Who is the manufacturer of Aveta System?

Meditrina, Inc. filed the 510(k) submission for Aveta System (K190372).

What is the FDA product code for Aveta System?

HIH. It is classified under 21 CFR 884.1690 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for Aveta System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Aveta System?

Truclear Operative Hysteroscope 5C and Sheath 5C (K152143); Hysteroscopic Fluid Management System (K123732); Truclear Morcellator System and Truclear Morcellators (K132015).

Who can help prepare an FDA 510(k) submission like Aveta System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Aveta System

K190372 · Meditrina, Inc. · HIH · May 16, 2019 · Obstetrics/Gynecology

Device Facts

Record ID	K190372
Device Name	Aveta System
Applicant	Meditrina, Inc.
Product Code	HIH · Obstetrics/Gynecology
Decision Date	May 16, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.1690
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Aveta System is intended for intrauterine use by trained gynecologists to permit viewing of the cervical canal and the uterine cavity, provide liquid distension of the uterus and monitor the volume differential between the irrigation fluid flowing into and out of the uterus during diagnostic and surgical procedures to resect and remove tissue such as submucous myomas, endometrial polyps and retained products of conception.

Device Story

The Aveta System is an integrated hysteroscopic platform for diagnostic and operative procedures. It consists of a controller with integrated fluid management, a disposable hysteroscope, and a mechanical resecting device. The controller uses a dual peristaltic pump to manage saline inflow/outflow, maintaining intrauterine pressure and monitoring fluid deficit. The hysteroscope features a CMOS sensor and LED light source for visualization, with images processed by the controller and displayed on an external monitor. For surgery, a motorized resecting handset oscillates a mechanical tip to remove tissue under suction. The system is used in clinical settings by gynecologists. The controller provides real-time feedback on pressure and fluid volume, allowing the physician to adjust parameters during the procedure. This integrated control helps maintain a clear view and safe operating environment, facilitating the removal of intrauterine pathologies while minimizing fluid-related risks.

Clinical Evidence

Bench testing only. Performance data included software verification/validation (IEC 62304), biocompatibility (ISO 10993-1), sterilization validation (ISO 11135, ISO 11137), packaging validation (ASTM D4169), accelerated aging (ASTM F1980), electrical safety/EMC (IEC 60601-1, 60601-1-2, 60601-2-18), and usability testing (IEC 62366). Functional testing confirmed system integrity, pressure control, fluid deficit monitoring, and tissue resection capabilities.

Technological Characteristics

Integrated system with CMOS-based disposable hysteroscope and LED illumination. Controller uses dual peristaltic pumps for fluid management (inflow/outflow) and pressure control (30-120 mmHg). Mechanical resection via motorized handset. Materials include stainless steel blades. Connectivity includes external monitor output. Sterilization via validated methods for disposable and reusable components. Software follows IEC 62304 standards.

Indications for Use

Indicated for trained gynecologists performing diagnostic and surgical hysteroscopy to view the cervical canal and uterine cavity, provide uterine distension, and resect/remove tissue including submucous myomas, endometrial polyps, and retained products of conception.

Regulatory Classification

Identification

A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.

Predicate Devices

Truclear Operative Hysteroscope 5C and Sheath 5C (K152143)
Hysteroscopic Fluid Management System (K123732)
Truclear Morcellator System and Truclear Morcellators (K132015)

Reference Devices

Endosee U-Scope Model 8000 (K123151)

