ND NABIL DIB INFUSION CATHETER

{0}------------------------------------------------ | TRANSLATIONAL RESEARCH INSTITUTE | |----------------------------------| |----------------------------------| #### ND INFUSION CATHETER K130569, 510(k) Summary Page 1 of 3 # 510(K) SUMMARY # Contact Information | Submitter's Name and Address: | TRANSLATIONAL RESEARCH INSTITUTE<br>3420 S Mercy Road, #312<br>Gilbert, Arizona 85297<br>Tel: 480-726-1904 / Fax: 480-612-0641 | |---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------| | Name of Contact Person: | DeAnn Dana, Project Manager<br>Translational Research Institute<br>3420 S Mercy Road, #312<br>Gilbert, AZ 85297<br>Tel: 480-726-1904 / Fax: 480-612-0641 | | Date Summary was Prepared: | October 14, 2013 | | Name of Device | | | Name of the Device:<br>Trade or Proprietary Name: | NDTM Nabil Dib Infusion Catheter<br>NDTM Nabil Dib Infusion Catheter | I rade or Proprietary Name: Common or Usual Name: Classification Name: CFR Reference Product Code Regulatory Class Nabil Dib Infusion Catheter Infusion Catheter Continuous Flush Catheter 21 CRF 870.1210 KRA Class II # Predicate Device | 510(K) | MANUFACTURER | DEVICE | APPROVAL DATE | |---------|------------------|---------------------------|---------------| | K081147 | Vascular Designs | IsoFlow Infusion Catheter | 05-29-09 | # Device Description The ND Infusion Catheter is a multilumen (3) and multichannel (6) balloon catheter designed to isolate a specific treatment region from blood flow while directing infusion of fluids into the specified region. The catheter has a length of 135cm and diameter of 3F, and is intended to be used with a 6F or larger guide catheter along with a 0.014" rapid exchange guide wire for positioning the catheter in the desired region. The bifurcated proximal hub provides for the following functionality: - 1) Balloon Port · Inflation of a compliant balloon to requlate blood flow during therapy infusion; target vessel diameter = 2.0 - 4.5 mm. - · Balloon is prepared via a 3-way stopcock connection using a 10cc syringe and inflated using a 50:50 contrast/saline solution delivered via a 1cc syringe for precise inflation under fluoroscopic guidance. 2) Infusion Port - · Infusion of a therapeutic agent into the vasculature through multiple fluid channels (each with diameter = 0.006"). - · Physician-specified fluid is administered through the infusion port via a 1-way stopcock connection using a 1cc syringe. K130569 510(K) SUMMARY {1}------------------------------------------------ ## TRANSLATIONAL RESEARCH INSTITUTE The catheter is designed with 3 shaft transitions. As a result, the catheter has 4 contiguous segments: PROXIMAL, MID, EXPANSION, and DISTAL. | SEGMENT | FUNCTIONALITY | |-----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | PROXIMAL | Two lumens in the PROXIMAL segment --- for fluid infusion and balloon<br>inflation -- extend from the bifurcated hub to the MID section. | | MID | MID section includes the guidewire Rx port and lumen. and the<br>balloon located distally. The balloon is compliant and designed to<br>expand to accommodate blood vessels with diameters of 2.0 - 4.5<br>mm while regulating blood flow during infusion. | | EXPANSION | EXPANSION segment extends distally from balloon towards the catheter<br>tip and is designed to provide for volumetric expansion of infusate. | | DISTAL | In DISTAL segment, infusion lumen divides into 6 independent<br>channels (0.006") delivering infusate to target region at multichannel tip. | Radiopaque marker bands at each end of the balloon and at the distal tip allow for catheter positioning under fluoroscopic guidance. ## Indications for Use The ND Infusion Catheter is a multi-channel balloon catheter designed to isolate a specific vascular treatment region from blood flow while allowing infusion of physician-specified fluids into the target region. ## Comparison to Predicate ## ND Infusion Catheter vs. Predicate Device | PARAMETER | ND Infusion Catheter | IsoFlow Infusion Catheter | |--------------------------|-----------------------------------------|---------------------------| | Length | 135 cm | 150 cm | | Diameter | 2.4F | 3.5F | | Number of Lumens | 3 | 3 | | Number of Infusion Ports | 6 | 3 | | Materials | Shaft -- Pebax<br>Balloon -- Pellethane | Not known | # Technical Testing The results of bench testing provide reasonable assurance that the device has been designed and performs in conformance to the requirements for its intended use. The technical testing included (but was not limited to) the following: - Balloon Fatigue - · Balloon Burst Testing - · Balloon Inflation/Deflation - · Balloon Radial Force Testing - · Track Force Testing - · Torque Strength Test - · Tensile Testing - · Separation Force at Break - · Flexibility-Kink Resistance Test - · Liquid Leakage