IntraNovo 25 Microcatheter

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The image is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 23, 2015 Texas Medical Technologies, Inc. % Viviana Gonzalez Consultant Pomamed Consulting LLC Po Box 9818 San Juan, PR 00908-0818 Re: K142817 > Trade/Device Name: IntraNovo 25 Microcatheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DOO Dated: March 9, 2015 Received: March 18, 2015 Dear Viviana Gonzalez, 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 {1}------------------------------------------------ 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 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, # Bram D. Zuckerman -S Bram D. Zuckerman, ivi.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) K142817 Device Name IntraNovo 25 Microcatheter #### Indications for Use (Describe) The IntraNovo 25 Microcatheter is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremities, and all coronary vessels. The Microcatheter is also intended for drug infusion in intra-arterial therapy and infusion of embolic materials for hemostasis. The Microcatheter should not be used in cerebral vessels. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------| | <div> <span> <b> </b> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 1 – Company Information & Contact Person | Company Name: | Texas Medical Technologies Inc. | |------------------|----------------------------------------------------| | Company Address: | 9005 Montana Ave. Ste. A<br>El Paso, Texas 79925 | | Telephone: | (915) 774-4321 | | Fax: | (915) 774-4323 | | Contact Person: | Cesar Rios, Quality Assurance & Regulatory Manager | | Date Prepared: | 4/22/2015 | 2 - Device Name & Classification | Proprietary Name: | IntraNovo 25 | |----------------------|-----------------------------------| | Common Name: | Microcatheter | | Classification Name: | Diagnostic Intravascular Catheter | | Regulation Number: | 21 CFR 870.1200 | | Product Code: | DQO | | Device Class: | II | #### 3 - Predicate Device Legally Marketed Substantially Equivalent Predicate Device | Proprietary Name: | PROGREAT | |----------------------|-----------------------------------| | Company Name: | Terumo Medical Corporation | | Common Name: | Catheter | | Classification Name: | Diagnostic Intravascular Catheter | | Regulation Number: | 21 CFR 870.1200 | | Product Code: | DQO | | Device Class: | II | | 510(k) Number: | K033583 | #### 4 - Device Description The IntraNovo 25 Microcatheter (the "IntraNovo 25" or the "Microcatheter") is an infusion catheter intended for intravascular use. The Microcatheter consists of a single lumen. The shaft consists of a lubricous inner liner made from polytetraflouroethylene (PTFE) with a stainless steel coil over the inner liner. The outer liner consists of different lengths of colored polyether block amide with varying durometers hardness. A lubricious hydrophilic coating covers the distal end of the IntraNovo 25 Microcatheter. Depending on the model, one or two radiopaque marker bands are placed at the distal end of the Microcatheter and {4}------------------------------------------------ above the stainless steel coil. A polycarbonate hub is attached to the proximal end of the Microcatheter with a strain relief placed over the distal end of the hub. The device shaft has an outer diameter of 2.9 French size on the proximal end and 2.7 French size on the distal end with an inner diameter of 0.025" throughout the shaft. The device is available in lengths of 110 cm, 130 cm, and 150 cm. The following accessories are included with the Microcatheter: a stainless steel steam shaping mandrel to allow for manual shaping of the distal tip and a 3.0 mL svringe. The device is supplied sterile and is intended for single use. The following table lists the models and sizes available for the IntraNovo 25 Microcatheter. | Design &<br>Development<br>Model Number | Commercial<br>Model Number | Shaft<br>Length<br>(cm) | Outer Diameter | | Inner<br>Diameter | Marker Band<br>Configuration | Tip Shape | |-----------------------------------------|----------------------------|-------------------------|----------------|---------|-------------------|------------------------------|-------------------------| | SMC-25110-S | MC-2711-2SN | 110 | 2.7 Fr. | 2.9 Fr. | 0.025" | 2 Marker Bands | Straight<br>(shapeable) | | SMC-25130-S | MC-2713-2SN | 130 | 2.7 Fr. | 2.9 Fr. | 0.025" | 2 Marker Bands | Straight<br>(shapeable) | | SMC-25150-S | MC-2715-2SN | 150 | 2.7 Fr. | 2.9 Fr. | 0.025" | 2 Marker Bands | Straight<br>(shapeable) | | SMC-25110-1S | MC-2711-1SN | 110 | 2.7 Fr. | 2.9 Fr. | 0.025" | 1 Marker Band | Straight<br>(shapeable) | | SMC-25130-1S | MC-2713-1SN | 130 | 2.7 Fr. | 2.9 Fr. | 0.025" | 1 Marker Band | Straight<br>(shapeable) | | SMC-25150-1S | MC-2715-1SN | 150 | 2.7 Fr. | 2.9 Fr. | 0.025" | 1 Marker Band | Straight<br>(shapeable) | Table 4.1. IntraNovo 25 Microcatheter Models and Sizes # 5 - Indications for Use The IntraNovo 25 Microcatheter is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremities, and all coronary vessels. The Microcatheter is also intended for drug infusion in intra-arterial therapy and infusion of embolic materials for hemostasis. The Microcatheter should not be used in cerebral vessels. - 6 Summary of Technological Characteristics Comparison Based on a comparison of the indications for use, fundamental design, technology and principles of operation, materials, performance, sterilization, and packaging, it is determined that the IntraNovo 25 Microcatheter is substantially equivalent to the predicate device. Table 6.1 below provides a comparison of the IntraNovo 25 Microcatheter and the predicate. {5}------------------------------------------------ | Technical Characteristics /<br>Principle of Operation | IntraNovo 25<br>Microcatheter | PROGREAT Catheter<br>(Predicate) | Substantially<br>Equivalent? | |-------------------------------------------------------|---------------------------------------|----------------------------------------------|------------------------------| | Length | 100cm - 150cm | 100cm - 150cm | Yes | | | Distal: 2.7 Fr.<br>Proximal 2.9 Fr. | Distal: 2.7 Fr.<br>Proximal: 2.9 Fr. | Yes | | Outer Diameter | | | Yes | | Inner Diameter | 0.025" | 0.025" | Yes | | Maximum Pressure | 5,171 kPa (750 psi) | 5,171 kPa (750 psi) | Yes | | Distal Curve | Straight (shapeable) | Straight (shapeable) | Yes | | Inner Liner Material | Polytetraflouroethylene<br>(PTFE)* | Polytetraflouroethylene<br>(PTFE) | Yes | | Coil Reinforcement Material | Stainless Steel* | Tungsten | Yes | | Radiopaque Marker | Platinum/Iridium* | Tungsten coil and/or<br>Platinum marker band | Yes | | Outer Shaft Material | Polyether Block Amide* | Unknown | Yes | | Luer Material | Polycarbonate* | Unknown | Yes | | Luer Connector | Female Luer Connector* | Female Luer Connector | Yes | | Hydrophilic Coated | Yes* | Yes | Yes | | Anatomical Site Use | Peripheral, Coronary | Peripheral, Coronary | Yes | | Supplied Accessories | Shaping Mandrel, Injection<br>Syringe | Shaping Mandrel,<br>Injection Syringe | Yes | | Delivery to Site | Over-the-wire | Over-the-wire | Yes | | Guidewire Compatibility | Maximum 0.021" | Maximum 0.021" | Yes | | Packaging | Polyethylene Hoop and<br>Tyvek Pouch | Polyethylene Hoop and<br>Tyvek Pouch | Yes | | Sterilization | EtO Gas | EtO Gas | Yes | Table 6.1 Comparison of the IntraNovo 25 Microcatheter and the Predicate Device. * Denotes a patient-contacting material. #### 7 - Testing Summary The following bench tests were performed to evaluate the design elements and performance characteristics of the IntraNovo 25 Microcatheter and to demonstrate substantial equivalence to the predicate device. The IntraNovo 25 Microcatheter met the predetermined acceptance criteria. Testing was performed on non-aged devices (T=0) as well as on devices subject to 2 years of accelerated aging (T=2). Tests results show that the IntraNovo 25 Microcatheter is substantially equivalent to the predicate device. {6}------------------------------------------------ # 7.1- Bench Testing Table Table 7.1 below provides a summary of the bench testing performed on the IntraNovo 25 Microcatheter. | Test # | Test Name | Applicable Standard or Internal Test Method | Test Results (T=0) and (T=2) | |--------|------------------------------------------|---------------------------------------------|------------------------------| | 1 | Guidewire & Guide Catheter Compatibility | Internal Test Method | T=0 Pass<br>T=2 Pass | | 2 | In-Vitro Track Force | Internal Test Method | T=0 Pass<br>T=2 Pass | | 3 | Durability of Hydrophilic Coating | Internal Test Method | T=0 Pass<br>T=2 Pass | | 4 | Lubricity of Hydrophilic Coating | Internal Test Method | T=0 Pass<br>T=2 Pass | | 5 | Tip Shape Retention | Internal Test Method | T=0 Pass<br>T=2 Pass | | 6 | Static Burst Pressure | ISO 10555 | T=0 Pass<br>T=2 Pass | | 7 | Dimensional & Physical Attributes | ISO 10555 | T=0 Pass<br>T=2 Pass | | 8 | Corrosion Resistance | ISO 10555 | T=0 Pass<br>T=2 Pass | | 9 | Dynamic Burst Pressure | Internal Test Method | T=0 Pass<br>T=2 Pass | | 10 | Air Leak | Internal Test Method | T=0 Pass<br>T=2 Pass | | 11 | Liquid Leakage | Internal Test Method | T=0 Pass<br>T=2 Pass | | 12 | Tensile Strength | ISO 10555 | T=0 Pass<br>T=2 Pass | | 13 | Flow Rate | Internal Test Method | T=0 Pass<br>T=2 Pass | | 14 | Kink Resistance | Internal Test Method | T=0 Pass<br>T=2 Pass | | 15 | Radiopacity | ASTM-F640-12 | T=0 Pass<br>T=2 Pass | | 16 | Torque to Failure | Internal Test Method | T=0 Pass<br>T=2 Pass | | 17 | Catheter Stiffness | Internal Test Method | T=0 Pass<br>T=2 Pass | | 18 | Packaging Integrity | ASTM F-88-09<br>ASTM-1929-98 | T=0 Pass<br>T=2 Pass | | 19 | Therapeutic Agents | Internal Test Method | T=0 Pass<br>T=2 Pass | | 20 | Female Luer Hub Verification | ISO 594 | T=0 Pass<br>T=2 Pass | | 21 | Shipping and Transportation Simulation | ISTA 3PA | T=0 Pass<br>T=2 Pass | | 22 | Coating Integrity | Internal Test Method | T=0 Pass<br>T=2 Pass | | 23 | Torque Response | Internal Test Method | T=0 Pass<br>T=2 Pass | | 24 | Particulate Evaluation | USP <788> | T=0 Pass<br>T=2 Pass | Table 7.1. Bench Testing Performed on the IntraNovo 25 Microcatheter. {7}------------------------------------------------ ## 7.2 – Biocompatibility The IntraNovo 25 Microcatheter is classified as an Externally Communicating Device, Circulating Blood, Limited Contact (≤24 hours). Biocompatibility testing was performed in accordance with ISO 10993 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process" (2009). Table 7.2 below describes the testing performed to determine biocompatibility. | Test Name | Test Description | Test Results | |--------------------------------|------------------------------------------------------------------------------|--------------| | Cytotoxicity - Test | Cytotoxicity - MEM Elution Test (ISO 10993-5:2009) | Pass | | Cytotoxicity - Test | Cytotoxicity-MTT Quantitative Evaluation (ISO 10993-5:2009) | Pass | | Sensitization - Test | Maximization Test for Delayed-Type Hypersensitivity Test (ISO 10993-10:2010) | Pass | | Irritation - Test | Intracutaneous (Intradermal) Reactivity Test (ISO 10993-10:2010) | Pass | | Systemic Toxicity - Test | Acute Systemic Toxicity Test (ISO 10993-11:2006) | Pass | | Pyrogenicity Test | Pyrogen Test in Rabbits (ISO10993-11/USP 37 <151>, rev. 5/2014) | Pass | | Hemolysis - Test | Hemolysis, Direct and Extraction Method (ASTM 756-08) | Pass | | Coagulation | Prothrombin Time Assay | Pass | | Complement Activation - Test | Complement Activation | Pass | | In vivo Thrombogenicity - Test | Thromboresistance in Dogs | Pass | Table 7.2. Summary of Biocompatibility Testing for the IntraNovo 25 Microcatheter ## 8 - Sterilization Testing Summary | Validation Sterilization Process | Sterility Assurance Level (SAL) | Validation Result | |----------------------------------|---------------------------------|-------------------| | Ethylene Oxide Gas | 10-6 | Pass | ## 9 - Conclusion The IntraNovo 25 Microcatheter is substantially equivalent in intended use, fundamental design, technology and principles of operation, materials, performance, sterilization, and packaging to the predicate device. Differences between the devices do not raise any new issues of safety or effectiveness.