Related Devices

K191958 — Aveta System · Meditrina, Inc. · Oct 1, 2019
K213171 — Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral) · Meditrina, Inc. · May 26, 2022
K191335 — Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags · Corinth Medtech, Inc. · Jun 6, 2019
K223813 — Aveta System 2.0 · Meditrina, Inc. · Aug 21, 2023
K190113 — Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags · Corinth Medtech, Inc. · Apr 24, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 text. May 16, 2019 Meditrina, Inc. Csaba Truckai President & CEO 1601 S. De Anza Blvd, Suite 165 Cupertino, CA 95014 Re: K190372 Trade/Device Name: Aveta System Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: Class II Product Code: HIH, HIG Dated: February 14, 2019 Received: February 15, 2019 Dear Csaba Truckai: 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. 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 {1}------------------------------------------------ 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.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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. Sharon M. Andrews Assistant Division Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K190372 Device Name Aveta System Indications for Use (Describe) The Aveta System is intended for intrauterine use by trained gynecologists to permit viewing of the cervical canal and the uterine cavity, provide liquid distension of the uterus and monitor the volume differential between the irrigation fluid flowing into and out of the uterus during diagnostic and surgical procedures to resect and remove tissue such as submucous myomas, endometrial polyps and retained products of conception. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------|------------------------------------------------------------------------------| | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </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}------------------------------------------------ # K190372: 510(k) Summary ### I. Submitter Information | Submitter name: | Meditrina, Inc. 1601 S. De Anza Blvd, Suite 165 Cupertino, CA 95014 | |-----------------|---------------------------------------------------------------------------------------------------------------------------------------------| | Contact person: | Csaba Truckai President & CEO Mobile: (415) 215-7233 Office: (408) 471-4877 Fax: (408) 609-3342 csabat@hermesinnovations.com | | Date Prepared: | 14 February 2019 | ### II. Product Classification | Device Name: | Aveta System | | |---------------------------|------------------------------|----------------| | Common Name: | Hysteroscope | Subject Device | | Regulation: | 21 CFR 884.1690 | | | Regulation Name: | Hysteroscope and accessories | | | Class: | II | | | Product Code: | HIH | | | Additional Product Codes: | HIG | | ### III. Predicate Device Information | Predicate Devices | Manufacturer | Predicate Device Names | 510(k)# | Clearance Date | |-------------------------------------------------------|--------------------------------------------------------|-------------------------------------------------------------------|---------|-------------------| | PREDICATE DEVICE (System) ( see NOTE 1 ) | Smith & Nephew (Truclear Morcellation System) | Truclear Operative Hysteroscope 5C and Sheath 5C | K152143 | September 2, 2015 | | | | Hysteroscopic Fluid Management System ( see NOTE 2 ) | K123732 | April 4, 2013 | | | | Truclear Morcellator System and Truclear Morcellators | K132015 | March 18, 2005 | NOTE 1: The Smith & Nephew Truclear Morcellation System (Controller, Hysteroscope and Fluid Management System) was originally cleared under K031787 as a system. Since the original clearance each system component has been modified per the 510(k) clearances noted above. NOTE 2: Originally cleared as IUR Fluid Management System / Hysteroscopy Pump HM6 by W.O.M. World of Medicine AG under K123732. Predicate has not been a subject of a design related recall. #### IV. Device Description The Aveta System is an integrated system which allows for visualization of the cervical canal and the uterine cavity for the purpose of performing diagnostic and operative hysteroscopic procedures. {4}------------------------------------------------ The Aveta System consists of the components listed in Table 1. The system includes a Controller with