Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)

Q: Who is the manufacturer of Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)?

Meditrina, Inc. filed the 510(k) submission for Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral) (K213171).

Q: What is the FDA product code for Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)?

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

Q: What is the regulatory pathway for Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)?

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

Q: Who can help prepare an FDA 510(k) submission like Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)?

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.

K213171 · Meditrina, Inc. · HIH · May 26, 2022 · Obstetrics/Gynecology

Device Facts

Record ID	K213171
Device Name	Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)
Applicant	Meditrina, Inc.
Product Code	HIH · Obstetrics/Gynecology
Decision Date	May 26, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.1690
Device Class	Class 2
Attributes	Therapeutic

Intended Use

AVETA SYSTEM: Hysteroscopy: 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. Cystoscopy: The Aveta System is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the system allows the user to perform various diagnostic and therapeutic procedures. AVETA DISPOSABLE HYSTEROSCOPE (Pearl/Opal/Coral): The Aveta Disposable Hysteroscope (Pearl/Opal/Coral) is intended to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. AVETA DISPOSABLE CYSTOSCOPE (Coral): The Aveta Disposable Cystoscope (Coral) is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the Cystoscope allows the user to perform various diagnostic and therapeutic procedures.

Device Story

Integrated endoscopic system for visualization and mechanical tissue resection; includes controller, disposable scopes (hysteroscope/cystoscope), and resecting devices. Controller uses dual peristaltic pumps for continuous saline irrigation/aspiration; monitors intrauterine/urinary tract pressure and fluid deficit. Resecting devices (mechanical) oscillate to remove tissue; some models feature integrated motors in the handset. Used in clinical settings by physicians. Output displayed on external monitor for real-time visualization and procedural monitoring. System aids in diagnostic and therapeutic procedures by maintaining cavity distension and enabling tissue removal, potentially reducing procedure time and improving patient outcomes.

Clinical Evidence

Bench testing only. Performance data included software verification/validation (IEC 62304), system integrity, pressure/flow accuracy, fluid deficit monitoring, optical testing, LED tip temperature, motor oscillation speed, biocompatibility (ISO 10993-1), sterilization (ISO 11135/11137), packaging (ASTM D4169), accelerated aging (ASTM F1980), and electrical safety/EMC (IEC 60601 series). Simulated use testing confirmed tissue resection and imaging capabilities.

Technological Characteristics

Integrated system with CMOS sensor, LED illumination, and dual peristaltic pump fluid management. Components include disposable scopes and mechanical resecting devices (stainless steel blades). Connectivity via external monitor. Sterilization per ISO 11135/11137. Software-controlled pressure regulation and fluid deficit monitoring. Electrical safety per IEC 60601-1, EMC per IEC 60601-1-2, and endoscopic safety per IEC 60601-2-18.

Indications for Use

Indicated for trained gynecologists performing diagnostic and surgical hysteroscopy (resection of myomas, polyps, retained products) and for endoscopic access/examination of the lower urinary tract (including bladder) in patients requiring diagnostic or therapeutic procedures.

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

Aveta System (K190372)

Reference Devices

Luminelle DTx Hysteroscopy System (K181909)
Aveta System (K191958)
Aveta Disposable Hysteroscope (K192100)

Related Devices

K223813 — Aveta System 2.0 · Meditrina, Inc. · Aug 21, 2023
K190372 — Aveta System · Meditrina, Inc. · May 16, 2019
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
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
K180752 — Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole · Corinth Medtech, Inc. · Jul 25, 2018

