EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue. January 3, 2019 Interscope, Inc. % Cynthia Nolte Director, Regulatory ICON Clinical Research LLC 2100 Pennbrook Parkway North Wales, Pennsylvania 19454 Re: K181127 Trade/Device Name: EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and Accessories Regulatory Class: Class II Product Code: PTE Dated: December 13, 2018 Received: December 14, 2018 Dear Cynthia Nolte: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about mediation-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, # Daniel G. Walter Jr -S for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K181127 Device Name Endo Rotor® Indications for Use (Describe) The EndoRotor® is intended for use in endoscopic procedures by a trained gastroenterologist to resect and remove tissue, not intended for biopsy, of the gastrointestinal (GI) system including post-endoscopic mucosal resection (EMR) tissue persistence with a scarred base and residual tissue from the peripheral margins following EMR. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | <div> <span> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> □ 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." {3}------------------------------------------------ ## 510(K) SUMMARY # Modification to the Interscope, Inc., EndoRotor®: Generation 2 (Gen 2) (per 21CFR 807.92) #### 1. SUBMITTER/510(K) HOLDER | Interscope, Inc. | | |----------------------------|-------------------------------------------| | 100 Main Street, Suite 108 | | | Whitinsville, MA 01588 | | | Phone: | +1 877-420-7299 | | Contact: | Jeffery Ryan, Co-Founder, President & CEO | | Contact Phone: | 617-360-1168 | | Contact Email: | Jeffery.ryan@interscopemed.com | | Date Prepared: | December 4, 2018 | #### 2. DEVICE NAME | Proprietary Name: | EndoRotor® | |----------------------------|-----------------------------------------| | Classification Name: | Endoscopic Morcellator Gastroenterology | | Regulation Name: | Hysteroscope and accessories | | Classification Regulation: | 21 CFR 884.1690 | | Product code: | PTE | The EndoRotor®, with the design modifications and expanded indications for use described in the current 510(k) premarket notification, will continue to be marketed as the EndoRotor®. ### 3. PREDICATE DEVICE | Manufacturer: | Interscope, Inc. | |----------------------------|-----------------------------------------| | Proprietary Name: | EndoRotor® | | Classification Name: | Endoscopic Morcellator Gastroenterology | | 510(k) Number: | K170120 | | Regulation Name: | Hysteroscope and accessories | | Classification Regulation: | 21 CFR 884.1690 | | Product Code: | PTE | #### 4. DEVICE DESCRIPTION The purpose of the current 510(k) Premarket Notification is to obtain clearance for modifications to the EndoRotor® design to expand the range of catheters available to gastroenterologists and improve the flexibility and ease of use of the device. In addition, the indications for use for the EndoRotor® have been clarified to include post-endoscopic mucosal resection (EMR) persistent tissue with a scarred base. {4}------------------------------------------------ The EndoRotor®, with the design modifications and expanded indications for use described in the current 510(k) premarket notification, will continue to be marketed as the EndoRotor® The new EndoRotor® will be referred to as the "modified EndoRotor" in this 510(k) Summary. The overall device description remains unchanged since initial FDA clearance. Both the predicate and modified EndoRotor® are powered resection tools consisting of a power console, foot control, specimen trap with pre-loaded filter, and a single-use resection catheter that is inserted into the working channel of a compatible endoscope. The design modifications to the EndoRotor® described in the current 510(k) premarket notification include enhancements to improve the ease of use of the console and catheter components as well as provide flexibility to the gastroenterologist. ## 5. INDICATION FOR USE/INTENDED USE The EndoRotor® is intended for use in endoscopic procedures by a trained gastroenterologist to resect and remove tissue, not intended for biopsy, of the gastrointestinal (GI) system including post-endoscopic mucosal resection (EMR) tissue persistence with a scarred base and residual tissue from the peripheral margins following EMR. The indications for use for the EndoRotor® described in the current 510(k) premarket notification were clarified to include post EMR persistent tissue with a scarred base. The modified EndoRotor® continues to