integrated fluid management which incorporates a dual peristaltic pump design to control the continuous inflow and outflow of saline to provide fluid distention of the uterine cavity. The Controller provides continuous monitoring of the intrauterine pressure to the set pressure, as well as monitoring of the volume differential between saline inflow from the uterus. The Controller connects to a sterile, single use Disposable Hysteroscope via a Reusable Hysteroscope Handset that allows visualization of the cervical canal and the uterine cavity and displays the images obtained from the hysteroscope on a standard monitor. For operative procedures, the Aveta System includes a sterile, mechanical Disposable Resecting Device powered by a motorized, Reusable Resecting Handset which is inserted through the sterile hysteroscope working channel to resect and remove endometrial polyps, submucous myomas and retained products of conception under suction. | Aveta System Component | Functions Performed | |-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Aveta Controller with Integrated Fluid Management | • Hysteroscopic image / video processing / storing recorded images • Fluid Management with irrigation and aspiration functions • Controls saline inflow and outflow for insufflation of the uterine cavity for visualization • Monitors and maintains intrauterine pressure to set pressure • Monitors volume differential (fluid deficit) • Controls Mechanical Resecting Device oscillation (Preset speed) • Displays image/video and procedural information on external monitor | | Aveta Disposable Hysteroscope (with tubing and fluid management cassette) | • Visualization of uterine cavity • Provides conduits/lumens for fluid inflow and outflow • Provides membrane in fluid inflow line to enable intrauterine pressure monitoring/control using pressure transducer in Controller • Includes cassette for proper connection with Controller pumps • Provides conduit for Disposable Resecting Device for operative hysteroscopy • Provides user interface for intrauterine set pressure and fluid deficit limit adjustments, and recording of images | | Aveta Reusable Hysteroscope Handset | | | Aveta Disposable Resecting Device Aveta Reusable Resecting Handset | • Mechanically resects and removes tissue under suction • Includes motor to provide oscillation of resection tip | | Additional Aveta System Components / Accessories • Monitor • Waste Management Kit • Scale • Roll Stand | • Displays image, procedural parameters and notifications • Collects tissue for pathology and stores the outflow fluid waste • Measures waste fluid / leaked fluid lost from cervix / hysteroscope • Mounts Controller and Monitor | ## Table 1. Aveta System Components {5}------------------------------------------------ # V. Indications for Use | Comparison of Indications for Use | | |-------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device | Indications For Use | | Aveta System (Subject Device) | The Aveta Diagnostic and Therapeutic Hysteroscopy System is intended for intrauterine use by trained gynecologists to permit viewing of the cervical canal and the uterine cavity, provide liquid distension of the uterus and monitor the volume differential between the irrigation fluid flowing into and out of the uterus during diagnostic and surgical procedures to resect and remove tissue such as submucous myomas, endometrial polyps and retained products of conception. | | Predicate System Component: | | | Truclear™ Morcellator System and Truclear™ Morcellators (K152143) | For intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as submucous myomas, endometrial polyps and retained products of conception. | | Predicate System Component: | | | Hysteroscopic Fluid Management System (K123732) | To provide liquid distension of the uterus for diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. | | Predicate System Component: | | | Truclear™ Operative Hysteroscope 5C and Sheath 5C (K132015) | To permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures. | #### Comparison of Indications for Use Although the subject device does not have identical indications compared to the individual predicate devices, the subject device has the same general intended use as each of the respective predicate components: 1) to permit viewing of the cervical canal and the uterine cavity during diagnostic and