IntraNovo Microcatheter

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 13, 2016 Texas Medical Technologies, Inc. % E.J. Smith Consultant Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114 Re: K153125 Trade/Device Name: IntraNovo Microcatheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: December 10, 2015 Received: December 14, 2015 Dear E.J. Smith: 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) 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, 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) Device Name IntraNovo Microcatheter #### Indications for Use (Describe) The IntraNovo 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 extremittes, 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) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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}------------------------------------------------ ### 510(k) Summary - 1. Company Information & Contact Person | Company Name:<br>Company Address | Texas Medical Technologies, Inc<br>9005 Montana Ave. Ste. A<br>El Paso, Texas 79925 | |----------------------------------|-------------------------------------------------------------------------------------| | Telephone:<br>Fax: | (915) 774-4321<br>(915) 774-4323 | | Date Prepared: | 10/20/2015 | - 2. Device Name & Classification | Proprietary Name: | IntraNovo Microcatheter | |----------------------|-----------------------------------| | Common Name: | Microcatheter | | Classification Name: | Diagnostic Intravascular Catheter | | Regulation Number: | 21 CFR 870.1200 | | Product Code: | DQO | | Device Class: | Class II | - 3. Predicate Device | Proprietary Name: | IntraNovo 25 Microcatheter | |----------------------|-----------------------------------| | Company Name: | Texas Medical Technologies, Inc. | | Common Name: | Microcatheter | | Classification Name: | Diagnostic Intravascular Catheter | | Regulation Number: | 21 CFR 870.1200 | | Product Code: | DQO | | Device Class: | Class II | | 510(k) Number: | K142817 | #### 4. Device Description The IntraNovo Microcatheter (the "IntraNovo 21" 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 polytetrafluoroethylene (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 Microcatheter. One radiopaque marker band is placed at the distal end of the Microcatheter and 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. {4}------------------------------------------------ The device shaft has an outer diameter of 2.9 French size on the proximal end and 2.4 French size on the distal end with an inner diameter of 0.021" throughout the shaft. The device is available in lengths of 110 cm and 130 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 syringe. | Design &<br>Development<br>Model<br>Number | Commercial<br>Model<br>Number | Shaft<br>Length<br>(cm) | Outer Diameter | | Inner<br>Diameter | Marker Band<br>Configuration | Tip Shape | |--------------------------------------------|-------------------------------|-------------------------|----------------|---------|-------------------|------------------------------|-------------------------| | SMC-21110-1S | MC-2411-1SN | 110 | 2.7 Fr. | 2.9 Fr. | 0.025" | 1 Marker Band | Straight<br>(shapeable) | | SMC-21130-1S | MC-2413-1SN | 130 | 2.7 Fr. | 2.9 Fr. | 0.025" | 1 Marker Band | Straight<br>(shapeable) | Table 4.1 IntraNovo Microcatheter Models and Sizes - 5. Indications for Use The IntraNovo 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. - Predicate Product Comparison Table 6. | Technical<br>Characteristics /<br>Principle of<br>Operation | IntraNovo<br>Microcatheter | IntraNovo 25<br>Microcatheter<br>(Predicate) | Comments | |-------------------------------------------------------------|----------------------------------------|----------------------------------------------|--------------------------| | 510(k) Number | | K142817 | | | Length | 100cm - 130cm | 100cm -130 cm-<br>150cm | Same | | Outer Diameter | Distal: 2.4 Fr.<br>Proximal 2.9 Fr. | Distal: 2.7 Fr.<br>Proximal 2.9 Fr. | Different 1<br>Identical | | Inner Diameter | 0.021" | 0.025" | Different 2 | | Maximum Pressure | 5,171 kPa (750 psi) | 5,171 kPa (750 psi) | Identical | | Distal Curve | Straight (shapeable) | Straight<br>(shapeable) | Identical | | Inner Liner<br>Material | Polytetraflouroethyl<br>ene<br>(PTFE)* | Polytetraflouroethy<br>lene<br>(PTFE)* | Identical | | Coil Reinforcement<br>Material | Stainless Steel* | Stainless Steel* | Identical | {5}------------------------------------------------ | Radiopaque Marker | Platinum/Iridium* | Platinum/Iridium* | Identical | |----------------------------|---------------------------------------|---------------------------------------|-------------| | Outer Shaft<br>Material | Polyether Block<br>Amide* | Polyether Block<br>Amide* | Identical | | Luer Material | Polycarbonate* | Polycarbonate* | Identical | | Luer Connector | Female Luer<br>Connector* | Female Luer<br>Connector* | Identical | | Hydrophilic Coated | Yes* | Yes* | Identical | | Anatomical Site<br>Use | Peripheral,<br>Coronary | Peripheral,<br>Coronary | Identical | | Supplied<br>Accessories | Shaping Mandrel,<br>Injection Syringe | Shaping Mandrel,<br>Injection Syringe | Identical | | Delivery to Site | Over-the-wire | Over-the-wire | Identical | | Guidewire<br>Compatibility | Maximum 0.018" | Maximum 0.021" | Different 3 | | Packaging | Polyethylene Hoop<br>and Tyvek Pouch | Polyethylene Hoop<br>and Tyvek Pouch | Identical | | Sterilization | EtO Gas | EtO Gas | Identical | ## 7. Discussion of Technological Characteristics Both devices are equivalent with respect to their indications for use, fundamental design, technology and principles of operation, materials, performance, sterilization, and packaging. The IntraNovo Microcatheter does differ from the predicate in outer diameter of 2.4 fr versus predicate's 2.7 fr, inner diameter of 0.021" versus the predicate's 0.025" and guidewire compatibility of a maximum 0.018" versus the predicate's 0.021". The following is a discussion of why no new issues of safety and effectiveness have been raised by these differences: - 1. Difference on the distal outer diameter does not impact the product performance or modifies the intended use. The smaller size is intended to reach smaller target vessels in the anatomy. The Microcatheter's instructions for use indicate the minimum sizes of devices compatible with the Microcatheter outer diameter. This difference does not raise any new issues of safety and effectiveness. - 2. Difference on the inner diameter does not impact on the product performance or modifies the intended use. The smaller size is intended to reach smaller target vessel in the anatomy. The Microcatheter's instructions for use indicate the maximum sizes of therapeutic agents compatible with the Microcatheter inner diameter. This difference does not raise any new issues of safety and effectiveness. - 3. Difference in the guidewire compatibility does not impact on the product performance or modifies the intended use. Device lumen is smaller and therefore the maximum guidewire compatible is smaller. This difference does not raise any new issues of safety and effectiveness. ## 8. Testing Summary {6}------------------------------------------------ The following bench tests were performed to evaluate the design elements and performance characteristics of the IntraNovo Microcatheter and to demonstrate substantial equivalence to the predicate device. The IntraNovo 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 Microcatheter is substantially equivalent to the predicate device. | Test<br># | Test Name | Applicable<br>Standard or<br>Internal Test<br>Method | Test<br>Results<br>(T=0)<br>and<br>(T=2) | |-----------|---------------------------------------------|------------------------------------------------------|------------------------------------------| | 1 | Guidewire & Guide<br>Catheter Compatibility | Internal Test<br>Method | T=0 Pass<br>T=2 Pass | | 2 | In-Vitro Track Force | Internal Test<br>Method | T=0 Pass<br>T=2 Pass | | 3 | Durability of Hydrophilic<br>Coating | Internal Test<br>Method | T=0 Pass<br>T=2 Pass | | 4 | Lubricity of Hydrophilic<br>Coating | Internal Test<br>Method | T=0 Pass<br>T=2 Pass | | 5 | Tip Shape Retention | Internal Test<br>Method | T=0 Pass<br>T=2 Pass | | 6 | Static Burst Pressure | ISO 10555 | T=0 Pass<br>T=2 Pass | | 7 | Dimensional & Physical<br>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<br>Method | T=0 Pass<br>T=2 Pass | | 10 | Air Leak | Internal Test<br>Method | T=0 Pass<br>T=2 Pass | | 11 | Liquid Leakage | Internal Test<br>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<br>Method | T=0 Pass<br>T=2 Pass | | 14 | Kink Resistance | Internal Test<br>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<br>Method | T=0 Pass<br>T=2 Pass | | 17 | Catheter Stiffness | Internal Test<br>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<br>Method | T=0 Pass<br>T=2 Pass | # 9. Bench Testing Table | Table 7.1. Bench Testing Performed on the IntraNovo Microcatheter. | | |--------------------------------------------------------------------|--| |--------------------------------------------------------------------|--| {7}------------------------------------------------ | 20 | Female Luer Hub<br>Verification | ISO 594 | T=0 Pass<br>T=2 Pass | |----|-------------------------------------------|-------------------------|----------------------| | 21 | Shipping and Transportation<br>Simulation | ISTA 3PA | T=0 Pass<br>T=2 Pass | | 22 | Coating Integrity | Internal Test<br>Method | T=0 Pass<br>T=2 Pass | | 23 | Torque Response | Internal Test<br>Method | T=0 Pass<br>T=2 Pass | | 24 | Particulate Evaluation | USP <788> | T=0 Pass<br>T=2 Pass | # 10. Biocompatibility The IntraNovo Microcatheter is classified as an Externally Communicating Device, Circulating Blood, Limited Contact (<24) hours. The final sterilized device is identical to IntraNovo 25 Microcatheter (K142817) in formulation, processing, sterilization, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents). Biocompatibility testing was not performed since the same materials of the IntraNovo 25 Microcatheter were used and biocompatibility testing results shown that these materials are biocompatible according to ISO 10993. The IntraNovo 25 Microcatheter was cleared under 510K number K142817 on 4/23/2015. ## 11. Sterilization Testing Summary | Adoption Cycle Sterilization<br>Process | Sterility Assurance Level<br>(SAL) | Result | |-----------------------------------------|------------------------------------|--------| | Ethylene Oxide Gas | $10^{-6}$ | Pass | | LAL - AAMI ST 72:2010 | | Pass | # 12. Conclusion The IntraNovo 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.