quality Assurance & Regulatory Affairs
PendraCare International B.V.
Van der Waalspark 22
9351 VC Leek
The Netherlands |
| Phone: | +31 594 554 077 (direct) |
| Phone: | +31 594 510 755 (general) |
| Fax: | +31 594 510 769 |
| Email: | broossien@pendracare.com |
| Date Prepared | 08 August, 2012 |
| Proprietary Name | Convey™ Guiding Catheter |
| Common Name | Percutaneous Catheter |
| Classification | Class II, 21 CFR Part 870.1250 |
| Review Panel | Cardiovascular |
| Product Code | DQY |
| Product Definition | 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 | Medtronic Launcher™ Guide Catheter (6F) K021256 17 May 2002 |
| | Medtronic Launcher™ Guide Catheter (5F) K030779 24 April 2003 |
| Device Description | The guiding catheter is a flexible plastic tube featuring a luer hub, a strain relief, a body, an intermediate tip, and a soft tip. The body and the intermediate tip exist of an inner liner (basecoat) and a outer jacket (topcoat) reinforced with a tightly wound stainless steel braid wire in between the layers. The central lumen of the catheter is used for the percutaneous, transluminal passage and placement of guidewires, diagnostic and therapeutic devices within the vascular system. After the catheter is inserted through the skin using a dilator, a sheath (introducer) and a guide wire it is brought into position. Subsequently, a guidewire is advanced through its lumen and tracked over by a diagnostic device (angiographic catheter, IVUS-catheter) and/or a therapeutic device (e.g., balloon dilatation catheter, stent and delivery system, embolization device) to the intended location. The distal section of the catheter has a variety of preformed shapes (e.g., Judkins Left (abbreviated as JL), Judkins Right (JR), Amplatz (AL), Multi-purpose, hockey stick) to facilitate placement of the catheter tip in the desired target vessel. Some catheter models feature two (2) |

1

.

	small "in-line" side holes in the intermediate tip section to maintain perfusion of the target vessel. This device is a single-use device (i.e., single patient, single procedure, single purpose use). After finalizing the procedure, the catheter is withdrawn, removed and discarded. The intravascular guiding catheter is a cardiovascular catheter with GMDN-code 17846 (and ECRI-code 17846) with GMDN definition: A flexible tube with a central lumen used for the percutaneous, transluminal passage and placement of guidewires and diagnostic and therapeutic devices within the vascular system. After the tube is inserted in position, a guidewire is advanced through its lumen and tracked over by a diagnostic / therapeutic device (e.g., balloon dilatation catheter, stent and delivery system, or embolization device) to the intended location. The distal section of the tube can have a variety of preformed shapes (e.g., straight, multi- purpose, hockey stick, renal double curve); This is a single-use device. (Reference www.GMDNagency.org).
Intended Use of
Device	The Convey Guiding Catheter is designed to provide a pathway through which therapeutic and diagnostic devices are introduced. The Convey Guiding Catheter is intended to be used in the coronary or peripheral vascular system.
Indications for
Use	The Convey Guiding Catheter is designed to provide a pathway through which therapeutic and diagnostic devices are introduced. The Convey Guiding Catheter is intended to be used in the coronary or peripheral vascular system.
Comparison of
Technological
Characteristics	The Convey™ 5F Guiding Catheter and Convey™ 6F Guiding Catheter incorporate substantially equivalent device materials and design, packaging materials and design, fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the predicate devices, the Medtronic Launcher 6F Guide Catheter (K021256) and the Medtronic Launcher 5F Guide Catheter (K030779).

Comparison to Predicate Devices Characteristics

Convey Characteristic	Medtronic Launcher 5F & 6F
Diameters 5F and 6F	Same diameters serving same function.
Effective Length 100cm	Same length.
Side holes 0 or 2	Same
Various pre-shaped distal catheter tip shape configurations that enable proper catheter positioning in target vessel	Equivalent distal catheter tip shapes
Atraumatic distal soft tip	Similar distal soft tip and same function.
Convey Characteristic	Medtronic Launcher 5F & 6F
Luer Hub	Similar design and material serving
same function.
Strain Relief	Similar design and material serving
same function.
Body basecoat (inner liner)	Similar design and material and
serving same function.
Braiding between base and top
coat	Same design and material serving
same function.
Body topcoat (outer jacket)	Similar design and material and
serving same function.
Polymer coating on top coat for
smooth guiding catheter
introduction	Lubricious layer not present at top coat
of predicate devices
Intermediate tip	Similar design and material serving
same function.
Soft tip	Similar designs with similar material
serving same function.
Manufacturing Methods	Similar methods (catheter extrusion,
catheter distal tip shaping, packaging)
Intended use	Same
Operating principle	Same
Sterilization Method	Same method (EtO sterilization)
Single use device	same
SAL	Same level of assurance.
Packaging process and design	Similar process and design ( catheter
positioned on mounting card in sterile
barrier pouch together with an IFU in
carton box)