be indicated to resect and remove residual tissue from the peripheral margins following EMR. # 6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICE/S Both the modified and predicate EndoRotor® devices are powered resection tools consisting of a power console, foot control, specimen trap with preloaded filter and a single-use resection catheter that is inserted into the working channel of a compatible endoscope. Resection of residual tissue with the catheter is achieved through reciprocating and rotational movement of the inner cannula relative to the fixed outer cannula while removal is performed via vacuum suction. The device is always under the control of a trained physician and is technique dependent with regards to depth of removal and avoiding perforation. To improve the flexibility, performance, and ease of the system, Interscope has implemented design enhancements to the catheter and console components as described below. ## Console The console houses the control panel, drive motor, vacuum control valve, and peristaltic irrigation pump drive. The principles of operation and overall characteristics of the modified {5}------------------------------------------------ EndoRotor® Console remain unchanged since initial clearance (K170120). The console was modified to "Generation 2" (Gen2) to improve usability and ease of use as described in Table 5-1. | Design Change | Justification of Design Change | |-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | New Mechanical Irrigation Pump | Offers improved usability and component quality. | | Addition of Lavage Button | Allows user to enable or disable irrigation flow. Improves<br>usability, giving user control of irrigation to improve the field of<br>view of the resection site. | | Reduction in Irrigation Flow Rate | Reduction in the irrigation flow rate from 5-12mL/min to a fixed<br>5mL/min. Improves usability, providing better visibility to the<br>resection site. | | Increase in Prime Flow Rate | Increase in the prime flow rate from 4mL/min to 25 mL/min and<br>duration from 10 to 25 seconds. Improves usability by allowing<br>complete priming with one button push. | | Increase in Pitch Valve Open Timing | Increase in the pinch valve open timing during load from 10 to 25<br>seconds. Improves usability by enabling increased prime flow rate. | Table 5-1. EndoRotor Gen2 Console Design Changes ## Catheter The catheter design was updated to produce "Generation II" (Gen2) catheters; overall design principles are the same. All catheters include a debriding cutter and support functions of lavage and aspiration from the anatomical site through the endoscope working channel to the EndoRotor® Specimen Trap. Design for all catheters was enhanced per Table 5-2 to provide more options to the clinician and procedure and improve performance. Additionally, Interscope has added two (2) new catheters. The two (2) new catheters (bolded in table below) were added to increase cutting efficiency. An overview of all available catheters and characteristics are provided in Table 5-3. | Design Change | Justification of Design Change | Applicability to Catheters | |------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------| | New cutting window1 orientation<br>interface, reinforced outer braided<br>shaft, added MobilizeⓇ lubricious<br>additive to outer braided shaft | Enables improved performance of orienting<br>the cutting window of the catheter to the<br>target tissue. | ER 10-01-OP2<br>ER 10-02-O3<br>ER 10-03-OP4<br>ER 10-03-OP-S<br>ER 10-03-F-S | | Modified catheter lengths | To expand compatibility with the range of<br>endoscope on the market. | | | Expanded cutting window geometry | To address limitations in certain anatomical<br>locations (i.e., frontal face resection) | ER 10-03-OP-S<br>ER 10-03-F-S | | Added serrated teeth to inner and<br>outer cutters | To increase cutting efficiency | | Table 5-2. EndoRotor® Gen2 Catheter Design Changes l New cutting window only applies to bolded catheters 2 Revised part number – originally cleared (K170120) as part no. ER 10-01 3 Revised part number – originally cleared (K170120) as part no. ER 10-02 4 Revised part number – originally cleared (K170120) as part no ER 10-03 {6}------------------------------------------------ | Part No. | Length | Compatible Endoscopes | Window<br>Size | Cutter<br>Serrated teeth<br>placement | |---------------|------------------|-----------------------------------------------------------------------------|----------------|---------------------------------------| | ER 10-01-OP1 | 3.2mm x 1890mm | Olympus