Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga.

{0}------------------------------------------------ Public Health Service Image /page/0/Picture/2 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. June 23, 2017 Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Arrow International, Inc. Ms. Fallon Young Associate Regulatory Affairs Specialist 2400 Bernville Road Reading, PA 19605 Re: K171146 Trade/Device Name: Arrow Seldinger Arterial Catheterization Device Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: May 25, 2017 Received: May 30, 2017 Dear Ms. Young: 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 of medical device {1}------------------------------------------------ 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 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, Fernando Agnel Fernando Aguel-S Bram D. Zuckerman, M.D. for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K171146 Device Name Arrow Seldinger Arterial Catheterization Device Indications for Use (Describe) The Arrow Seldinger Arterial Catheterization Devices permit access to the peripheral arterial circulation or to other small vessels. 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}------------------------------------------------ ### 510(K) SUMMARY (as required by the Safe Medical Devices Act of 1990 and in accordance with 21 CFR ## 8807.92(a)) FOR ## ARROW SELDINGER ARTERIAL CATHETERIZATION DEVICE #### 1. Submitter Information | Name: | Arrow International, Inc. (subsidiary of Teleflex Inc.) | |-------------------|---------------------------------------------------------| | Address: | 2400 Bernville Road<br>Reading, PA 19605-9607 | | Telephone Number: | (610) 378-0131 | | Contact Person: | Fallon Young<br>Associate Regulatory Affairs Specialist | | Telephone Number: | (610) 984-7188 | | Fax Number: | (610) 374-5360 | | Email: | fallon.young@teleflex.com | | Date Prepared: | April 18, 2017 | ### 2. Device Name | Device Trade Name: | Arrow Seldinger Arterial Catheterization Device | |----------------------------------|-------------------------------------------------| | Common Name: | Percutaneous Arterial Catheter | | Classification Name: | Catheter, percutaneous | | (Class II, DQY, 21 CFR 870.1250) | | ### 3. Predicate Devices - . K093050: Arrow Seldinger Arterial Catheterization Devices ## 4. Device Description The subject Arrow Seldinger Arterial Catheterization Devices consist of either an introducer needle or catheter-over-needle assembly, spring wire guide, and a catheter assembly that incorporates an extension tubing segment with a slide clamp and a luer hub with dust cap. These components are used together for catheter insertion using the "Seldinger" catheter-over-guide-wire insertion technique. The predicate Arrow Seldinger Arterial Catheterization Devices are currently available in 18 ga. and 20 ga. configurations with usable lengths of 5cm to 23cm. The subject device will extend the device configurations to include 22 ga. and 24 ga. catheters with usable lengths of 2.5 cm to 23 cm and will add guide wire sizes that are compatible with the {4}------------------------------------------------ additional catheter sizes. The subject device also introduces a new catheter and juncture hub material in place of the predicate materials for all gauge sizes. The overall device description of the subject and predicate Arrow Seldinger Arterial Catheterization Devices is the same. ## 5. Intended Use The Arrow Seldinger Arterial Catheterization Devices permit access to the peripheral arterial circulation or to other small vessels. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. ## 6. Indications for Use The Arrow Seldinger Arterial Catheterization Devices permit access to the peripheral arterial circulation or to other small vessels. ## 7. Technological Characteristics The subject Arrow Seldinger Arterial Catheterization Devices employs the same fundamental scientific technology as the predicate Arrow Seldinger Arterial Catheterization Devices. The changes made to the subject device Arrow Seldinger Arterial Catheterization Devices are the product line extension and catheter extrusion and juncture hub material changes. Arrow International's legally marketed predicate device, the Arrow Seldinger Arterial Catheterization Device (K093050), was cleared with the configurations of 18 and 20 gauge catheters with usable lengths of 5-23 centimeters. The subject device configurations will extend the product line to include 22 and 24 gauge catheters with usable lengths of 2.5-23 centimeters. The product line expansion modifications add compatible spring wire guide sizes and a commercially available catheter-over-needle assembly component for use with the 24 ga. device. The subject device modifications also include a material