(240 days)
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.
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 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.
The provided document is a 510(k) Premarket Notification for the Meditrina Aveta System. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness from scratch in the same way a PMA (Premarket Approval) would. As such, the information provided focuses on comparative performance and engineering tests, rather than clinical efficacy studies with specific acceptance criteria related to disease detection or treatment outcomes.
Therefore, the document does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 as it pertains to acceptance criteria for algorithmic performance, sample sizes for test sets, expert-established ground truth, MRMC studies, or multi-reader studies. The "performance data" section (Section VII) lists various engineering and bench tests, but these are not for the purpose of demonstrating diagnostic or clinical performance in a "study" as implied by the request.
The "study that proves the device meets the acceptance criteria" in this context refers to the bench and engineering tests conducted to demonstrate that the modified Aveta System performs equivalently to its predicate and meets safety standards.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance:
The document does not provide a table of acceptance criteria and reported device performance in the sense of accuracy metrics (e.g., sensitivity, specificity) for a diagnostic AI/ML device. The "performance data" section lists types of tests performed (e.g., "Pressure accuracy and control," "Optical testing," "Motor/Oscillation speed"), but it does not specify the numerical acceptance criteria for these tests nor the exact quantitative results achieved by the device against those criteria. It only states that the tests were performed "per approved test protocols."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No information about sample sizes for a clinical "test set" or data provenance (country, retrospective/prospective) is provided. The performance data listed (Section VII) refers to engineering and bench tests on the device's components and system function (e.g., integrity, dimensional inspection, functional testing). These are not data sets for an AI/ML algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided. The study is a 510(k) submission, focused on engineering and functional equivalence rather than clinical diagnostic performance that would require expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable/not provided. No clinical test set requiring adjudication is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC study or any study involving human readers with or without AI assistance is mentioned. The device described appears to be an endoscopic system, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable/not provided. The device is a physical system for visualization and surgical procedures, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable/not provided. The "ground truth" in this context would be the design specifications and functional requirements met by the engineering tests, not a clinical ground truth for diagnostic accuracy.
8. The sample size for the training set:
Not applicable/not provided. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable/not provided. This device is not an AI/ML algorithm that requires a training set with established ground truth.
In summary, the provided document details a 510(k) submission for a medical device (Aveta System, a hysteroscope/cystoscope system). It focuses on demonstrating substantial equivalence to a predicate device through engineering and bench testing, rather than reporting on the performance of an AI/ML model for diagnostic purposes as implied by the structure of your questions.
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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.
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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
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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) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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K213171 510(k) Summary
I. Submitter Information
| Submitter name: | Meditrina, Inc.1190 Saratoga Avenue, Suite 180San Jose, CA 95129 |
|---|---|
| Contact person: | Csaba TruckaiPresident & CEOEmail: csabat@hermesinnovations.comPhone: 415-215-7233Fax: 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 insufflatorsEndoscope 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 DeviceNames | 510(k)# | Clearance Date |
|---|---|---|---|---|
| PREDICATEDEVICE | Meditrina, Inc. | Aveta System | K190372 | May 16, 2019 |
| Reference Device | UVision360, Inc. | Luminelle DTxHysteroscopy 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
