Cathtong I PICC Catheter

{0}------------------------------------------------ Image /page/0/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 a stylized image of three human profiles facing right, stacked on top of each other, with a flowing design element below them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 1, 2016 L&Z US, Inc. Ms. Jenella Coutts Director of Regulatory Affairs 6 Horizon Road, #2301 Fort Lee. New Jersey 07024 Re: K153469 Trade/Device Name: CATHTONG™ I PICC Catheter Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: July 29, 2016 Received: August 3. 2016 Dear Ms. Coutts: 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. {1}------------------------------------------------ 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 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, Tina Kiang -s Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K153469 Device Name CATHTONGTM I PICC Catheter #### Indications for Use (Describe) The CATHTONG™ I PICC Catheter is intended for short or long-term peripheral access to the central venous system for infusion, intravenous therapy, blood sampling, power injection of contrast media, the administration of fluids, medications and nutrients, and allows for central venous pressure monitoring. The maximum recommended infusion rate is ImL/sec for 3F and 3.5mL/sec for 4F single-lumen catheters. The maximum pressure of power injection with the CATHTONG™ I PICC Catheter may not exceed 325 psi. The CATHTONG™ I PICC Catheter is indicated for adult patients. Catheter Size Maximum Flow Rate Injection Limit Setting 3 Fr Single Lumen 1 ml/sec 325 psi 4 Fr Single Lumen 3.5 ml/sec 325 psi Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### 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}------------------------------------------------ # 510(k) Summary | Submitter Information: | L&Z US, Inc.<br>6 Horizon Road, #2301<br>Fort Lee, NJ 07024 | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Jenella Coutts<br>Director of Regulatory Affairs | | Email Address: | jcoutts@lingzeus.com | | Phone Number: | (718) 601-0889 ext. 1 | | Fax Number: | (718) 228-2441 | | Date of Submission: | August 31, 2016 | | Trade Name: | CATHTONG™ I PICC Catheter | | Common Name: | Peripherally Inserted Central Catheter (PICC) | | Regulation Number: | 21 CFR 880.5970 | | Regulation Name: | Percutaneous, implanted, long-term intravascular catheter | | Regulatory Class: | II | | Product Code: | LJS | | Classification Panel: | General Hospital | | Primary Predicate: | NMI PICC IV<br>Common Name: Peripherally Inserted Central Catheter (PICC)<br>Regulation Number: 21 CFR 880.5970<br>Regulation Name: Percutaneous, implanted, long-term<br>intravascular catheter<br>Regulatory Class: II<br>Product Code: LJS<br>Classification Panel: General Hospital<br>510(K) #: K140266<br>Manufacturer: Navilyst Medical, Inc. | # Device Description: CATHTONG™ I PICC Catheters are radiopaque polyurethane-based peripherally inserted central venous catheters for short or long-term use. The CATHTONG™ I PICC {4}------------------------------------------------ Catheters are 55 cm in length with markings in 5 cm increments and available in 3 Fr and 4 Fr single lumen. The catheter is packaged as a kit with accessories necessary for implantation of a PICC catheter using a Seldinger or modified Seldinger technique. ### Intended Use/Indications for Use: The CATHTONG™ I PICC Catheter is intended for short or long-term peripheral access to the central venous system for infusion, intravenous therapy, blood sampling, power injection of contrast media, the administration of fluids, medications and nutrients, and allows for central venous pressure monitoring. The maximum recommended infusion rate is 1mL/sec for 3F and 3.5mL/sec for 4F single-lumen catheters. The maximum pressure of power injection with the CATHTONG™ I PICC Catheter may not exceed 325 psi. The CATHTONG™ I PICC Catheter is indicated for adult patients. | Catheter Size | Maximum Flow Rate | Injection Limit Setting | |-------------------|-------------------|-------------------------| | 3 Fr Single Lumen | 1 mL/sec | 325 psi | | 4 Fr Single Lumen | 3.5 mL/sec | 325 psi | Table E-1 Device comparisons table | Characteristics | Subject Device: | Primary Predicate : | |---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | CATHTONG™ I PICC Catheter | NMI PICC IV<br>K140266<br>SE 03.05.2014 | | Indications for Use<br>Statement | The CATHTONG™ I PICC Catheter is<br>intended for short or long-term<br>peripheral access to the central venous<br>system for infusion, intravenous<br>therapy, blood sampling, power<br>injection of contrast media, the<br>administration of fluids, medications<br>and nutrients, and allows for central<br>venous pressure monitoring. The<br>maximum recommended infusion rate is<br>1mL/sec for 3F and 3.5mL/sec for 4F<br>single-lumen catheters. The maximum<br>pressure of power injection with the<br>CATHTONG™ I PICC Catheter may<br>not exceed 325 psi. The<br>CATHTONG™ I PICC Catheter is<br>indicated for adult patients.