operative procedures, 2) to provide liquid distension of the uterus and monitor fluid volume differential, and 3) to resect and remove tissue such as submucous myomas, endometrial polyps, and retained products of conception. When comparing each component function of the subject device to the indications of the respective predicate components, the subject and predicate devices have the same intended use. {6}------------------------------------------------ ### VI. Comparison of Technological Characteristics with the Predicate Device Aveta System and the predicate system have similar technological characteristics in terms of basic operating principle and basic design features with minor differences. ## Technological Comparison of Aveta System with Predicate System | | Subject Device | Predicate Devices (System) [Original K031787] | | | Reference Device | | |-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--| | 510k# | TBD | K132015 | K123732 | K152143 | K123151 | | | Manufacturer: | Meditrina Inc. | Smith and Nephew, Inc. | | | Endosee Corporation (Cooper Surgical) | | | Device Names | Aveta System | Truclear™ Morcellator System and Truclear™ Morcellators | Hysteroscopic Fluid Management System | Truclear™ Operative Hysteroscope 5C and Sheath 5C | Endosee® U-Scope Model 8000 | | | CONTROLLER FUNCTIONS | | | | | | | | Hysteroscope Functions | | | | | | | | Visualization and Image Processing | CMOS sensor and light source in Hysteroscope and image processed by the Controller microprocessor | N/A | N/A | Regular Optics with CCD sensor and light source and camera; images process by Controller | CMOS sensor, and light source in Hysteroscope and image processed by internal microprocessor in reusable handset | | | Viewing Functions | Controller connects to a separate Monitor for diagnostic and operative information; Screen displays IU pressure, fluid deficit with graphical user interface. | N/A | Pressure and Fluid Deficit data is displayed on the unit. Image is displayed on the Monitor. | N/A | Monitor integrated in the Reusable Handset Camera | | | Fluid Management Functions | | | | | | | | Fluid Distention | Continuous flow of saline/fluid | N/A | Same | N/A | Saline inflow | | | Irrigation for Distention | Peristaltic pump with dual pressure sensors for irrigation of fluids | N/A | Same | N/A | N/A | | | Aspiration | Peristaltic pump for aspiration of fluids and for resected tissue and fluids | N/A | Facility vacuum pump provides suction for aspiration of resected tissue and fluids | N/A | N/A | | | Intrauterine Pressure Measurements | Obtains two independent intrauterine pressure measurements by sensing pressure of the irrigation tube | N/A | Same | N/A | N/A | | | Set Pressure Range | 30-120 mmHg | N/A | 15-120 mmHg | N/A | N/A | | | Set Pressure User Adjustments | Allows user to increase/decrease the set pressure | N/A | Same | N/A | N/A | | | | Subject Device | Predicate Devices (System) [Original K031787 | | | Reference Device | | | 510k# | TBD | K132015 | K123732 | K152143 | K123151 | | | Manufacturer: | Meditrina Inc. | Smith and Nephew, Inc. | | | Endosee Corporation (Cooper Surgical) | | | Device Names | Aveta System | Truclear™ Morcellator System and Truclear™ Morcellators | Hysteroscopic Fluid Management System | Truclear™ Operative Hysteroscope 5C and Sheath 5C | Endosee® U-Scope Model 8000 | | | Pressure Relief for overpressure risk mitigation | Reverse rotation of irrigation peristaltic pump at 150 mmHg | N/A | Same | N/A | N/A | | | Over Pressure Controls | Above 100 mmHg requires positive action by the user with two presses to confirm setting is intentional up to 120 mmHg max. Display Notification appears. | N/A | Same | N/A | N/A | | | User Pressure Adjustments to Set Pressure | 5 mmHg at a time up to 120 mmHg max. | N/A | Same | N/A | N/A | | | Fluid Deficit Measurement (Weight based measurement which includes aspirated fluid and fluid leaking from cervix) | Obtains difference between three independent weight measurement sensors to determine the Fluid Deficit: 1) Irrigation minus 2) Aspiration and 3) fluid lost from cervix as measured by scale | N/A | Obtains difference between two independent weight measuring sensors to determine Fluid Deficit | N/A | N/A | | | Flow Rate | 180-500 mL/min preset fixed flow rates | N/A | 30- 700mL/min user adjustable | N/A | N/A | | | Mechanical Resection Functions | | | | | | | | Mechanical Resecting Device | Connects to the Disposable or Reusable Resecting Handset by an electrical connection to provide a dc motor control with a preset programmed motor oscillation speed. | Same | N/A | N/A | N/A | | | HYSTEROSCOPE SYSTEM | | | | | | | | Disposable Hysteroscope | | | | | | | | Irrigation and Aspiration Lumens | Independent sterile saline irrigation and aspiration lumens | N/A | N/A | Same | Independent sterile irrigation lumen. No aspiration lumen | | | Insertion OD | 5.5 mm | N/A | N/A | 5.7 mm | Oval - 3.8mm x 4.6 mm | | | Working Length | 224 mm | N/A | N/A | 205 mm | 287 mm | | | | Subject Device | Predicate Devices (System) [Original K031787] | | | Reference Device | | | 510k# | TBD | K132015 | K123732 | K152143 | K123151 | | | Manufacturer: | Meditrina Inc. | Smith and Nephew, Inc. | | | Endosee Corporation (Cooper Surgical) | | | Device Names | Aveta System | Truclear™ Morcellator System and Truclear™ Morcellators | Hysteroscopic Fluid Management System | Truclear™ Operative Hysteroscope 5C and Sheath 5C | Endosee® U-Scope Model 8000 | | | Illumination | LEDs (Light Emitting Diode) | N/A | N/A | Fiber optic | LED (Light Emitting Diode) | | | Working Channel | 3.5 mm working channel | N/A | N/A | 3 mm working channel | No working channel | | | Camera | Digital CMOS Camera | N/A | N/A | Fiberoptic image guide coupled to External CCD (not part of the system) | Same | | | Proximal Connection (to Camera and Light Controls) | Entire device including the cable and handset is sterile in one package | N/A | N/A | Mechanical connection to the reusable remote camera head and light cable | Electromechanical connection at the proximal end to Reusable Handle | | | Reusable Hysteroscope Handset | | | | | | | | Image Processing | Processes images generated by the Disposable Hysteroscope CMOS sensor | N/A | N/A | No images processing capabilities. Images are processed by the external CCD video camera attached to Endoscope eye piece (not part of the system) | Same | | | User Controls | · Set Pressure Controls • Fluid Deficit Limit Controls · Image capture capability · Mode Selection with preprogrammed flowrates for each Mode | N/A | · Set Pressure Controls • Fluid Deficit Limit Controls · Flow Rate Adjustment | · Light, Image adjustments and Image Capture using compatible device | · Image capture button. · Increase illumination power button. · ON/OFF button. · Touch screen for patient ID, time set entry | | | RESECTING SYSTEM | | | | | | | | Disposable Resecting Device | | | | | | | | Cutting Window | 8 mm | 7 mm | N/A | N/A | N/A | | | Blade Material | Stainless steel | Same | N/A | N/A | N/A | | | Working Length | 328 mm | 357 mm | N/A | N/A | N/A | | | Insertion OD | 3.4 mm | 2.9 mm | N/A | N/A | N/A | | | | Subject Device | Predicate Devices (System) [Original K031787] | | | Reference Device | | | 510k# | TBD | K132015 | K123732 | K152143 | K123151 | | | Manufacturer: | Meditrina Inc. | Smith and Nephew, Inc. | | | Endosee Corporation (Cooper Surgical) | | | Device Names | Aveta System | Truclear™ Morcellator System and Truclear™ Morcellators | Hysteroscopic Fluid Management System | Truclear™ Operative Hysteroscope 5C and Sheath 5C | Endosee® U-Scope Model 8000 | | | Device Rotation for Resection | Rotatable distal portion of the hub allows the user to orient the resection window towards the target tissue | Not rotatable. User must turn Resecting Handset to orient window direction for resection | N/A | N/A | N/A | | | Aspiration During Resection | Aspiration is provided via peristaltic suction pump | Aspiration provided by facility vacuum pump | N/A | N/A | N/A | | | Tissue Collection | Tissue catch provided for resected tissue chips | Same | N/A | N/A | N/A | | | Disposable (Sterile) and Reusable (Steam Sterilizable) Resecting Handset | | | | | | | | Resection Mechanism | Mechanical | Mechanical | N/A | N/A | N/A | | | User Controls | Handset Controls | Foot Switch Controls | N/A | N/A | N/A | | | Mechanical Connection | Locks Disposable Resecting Device | Locks Disposable Resecting Device | N/A | N/A | N/A | | | Rotational Speed | 1500 RPM (pre-set - not user adjustable) | 100 - 2500 RPM (user adjustable) | N/A | N/A | N/A | | | WASTE MANAGEMENT KIT | | | | | | | | How Provided | Non-sterile, Single-Use | N/A | Facility provided (Not part of the system). Non- sterile, Single- Use | N/A…