Reprocessed Inquiry Steerable Diagnostic EP Catheter

{0}------------------------------------------------ Image /page/0/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping and merging into a single form. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 10, 2016 Innovative Health, LLC. Rafal Chudzik Director of Engineering 1435 North Hayden Road, Suite 100 Scottsdale, Arizona 85257 Re: K160496 Trade/Device Name: Reprocessed Inquiry H-Curve Steerable Diagnostic EP Catheters (See attached list of models) Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: May 4, 2016 Received: May 5, 2016 Dear Rafal Chudzik: 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ 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. Mude Jellman for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ | Item Number | Model/<br>Description | Description | Electrodes | Spacing<br>(mm) | Curve | French<br>Size | Usable<br>Length<br>(cm) | |-------------|-----------------------|---------------------------------------------|------------|-----------------|---------|----------------|--------------------------| | 81120 | 1120-7-17-H | Inquiry Steerable<br>Diagnostic EP Catheter | 20 | 1-7-1 | H-Curve | 7 | 110 | | 81130 | 1120-7-19-HL | Inquiry Steerable<br>Diagnostic EP Catheter | 20 | 1-9-1 | H-Large | 7 | 110 | | 81136 | 1120-7-5-HL-UP | Inquiry Steerable<br>Diagnostic EP Catheter | 20 | 5 | H-Large | 7 | 110 | | 81128 | 1121-7-5-H-UP | Inquiry Steerable<br>Diagnostic EP Catheter | 21 | 5 | H-Curve | 7 | 110 | | 81124 | 1124-7-271-H | Inquiry Steerable<br>Diagnostic EP Catheter | 24 | 2-7-1 | H-Curve | 7 | 110 | | 81134 | 1124-7-291-HL | Inquiry Steerable<br>Diagnostic EP Catheter | 24 | 2-9-1 | H-Large | 7 | 110 | # Reprocessed Single-Use Devices Included in K160496 Clearance {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K160496 #### Device Name Reprocessed Inquiry H-Curve Steerable Diagnostic Electrophysiology Catheter Indications for Use (Describe) The Reprocessed Inquiry H-Curve Steerable Diagnostic Electrophysiology Catheter is a steerable electrophysiology catheter used for recording intracardiac stimulation during diagnostic electrophysiological studies. The catheters are to be used to map the atrial regions of the heart. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <svg class="bi bi-check-square-fill" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2zm10.03 4.97a.75.75 0 0 0-1.08.022L7.477 9.417 5.384 7.323a.75.75 0 0 0-1.06 1.06L6.97 11.03a.75.75 0 0 0 1.079-.02l3.992-4.99a.75.75 0 0 0-.01-1.05z" fill-rule="evenodd"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### 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." {4}------------------------------------------------ # SECTION 5: 510(k) SUMMARY As required by 21 CFR 807.92(c) #### Submitter's Name and Address: Innovative Health, LLC. 1435 N. Hayden Road, Suite 100 Scottsdale, AZ 85257 ### Contact Name and Information: Rafal Chudzik Director of Engineering (480) 525-6006 (office) (844) 965-9359 (fax) rchudzik@innovative-health.com ### Date prepared: February 19, 2016 #### Device Information: | Trade/Proprietary Name: | Reprocessed Inquiry H-Curve Steerable Diagnostic<br>Electrophysiology Catheters | |-------------------------|---------------------------------------------------------------------------------| | Common Name: | Diagnostic Electrophysiology Catheter | | Classification Name: | Catheter, Recording, Electrode, Reprocessed | | Classification Number: | Class II, 21 CFR 870.1220 | | Product Code: | NLH | ## Predicate Device: | 510(k) Number | 510(k) Title | Manufacturer | |---------------|-------------------------------------------------------------------------------------------------|-------------------------| | K082061 | Inquiry H-Curve TV Steerable Diagnostic<br>Catheter | Irvine Biomedical, Inc. | | K042775 | Inquiry AFocus, Inquiry AFocus II and<br>Inquiry Optima Steerable<br>Electrophysiology Catheter | Irvine Biomedical, Inc. | | K961924 | IBI-1100 Steerable Electrophysiology<br>Catheter System | Irvine Biomedical, Inc. | #### Reference Device: | 510(k) Number | 510(k) Title | Reprocessor | |---------------|--------------------------------------------|-------------------------------------| | K112232 | Reprocessed Electrophysiology<br>Catheters | Stryker Sustainability<br>Solutions | #### Device Description: The Reprocessed Inquiry H-Curve Steerable Diagnostic Electrophysiology (EP) Catheters are flexible, insulated catheters constructed of thermoplastic elastomer material and noble metal electrodes. The tip of the steerable catheters may be manipulated with the control mechanism located in the handle at the proximal end of the catheter. {5}------------------------------------------------ | Item Number | Model/<br>Description | Description | Electrodes | Spacing<br>(mm) | Curve | French<br>Size | Usable<br>Length<br>(cm) | |-------------|-----------------------|---------------------------------------------|------------|-----------------|---------|----------------|--------------------------| | 81120 | 1120-7-17-H | Inquiry Steerable<br>Diagnostic EP Catheter | 20 | 1-7-1 | H-Curve | 7 | 110 | | 81130 | 1120-7-19-HL | Inquiry Steerable<br>Diagnostic EP Catheter | 20 | 1-9-1 | H-Large | 7 | 110 | | 81136 | 1120-7-5-HL-UP | Inquiry Steerable<br>Diagnostic EP Catheter | 20 | 5 | H-Large | 7 | 110 | | 81128 | 1121-7-5-H-UP | Inquiry Steerable<br>Diagnostic EP Catheter | 21 | 5 | H-Curve | 7 | 110 | | 81124 | 1124-7-271-H | Inquiry Steerable<br>Diagnostic EP Catheter | 24 | 2-7-1 | H-Curve | 7 | 110 | | 81134 | 1124-7-291-HL | Inquiry Steerable<br>Diagnostic EP Catheter | 24 | 2-9-1 | H-Large | 7 | 110 | Table 1: Models Included in Clearance ### Indications for Use: The Reprocessed Inquiry H-Curve Steerable Diagnostic Electrophysiology Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies. The catheters are to be used to map the atrial regions of the heart. # Technoloqical Characteristics: The purpose, design, materials, function, and intended use of the Reprocessed Inquiry Steerable Diagnostic Electrophysiology (EP) Catheters are identical to the predicate devices. There are no changes to the claims, clinical applications, patient population, performance specifications, or method of operation. In addition, Innovative Health's reprocessing of these devices includes removal of visible soil and decontamination. Each device is inspected and function tested prior to packaging and labeling. # Functional and Safety Testing: Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Inquiry Steerable Diagnostic EP Catheter. This included the following: - Biocompatibilitv - Cleaning Validation ● - Sterilization Validation ● - Functional Testing - Visual Inspection ● - Dimensional Verification - Electrical Continuity and Resistance ● - Simulated Use ● - Mechanical Characteristics ● - Electrical Safety Testing . - Dielectric and Current Leakage . - Packaging Validation The Reprocessed Inquiry Steerable Diagnostic EP Catheters are reprocessed no more than one (1) time. Each device is marked and tracked. After the device has reached the maximum number of reprocessing cycles, the device is rejected from further reprocessing. Reprocessing is performed only by Innovative Health. Innovative Health {6}------------------------------------------------ restricts its reprocessing to exclude devices previously reprocessed by other reprocessors. ## Conclusion: Innovative Health concludes that the Reprocessed Inquiry Steerable Diagnostic EP Catheters are as safe and effective as the predicate devices described herein.