SUPERCATH Z3V

{0}------------------------------------------------ K112290 # Section 6- 510(k) Summary ## a. Owner/Company name, address TOGO MEDIKIT CO., LTD. 17148-6 Aza Kamekawa, Oaza Hichiya Hyuga City, Miyazaki Prefecture 883-0062, Japan Daisuke Nagamizu Manager, Regulatory Affairs Section Quality Assurance Department Phone: 011-81-982-53-8000 Fax: 011-81-982-53-8008 Email: qc2@togomedikit.co.jp # b. Contact/Application Correspondent Fumiaki Kanai, Ph.D. President and CEO MIC International 4-1-17 Hongo, Bunkyo-ku Tokyo, 113-0033, Japan Phone: 011-81-3-3818-8577 Fax: 011-81-3-3818-8573 Email: kanaif(@mici.co.jp - Date prepared c. July 20, 2011 #### d. Name of device Trade Name: SUPERCATH Z3V Common Name: Intravascular Catheter Classification Name: Catheter, Intravascular, Therapeutic, Short-term less than 30 days Classification Regulation: 21 CFR 880.5200 TOGO MEDIKIT CO., LTD. JULY 20, 2011 APR 1 6 2012 {1}------------------------------------------------ ### e. Predicate devices The SUPERCATH Z3V is substantially equivalent to the following legally marketed devices: | 510(k): | k050114 | |---------------|---------------| | Trade name: | SUPERCATH Z3V | | Product code: | FOZ | | 510(k): | k093546 | | Trade name: | SUPERCATH 5 | | Product code: | FOZ | Since the same name as predicate device is used, the new device under application is hereinafter called "the SUPERCATH Z3V (PROPOSED)" and the predicate device is called "the SUPERCATH Z3V (k050114)'' for convenience of discussion in this application #### f. Description of the device The SUPERCATH Z3V (PROPOSED) is an intravascular catheter and is available in following eight models. - 1. with a check valve - 2. with a wing - 3. with a filter adapter - 4. with a check valve and a wing - 5. with a check valve and a filter adapter - 6. with a wing and a filter adapter - 7. with a check valve, a wing, and a filter adapter - 8. without a check valve, a wing, or a filter adapter The SUPERCATH Z3V (PROPOSED) is intended to access a vein or artery and to administer fluids. The SUPERCATH Z3V (PROPOSED) is designed for single use, is intended for short-term use (less than 30 days), and is intended to minimize inadvertent needlesticks and to reduce accidental needlesticks by the safety system. In the safety system, the metallic introducer needle is retracted into the extendable needle casing. The SUPERCATH Z3V (PROPOSED) catheter hub has a built-in check valve which together with the healthcare professional's finger pressure on the blood vessel, assists to reduce blood flashback when the metallic introducer needle is withdrawn following blood vessel puncture. The built-in check valve is not intended to stop bleeding completely. Some of the SUPERCATH Z3V (PROPOSED) has a filter adapter. The filter adapter can be removed and the SUPERCATH Z3V (PROPOSED) can be connected to a syringe in place of the filter adapter, under negative pressure and assist visual confirmation of blood access. The SUPERCATH Z3V (PROPOSED) is available in 14G, 18G, 20G, 22G, and 24G. TOGO MEDIKIT CO., LTD. JULY 20, 2011 SECTION 6 6-3 OF 6-6 {2}------------------------------------------------ · Without Wing and Filter Adapter Image /page/2/Figure/2 description: This image shows a diagram of a catheter. The catheter tube is on the left side of the image, and the introducer needle is inside the catheter tube. The catheter hub is located in the middle of the image, and the needle hub is on the right side of the image. A filter is located at the end of the needle hub. ## g. Indications for Use ## Indication for Use The SUPERCATH Z3V (PROPOSED) is intended to access a vein or artery and to administer fluids. The SUPERCATH Z3V (PROPOSED) is designed for single use, is intended for short-term use (less than 30 days), and is intended to minimize inadvertent needlesticks and to reduce accidental needlesticks. ## h. Statement of substantial equivalence The SUPERCATH Z3V (PROPOSED) was essentially modified from the SUPERCATH Z3V (k050114). Thus, most of the characteristics of the SUPERCATH Z3V (PROPOSED) are similar to those of the SUPERCATH Z3V (k050114). The similarities are: - . Same intended use - Same catheter material (Polyurethane) . - Radiopaque . - Flashback Visualization . - . Needlestick Injury Prevention Feature - . Check Valve - . Ethylene Oxide Sterilized - Single Sterile Wrapped - . Multiple Gauge Sizes and Needle Lengths - Wing and Filter adapter . The SUPERCATH Z3V (PROPOSED) contains the following modifications as compared to the SUPERCATH Z3V (k050114): - · Change color additives for the catheter hubs - · Change the shape of a wing, a tab, and a protector for models with a wing - · Change the effective length of the catheter - · Change the unit container from a film bag to blister packaging There is another predicate device for SUPERCATH Z3V (PROPOSED), which is the SUPERCATH 5 (k093546). Since the packaging (blister packaging) is identical between the SUPERCATH 5 (k093546) and the SUPERCATH Z3V (PROPOSED), the packaging test report for the SUPERCATH 5 (k093546) is used for the SUPERCATH Z3V (PROPOSED). TOGO MEDIKIT CO., LTD. JULY 20, 2011 SECTION 6 6-4 OF 6-6 {3}------------------------------------------------ In order to evaluate biocompatibility for the SUPERCATH Z3V (PROPOSED), TOGO MEDIKIT performed biocompatibility