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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 ComponentsAveta System Component | Functions Performed |
|---|---|
| Aveta Controllerand Footswitch | • Displays image/video and procedural information on externalmonitor.• 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 uterinecavity or lower urinary tract with the bladder for visualization.• Monitors and maintains intrauterine pressure or lover urinarytract 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 ResectingDevices with Handsets for oscillation at a preset speed formechanical 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 CystoscopeCollectively, they are called AvetaDisposable Scope or Endoscope. | • Hysteroscope: Visualization of cervical canal and uterine cavity• Cystoscope: Visualization of the lower urinary tract includingthe bladder• Provides conduits/lumens for fluid inflow and outflow• Provides conduit (working channel) for operative instrumentsfor operative procedures• Provides user interface for intrauterine or urethral cavity setpressure 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 orurethral cavity pressure monitoring/control using pressuretransducer in Controller• Provides conduits for irrigation of saline and aspiration of waste.• Provides FMA Cassette with tubing for peristaltic pumpfunctions of Aveta Controller. |
Table 1 Aveta System Components
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| Aveta System Component | Functions Performed |
|---|---|
| Aveta Disposable Resecting Device:• Aveta Wave+ Disposable ResectingDevice, 3.9mm (DRD-Wave+)• Aveta Max Disposable ResectingDevice, 3.9mm (DRD-Max)• Aveta Disposable Resecting Device,3.9 (DRD-3.9)• Aveta Flex Disposable ResectingDevice, 2.9mm (DRD-Flex)• Aveta Smol Disposable ResectingDevice, 2.9mm (DRD-Smol)• Aveta Disposable Resecting Device,2.9 and (DRD-2.9)• Aveta Auto Disposable ResectingDevice (AUTO) | • Mechanically resects and removes tissue under suction• DRD-2.9 and DRD-3.9 require use of DRH or RRH foroscillation of resection tip• DRD-Wave+, DRD-Max, DRD-Flex, DRD-Smol, AUTOinclude motor in the device handle to oscillate resection tip• The motor in the device handle for AUTO also providessuction by peristaltic action and is only for use with thepressurized 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 wasteand collects fluid from the patient's under-buttocks drape.• Part of Waste Management Accessory.• Provides connection from the hysteroscope pigtail outside thesterile field to the Controller.• Roll Stand mounts the monitor and Controller for the systemDrape Pump transfers collected waste fluid from drape to WasteBag.• Commercially available surgical monitor. Displays image,procedural parameters and notifications. |
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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 topermit viewing of the cervical canal and the uterine cavity, provide liquiddistension of the uterus and monitor the volume differential between the irrigationfluid flowing into and out of the uterus during diagnostic and surgical proceduresto resect and remove tissue such as submucous myomas, endometrial polyps andretained products of conception.Cystoscopy:The Aveta System is intended for use in endoscopic access to and examination ofthe lower urinary tract, including the bladder. When combined with accessoryinstruments, the system allows the user to perform various diagnostic andtherapeutic procedures. |
| Aveta Disposable Hysteroscope(Subject Device) | AVETA DISPOSABLE HYSTEROSCOPE (Pearl/Opal/Coral):The Aveta Disposable Hysteroscope (Pearl/Opal/Coral) is intended to permitviewing of the cervical canal and the uterine cavity for the purpose of performingdiagnostic and surgical procedures. |
| Aveta Disposable Cystoscope(Subject Device) | AVETA DISPOSABLE CYSTOSCOPE (Coral):The Aveta Disposable Cystoscope (Coral) is intended for use in endoscopic accessto and examination of the lower urinary tract, including the bladder. Whencombined with accessory instruments, the Cystoscope allows the user to performvarious diagnostic and therapeutic procedures. |
| Aveta System(Predicate Device – K190372) | The Aveta System is intended for intrauterine use by trained gynecologists to permitviewing of the cervical canal and the uterine cavity, provide liquid distension of theuterus and monitor the volume differential between the irrigation fluid flowing intoand out of the uterus during diagnostic and surgical procedures to resect and removetissue such as submucous myomas, endometrial polyps and retained products ofconception. |
| UVision360 Luminelle DTxHysteroscopy System(Reference Device – K181909) | Hysteroscopy: The LUMINELLE DTx Hysteroscopy System is used to permitdirect viewing of the cervical canal and uterine cavity for the purpose of performingdiagnostic and surgical procedures.Note: Hysteroscopes are used as tools to access the uterine cavity and are not, in andof 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 painGenerally recognized indications for operative hysteroscopy include:• Directed endometrial biopsy• Polypectomy• Submucous myomectomy• Transection of intrauterine adhesions |