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 seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. May 26, 2022 Meditrina, Inc. Csaba Truckai President & CEO 1190 Saratoga Avenue, Suite 180 San Jose, CA 95129 Re: K213171 Trade/Device Name: Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral) Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and Accessories Regulatory Class: II Product Code: HIH, HIG, FAJ Dated: April 21, 2022 Received: April 25, 2022 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. {1}------------------------------------------------ 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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Jason R. Roberts, Ph.D. Assistant 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) K213171 #### Device Name Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral) ## Indications for Use (Describe) ## AVETA SYSTEM: #### Hysteroscopy: 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. #### Cystoscopy: The Aveta System is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the system allows the user to perform various diagnostic and therapeutic procedures. #### AVETA DISPOSABLE HYSTEROSCOPE (Pearl/Opal/Coral): The Aveta Disposable Hysteroscope (Pearl/Opal/Coral) is intended to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. #### AVETA DISPOSABLE CYSTOSCOPE (Coral): The Aveta Disposable Cystoscope (Coral) is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the Cystoscope allows the user to perform various diagnostic and therapeutic procedures. | 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}------------------------------------------------ #### K213171 510(k) Summary ### I. Submitter Information | Submitter name: | Meditrina, Inc. 1190 Saratoga Avenue, Suite 180 San Jose, CA 95129 | |-----------------|---------------------------------------------------------------------------------------------------------------------| | Contact person: | Csaba Truckai President & CEO Email: csabat@hermesinnovations.com Phone: 415-215-7233 Fax: 408-418-4815 | | Date Prepared: | 25 May 2022 | ### II. Product Classification | Device Name: | Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral) | | |---------------------------|--------------------------------------------------------------------------------------------------------|----------------| | Common Name: | Hysteroscope | | | Regulation: | 21 CFR 884.1690 | | | Regulation Name: | Hysteroscope and accessories; Hysteroscopic insufflators Endoscope and accessories | Subject Device | | Class: | II | | | Product Code: | HIH | | | Additional Product Codes: | HIG | | | Additional Product Codes: | FAJ | | #### III. Predicate Device Information | Predicate Devices | Manufacturer | Predicate Device Names | 510(k)# | Clearance Date | |---------------------|------------------|--------------------------------------|---------|-----------------| | PREDICATE DEVICE | Meditrina, Inc. | Aveta System | K190372 | May 16, 2019 | | Reference Device | UVision360, Inc. | Luminelle DTx Hysteroscopy System | K181909 | August 16, 2018 | 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 intended cavity for the purpose of performing diagnostic and operative procedures (hysteroscopy and cystoscopy). 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 cavity. The Controller {4}------------------------------------------------ Aveta System, Aveta Hysteroscope, Aveta Cystoscope Traditional 510(k) Premarket Notification provides continuous monitoring of the cavity pressure to the set pressure. For hysteroscopy, it also monitors the volume differential between saline inflow from the uterus (fluid deficit). The Controller connects to a sterile, single use disposable Scope (available in various configurations, see below) that allows visualization of the cavity and displays the images obtained from the Scope on a standard monitor. For operative hysteroscopy procedures, the Aveta System includes sterile, mechanical Disposable Resecting Device (available in various configurations, see below) powered by an integrated motor in the device handset or by use of an external Resecting Handset (available in two configurations, as a disposable device or a reusable device). The resecting device is inserted through the working channel of the sterile hysteroscope to resect the target tissue/pathology. For cystoscopy, when combined with accessory instruments the cystoscope is used for diagnostic and therapeutic procedures. | Table 1. Aveta System Components Aveta System Component | Functions Performed | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Aveta Controller and Footswitch | • Displays image/video and procedural information on external monitor. • Image / video processing / storing of the images. • Enables visualization functions of the Hysteroscope / Cystoscope. • Fluid Management with irrigation and aspiration functions. • Controls saline inflow and outflow for distention of the uterine cavity or lower urinary tract with the bladder for visualization. • Monitors and maintains intrauterine pressure or