tests. The test results did not raise biocompatibility concern. For the difference of the catheter effective length, TOGO MEDIKIT performed "Flowrate test" to evaluate flow through the catheter. The test results were compliant with ISO standard as with using the SUPERCATH Z3V (k050114) and confirmed the difference does not raise safety and effective concern, In order to evaluate overall effects of the above changes on safety and effectiveness, performance testing, sterilization validation, biocompatibility testing, simulated clinical study, and risk analysis were performed. In conclusion, those testing and analysis demonstrated that the above listed modifications did not raise any new safety or effectiveness concerns. # i. Risk Analysis The SUPERCATH Z.3V (PROPOSED) was evaluated in accordance with ISO14971:2007. The risk management of the device was deemed satisfactory. #### Bench Testing j. The following bench tests were performed to ensure the safety and effectiveness of the SUPERCATH Z3V (PROPOSED), verify conformity to the recognized standards and demonstrate substantial equivalence to the SUPERCATH Z3V (k050114). - Tensile Strength for the Catheter The tensile strength of the catheter meets acceptable minimum force until breakage when tested according to ISO 10555-1. - Tensile Strength for the Wing The tensile strength of the wing meets acceptable minimum force until breakage when tested according to in-house standard. - Air and Liquid Leakage for the Hub Attachment The catheter hub is impervious to air/liquid infiltration when subjected to positive pressure and aspiration when tested according to ISO 10555-1. - · Flow rate The flow rate through catheter meets allowable limits when tested according to ISO 10555-5. - Leakage at the Check Valve under pressure The built-in check valve is impervious to liquid infiltration when subjected to positive pressure according to in-house standard. - · Leakage (Liquid) from vent fitting It was checked that the vent fitting (filter paper) is impervious to liquid infiltration when subjected to positive pressure when tested according to ISO 10555-5 All SUPERCATH Z3V (PROPOSED) samples were compliant with the ISO and in-house standards and demonstrated substantial equivalence to the SUPERCATH Z3V (k050114). TOGO MEDIKIT CO., LTD. JULY 20, 2011 {4}------------------------------------------------ ## k. Biocompatibility Testing As mentioned above, there is a change of color additives in the catheter hub between the SUPERCATH Z3V (PROPOSED) and the SUPERCATH Z3V (k050114). In order to evaluate biocompatibility for the SUPERCATH Z3V (PROPOSED), TOGO MEDIKIT performed following biocompatibility tests; ## · Cytotoxicity - · Intracutaneous reactivity - · Delayed hypersensitivity - · Acute Systemic Toxicity - · Pyrogen test - · LAL test - Leachable test In the biocompatibility testing reports, no biocompatibility concern was raised. #### 1. Sharps Injury Prevention Feature In accordance with FDA's guidance "Medical Devices with Sharps Injury Prevention Features", Document issued on: August 9, 2005, Togo MEDIKIT performed "Simulated Clinical Use of Study". Requirement in the statistical significant safety feature was confirmed for the sharp needle injury prevention feature of the SUPERCATH Z3V (PROPOSED). ### m. Conclusion The SUPERCATH Z3V (PROPOSED) has the same intended use, similar technological characteristics, components and materials as compared to predicates devices including the SUPERCATH Z3V (k050114) and the SUPERCATH 5 (k093546). Based on the information presented above regarding substantial equivalence, TOGO MEDIKIT concludes that the SUPERCATH Z3V (PROPOSED) is substantially equivalent to predicates devices including the SUPERCATH Z3V (k050114) and the SUPERCATH 5 (k093546) and does not raise any new questions regarding safety or effectiveness. TOGO MEDIKIT CO., LTD. JULY 20, 2011 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing service to the nation. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle. # DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 TOGO MEDIKIT Company, Limited Fumiaki Kanai, Ph.D. President and CEO MIC International 4-1-17 Hongo, Bunkyo-ku Tokyo, 113-0033, Japan Re: K112290 Trade/Device Name: SUPERCATH Z3V Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: March 2, 2012 Received: March 6, 2012 Dear Dr. Kanai: 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 Eederal Register. APR 1 6 2012 {6}------------------------------------------------ # Page 2 - Dr. Kanai 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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 vours. Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {7}------------------------------------------------ # Indications for Use 510(k) Number (If known): Y_12290 Device Name: SUPERCATH Z3V #### Indication for Use The SUPERCATH Z3V is intended to access a vein or artery and to administer fluids. The SUPERCATH Z3V is designed for single use, is intended for short-term use (less than 30 days), and is intended to minimize inadvertent needlesticks and to reduce accidental needlesticks. # Prescription Use (Per 21 CFR 801 Subpart D) AND/OR Over-the Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Ryhl Whin: for RZC. Apr 13, 2012 (Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number:_