colonoscopes 3.2mm x 1680mm;<br>Pentax colonoscopes 3.2 mm x 1700mm | | Inner cutter | | ER 10-02-O2 | 3.2mm x 1540mm | Olympus colonoscopes 3.2mm x 1330mm | 3.0mm2 | Inner cutter | | ER 10-03-OP3 | 3.2mm x 1240mm | Olympus gastroscopes 3.2mm x 1030mm;<br>Pentax gastroscopes 3.2mm x 1050mm | | Inner cutter | | ER 10-03-OP-S | 3.2mm x 1240mm | Olympus gastroscopes 3.2mm x 1030mm;<br>Pentax gastroscopes 3.2mm x 1050mm | 4.4 mm2 | Inner and outer cutter | | ER 10-03-F-S | 3.2 mm x 1270 mm | Fuji gastroscopes 3.2 mm x 1100 mm | | Inner and outer cutter | Table 5-3. Gen2 EndoRotor® Catheters l Revised part number – originally cleared (K170120) as part no. ER 10-01 2Revised part number – originally cleared (K170120) as part no. ER 10-02 3 Revised part number – originally cleared (K170120) as part no ER 10-03 #### 7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE Interscope has completed verification testing to support the Catheter and Console design changes, as summarized in Section 6 of this 510(k) summary. Testing executed was limited to the design changes and met all acceptance criteria as summarized in Table 5-4. | EndoRotor® Component | Testing Performed | Results | |----------------------|-------------------------------------------------------|-----------------------------------------------------------------| | EndoRotor® Catheter | • Biocompatibility Testing<br>• Functional Testing | • All components biocompatible<br>• All acceptance criteria met | | EndoRotor® Console | • Power-up and Set-up Testing<br>• Functional Testing | • All acceptance criteria met | Table 5-4. Testing to Support Gen2 Design Changes The EndoRotor® design, as cleared under K170120, was verified and validated through a series of physical and mechanical performance tests on the catheter and console as well as animal testing. Those tests that are applicable to the modified EndoRotor® are summarized in Table 5-5. ## Table 5-5. Non-Clinical Performance Testing of EndoRotor® Cleared Under K170120 Applicable to the Modified EndoRotor® | EndoRotor® Component | Testing Performed | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | EndoRotor® Catheter | • Sterilization validation<br>• Pyrogenicity testing<br>• Shelf-life<br>• Packaging validation<br>• Transport testing | | EndoRotor® Console | • Design verification testing<br>• Electrical Safety and Electromagnetic Compatibility Testing | | Animal Testing | The safety and performance of the EndoRotor® was evaluated in a porcine animal model which included one hundred and twenty-four (124) mucosal resections over 6 animals (4 recovery and 2 acute) and 3 organs (colon, stomach, esophagus). All animals tolerated the treatment well and results showed the EndoRotor® system was associated with favorable and clinically acceptable tissue response.<br>Design validation and usability assessment were completed in a porcine model with (4) | {7}------------------------------------------------ | EndoRotor® Component | Testing Performed | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | additional animals without complication. No difference was noted in the safety profile of<br>the device. | | Procedural Testing | Specimen Trap: EndoRotor® was evaluated to determine that when proper procedure is<br>followed as provided in the labeling, including a post procedure flush, there is no<br>residual specimen in the catheter. | ### 8. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE Usability studies were conducted to evaluate the clinical performance of the predicate EndoRotor®. The modifications to the console and catheter were made to improve EndoRotor performance for tissue resection and removal in procedures where biopsy is not required. The results confirmed that all system requirements related to usability were met. These studies are applicable to the modified EndoRotor®. An investigator-led study was conducted to support the safety and effectiveness of the EndoRotor® for post-endoscopic mucosal resection (EMR) persistent tissue with a scarred Gastroenterologists in Queens Alexandra Hospital, located in Portsmouth, United base. Kingdom. completed an investigator-led series utilizing the predicate EndoRotor® in management of post EMR tissue persistence with a scarred base. In a pending peer review manuscript Khandiah K, Subramanian S, Thayalasekaran S, Chedgy F and Bhandari P. Nineteen (19) patients were referred to Queens Alexandra Hospital, a tertiary center, following diagnosed tissue persistence following EMR. Scarred sites of the colon, in each of the nineteen (19) patients, were