Who is the manufacturer of Aveta System?

Meditrina, Inc. filed the 510(k) submission for Aveta System (K191958).

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: Special).

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

K191958 · Meditrina, Inc. · HIH · Oct 1, 2019 · Obstetrics/Gynecology

Device Facts

Record ID	K191958
Device Name	Aveta System
Applicant	Meditrina, Inc.
Product Code	HIH · Obstetrics/Gynecology
Decision Date	Oct 1, 2019
Decision	SESE
Submission Type	Special
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

Aveta System is a fluid management and tissue resection platform for hysteroscopy. It consists of a central Controller, fluid management accessories, and resecting handsets. The system manages uterine distension by controlling saline inflow/outflow and monitors fluid deficit. For therapeutic procedures, a mechanical resecting handset oscillates to remove tissue under suction. The modified system introduces an Aveta Handswitch, allowing the Controller to interface with third-party hysteroscopes (e.g., Hologic MyoSure XL, Medtronic TruClear 8.0) in addition to the proprietary Aveta Disposable Hysteroscope. The Controller processes images/video for display on an external monitor and provides a GUI for setting intrauterine pressure and flow parameters. Used in office or OR settings by gynecologists; the handswitch allows a circulating nurse to manage fluid parameters. The system improves procedural efficiency by enabling precise pressure regulation and fluid deficit monitoring during tissue resection, benefiting patients by facilitating minimally invasive removal of intrauterine pathologies.

Clinical Evidence

Bench testing only. Functional testing verified Aveta Handswitch pressure/flow control. Simulated use testing in a model uterine system demonstrated that the Aveta System successfully regulates cavity pressure when used with compatible third-party hysteroscopes (TruClear 8.0 and Myosure XL) across diagnostic and therapeutic modes.

Technological Characteristics

System includes Controller (reusable), Fluid Management Accessory (sterile, single-use, PVC/ABS), and Resecting Handsets (stainless steel/ABS). Sensing principle: pressure transducer in Controller monitors intrauterine pressure via fluid inflow line. Connectivity: connects to external monitor and third-party hysteroscopes. Sterilization: EO for fluid management accessory; Gamma for disposable resecting devices; steam for reusable handsets. Software: rule-based control for fluid management and pressure regulation.

Indications for Use

Indicated for intrauterine visualization, liquid distension, and tissue resection (submucous myomas, endometrial polyps, retained products of conception) in patients requiring diagnostic or surgical hysteroscopy. Used by trained gynecologists.

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

Hologic Myosure XL Hysteroscope (K122563)
Covidien (Medtronic) TruClear 8.0 Hysteroscope (K031787)

