Endophys Pressure Sensing Sheath Kit- 8F

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 30, 2017 Endophys Holdings, LLC % Mark Job Regulatory Technology Services, LLC 1394 25th Street. NW Buffalo, Minnesota 55313 Re: K173399 Trade/Device Name: Endophys Pressure Sensing Sheath Kit Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB, DXO Dated: October 27, 2017 Received: October 31, 2017 Dear Mark Job: 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-related 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. {1}------------------------------------------------ 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. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Kenneth J. Cavanaugh -S for Bram D. Zuckerman, M.D. 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) K173399 Device Name Endophys Pressure Sensing Sheath Kit ### Indications for Use (Describe) The Endophys Pressure Sensing Sheath Kit (Endophys Pressure Sensing Sheath, vessel dilator and guidewire) is intended to facilitate the introduction of diagnostic and interventional devices into the vasculature and to continuously measure blood pressure during the procedure when used with the Endophys Blood Pressure Monitor. Together, the Pressure Sensing Sheath and the Blood Pressure Monitor comprise the Endophys Pressure Sensing Access System (PSASTM). 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 for the Endophys Pressure Sensing Sheath Kit The updated 510(k) Summary is provided on the following pages. {4}------------------------------------------------ ## 510(k) Summary # 510(k) Summarv Endophys Pressure Sensing Sheath Kit #### I. SUBMITTER Endophys, Inc. Thanksgiving Tower, Suite 3500 1601 Elm Street Dallas, TX 75201 Contact person: Phillip D. Purdy, M.D. Phone: 214-801-0578 Fax: 214-377-0709 Date prepared: October 18, 2017 #### II. DEVICE Name of the device: Endophys Pressure Sensing Sheath Kit Common of usual name: Introducer Catheter and accessories Classification name: Catheter Introducer Regulatory Class: 2 Product Code: DYB (classification); DXO (subsequent) #### III. PREDICATE DEVICE Endophys Pressure Sensing Sheath Kit (K160272) This predicate has not been subject to a design-related recall No reference devices were used in this submission. #### IV. DEVICE DESCRIPTION The Endophys Pressure Sensing Sheath Kit is comprised of the Endophys Pressure Sensing Sheath, vessel dilator and guidewire. The Endophys Pressure Sensing Sheath and accessories are provided sterile (EO). The Pressure Sensing Sheath ("PSS") is an introducer sheath with an integrated fiber optic pressure transducer. The PSS is provided with a dilator and a guidewire, which together make up the Endophys Pressure Sensing Sheath Kit ("PSS Kit"). The PSS Kit is intended to be used only with the Endophys Blood Pressure Monitor ("BPM"), which connects to the PSS and displays the blood pressure measurements. Together with the BPM, the PSS is used to continuously monitor patient blood pressure during procedures requiring vascular access. The PSS introducer sheath is used to assist vascular access in the same manner as do standard catheter introducers. The PSS introducer sheath has an integrated pressure sensor that provides high resolution, continuous and {5}------------------------------------------------ instantaneous pulse wave hemodynamics to monitor blood pressure. Together, the Pressure Sensing Sheath and the Blood Pressure Monitor comprise the Endophys Pressure Sensing Access System (PSASTM). The vessel dilator is used to facilitate insertion of the PSS, and is packaged with the Endophys PSS Kit. Once the PSS has been properly positioned in the vessel, the dilator is removed. The guidewire is J tipped, 50cm (length), 0.89mm (diameter), and is used to assist in the placement of the dilator/PSS Introducer Sheath through the skin and into the vasculature. Once the dilator and introducer are positioned over the guidewire, the guidewire is removed through the dilator. #### V. INDICATION FOR USE The Endophys Pressure Sensing Sheath Kit (Endophys Pressure Sensing Sheath, vessel dilator and guidewire) is intended to facilitate the introduction of diagnostic and interventional devices into the vasculature and to continuously measure blood pressure during the procedure when used with the Endophys Blood Pressure Monitor. Together, the Pressure Sensing Sheath and the Blood Pressure Monitor comprise the Endophys Pressure Sensing Access System (PSAS"). #### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE Introducer catheters, by nature, are tubular structures intended to provide a pathway for therapeutic and/or diagnostic devices into the human vasculature. Specialized introducer catheters have been developed which incorporate sensors into these devices to allow active monitoring of blood pressure during interventional procedures. Blood pressure monitoring using a fiber optic transducer is the technological principle for both the subject and predicate devices. The technology requires use of a compatible blood pressure monitor to provide