change to the catheter extrusion and a material change to the juncture hub. Testing on the modifications to the subject device verified that the changes presented no different questions of safety or efficacy. Below is a comparison table to highlight the similarities and differences in the subject and predicate Arrow Seldinger Arterial Catheterization Devices. {5}------------------------------------------------ | DEVICE COMPARISON TABLE | | | | |---------------------------|-------------------------------------------------------------------------------------|------------------------------------------------------------------------|--| | | Predicate Device:<br>Arrow Seldinger Arterial<br>Catheterization Devices<br>K093050 | Subject Device:<br>Arrow Seldinger Arterial<br>Catheterization Devices | | | Indications for Use | The Arrow Seldinger Arterial | SAME: The Arrow Seldinger | | | | Catheterization Devices permit | Arterial Catheterization Devices | | | | access to the peripheral arterial | permit access to the peripheral | | | | circulation or to other small | arterial circulation or to other | | | | vessels | small vessels | | | Device Design Feature | | | | | Catheter Gauge Sizes | 18 ga, 20 ga | 18 ga, 20 ga, 22 ga, 24 ga | | | Catheter Usable Length | 5cm - 23cm (2"- 9 1/4") | 2.5cm - 23cm | | | | | (0.98"- 9 1/4") | | | Introducer needle size | 18 ga .: 18 ga X 5cm-7cm (2"-<br>2 3/4") | SAME: 18 ga .: 18 ga X 5cm-<br>7cm (2"- 2 3/4") | | | | 20 ga.: 20 ga. X 4 cm-7cm (1 | SAME: 20 ga .: 20 ga. X 4cm- | | | | 1/2 " - 2 3/4") | 7cm (1 ½"- 2 ¾") | | | | | NEW: 22 ga.: 22 ga. X 4cm (1 | | | | | 1/2") | | | Catheter-Over-Needle Size | N/A | Needle: 26 ga. X 2cm (3/4") | | | (only 24 ga.) | | Catheter: 24 ga. X 2cm (3/4") | | | Spring Wire Guide Size | 18 ga .: 0.64mm diameter X | SAME: 18 ga.: 0.64mm | | | | 33.5cm-60cm (13"-23") | diameter X 33.5cm-60cm (13"- | | | | 20 ga.: 0.533mm diameter X | 23") | | | | 35cm-50cm (13 3/4"-20") | SAME: 20 ga.: 0.533mm | | | | | diameter X 35cm-50cm (13 ¾"- | | | | | 20") | | | | | SAME: 22 ga.: 0.533mm | | | | | diameter X 35cm (13 3/4")<br>NEW: 24 ga .: 0.46mm diameter | | | | | X 25cm (9 3/4") | | | Spring Wire Guide Tip | Straight and J-tip | SAME: Straight and J-tip | | | Spring Wire Guide Depth | Yes, etched on straight spring | SAME: Yes, etched on straight | | | Markings | wire guides. Not on J-tip | spring wire guides. Not on J-tip | | | | spring wire guides | spring wire guides | | | Introducer Method | Introducer needle | Introducer needle and | | | | | introducer catheter-over-needle | | | Sterilization | | | | | Sterilization Method | EO | SAME: EO | | | Shelf life and packaging | | | | | Shelf life | 5 years | 2 years | | | Packaging | PET/LDPE film mated with | SAME: PET/LDPE film mated | | | | Tyvek | with Tyvek | | Apart from the additional catheter sizes with associated component additions and the material changes to the extrusion and juncture hub, no other changes have been made to the subject Arrow Seldinger Arterial Catheterization Devices in comparison to Arrow International's legally marketed predicate, the Arrow Seldinger Arterial Catheterization {6}------------------------------------------------ Devices (K093050). The indications for use and fundamental scientific technology of the subject and predicate devices are the same. ## 8. Nonclinical Testing Bench testing performed on the subject Arrow Seldinger Arterial Catheterization Devices supports substantial equivalence to the predicate device. The following testing has been conducted as a result of the device modifications: - . Biocompatibility in accordance with ISO 10993-1 - Applicable requirements from ISO 10555-1 ● - Surface: Extraneous Matter and External Surface O - Resistance to Kink O - Peak Tensile Force o - Air Leakage O - Liquid Leakage o - Applicable requirements from ISO 11070 including: ● - Surface: Extraneous Matter and Defects O - Guide wire Fracture O - Guide wire Flexure O - Guide wire Tensile O - Needle Point o - Peak Tensile Force O - Strength of Union of Needle Tube and Needle Hub O - Guide wire Stiffness ● - Guide wire Interface - Simulated Blood Withdrawal - . Pressure Monitoring - . Penetration Force - Radio Detectability ### 9. Conclusions The predicate and subject Arrow Seldinger Arterial Catheterization Devices have the same indications for use, intended use, and fundamental scientific technology, and are manufactured using the same processes, conditions, and aids. The results of the risk assessment and resultant testing performed have demonstrated that the proposed device {7}------------------------------------------------ modifications present no different questions of safety or effectiveness and therefore the subject device is considered substantially equivalent to the cited predicate devices.