<br><br>Catheter Size: 3 Fr Single Lumen<br>Maximum Flow Rate 1 mL/sec,<br>Injection Limit Setting 325 psi.<br><br>Catheter Size 4 Fr Single Lumen,<br>Maximum Flow Rate 3.5 mL/sec,<br>Injection Limit Setting 325 psi. | The NMI PICC IV is indicated for short<br>or long-term peripheral access to the<br>central venous system for intravenous<br>therapy, including but not limited to, the<br>administration of fluids, medications<br>and nutrients, the sampling of blood, for<br>central venous pressure monitoring and<br>for power injection of contrast media.<br>The maximum recommended flow rate<br>is 1mL/sec for 3F and 3.5mL/sec for 4F.<br>The maximum pressure of injection<br>with the NMI IV PICC catheter may not<br>exceed 325 psi. | | Dwell Time | Short or long-term (Less than or greater<br>than 30 days) | Short or long-term (Less than or greater<br>than 30 days) | | Regulation | 21CFR880.5970 Percutaneous,<br>implanted, long-term intravascular<br>catheter | Same | | Product Code | LJS | LJS | | Target Population | Adults | Adults | | Catheter Materials | Radiopaque polyurethane (Carbothane) | Radiopaque polyurethane | | Length | 55 cm (3F), 55cm (4F) | 55 cm (3F), 55cm(4F) | | # Lumens and catheter size | One (3F, 4F) | One (3F, 4F, 5F), Two (5F, 6F), Three<br>(6F) | | Markings | Every 5 cm | Every 5 cm | | Catheter Design | Standard tapered catheter | Reverse tapered catheter | | Contrast Injectables | Yes | Yes | | Supplied Sterile<br>(Sterilization Method) | Provided sterile using EO sterilization<br>Method | Provided sterile using EO sterilization<br>Method | | | | | | Labeling Shelf-Life | 16 Months | 6 Months | | Accessories in Package | Guidewire Straight Tip, Guidewire,<br>Multi Compartment Tray, Micro Access<br>with Dilator, Introducer Needle, Needle<br>Receptacle, Safety Scalpel, Syringe,<br>Scissors, Instructions For Use,<br>SorbaView® Ultimate Dressing,<br>Universal Tape Strip, Wingguard®<br>Xtra, Tape Measure, Fenestrated Drape | "Available kitted with a range of<br>procedural accessories for user<br>convenience" | | | | | | | | | | | | | | | | | | | | | | | | | | Maximum recommended<br>infusion rating for power<br>injection | 3F SL: 1mL/sec<br>4F SL: 3.5mL/sec | 3F SL: 1mL/sec<br>4F SL: 3.5mL/sec | | Injection Pressure Limit<br>Setting | 325 psi | 325 psi | | | | | | Available performance data<br>to support SE determination | Yes | Yes | | | | | | Special labeling performance<br>claim | None | "Demonstrate resistance to blood<br>components (platelet and thrombus)<br>accumulation" | | | | | | | | | {5}------------------------------------------------ {6}------------------------------------------------ # Similarity to the Predicate The proposed device, CATHTONG™ I PICC Catheter, has the same intended use, intended function, catheter length, maximum recommended infusion rating, pressure limit for power injection of contrast media and are also made of the same materials as the primary predicate device, NMI PICC IV. They both are intended for short or long-term peripheral access to the central venous system for infusion, intravenous therapy, blood sampling, power injection of contrast media, and allow for central venous pressure monitoring in adult patients. There are no changes in the fundamental clinical indications for both PICC catheters. There are no {7}------------------------------------------------ additional contra-indications or warnings. Both devices are sterilized by ethylene oxide with acceptable low EO residues. #### Difference to the Predicate The only differences between the proposed device and the predicate are the number of the lumen, the catheter size, the taper design, the accessories in the kit package, and special functional performance claim. The proposed device has only one single lumen configuration with 3F and 4F sizes, while the predicate device has single, double and triple lumen configurations with 3F, 4F, 5F and 6F sizes. The proposed device and the predicate do differ in that the predicate has a reverse tapered catheter design while the proposed device is the standard tapered design. However, upon testing both proposed and the predicate devices maintained identical maximum flow rates, therefore