CONVEY GUIDING CATHETER

K120585 · Pendracare International, B.V. · DQY · Aug 8, 2012 · Cardiovascular

Device Facts

• Record ID: K120585
• Device Name: CONVEY GUIDING CATHETER
• Applicant: Pendracare International, B.V.
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 8, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended 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.

Device Story

Convey™ Guiding Catheter is a flexible, single-use plastic tube used to facilitate the placement of guidewires, diagnostic devices (e.g., IVUS, angiographic catheters), and therapeutic devices (e.g., stents, balloon dilatation catheters) within the coronary or peripheral vascular system. The device features a luer hub, strain relief, and a multi-layered body (inner liner, stainless steel braid reinforcement, outer jacket) with a soft distal tip. Distal sections are pre-shaped (e.g., Judkins, Amplatz, hockey stick) to assist in vessel navigation; some models include side holes for perfusion. Operated by clinicians in a clinical setting, the catheter is inserted percutaneously over a guidewire. The device provides a stable conduit for interventional procedures, allowing the physician to track diagnostic or therapeutic tools to the target location, thereby enabling minimally invasive vascular interventions.

Clinical Evidence

Substantial equivalence supported by non-clinical design verification and two European clinical post-market surveillance studies. Bench testing included shape retention, radial stiffness, kink resistance, coating integrity, friction/wear, tensile strength, and radiopacity. Biocompatibility testing performed per ISO 10993-1 (haemocompatibility, cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity). No clinical performance metrics (e.g., sensitivity/specificity) were required for this device type.

Technological Characteristics

Flexible catheter with luer hub, strain relief, and reinforced body (stainless steel braid between inner liner and outer jacket). Features atraumatic soft tip and optional side holes. Dimensions: 5F and 6F diameters, 100cm length. Materials evaluated per ISO 10993. Sterilization: Ethylene Oxide (EtO). Lubricious polymer coating on outer jacket. Single-use.

Indications for Use

Indicated for use in the coronary or peripheral vascular system to provide a pathway for the introduction of therapeutic and diagnostic devices.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

{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.<br>Van der Waalspark 22<br>9351 VC Leek<br>The Netherlands |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and Information | Bert Roossien, Ph.D.<br>Manager Quality Assurance & Regulatory Affairs<br>PendraCare International B.V.<br>Van der Waalspark 22<br>9351 VC Leek<br>The Netherlands |
| Phone: | [phone] (direct) |
| Phone: | [phone] (general) |
| Fax: | [phone] |
| Email: | [e-mail] |
| 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<br>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<br>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<br>Technological<br>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<br>same function. |
| Strain Relief | Similar design and material serving<br>same function. |
| Body basecoat (inner liner) | Similar design and material and<br>serving same function. |
| Braiding between base and top<br>coat | Same design and material serving<br>same function. |
| Body topcoat (outer jacket) | Similar design and material and<br>serving same function. |
| Polymer coating on top coat for<br>smooth guiding catheter<br>introduction | Lubricious layer not present at top coat<br>of predicate devices |
| Intermediate tip | Similar design and material serving<br>same function. |
| Soft tip | Similar designs with similar material<br>serving same function. |
| Manufacturing Methods | Similar methods (catheter extrusion,<br>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<br>positioned on mounting card in sterile<br>barrier pouch together with an IFU in<br>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 <b>Nature</b> of body contact: |
| | <ul><li>External Communicating Device:</li><li>Circulating blood: devices that contact circulating blood</li></ul> |
| | Categorization by <b>Duration</b> of Contact: |
| | <ul><li>Limited Exposure (A): devices whose single or multiple use or contact is likely to be up to 24 h.</li></ul> |
| | ISO 10993-4: Haemocompatibility: |
| | <ul><li>Hemolysis</li><li>In vitro Haemocompatibility</li><li>Coagulation Tests Prothrombin Time Assay (PT)</li><li>Coagulation Unactivated Partial Thromboplastin Time Assay (UPTT).</li></ul> |
| | 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 |

{4}------------------------------------------------

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.

{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 [phone] or [phone] 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