| Device | Indications For Use |
| • Endometrial ablationCystoscopy: The LUMINELLE DTx Hysteroscopy System is intended for use inendoscopic access to and examination of the lower urinary tract, including thebladder. When combined with accessory instruments, the System allows the user toperform various diagnostic and therapeutic procedures. |
Comparison of Indications for Use
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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 | PRIMARYPredicateDevice | Reference Device | |||
|---|---|---|---|---|---|
| 510k# | K213171 | K190372 | K191958 | K192100 | K181909 |
| Manufacturer: | Meditrina Inc. | Meditrina, Inc. | UVision360 | ||
| Device Names | Aveta SystemAveta HysteroscopeAveta Cystoscope | Aveta System | Aveta System | Aveta DisposableHysteroscope | Luminelle DTxHysteroscopySystem |
| CONTROLLER FUNCTIONS | Hysteroscope Functions | ||||
| Visualizationand ImageProcessing | CMOS sensor, andlight source inEndoscope withimage processing bythe Controller | CMOS sensor,and light sourcein Hysteroscopewith imageprocessing bythe Controller | N/A(Used in combination withhysteroscope and accessoriesof the commercial 3rd partyhysteroscope) | CMOS sensor, andlight source inHysteroscope withimage processingby the Controller | N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate. |
| ViewingFunctions | Controller connectsto a commerciallyavailable externalMonitor anddisplays image fromthe cavity, playstone, displays cavitypressure, fluiddeficit withgraphical userinterface. | Controllerconnects to acommerciallyavailable externalMonitor anddisplays imagefrom the cavity,plays tone,displays cavitypressure, fluiddeficit withgraphical userinterface. | Controller connects to acommercially availableexternal Monitor andplays tone, displayscavity pressure, fluiddeficit with graphicaluser interface butdoesn't display imagefrom cavity. | Controllerconnects to acommerciallyavailable externalMonitor anddisplays imagefrom the cavityand plays tone. | N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate. |
| Fluid Management Functions | |||||
| FluidDistension | Continuous flow ofsaline/fluid | Continuous flowof saline/fluid | YES | N/A | N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate. |
| Subject Device | PRIMARYPredicateDevice | Reference Device | |||
| 510k# | K213171 | K190372 | K191958 | K192100 | K181909 |
| Manufacturer: | Meditrina Inc. | Meditrina, Inc. | UVision360 | ||
| Device Names | Aveta SystemAveta HysteroscopeAveta Cystoscope | Aveta System | Aveta System | Aveta DisposableHysteroscope | Luminelle DTxHysteroscopySystem |
| Irrigation forDistension | Peristaltic pumpwith dual pressuresensors for irrigationof fluids | Peristaltic pumpwith dual pressuresensors forirrigation of fluids | Peristaltic pump withdual pressure sensors forirrigation of fluids | N/A | N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate. |
| Aspiration ofbodily fluidsand tissue | Integrated Peristalticpump for aspiration. | IntegratedPeristaltic pumpfor aspiration. | Integrated Peristalticpump for aspiration. | N/A | N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate. |
| IntrauterinePressureMeasurements | Obtains twoindependent,intrauterine pressuremeasurement bysensing pressure ofthe irrigation tube | Obtains twoindependent,intrauterinepressuremeasurement bysensing pressureof the irrigationtube | Obtains twoindependent, intrauterinepressure measurementby sensing pressure ofthe irrigation tube | N/A | N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate. |
| Set PressureRange | Hysteroscopy:30-120 mmHgCystoscopy:30-60mmHg | Hysteroscopy:30-120 mmHgCystoscopy: N/A | Hysteroscopy:30-120 mmHgCystoscopy: N/A | N/A | N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate. |
| Set PressureUserAdjustments | Allows user toincrease/decrease theset pressure | Allows user toincrease/decreasethe set pressure | Allows user toincrease/decrease theset pressure | N/A | N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate. |
| Pressure Reliefforoverpressurerisk mitigation | Hysteroscopy:Reverse rotation ofirrigation peristalticpump at 150mmHgCystoscopy:Reverse rotation ofirrigation peristalticpump at 75mmHg | Hysteroscopy:Reverse rotationof irrigationperistaltic pump at150mmHgCystoscopy: N/A | Hysteroscopy:Reverse rotation ofirrigation peristaltic pumpat 150mmHgCystoscopy: N/A | N/A | N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate. |
| Fluid DeficitMeasurement | YES | YES | YES | N/A | N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate. |
| Flow Rate | 180-500 mL/minpreset fixed flowrates | 180-500 mL/minpreset fixed flowrates | 180-500 mL/min presetfixed flow rates | N/A | N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate. |