Related Devices

K190372 — Aveta System · Meditrina, Inc. · May 16, 2019
K240886 — Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205) · Hologic, Inc. · Jul 25, 2024
DEN130040 — IOGYN SYSTEM · Iogyn, Inc. · Mar 28, 2014
K233710 — Symphion Operative Hysteroscopy System · Minerva Surgical, Inc. · Jan 17, 2024
K213171 — Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral) · Meditrina, Inc. · May 26, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. October 1, 2019 Meditrina, Inc. Csaba Truckai President & CEO 1190 Saratoga Avenue, Suite 180 San Jose, CA 95129 Re: K191958 Trade/Device Name: Aveta System Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH, HIG Dated: August 30, 2019 Received: September 3, 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 {1}------------------------------------------------ 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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, for Sharon Andrews 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) K191958 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) | | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | <table style="border:none"><tr><td>☑ Prescription Use (Part 21 CFR 801 Subpart D)</td></tr><tr><td>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</td></tr></table> | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | | | | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # K191958: 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 Mobile: (415) 215-7233 Fax: (408) 418-4815 Office: (408) 471-4877 csabat@hermesinnovations.com | | Date Prepared: | 30 September 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 (21 CFR 884.1700) | | # III. Predicate Device Information | Predicate Devices | Manufacturer | Predicate Device Names | 510(k)# | Clearance Date | |-------------------|-----------------|------------------------|---------|----------------| | Predicate Device | Meditrina, Inc. | Aveta System | K190372 | May 16, 2019 | The predicate has not been a subject of a design related recall. # IV. Device Description The modified Aveta System is used by physicians in an office or operating room setting. The Aveta Controller acts as the hub of the system. For diagnostic procedures, the Aveta Fluid Management Accessory, the Aveta Handswitch, the Aveta Scale, the Waste Management Bags, saline bags and an external monitor are all connected to the Aveta Controller. The inflow and outflow of the fluid management accessory are connected to the corresponding ports of a compatible hysteroscope. For therapeutic procedures, the Aveta Reusable Resecting Handset or the Aveta Disposable Resecting Handset are connected to the Aveta Controller for powering the Aveta Disposable Resecting Device. Provided in Table 1 are additional details on the components of the modified Aveta System. | Aveta System Component | Device Characteristics | Materials; Patient Contact and Contact Duration* | Functions Performed | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Aveta Controller with Integrated Fluid Management (P/N 212-002) | Non-sterile, reusable, used outside the sterile field | No patient contact | · Hysteroscopic image / video processing / storing recorded images • Fluid Management with irrigation and aspiration functions | | Aveta System Component | Device Characteristics | Materials; Patient Contact and Contact Duration* | Functions Performed | | | | | • 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 Fluid Management Accessory (P/N 205- 023) | Sterile (EO), single use, used in the sterile field | Polymers (PVC, ABS); indirect patient contact for limited duration. | • 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 | | Aveta Disposable Resecting Device (P/N 204-003) | Sterile (Gamma), single use, used in the sterile field | Stainless steel, polymers (ABS); direct contact with patient for limited duration. | • Mechanically resects and removes tissue under suction | | Aveta Disposable Resecting Handset (P/N 211-001) | Sterile (Gamma), single use, used in the sterile field | Stainless steel, ABS; No patient contact | • Includes motor to provide oscillation of resection tip | | Aveta Reusable Resecting Handset (P/N 211-001) | Non-sterile, reusable, cleaned and steam sterilized prior to each use | Stainless steel, polymers; No patient contact | • Includes motor to provide oscillation of resection tip | | Additional Aveta System Components / Accessories • Monitor • Waste Management Kit (P/N 205-001) • Waste Scale Bag (P/N 205-003) • Aveta Scale (P/N 212-020) • Aveta Roll Stand (P/N 200-020) • Aveta Handswitch (P/N 218-002) | • Non-sterile, reusable • Non-sterile, single use • Non-sterile, single use • Reusable, outside the sterile field • Reusable, outside the sterile field • Reusable, outside the sterile field | (No patient contact with any of the additional accessories) • Non-sterile, reusable • Non-sterile, single use • Polymer • Stainless steel, hardware • Stainless steel, hardware • ABS, hardware | • Displays image, procedural parameters and notifications • Collects tissue for pathology and stores the outflow fluid waste • Collects waste fluid from patient drape • Measures waste fluid / leaked fluid lost from cervix / hysteroscope • Mounts Controller and Monitor • Provides user interface for intrauterine set pressure, fluid deficit limit adjustments and different flow modes. | ## Table 1. Modified Aveta System Components {4}------------------------------------------------ *: For devices with patient contact, the materials with direct or indirect patient contact were verified for biocompatibility for the contact duration per ISO 10993-1. {5}------------------------------------------------ ### V. Indications for Use The indications for use of the subject device is identical to that of the predicate Aveta System. | Comparison of Indications for Use | | |---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device | Indications For Use | | Aveta System (modified) (Subject Device) | 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. | | Aveta System (Predicate Device) | 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. | ### Comparison of Indications for Use ## VI. Comparison of Technological Characteristics with the Predicate Device The modified Aveta System and the cleared Aveta System have the same technological characteristics in terms of basic operating principles and basic design