20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System

{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 in a circular arrangement around a central emblem. The emblem consists of a stylized representation of three human profiles facing to the right, stacked one behind the other, with flowing lines beneath them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 11, 2016 Mr. Greg Last Ouality Systems and Regulatory Affairs Manager Tangent Medical Technologies. Incorporated 8170 Jackson Road, Suite A Ann Arbor, Michigan 48103 Re: K160374 Trade/Device Name: NovaCath™ Secure IV Catheter System Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: February 8, 2016 Received: February 10, 2016 Dear Mr. Last: 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 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 for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K160374 Device Name NovaCathTM Secure IV Catheter System ### Indications for Use (Describe) The NovaCath™ Secure IV Catheter System is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravascularly. The needle-shielding feature aids in the prevention of needlestick injuries. Upon catheter insertion, blood is contained within the device to aid in the prevention of blood exposure. The NovaCath™ device may be utilized in any patient population with consideration given to vascular anatomy and appropriateness of procedure. The 18, 20, and 22 gauge NovaCath™ devices are suitable for use with power injectors for a maximum of 300psi. | 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}------------------------------------------------ # Special 510(k): Device Modification 510(k) Summary Tangent Medical Technologies, Inc. NovaCath Secure IV Catheter System | Submission Date: | February 8, 2016 | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submission Owner<br>Information: | Tangent Medical Technologies, Inc.<br>8170 Jackson Rd. STE A<br>Ann Arbor, MI 48103 | | Contact<br>Information: | Greg Last<br>Quality Systems and Regulatory Affairs Manager<br>Greg@tangentmedical.com<br>Tel: 734-527-4051<br>Fax: 734-253-2043 | | Device Name: | NovaCath™ Secure IV Catheter System | | Proprietary<br>Name: | NovaCath™ Secure IV Catheter System | | Common Name: | Intravascular Catheter (short-term, less than 30 days, therapeutic) | | Classification<br>Name: | Intravascular Catheter | | Classification<br>Code: | FOZ | | Regulation<br>Number: | 21 CFR §880.5200 | | Predicate<br>Device: | NovaCath™ Secure IV Catheter System (K120839) | | Device<br>Description: | The NovaCath™ Secure IV Catheter System is a short-term, therapeutic, IV catheter. The<br>NovaCath™ currently has four commercially available models. This special 510(k) adds<br>two additional models of different catheter lengths to the existing gauge size portfolio.<br>Two (2) additional models: | | Gauge | 20G | 24G | |-----------------|-------|-------| | Catheter Length | 1.25" | 0.56" | {4}------------------------------------------------ | Gauge | 18G | 20G | 22G | 24G | |-----------------|-------|-------|-------|-------| | Catheter Length | 1.25" | 1.00" | 1.00" | 0.75" | Are being added to the existing four (4) models cleared in K120839: The NovaCath™ Secure IV Catheter System is comprised of an over-the-needle, radiopaque intravascular catheter, integrated extension tubing with a secondary stabilization hub, a female luer lock and clamp, and a passive safety needle shielding mechanism. The design of the NovaCath™ Secure IV Catheter System is considered a closed system since it protects users from blood exposure during the catheter insertion procedure. Blood is contained within the device after needle withdrawl by a self-sealing septum and luer lock, which is provided with a one-time use vent plug. The clamp on the extension tubing is provided to eliminate blood exposure when the vent plug is replaced with an infusion set connection or other end cap. Intended Use: The intended use of the device is identical to the predicate device. > The NovaCath™ Secure IV Catheter System is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravascularly. The needle-shielding feature aids in the prevention of needlestick injuries. Upon catheter insertion, blood is contained within the device to aid in the prevention of blood exposure. The NovaCath™ device may be utilized in any patient population with consideration given to vascular anatomy and appropriateness of procedure. The 18, 20, and 22 gauge NovaCath™ devices are suitable for use with power injectors for a maximum of 300psi. Comparison of The intended use of the device and the technological characteristics of the device are Technological unchanged from the predicate device. The two models being added to the NovaCath™ Characteristics: product line per this special 510(k) use the same technology and materials as the four commercially available models. The differences are in the needle length, catheter length, and housing sizes. > The table below provides a comparison summary of the technological characteristics between the subject and predicate device. {5}------------------------------------------------ | Substantial Equivalence Comparison | | | |------------------------------------------------|----------------------------------------------|--------------------------------------------| | Comparison Criteria | Subject Device<br>(NovaCath 201250 & 240560) | Predicate Device<br>(NovaCath K120839) | | Same Intended Use | Yes | Yes | | Prescription Device (Rx Only) | Yes | Yes | | Biocompatible Polyurethane Catheter | Yes | Yes | | Biocompatible Materials of Fabrication | Yes | Yes | | Closed System | Yes | Yes | | Built-In Extension from Main Assembly | Yes | Yes | | Flashback Visualization | Yes | Yes | | Sharps Injury Prevention Feature | Yes, Passive Integrated | Yes, Passive Integrated | | Mechanical | Yes, Manual Needle<br>Retraction | Yes, Manual Needle Retraction | | Intended Anatomical Location | Yes, Peripheral Vasculature | Yes, Peripheral Vasculature | | Distal End Configuration | Yes, Meets ISO 10555-5 | Yes, Meets ISO 10555-5 | | Proximal End Configuration | Yes, Female Luer Access Port | Yes, Femal Luer Access Port | | Flow Rate (ml/min) | Yes, 20G: 40 ml/min<br>Yes, 24G: 14 ml/min | Yes, 20G: 46 ml/min<br>Yes, 24G: 14 ml/min | | Catheter Stabilization | Yes, Primary and Secondary | Yes, Primary and Secondary | | EO Sterilization Method | Yes | Yes | | Packaged Sterile, Single Use | Yes | Yes | | Non-Pyrogenic | Yes | Yes | | Made without Latex Rubber | Yes | Yes | | Made without DEHP | Yes | Yes | | For Use with Power Injections up to<br>300 psi | Yes, 20G;<br>24G Contraindicated | Yes, 18G, 20G, 22G;<br>24G Contraindicated | The device was developed and tested in accordance with released company procedures Summary of on design control (per 21 CFR 820.30) and risk analysis (per ISO 14971:2009). A Device declaration of conformity to design controls is located within the 510(k). Evaluation: The risk analysis method used to assess the impact of the modifications was a Failure Modes and Effects Analysis (FMEA) per released procedures. The design verification tests completed are as follows: | Modification | Test Performed | Consensus Standard | |-----------------------------------------------------------------|-----------------------------------------------------------|--------------------| | 20Gx1.25" Catheter | Power Injection Test for Flow<br>Rate and Device Pressure | ISO 10555-1:2013 | | 20Gx1.25" Catheter | Flow Rate Test | ISO 10555-1:2013 | | 24G x0.56" Catheter | Flow Rate Test | ISO 10555-1:2013 | | 24G x0.56" Catheter<br>Modified Housing<br>("Slider") Component | Test Access to the Sharp in<br>Safe Mode | ISO 23908:2011 | {6}------------------------------------------------ #### Conclusions: The NovaCath™ Secure IV Catheter System as described in this Special 510(k) has been found to perform in the substantial equivalent manner as the predicate device.