Under Pressure K130569 {2}------------------------------------------------ ## TRANSLATIONAL RESEARCH INSTITUTE # Biocompatibility Blood-contacting materials were tested for biocompatibility as summarized below. | TEST | RESULTS | CONCLUSIONS | |------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------| | Cytotoxicity -- L929 MEM Elution<br>Test | Test article meets requirements of the test and is<br>not considered to have a cytotoxic effect. | Non-Cytotoxic | | Cytotoxicity -- L929 Neutral Red<br>Uptake Test | Test article meets requirements of the test and is<br>not considered to have a cytotoxic effect. | Non-Cytotoxic | | Sensitization -- Kligman<br>Maximization Test | Grade I sensitization rate is not considered<br>significant and the test article meets the<br>requirements of the ISO 10993-10 guidelines. | Non-Sensitizing | | Irritation -- Intracutaneous Injection<br>Test | The test article sites did not show a significantly<br>greater biological reaction than the sites injected<br>with the control article. | Non-Irritating | | Systemic Toxicity -- Systemic<br>Injection Test | The test article did not induce a significantly<br>greater biological reaction than the control<br>extracts, when tested in Swiss Albino mice. | Nontoxic | | Genotoxicity -- S Typhimurium<br>& E Coli Reverse Mutation | The mean number of revertants per plate was<br>calculated for the test article extracts, and for the<br>negative and positive control articles.<br>A statistically significant increase in the number of<br>colonies was not observed with the test article. | Non-Genotoxic | | Hemolysis -- Rabbit Blood | The test article meets the requirements of the test<br>and is not considered hemolytic. | Non-Hemolytic | | Thrombogenicity - Study in Dogs | Minimal thrombosis with a Grade of 0 (a very small<br>clot is acceptable) was observed in 2/2 test sites<br>and in 2/2 control sites; the amount of thrombosis<br>was not considered significant. | Non-Thrombogenic | | Complement Activation Assay | The test article meets the requirements of the test<br>and is not considered having activated the<br>complement system in human plasma. | Non-Complement<br>Activating | | Coagulation - Unactivated PTT<br>Assay | The test article meets the requirements of the test<br>and is not considered having an effect on the<br>coagulation of human plasma via UPTT. | Non-Coagulating | | Hemocompatibility -- In Vitro Assay | The test article meets the requirements of the test<br>and is not considered having an effect on selected<br>hematological parameters. | Hemocompatible | #### Animal Studies An acute animal study in the swine arterial vasculature catheter demonstrated excellent trackability, pushability, balloon inflation, deflation, removal, infusion of fluid through the infusion lumen, marker band visibility, and no hub or catheter leak. There was no vascular injury in any of the vessels that were evaluated (LCx, LAD, RCA, Renal, Femoral, Iliac, Carotid) as assessed by angiography and gross examination. In summary, this study robustly validated the functional performance and safety of the ND Infusion Catheter. # The results of the Technical Testing, Biomaterial Assessments, and Animals Study summarized above did not raise new safety or performance questions. #### Conclusions Based on the above testing, the ND Infusion Catheter is substantially equivalent to devices legally marketed in the United States. {3}------------------------------------------------ Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three intertwined figures instead of snakes. Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 15, 2013 Translational Research Institute DeAnn Dana, RN Project Manager 3420 S Mercy Rd #312 Gilbert, AZ 85297 US Re: K130569 > Trade/Device Name: ND™ Nabil Dib Infusion Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: October 15, 2013 Received: October 16, 2013 Dear Ms. Dana, 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 {4}------------------------------------------------ Page 2 - Deann Dana, Rn ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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 Small Manufacturers. International and Consumer Assistance at its tollfree 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 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.A. Lillehemen for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ K130569 Page 1 of 1 # Indications for Use Statement Device Name: ND™ Nabil Dib Infusion Catheter . K130569 510(k) Number: Indications for Use: The ND Infusion Catheter is a multi-channel balloon catheter designed to isolate a specific vascular treatment region from biood flow while allowing infusion of physician-specified fluids into the target region. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) M.A. Stilleman