features with minor differences. The primary difference is the inclusion of a new component, Aveta Handswitch, which allows for the Aveta System to be used with commercially available hysteroscopes. | | Subject Device | PREDICATE Device | |---------------|----------------|------------------| | 510k# | K191958 | K190372 | | Manufacturer: | Meditrina Inc. | Meditrina Inc. | | Device Names | Aveta System | Aveta System | ### AVETA CONTROLLER | Endoscope Functions | | | |------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Endoscope Functions (performed by commercially available hysteroscope or the AVETA CONTROLLER) | Endoscope Functions (performed by AVETA CONTROLLER) | | Visualization and Image Processing | If using commercially available hysteroscope accessories: Regular Optics with CCD sensor, Light Source and Camera Controller from compatible device If using Aveta Disposable Hysteroscope: Identical to predicate (Aveta controller) | CMOS sensor, and light source in Aveta Disposable Hysteroscope with image processing by the Aveta Controller | | Image and Procedural Parameter Display | If using commercially available hysteroscope accessories: External Camera Controller connects to an external commercially available Monitor and displays images. If using Aveta Disposable Hysteroscope: Identical to predicate (Aveta Controller) | Aveta Controller connects to a commercially available external Monitor for diagnostic and operative information; Screen displays cavity pressure, fluid deficit with graphical user interface. | | Fluid Management Functions (performed by AVETA CONTROLLER) | | | | Controller: | No change from cleared device | As in K190372 | | OTHER COMPONENTS (BESIDES CONTROLLER) | | | | HYSTEROSCOPE | | | {6}------------------------------------------------ | | Subject Device | PREDICATE Device | |----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------| | 510k# | K191958 | K190372 | | Manufacturer: | Meditrina Inc. | Meditrina Inc. | | Device Names | Aveta System | Aveta System | | Hysteroscope: | Commercially available hysteroscope and accessories such as: Hologic Myosure XL Hysteroscope (K122563) Covidien (Medtronic) TruClear 8.0 Hysteroscope (K031787) Aveta Disposable Hysteroscope included in K190372 | Aveta Disposable Hysteroscope 510(k) Cleared per K190372 | | Fluid Management Control Functions: | Aveta Handswitch Aveta Disposable Hysteroscope included in K190372 | Aveta Disposable Hysteroscope 510(k) Cleared per K190372 | | AVETA FLUID MANAGEMENT ACCESSORY | | | | Device: | No change from cleared device | As in K190372 | | AVETA DISPOSABLE RESECTING DEVICE | | | | Device: | No change from cleared device | As in K190372 | | AVETA DISPOSABLE RESECTING HANDSET | | | | Device: | No change from cleared device | As in K190372 | | SYSTEM ACCESSORIES | | | | AVETA HANDSWITCH | | | | How Provided | Non-critical component (Non-sterile, Reusable, used outside the sterile field) | Not included in K190372 | | Function | Provides user a means to control the fluid management functions | Fluid management functions controlled by cleared Aveta Disposable Hysteroscope. | | Cleaning/ Disinfection | Same as that for cleared Aveta System (predicate). | Validated (per AAMI TIR 12 and AAMI TIR 30) instructions in IFU | | AVETA WASTE MANAGEMENT KIT | | | | Device: | No change from cleared device | As in K190372 | | AVETA WASTE SCALE BAG | | | | Device: | No change from cleared device | As in K190372 | | AVETA ROLL STAND | | | | Device: | No change from cleared device | As in K190372 | | MONITOR | | | | Device: | No change from cleared device | As in K190372 | | AVETA SCALE | | | | | Subject Device | PREDICATE Device | | 510k# | K191958 | K190372 | | Manufacturer: | Meditrina Inc. | Meditrina Inc. | | Device Names | Aveta System | Aveta System | | Device: | No change from cleared device | As in K190372 | {7}------------------------------------------------ The modified Aveta System is identical to the cleared Aveta System with the following exceptions: - The modified Aveta System allows the cleared Aveta System (per K190372) components to be a) used in combination with commercially available (non-Meditrina) hysteroscopes instead of the cleared Meditrina Aveta Disposable Hysteroscope. The commercially available (non-Meditrina) hysteroscopes may be: - · Hologic MyoSure XL Hysteroscope P/N 50-200XL (optional Outflow Channel P/N 50-201XL) (K122563). - · Covidien (Medtronic) TruClear 8.0 Hysteroscope P/N 7209208 w/ Outer Sheath P/N 7209309 (K031787). - b) When used in combination with commercially available hysteroscopes, the modified Aveta System includes a new accessory called the Aveta Handswitch. The Aveta Handswitch enables a circulating nurse to control fluid management parameters such as flow rate and fluid deficit similar to the controls on the handle of Aveta Disposable Hysteroscope. Besides the change described above, there is no change to the components of the cleared Aveta System (K190372). The addition of the handswitch and ability for the Aveta System to be utilized with third-party hysteroscopes do not raise different questions of safety and effectiveness. ## VII. Non-Clinical Performance Testing The following summary results of design control activities have been provided in support of the substantial equivalence determination. - Functional Testing with use of the Aveta Handswitch: Pressure control and flow control ● verification were performed to ensure the Handswitch controls function as expected. - Simulated Use with labeled compatible hysteroscopes (TruClear 8.0 and Myosure XL): ● Regulation of cavity pressure was demonstrated in a model uterine system with the TruClear 8.0 and Myosure XL utilizing the Aveta System in various operational modes (e.g., diagnostic, therapeutic). Results demonstrate the subject device met specifications. ## VIII. Conclusions The subject device has the same intended use as the predicate. Differences in technology, including the ability of the subject device to be utilized with third-party hysteroscopes and the addition of the Aveta Handswitch do not raise different questions of safety and effectiveness. Performance testing evaluating the differences was conducted, and the results of the testing demonstrate that the subject device is as safe and effective as the predicate. Therefore, the subject Aveta System is substantially equivalent to the predicate Aveta System (K190372).