Turbo-Flo PICC Sets

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three intertwined figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus. The seal is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 7, 2016 Cook Incorporated Mr. Steven Lawrie Regulatory Affairs Manager 750 Daniels Way Bloomington, Indiana 47404 Re: K161496 Trade/Device Name: Turbo-Flo® PICC Sets Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: July 11, 2016 Received: July 12, 2016 Dear Mr. Lawrie: 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, Image /page/1/Picture/8 description: The image shows a signature and the name "Tina Kiang" in a clear, sans-serif font. Below the name, there is a small "-s" written. The signature is complex and illegible, featuring looping lines and curves. 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) K161496 Device Name Turbo-Flo® PICC Sets Indications for Use (Describe) Turbo-Flo Peripherally Inserted Central Venous Catheter (PICC) Sets and Trays are intended for venous pressure monitoring, blood sampling and administration of drugs and fluids. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, large, bold font on a red background. Below the word "COOK" is the word "MEDICAL" in white, smaller, bold font on a red background. # 510(k) SUMMARY # K161496 Turbo-Flo® PICC Sets 21 CFR § 807.92 Date Prepared: October 5, 2016 #### Submitted By: Submission: Applicant: Contact: Applicant Address: Contact Phone Number: Contact Fax Number: Email: # Device Information: Trade Name: Common Name: Regulation Number: Regulation Name: Regulatory Class: Product Code: Classification Panel: #### Predicate Device: Trade Name: 510(k) Number: Common Name: Regulation Number: Regulation Name: Regulatory Class: Product Code: Classification Panel: # Reference Device: Trade Name: 510(k) Number: Common Name: Regulation Number: Regulation Name: Regulatory Class: Traditional 510(k) Premarket Notification Cook Incorporated Steven Lawrie Cook Incorporated 750 Daniels Way Bloomington, IN 47404 (812) 335-3575 x104518 (812) 332-0281 RegSubmissions@CookMedical.com # Turbo-Flo® PICC Sets Catheter, intravascular, therapeutic, long-term greater than 30 days 21 CFR §880.5970 Percutaneous, implanted, long-term intravascular catheter Class II ris General Hospital # Turbo-Flo® PICC K041848 Catheter, intravascular, therapeutic, long-term greater than 30 days 21 CFR §880.5970 Percutaneous, implanted, long-term intravascular catheter Class II LIS General Hospital # Turbo-JeCT PICC K072625 Catheter, intravascular, therapeutic, long-term greater than 30 days 21 CFR §880.5970 Percutaneous, implanted, long-term intravascular catheter Class II {4}------------------------------------------------ Product Code: LIS Classification Panel: General Hospital # Purpose of the Submission: Cook is submitting this premarket notification to obtain FDA's determination that the Turbo-Flo® PICC Sets are substantially equivalent to the Turbo-Flo® PICC cleared under K041849. The modifications of the subject device as compared to the predicate include changing the depth marking ink printed on the Turbo-Flo® PICC catheter shaft and the removal of the power injection indication. # Device Description: The 4 and 5 Fr Turbo-Flo® PICC Sets with single or double lumen configurations are radiopaque polyurethane peripherally inserted central venous catheters for short- or long-term use, and can be inserted over-the-wire or through a Peel-Away® introducer. The set components may include the PICC, obturator, Peel-Away® introducer, entry needles, wire guide, and other convenience components. The set is supplied sterile and is intended for one-time use. # Intended Use: Turbo-Flo® Peripherally Inserted Central Venous Catheter (PICC) Sets and Trays are intended for venous pressure monitoring, blood sampling and administration of drugs and fluids. ### Comparison to Predicate Device: Turbo-Flo® PICC Sets and the predicate device, the Turbo-Flo® PICC (K041849), are substantially equivalent in that these devices have the same design, intended use, technological characteristics, method of placement, and included accessories. Both devices are intended for short- or long-term use for venous pressure monitoring, blood sampling, and administration of drugs and fluids. The modifications of the subject device as compared to the predicate include changing the depth marking ink printed on the Turbo-Flo® PICC catheter shaft and the removal of the power injection indication, as shown in the following comparison table. {5}------------------------------------------------ | | Predicate Device | Subject Device | Reference Device | |-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Turbo-Flo PICC<br>(K041849) | Turbo-Flo PICC | Turbo-JeCT PICC<br>(K072625) | | Manufacturer | Cook Incorporated | Cook Incorporated | Cook Incorporated | | Regulation | 21 CFR §880.5970 | Identical | Identical | | Class | Class II | Identical | Identical | | Product Code | LJS | Identical | Identical | | Classification<br>Name | Percutaneous,<br>implanted, long-term<br>intravascular catheter | Identical | Identical | | Intended Use/<br>Indications for<br>Use | Indicated for short- or<br>long-term use for<br>venous pressure<br>monitoring, blood<br>sampling,<br>administration of drugs<br>and fluids, and for use<br>with power injectors for<br>delivery of contrast in<br>CT studies.<br>The maximum pressure<br>setting/limit of power<br>injectors used with the<br>Turbo-Flo PICC may<br>not exceed 300 psi for<br>the 5 Fr single lumen<br>and 200 psi for the 4 Fr<br>single lumen and 5 Fr<br>double lumen. The<br>Turbo-Flo PICC is<br>indicated for a single<br>injection of contrast<br>media through a power<br>injection. | Intended for venous<br>pressure monitoring,<br>blood sampling and<br>administration of drugs<br>and fluids. | Indicated for short- or<br>long-term use for<br>venous pressure<br>monitoring, blood<br>sampling,<br>administration of drugs<br>and fluids, and for use<br>with power injectors for<br>delivery of contrast in<br>CT studies.<br>The Turbo-JeCT<br>PICC is indicated for<br>multiple injections of<br>contrast media through<br>a power injector. The<br>maximum pressure<br>limit setting for power<br>injectors used with the<br>Turbo-Ject PICC may<br>not exceed 325 psi and<br>the flow rate may not<br>exceed the maximum<br>flow rate indicated. | | Duration of<br>Use | Short-term or long-term | Identical | Identical | | French Size | 4, 5 | Identical | Identical | | Length (cm) | 60 | Identical | Identical | | # of Lumens | Single or Double | Identical | Identical | | Shaft Material | Polyurethane | Identical | Identical | | Depth | 5 cm increments, | 1 cm increments, | 1 cm increments, | | Marking | Imaje #5101 black ink | Imaje #5135E black ink | Imaje #5135E black ink | | Sterilization | EtO, SAL 106 | Identical | Identical | | Shelf Life | 3 years | Identical | Identical | | Packaging | Tray with Tyvek<br>lidstock | Identical | Identical | {6}------------------------------------------------ # Performance Data: As the ink printed on the subject device is utilized in Cook Turbo-JeCT® PICC catheters (K072625) which are also manufactured with polyurethane tubing and undergo the same manufacturing (including ink printing process) and sterilization processes, no testing is warranted for the minor modification on the subject device. In addition, the removal of the power injection, an add-on feature, raises no new questions of safety or effectiveness. Therefore, no performance testing is required for this submission. # Conclusion: The subject device does not raise new questions of safety or effectiveness compared to the predicate device. This supports a determination of substantial equivalence.