2

Comparison of Technological

Characteristics (Continued)

Comparison to Predicate Devices in Materials and Manufacturing

3

Performance Data	Substantial Equivalence of the Convey™ Guiding Catheter with the predicate devices has been demonstrated via data collected from non-clinical design verification tests and two European clinical post market surveillance (comparison) studies (design validation). Biocompatibility of the device was tested in several biological evaluation tests completed per current ISO 10993-series of standards.
	Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing.
	The following biocompatibility tests were completed on the Convey™ Guiding Catheter considering Categorization per Material Characterization for Medical Application per ISO 10993-1 and USP.
	Categorization by Nature of body contact:
	External Communicating Device:Circulating blood: devices that contact circulating blood
	Categorization by Duration of Contact:
	Limited Exposure (A): devices whose single or multiple use or contact is likely to be up to 24 h.
	ISO 10993-4: Haemocompatibility:
	HemolysisIn vitro HaemocompatibilityCoagulation Tests Prothrombin Time Assay (PT)Coagulation Unactivated Partial Thromboplastin Time Assay (UPTT).
	ISO 10993-5: Cytotoxicity - MEM-elution (USP)
	ISO 10993-7: Ethylene Oxide Sterilization Residuals
	ISO 10993-10: Sensitization (USP)
	ISO 10993-10: Irritation / Intracutaneous Reactivity (USP )
	ISO 10993-11: Acute Systemic Toxicity (USP )
	ISO 10993-11: Material Mediated Pyrogenicity (USP )
	USP : Packaging Plastic Containers Leachables

4

Additional USP tests conducted:

USP Endotoxin-Mediated Pyrogenicity

USP Particulate testing (light obscuration) (after simulated use)

The following in-vitro performance tests (following simulated use, if applicable) were completed of the Convey™ Guiding Catheter:

Shape Conformance (Shape retention) -
-Inner Diameter
-Outer Diameter
-Catheter Usable Length
-Coating Length
・ C-Kink (Bending Kink Diameter)
-Euler Kink (Axial Kink Displacement)
Radial Stiffness (Collapse) -
Coating Integrity (Visual Inspection) ・
Outer Friction & Wear (Coating Integrity functional test) .
Three Point Bending Test (Bending Stiffness Body) ・
-Pull Force (after simulated use)
Radiopacity -
Torque Strength •

Conclusion

In summary, the subject PendraCare's Convey™ 5F Guiding Catheter and Convey™ 6F Guiding Catheter are substantial equivalent to the predicate devices Medtronic's 5F Launcher Guide Catheter (#K030779 dated April 24, 2003)] and Medtronic's 6F Launcher Guide Catheter (# K021256 dated May 17, 2002) with respect to the intended use, operating principles, fundamental design, catheter dimensions, materials, technology, packaging, labeling and sterility.

5

DEPARTMENT OF HEALTH & HUMAN SERVICES

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" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Public Health Service

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

8 2012 AUG

PendraCare International B.V. c/o Corvitex Corporation Tom Nolan Managing Director 7205 Laketree Drive Raleigh, North Carolina 27615

Re: K120585

Trade/Device Name: Convey™ 5F Guiding Catheter; Convey ™ 6F Guiding Catheter Regulatory Number: 21 CFR Part 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II (two) Product Code: 74 DQY Dated: July 30, 2012 Received: July 31, 2012

Dear Mr. Nolan:

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 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.

6

Page 2 – Tom Nolan

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 yours.

M.y. Killehan

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

Enclosure

7

Indications for Use Statement

510(k) Number (if known): K120585

Device Name: Convey™ 5F Guiding Catheter,

Convey™ 6F Guiding Catheter

Indications for Use:

The Guiding Catheter is designed to provide a pathway through which therapeutic and diagnostic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.

Prescription Use _ × (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-C Division of Cardiovascular Devices

Page 1 of 1

X120585 510(k) Number