this data to the clinician. At a high level, the subject and predicate device are based on the following same technological elements: | • Product Code | | • UV Adhesive | |------------------------------|--|--------------------------------| | • Device Classification Name | | • Pressure Sensor Type | | • 21 CFR Regulation Number | | • Sensor Location | | • Indications for Use | | • Pressure Range | | • Principle of Operation | | • Accuracy of Pressure Reading | | • Target Population | | • Calibration | | • Anatomical Site | | • Power Source | Page 3 {6}------------------------------------------------ | • Where Used | • Sensor Fiber | |----------------------------------------|------------------------------------| | • Contraindications | • Sensor Diaphragm, Pedestal | | • Human Factors | • 2-Part Epoxy | | • Placement | • 3-Way Stopcock | | • Not Resterilized | • Dilator Sheath Connectivity | | • Sterilization Method | • Guidewire length | | • Method of Blood Pressure measurement | • Guidewire width | | • Components | • Guidewire tip configuration | | • Instructions For Use | • Guidewire Source | | • Labeling | • Guidewire straightener | | • Biocompatibility Test Results | • Guidewire Wire and core material | | • Sheath Taper Length | • Guidewire Hoop and Clip | | • Suture Ring | • Guidewire Luer Lock | | • Radiopaque Marker | • Sterile Barrier System | | • Molded Y-Hub | • Primary Barrier Material | | • Hemostasis Valve | • Die-Cut Card Material | | • Primary Lumen Liner | • Shelf Carton | | • Secondary Lumen Liner | • Pouch/Shelf/Shipper Box Label | | • Braided Wire (Encapsulated) | • Shipping Carton | The following technological differences exist between the subject and predicate device: | Sheath Size | Dilator Size | |------------------------------|--------------------------| | • | • | | Sheath Inside Diameter | Dilator Working Length | | • | • | | Sheath Outside Diameter | Dilator Tube/Extrusions | | • | • | | Overall Length | Hub Resin | | • | • | | Effective Length | Hub Ink (proposed device | | • | only) | | Outer Jacket Material | | | • | Hub Colorant | | Hemostasis Valve Adapter | | | • | Shelf Life | | UV Adhesive (proposed device | | | only) | • | #### PERFORMANCE DATA VII. The following performance data was provided in support of the substantial equivalence. - 6% Luer Conical Fittings Gauge Test . - 6% Luer Conical Fittings Separation Force 트 - 6% Luer Conical Fittings Stress Cracking 트 - Dimensional Analysis - 트 Sensor Accuracy - Guide Wire / Device Compatibility - 트 Radiopacity - Flexibility Tip deflection ■ Page 4 {7}------------------------------------------------ - Flexibility Kink Resistance ■ - Flexibility - Sensor Functionality - Tip Compression 트 - Liquid Leak Under Pressure - 트 Liquid Leak through Hemostasis Valve - 트 Separation Force at Break - Pouch Peel Strength - ' Dilator to Hemostasis Valve Separation Force - 트 Acute Systemic Injection - 트 Ames Reverse Mutation Assay - 트 C3A and SC5B-9 Complement Activation Test - Direct Contact - In Vitro Hemocompatibility Test - Direct Contact - 트 Intracutaneous Injection Test - Kligman Maximization (Sensitization) Test - L929 MEM Elution - " L929 Neutral Red Uptake - Mouse Lymphoma Mutagenesis Assay with Confirmation - ISO - 트 Pyrogenicity Material Mediated - 트 Rabbit Blood Hemolysis Test Complete - 트 Thrombogenicity in Dogs - 트 Unactivated PTT Test Direct Contact - Shelf Life Testing - I Corrosion Testing The modified Endophys Pressure Sensing Sheath met all specified criteria and based on the design verification performance, the conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device. #### SUBSTANTIAL EQUIVALENCE VIII. The indications for use for the predicate device is substantially equivalent to the indications for use for the proposed PSS Kit. Furthermore, the PSS Kit has the same intended use, patient population, and anatomical sites as well as similar technological characteristics as the predicate device. The differences in technological characteristics have been analyzed and addressed through testing. Any differences in the technological characteristics between the devices do not raise different questions of safety or effectiveness. Thus, the Endophys Pressure Sensing Sheath Kit is substantially equivalent to the predicate device. #### IX. CONCLUSION The PSS Kit contains a catheter introducer sheath with an integrated fiber | Endophys, Inc. | |--------------------------------------| | Traditional 510(k) Notification | | Endophys Pressure Sensing Sheath Kit | Page 5 {8}------------------------------------------------ optic pressure transducer, a dilator, and a guidewire for standard interventional procedures. The PSS Kit has the same intended use, patient population, and anatomical sites as well as similar technological characteristics as the predicate device. The differences in technological characteristics have been analyzed and addressed through testing. As such, the PSS Kit is substantially equivalent to the predicate device. #### X. SUMMARY The PSS Kit is substantially equivalent to the predicate device.