this different design feature does not dispute equivalence. In terms of kit package content, the proposed PICC device contains Guidewire Straight Tip, Guidewire, Multi Compartment Tray, Micro Access with Dilator, Introducer Needle, Needle Receptacle, Safety Scalpel, Syringe, Scissors, Instructions For Use, SorbaView® Ultimate Dressing, Universal Tape Strip, Wingguard® Xtra, Tape Measure, Fenestrated Drape in its kit package, while the predicate contains "a range of procedural accessories for user convenience". In addition, the predicate device makes "resistance to blood components (platelet and thrombus) accumulation" labeling claim, while the proposed device does not make any functional performance claim. #### Non-clinical Testing: - . Flexural fatigue and flexibility - . Peak tensile force - Liquid leakage under pressure . - . Air leakage {8}------------------------------------------------ - Flow rate ● - Power injection - Burst pressure - Power injection Flow rate ● - Catheter collapse - Radiopacity - Gauging - Irritation/Intracutaneous Reactivity ● - Cytotoxicity Test (MEM Elution) ● - Partial Thromboplastin Time (PTT) - Material Mediated Pyrogen Test ● - Kligman Maximization Test - Intramuscular Implantation Test 13 ● Week Implantation - 28-Day Systemic Toxicity in Rats via Intramuscular Implantation - Systemic Injection Test ● - Liquid Leakage ● - Separation Force ● - Unscrewing Torque ● - Ease of Assembly - Resistance to Overriding . - Stress Cracking . - Salmonella Typhirmurium and ● Escherichia Coli Reverse Mutation Assay - C3A and SCB-9 Complement . Activation Test (Direct Contact) - Rabbit Blood Hemolysis Test . - Thrombogenicity Study in Swine . - Mouse Lymphoma Mutagenesis ● Assay with Confirmation - . Rodent Blood Micronucleus Assay - LAL Testing for Pyrogenicity ● ### Standards: ISO 10551 -1:2013 Sterile, single-use intravascular catheters Part 1: General Requirements ISO 10551 -3: 2013 Sterile, single-use intravascular catheters Part 3: Central venous catheters ISO 594-1: 1986 Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment Part 1: General Requirements. ISO 594-2: 1998 Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment Part 2: Lock Fittings FDA's "Guidance on Premarket Notification [510(k)] Submissions for Short-term and Long-term Intravascular Catheters, dated March 16, 1995. ISO 10993-3, 2014 Biological Evaluation of Medical Devices- Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity ISO/TR 10993-33, 2015 Biological Evaluation of Medical Devices- Part 33: Guidance on Tests to Evaluate Genotoxicity - Supplement to ISO 10993-3 ISO 10993-4, 2006 Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood, as amended 2006 ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5; Tests for In Vitro Cytotoxicity ISO 10993-6, 2007 Biological Evaluation of Medical Devices Part 6: Tests for Local Effects after Implantation ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin Sensitization ISO 10993-11:2006 Biological Evaluation of Medical Devices Part 11: Tests for Systemic Toxicity ISO 11135-1:2007 Sterilization of health care products – Ethylene oxide Part 1 Requirements for development, validation and routine control of a sterilization process for medical devices {9}------------------------------------------------ ### Substantial Equivalence Rationale: #### Intended Use The intended use of the proposed device, CATHTONG™ I PICC Catheter, is identical to the primary predicate, NMI PICC IV (K140266). There are no changes in the fundamental clinical indications. There are no additional contraindications or warnings. ### Design and Technological Characteristics The CATHTONG™ I PICC Catheter has the same catheter material (polyurethane), dimensions, configuration, and device properties as the predicate. The only minor design difference is the standard tapered catheter design for the proposed device versus reverse tapered catheter design for the predicate. However, this does not impact the effectiveness or safety of the proposed device as upon testing both devices safely maintained identical maximum flow rates. # Non-clinical Test Results The non-clinical test results in this submission demonstrate that CATHTONG™ I PICC Catheter meets the expected performance requirements for a PICC device, and is therefore substantially equivalent to the predicate relative to safety and mechanical properties as a PICC. ### Conclusion Based upon the indications for use, technological characteristics, and non-clinical testing the CATHTONG™ I PICC Catheter has demonstrated to be Substantially Equivalent to the predicate device, NMI PICC IV (K140266).