evaluated by physicians and found to have lesions determined difficult to resect and no longer amenable to EMR due to scarring from previous EMR. The EndoRotor was used to perform resection of the identified patient site and successfully demonstrated the ability to superficially resect the scarred areas. The procedure outcomes using the EndoRotor® ensured muscle and luminal preservation in addition to disease eradication in fifteen (15) patients in twenty-one (21) procedures (1.4 procedure average) with no incidences of perforation or delayed bleeding, all patients were seen at follow up n=4 months. Study outcomes showed EndoRotor® directly led to successful avoidance of surgery in 78.9% of patients Physicians in Western Europe (Austria, Germany, The Netherlands, Switzerland and the United Kingdom) completed seventy-eight (78) commercial EndoRotor® procedures to treat the aforementioned scarred lesions. Similarly disease eradication and luminal preservation was achieved within two (2) procedures or less with seventy (70) patients requiring one (1) treatment and eight (8) patients requiring two (2) procedures without complication. The compiled data provides real world clinical evidence to support the expanded indications for use. The clinical experience outlined in this Premarket Notification supports the clinical safety and efficacy of the EndoRotor for use in the expanded indications. {8}------------------------------------------------ #### 9. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS Interscope concludes that the modified EndoRotor® is substantially equivalent to the predicate EndoRotor® cleared by FDA (K170120). The results of bench testing to verify the performance of the Gen2 catheters and console, in addition to the thirty eight (38) procedures demonstrating successful treatment of post EMR tissue persistence, support the safety and effectiveness of the modified EndoRotor for the expanded indications for use. A comparison of the currently marketed EndoRotor® and the EndoRotor®: Gen2 is provided in Table 5-6. | | Proposed Device | Predicate | Same/Different | |---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sponsor | Interscope, Inc. | Interscope, Inc. | | | Device name | EndoRotor® | EndoRotor® | Same | | Regulatory Status | Proposed | K170120 | N/A | | Device<br>Classification<br>Code/Name | PTE – Endoscopic Morcellator<br>Gastroenterology | PTE - Endoscopic Morcellator<br>Gastroenterology | Same | | Regulation<br>Number | 21CFR 884.1690 | 21CFR 884.1690 | Same | | Regulation Name | Hysteroscope and accessories | Hysteroscope and accessories | Same | | Indications for<br>Use | The EndoRotor® is intended<br>for use in endoscopic<br>procedures by a trained<br>gastroenterologist to resect and<br>remove residual tissue, not<br>intended for biopsy, of post<br>endoscopic mucosal resection<br>(EMR) tissue persistence with<br>a scarred base, and residual<br>tissue from the peripheral<br>margins following EMR. | The EndoRotor® is intended for<br>use in endoscopic procedures<br>by a trained gastroenterologist<br>to resect and remove residual<br>tissue from the peripheral<br>margins following EMR<br>(Endoscopic Mucosal<br>Resection).<br>The EndoRotor® should not be<br>used for tissue intended biopsy. | Same:<br>-Intended Use - clarification on<br>original intended use post<br>EMR tissue persistence with<br>a scarred base<br>Different:<br>- Addition of EMR tissue<br>persistence with a scarred<br>base | | Components | • Control unit including<br>peristaltic pump, motor drive<br>and pinch valve<br>• Catheter with cutting device<br>mounted on distal end<br>• Foot control to control drive<br>motor<br>• Specimen trap with pre-<br>loaded micron filter | • Control unit including<br>peristaltic pump, motor drive<br>and pinch valve<br>• Catheter with cutting device<br>mounted on distal end<br>• Foot control to control drive<br>motor<br>• Specimen trap with pre-<br>loaded micron filter | Different:<br>Three (3) new catheters will<br>be available; two (2) to<br>accommodate endoscope<br>variability among<br>manufactures and one (1) to<br>support faster tissue<br>acquisition | | Principle of<br>Operation | Mechanical resection using a<br>cutting cannula with<br>simultaneous aspiration | Mechanical resection using a<br>cutting cannula with<br>simultaneous aspiration | Same | | Reuse status | Single use | Single use | Same | | Table 5-6. Side-by-Side Comparison for Determination of Substantial Equivalence | | | | |---------------------------------------------------------------------------------|--|--|--| | | | | |