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.

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 After finalizing the procedure, the catheter is withdrawn, removed and discarded.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).

AI/ML Overview

The PendraCare Convey™ Guiding Catheter (K120585) obtained 510(k) clearance by demonstrating substantial equivalence to predicate devices, namely the Medtronic Launcher™ Guide Catheter (5F and 6F). The device met its acceptance criteria through a combination of non-clinical design verification tests, biocompatibility testing, and two European clinical post-market surveillance studies.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Characteristic	Acceptance Criteria	Reported Device Performance (Summary)
Biocompatibility	Hemolysis (ISO 10993-4)	Pass	Compliant (Implied by "completed")
	In vitro Haemocompatibility (ISO 10993-4)	Pass	Compliant (Implied by "completed")
	Coagulation Tests PT (ISO 10993-4)	Pass	Compliant (Implied by "completed")
	Coagulation UPTT (ISO 10993-4)	Pass	Compliant (Implied by "completed")
	Cytotoxicity (ISO 10993-5, MEM-elution)	Pass	Compliant (Implied by "completed")
	Ethylene Oxide Sterilization Residuals (ISO 10993-7)	Pass	Compliant (Implied by "completed")
	Sensitization (ISO 10993-10)	Pass	Compliant (Implied by "completed")
	Irritation/Intracutaneous Reactivity (ISO 10993-10)	Pass	Compliant (Implied by "completed")
	Acute Systemic Toxicity (ISO 10993-11)	Pass	Compliant (Implied by "completed")
	Material Mediated Pyrogenicity (ISO 10993-11)	Pass	Compliant (Implied by "completed")
	Packaging Plastic Containers Leachables (USP <661>)	Pass	Compliant (Implied by "completed")
	Endotoxin-Mediated Pyrogenicity (USP <85>)	Pass	Compliant (Implied by "completed")
	Particulate Testing (USP <788>)	Pass	Compliant (Implied by "completed")
In-vitro Performance	Shape Conformance (Shape retention)	Maintain defined shape characteristics	Compliant (Implied by "completed")
	Inner Diameter	Within specified range	Compliant (Implied by "completed")
	Outer Diameter	Within specified range	Compliant (Implied by "completed")
	Catheter Usable Length	Within specified range	Compliant (Implied by "completed")
	Coating Length	Within specified range	Compliant (Implied by "completed")
	C-Kink (Bending Kink Diameter)	Meet minimum bending radii without kinking	Compliant (Implied by "completed")
	Euler Kink (Axial Kink Displacement)	Meet axial flexibility requirements	Compliant (Implied by "completed")
	Radial Stiffness (Collapse)	Resist collapse under specified pressure	Compliant (Implied by "completed")
	Coating Integrity (Visual Inspection)	Free from defects	Compliant (Implied by "completed")
	Outer Friction & Wear (Coating Integrity functional test)	Maintain functional integrity	Compliant (Implied by "completed")
	Three Point Bending Test (Bending Stiffness Body)	Meet flexibility specifications	Compliant (Implied by "completed")
	Pull Force (after simulated use)	Meet specified force retention	Compliant (Implied by "completed")
	Radiopacity	Clearly visible under fluoroscopy	Compliant (Implied by "completed")
	Torque Strength	Withstand specified torque without failure	Compliant (Implied by "completed")
Clinical Performance	Post Market Surveillance (Comparison) Studies	No new safety or performance issues compared to predicate devices	Substantial equivalence demonstrated

Note: The document states that the tests were "completed" and their results "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." This implicitly indicates that the device met its acceptance criteria for each test.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Test Set: Not explicitly stated for each test. For biocompatibility and in-vitro performance, the sample sizes would be determined by the specific ISO/USP standards. For the clinical studies, the sample size is also not specifically mentioned, only that there were "two European clinical post market surveillance (comparison) studies."
Data Provenance:
- Biocompatibility and In-vitro Performance: Laboratory testing.
- Clinical Studies: Retrospective/Prospective (not specified, but likely retrospective given they are "post market surveillance" studies on existing device types, although comparison studies could be prospective). The country of origin is Europe.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the given text. For the bench testing and biocompatibility, expert interpretation may be involved in assessing results, but the document does not detail this. For the clinical post-market surveillance studies, the "ground truth" would be clinical outcomes and comparative performance data, which would typically be assessed by medical professionals in a clinical setting, but the number and qualifications of experts are not described.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

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 PendraCare Convey™ Guiding Catheter is a medical device (catheter), not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this submission.

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

No. As stated above, this is a physical medical device, not an algorithm or AI system. Standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

For biocompatibility and in-vitro performance tests, the "ground truth" is defined by the specific requirements and benchmarks set forth in the referenced ISO and USP standards. Meeting these standards is considered the ground truth for safety and performance characteristics.
For the clinical post-market surveillance studies, the "ground truth" would refer to the observed clinical outcomes and performance of the device in comparison to the predicate devices in real-world clinical use. This would generally involve patient data, procedural success rates, and adverse event reporting.

8. The Sample Size for the Training Set

Not Applicable. This submission is for a physical medical device. There is no machine learning algorithm involved that would require a "training set."

9. How the Ground Truth for the Training Set was Established

Not Applicable. As no training set is used for this device.

Summary

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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 229351 VC LeekThe Netherlands
Contact Name and Information	Bert Roossien, Ph.D.Manager Quality Assurance & Regulatory AffairsPendraCare International B.V.Van der Waalspark 229351 VC LeekThe 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)

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	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 ofDevice	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 forUse	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 ofTechnologicalCharacteristics	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 servingsame function.
Strain Relief	Similar design and material servingsame function.
Body basecoat (inner liner)	Similar design and material andserving same function.
Braiding between base and topcoat	Same design and material servingsame function.
Body topcoat (outer jacket)	Similar design and material andserving same function.
Polymer coating on top coat forsmooth guiding catheterintroduction	Lubricious layer not present at top coatof predicate devices
Intermediate tip	Similar design and material servingsame function.
Soft tip	Similar designs with similar materialserving 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 ( catheterpositioned on mounting card in sterilebarrier pouch together with an IFU incarton box)

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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<87>)
	ISO 10993-7: Ethylene Oxide Sterilization Residuals
	ISO 10993-10: Sensitization (USP<1184>)
	ISO 10993-10: Irritation / Intracutaneous Reactivity (USP <88>)
	ISO 10993-11: Acute Systemic Toxicity (USP <88>)
	ISO 10993-11: Material Mediated Pyrogenicity (USP <35>)
	USP <661>: Packaging Plastic Containers Leachables

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Additional USP tests conducted:

USP <85> Endotoxin-Mediated Pyrogenicity

USP <788> 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.

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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.

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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

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Indications for Use Statement

510(k) Number (if known): K120585

Device Name: Convey™ 5F Guiding Catheter,

Convey™ 6F Guiding Catheter

Indications for Use:

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

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).