lover urinary tract cavity pressure to set pressure. • Monitors volume differential (fluid deficit for hysteroscopy). • Provides ON/OFF function of the Resecting Device. • Provides power to the Resecting Handsets, Disposable Resecting Devices with Handsets for oscillation at a preset speed for mechanical resection function of Disposable Resecting Device. • Provides power to the Drape Pump. | | Aveta Hysteroscope/Aveta Cystoscope • Aveta Pearl Disposable Hysteroscope • Aveta Coral Disposable Hysteroscope • Aveta Opal Disposable Hysteroscope • Aveta Coral Disposable Cystoscope Collectively, they are called Aveta Disposable Scope or Endoscope. | • Hysteroscope: Visualization of cervical canal and uterine cavity • Cystoscope: Visualization of the lower urinary tract including the bladder • Provides conduits/lumens for fluid inflow and outflow • Provides conduit (working channel) for operative instruments for operative procedures • Provides user interface for intrauterine or urethral cavity set pressure and fluid deficit limit adjustments (for hysteroscopy), flush, and recording of images | | Aveta Fluid Management Accessory | • Provides membrane in fluid inflow line to enable intrauterine or urethral cavity pressure monitoring/control using pressure transducer in Controller • Provides conduits for irrigation of saline and aspiration of waste. • Provides FMA Cassette with tubing for peristaltic pump functions of Aveta Controller. | ## Table 1 Aveta System Components {5}------------------------------------------------ | Aveta System Component | Functions Performed | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Aveta Disposable Resecting Device: • Aveta Wave+ Disposable Resecting Device, 3.9mm (DRD-Wave+) • Aveta Max Disposable Resecting Device, 3.9mm (DRD-Max) • Aveta Disposable Resecting Device, 3.9 (DRD-3.9) • Aveta Flex Disposable Resecting Device, 2.9mm (DRD-Flex) • Aveta Smol Disposable Resecting Device, 2.9mm (DRD-Smol) • Aveta Disposable Resecting Device, 2.9 and (DRD-2.9) • Aveta Auto Disposable Resecting Device (AUTO) | • Mechanically resects and removes tissue under suction • DRD-2.9 and DRD-3.9 require use of DRH or RRH for oscillation of resection tip • DRD-Wave+, DRD-Max, DRD-Flex, DRD-Smol, AUTO include motor in the device handle to oscillate resection tip • The motor in the device handle for AUTO also provides suction by peristaltic action and is only for use with the pressurized saline bag | | Aveta Disposable Resecting Handset (DRH) | • Includes motor for oscillation of resection tip (used with DRD- 2.9 and DRD-3.9) | | Aveta Reusable Resecting Handset (RRH) | • Includes motor for oscillation of resection tip (used with DRD- 2.9 and DRD-3.9) | | Additional Aveta System Components / Accessories • Waste Management Accessory • Waste Bag (6L) • Aveta Reusable Cable, Opal • Roll Stand with Drape Pump • Monitor | • Collects tissue for pathology and stores the outflow fluid waste and collects fluid from the patient's under-buttocks drape. • Part of Waste Management Accessory. • Provides connection from the hysteroscope pigtail outside the sterile field to the Controller. • Roll Stand mounts the monitor and Controller for the system Drape Pump transfers collected waste fluid from drape to Waste Bag. • Commercially available surgical monitor. Displays image, procedural parameters and notifications. | {6}------------------------------------------------ ### V. Indications for Use There is no difference in the indications for use for the Aveta System (subject device) when compared to the combined indications of the predicate system components. | Device | Indications For Use | |---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Aveta System (Subject Device) | AVETA SYSTEM: Hysteroscopy: 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. Cystoscopy: The Aveta System is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the system allows the user to perform various diagnostic and therapeutic procedures. | | Aveta Disposable Hysteroscope (Subject Device) | AVETA DISPOSABLE HYSTEROSCOPE (Pearl/Opal/Coral): The Aveta Disposable Hysteroscope (Pearl/Opal/Coral) is intended to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. | | Aveta Disposable Cystoscope (Subject Device) | AVETA DISPOSABLE CYSTOSCOPE (Coral): The Aveta Disposable Cystoscope (Coral) is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the Cystoscope allows the user to perform various diagnostic and therapeutic procedures. | | Aveta System (Predicate Device – K190372) | 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. | | UVision360 Luminelle DTx Hysteroscopy System (Reference Device – K181909) | Hysteroscopy: The LUMINELLE DTx Hysteroscopy System is used to permit direct viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures. Note: Hysteroscopes are used as tools to access the uterine cavity and are not, in and of themselves, a method of surgery. Generally recognized indications for diagnostic hysteroscopy include: • Abnormal bleeding • Infertility and pregnancy wastage • Evaluation of abnormal hysterosalpingogram • Intrauterine foreign body • Amenorrhea • Pelvic pain Generally recognized indications for operative hysteroscopy include: • Directed endometrial biopsy • Polypectomy • Submucous myomectomy • Transection of intrauterine adhesions | | Device | Indications For Use | | | • Endometrial ablation Cystoscopy: The LUMINELLE DTx Hysteroscopy System is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the System allows the user to perform various diagnostic and therapeutic procedures. | ### Comparison of Indications for Use {7}------------------------------------------------ The indications for use for the subject Aveta System is identical to the reference device and has minor difference to the cleared Aveta System. #### VI. Comparison of Technological Characteristics with the Predicate Device A veta System and the predicate system have the same or similar technological characteristics in terms of basic operating principle and basic design features with minor differences. | | Subject Device | PRIMARY Predicate Device | Reference Device | | | |--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------| | 510k# | K213171 | K190372 | K191958 | K192100 | K181909 | | Manufacturer: | Meditrina Inc. | Meditrina, Inc. | | | UVision360 | | Device Names | Aveta System Aveta Hysteroscope Aveta Cystoscope | Aveta System | Aveta System | Aveta Disposable Hysteroscope | Luminelle DTx Hysteroscopy System | | CONTROLLER FUNCTIONS | | | Hysteroscope Functions | | | | Visualization and Image Processing | CMOS sensor, and light source in Endoscope with image processing by the Controller | CMOS sensor, and light source in Hysteroscope with image processing by the Controller | N/A (Used in combination with hysteroscope and accessories of the commercial 3rd party hysteroscope) | CMOS sensor, and light source in Hysteroscope with image processing by the Controller | N/A: All technical information for the SE comparison will be taken from the primary predicate. | | Viewing Functions | Controller connects to a commercially available external Monitor and displays image from the cavity, plays tone, displays cavity pressure, fluid deficit with graphical user interface. | Controller connects to a commercially available external Monitor and displays image from the cavity, plays tone, displays cavity pressure, fluid deficit with graphical user interface. | Controller connects to a commercially available external Monitor and plays tone, displays cavity pressure, fluid deficit with graphical user interface but doesn't display image from cavity. | Controller connects to a commercially available external Monitor and displays image from the cavity and plays tone. | N/A: All technical information for the SE comparison will be taken from the primary predicate. | | Fluid Management Functions | | | | | | | Fluid Distension | Continuous flow of saline/fluid | Continuous flow of saline/fluid | YES | N/A | N/A: All technical information for the SE comparison will be taken from the primary predicate. | | | Subject Device | PRIMARY Predicate Device | Reference Device | | | | 510k# | K213171 | K190372 | K191958 | K192100 | K181909 | | Manufacturer: | Meditrina Inc. | Meditrina, Inc. | | | UVision360 | | Device Names | Aveta System Aveta Hysteroscope Aveta Cystoscope | Aveta System | Aveta System | Aveta Disposable Hysteroscope | Luminelle DTx Hysteroscopy System | | Irrigation for Distension | Peristaltic pump with dual pressure sensors for irrigation of fluids | Peristaltic pump with dual pressure sensors for irrigation of fluids | Peristaltic pump with dual pressure sensors for irrigation of fluids | N/A | N/A: All technical information for the SE comparison will be taken from the primary predicate. | | Aspiration of bodily fluids and tissue | Integrated Peristaltic pump for aspiration. | Integrated Peristaltic pump for aspiration. | Integrated Peristaltic pump for aspiration. | N/A | N/A: All technical information for the SE comparison will be taken from the primary predicate. | | Intrauterine Pressure Measurements | Obtains two independent, intrauterine pressure measurement by sensing pressure of the irrigation tube | Obtains two independent, intrauterine pressure measurement by sensing pressure of the irrigation tube | Obtains two independent, intrauterine pressure measurement by sensing pressure of the irrigation tube | N/A | N/A: All technical information for the SE comparison will be taken from the primary predicate. | | Set Pressure Range | Hysteroscopy: 30-120 mmHg Cystoscopy: 30-60mmHg | Hysteroscopy: 30-120 mmHg Cystoscopy: N/A | Hysteroscopy: 30-120 mmHg Cystoscopy: N/A | N/A | N/A: All technical information for the SE comparison will be taken from the primary predicate. | | Set Pressure User Adjustments | Allows user to increase/decrease the set pressure | Allows user to increase/decrease the set pressure | Allows user to increase/decrease the set pressure | N/A | N/A: All technical information for the SE comparison will be taken from the primary predicate. | | Pressure Relief for overpressure risk mitigation | Hysteroscopy: Reverse rotation of irrigation peristaltic pump at 150mmHg Cystoscopy: Reverse rotation of irrigation peristaltic pump at 75mmHg | Hysteroscopy: Reverse rotation of irrigation peristaltic pump at 150mmHg Cystoscopy: N/A | Hysteroscopy: Reverse rotation of irrigation peristaltic pump at 150mmHg Cystoscopy: N/A | N/A | N/A: All technical information for the SE comparison will be taken from the primary predicate. | | Fluid Deficit Measurement | YES | YES | YES | N/A | N/A: All technical information for the SE comparison will be taken from the primary predicate. | | Flow Rate | 180-500 mL/min preset fixed flow rates | 180-500 mL/min preset fixed flow rates | 180-500 mL/min preset fixed flow rates | N/A | N/A: All technical information for the SE comparison will be taken from the primary predicate. | | | Subject Device | PRIMARY Predicate Device | Reference Device | | | | 510k# | K213171 | K190372 | K191958 | K192100 | K181909 | | Manufacturer: | Meditrina Inc. | Meditrina, Inc. | | UVision360 | | | Device Names | Aveta System Aveta Hysteroscope Aveta Cystoscope | Aveta System | Aveta System | Aveta Disposable Hysteroscope | Luminelle DTx Hysteroscopy System | | Mechanical Resecting Device | Connects to the Resecting Handset by an electrical connection to provide motor control with a preset fixed motor rotation/oscillation speed. | Connects to the Resecting Handle by an electrical connection to provide motor control with a user adjustable motor oscillation speed. | Connects to the Resecting Handle by an electrical connection to provide motor control with a user adjustable motor oscillation speed. | Connects to the Resecting Handle by an electrical connection to provide motor control with a user adjustable motor oscillation speed. | N/A: All technical information for the SE comparison will be taken from the primary predicate. | | SCOPE | | | | | | | | | | Disposable Hysteroscope/Cystoscope | | | | Irrigation and Aspiration Lumens | Independent sterile saline irrigation and aspiration lumens | Independent sterile saline irrigation and aspiration lumens | N/A | Independent sterile saline irrigation and aspiration lumens | N/A: All technical information for the SE comparison will be taken from the primary predicate. | | Insertion OD | Pearl Hysteroscope: 5.7mm Coral Hysteroscope: 4.6mm Opal Hysteroscope: 4.6mm Coral Cystoscope: 4.6mm | 5.5 mm | N/A | 5.5 mm | N/A: All technical information for the SE comparison will be taken from the primary predicate. | | Working Length | Pearl Hysteroscope: 216mm Coral Hysteroscope 206mm Opal Hysteroscope 206mm Coral Cystoscope: 206mm | 224mm | N/A | 224mm | N/A: All technical information for the SE comparison will be taken from the primary predicate. | | Illumination | LEDs (Light Emitting Diode) | LEDs (Light Emitting Diode) | N/A | LEDs (Light Emitting Diode) | N/A: All technical information for the SE comparison will be taken from the primary predicate. | | Working Channel | Pearl Hysteroscope: 4.0mm Coral Hysteroscope: 3.0mm Opal Hysteroscope: 3.0mm Coral Cystoscope: 3.0mm | 3.5mm | N/A | 3.5mm | N/A: All technical information for the SE comparison will be taken from the primary predicate. | | | Subject Device | PRIMARY Predicate Device | Reference Device | | | | 510k# | K213171 | K190372 | K191958 | K192100 | K181909 | | Manufacturer: | Meditrina Inc. | Meditrina, Inc. | | UVision360 | | | Device Names | Aveta System Aveta Hysteroscope Aveta Cystoscope | Aveta System | Aveta System | Aveta Disposable Hysteroscope | Luminelle DTx Hysteroscopy System | | Camera | Digital CMOS Camera | Digital CMOS Camera | N/A | Digital CMOS Camera | N/A: All technical information for the SE comparison will be taken from the primary predicate. | | Cutting Window | DRD-Wave+: 8mm DRD-Max: 11mm DRD-3.9: 10mm DRD-Flex: 7mm DRD-Smol: 7mm DRD-2.9: 7mm AUTO: 8mm | 8 mm | N/A | N/A | N/A: All technical information for the SE comparison will be taken from the primary predicate. | | Blade Material | Stainless steel | Stainless steel | N/A | N/A | N/A: All technical information for the SE comparison will be taken from the primary predicate. | | Working Length | DRD-Wave+: 339mm DRD-Max: 339mm DRD-3.9: 328mm DRD-Flex: 339mm DRD-Smol: 339mm DRD-2.9: 328mm AUTO: 318mm | 328 mm | N/A | N/A | N/A: All technical information for the SE comparison will be taken from the primary predicate. | | Insertion OD | DRD-Wave+: 3.9mm DRD-Max: 3.9mm DRD-3.9: 3.9mm DRD-Flex: 2.9mm DRD-Smol: 2.9mm DRD-2.9: 2.9mm AUTO: 2.9mm | 3.4 mm | N/A | N/A | N/A: All technical information for the SE comparison will be taken from the primary predicate. | | Rotational Speed | 3000RPM | 2000RPM | N/A | N/A | N/A: All technical information for the SE comparison will be taken from the primary predicate. | | Suction Assisted Resection? | YES | YES | N/A | N/A | N/A: All technical information for the SE comparison will be taken from the primary predicate. | | Disposable (Sterile) and Reusable (Steam Sterilizable) Resecting Handset | | | | | | | | Subject Device | PRIMARY Predicate Device | Reference Device | | | | 510k# | K213171 | K190372 | K191958 | K192100…