| Subject Device | PRIMARYPredicateDevice | Reference Device | |||
| 510k# | K213171 | K190372 | K191958 | K192100 | K181909 |
| Manufacturer: | Meditrina Inc. | Meditrina, Inc. | UVision360 | ||
| Device Names | Aveta SystemAveta HysteroscopeAveta Cystoscope | Aveta System | Aveta System | Aveta DisposableHysteroscope | Luminelle DTxHysteroscopySystem |
| MechanicalResectingDevice | Connects to theResecting Handsetby an electricalconnection toprovide motorcontrol with a presetfixed motorrotation/oscillationspeed. | Connects to theResectingHandle by anelectricalconnection toprovide motorcontrol with auser adjustablemotoroscillationspeed. | Connects to theResecting Handle by anelectrical connection toprovide motor controlwith a user adjustablemotor oscillation speed. | Connects to theResecting Handleby an electricalconnection toprovide motorcontrol with a useradjustable motoroscillation speed. | N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate. |
| SCOPE | |||||
| Disposable Hysteroscope/Cystoscope | |||||
| Irrigation andAspirationLumens | Independent sterilesaline irrigation andaspiration lumens | Independentsterile salineirrigation andaspiration lumens | N/A | Independentsterile salineirrigation andaspiration lumens | N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate. |
| Insertion OD | Pearl Hysteroscope:5.7mmCoral Hysteroscope:4.6mmOpal Hysteroscope:4.6mmCoral Cystoscope:4.6mm | 5.5 mm | N/A | 5.5 mm | N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate. |
| WorkingLength | Pearl Hysteroscope:216mmCoral Hysteroscope206mmOpal Hysteroscope206mmCoral Cystoscope:206mm | 224mm | N/A | 224mm | N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate. |
| Illumination | LEDs(Light EmittingDiode) | LEDs(Light EmittingDiode) | N/A | LEDs(Light EmittingDiode) | N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate. |
| WorkingChannel | Pearl Hysteroscope:4.0mmCoral Hysteroscope:3.0mmOpal Hysteroscope:3.0mmCoral Cystoscope:3.0mm | 3.5mm | N/A | 3.5mm | N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate. |
| Subject Device | PRIMARYPredicateDevice | Reference Device | |||
| 510k# | K213171 | K190372 | K191958 | K192100 | K181909 |
| Manufacturer: | Meditrina Inc. | Meditrina, Inc. | UVision360 | ||
| Device Names | Aveta SystemAveta HysteroscopeAveta Cystoscope | Aveta System | Aveta System | Aveta DisposableHysteroscope | Luminelle DTxHysteroscopySystem |
| Camera | Digital CMOSCamera | Digital CMOSCamera | N/A | Digital CMOSCamera | N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate. |
| CuttingWindow | DRD-Wave+: 8mmDRD-Max: 11mmDRD-3.9: 10mmDRD-Flex: 7mmDRD-Smol: 7mmDRD-2.9: 7mmAUTO: 8mm | 8 mm | N/A | N/A | N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate. |
| Blade Material | Stainless steel | Stainless steel | N/A | N/A | N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate. |
| WorkingLength | DRD-Wave+: 339mmDRD-Max: 339mmDRD-3.9: 328mmDRD-Flex: 339mmDRD-Smol: 339mmDRD-2.9: 328mmAUTO: 318mm | 328 mm | N/A | N/A | N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate. |
| Insertion OD | DRD-Wave+: 3.9mmDRD-Max: 3.9mmDRD-3.9: 3.9mmDRD-Flex: 2.9mmDRD-Smol: 2.9mmDRD-2.9: 2.9mmAUTO: 2.9mm | 3.4 mm | N/A | N/A | N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate. |
| RotationalSpeed | 3000RPM | 2000RPM | N/A | N/A | N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate. |
| SuctionAssistedResection? | YES | YES | N/A | N/A | N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate. |
| Disposable (Sterile) and Reusable (Steam Sterilizable) Resecting Handset | |||||
| Subject Device | PRIMARYPredicateDevice | Reference Device | |||
| 510k# | K213171 | K190372 | K191958 | K192100 | K181909 |
| Manufacturer: | Meditrina Inc. | Meditrina, Inc. | UVision360 | ||
| Device Names | Aveta SystemAveta HysteroscopeAveta Cystoscope | Aveta System | Aveta System | Aveta DisposableHysteroscope | Luminelle DTxHysteroscopySystem |
| ResectionMechanism | Mechanical | Mechanical | N/A | N/A | N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate. |
| User Controls | Handset Controls | Handset Controls | N/A | N/A | N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate. |
| MechanicalConnection | Locks DisposableResecting Device | LocksDisposableResectingDevice | N/A | N/A | N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate. |
| RotationalSpeed | 2000 RPM(pre-set - not useradjustable) | 2000 RPM(pre-set - notuser adjustable) | N/A | N/A | N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate. |
Technological Comparison of Aveta System with Predicate System
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Aveta System, Aveta Hysteroscope, Aveta Cystoscope Traditional 510(k) Premarket Notification
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Aveta System, Aveta Hysteroscope, Aveta Cystoscope Traditional 510(k) Premarket Notification
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Aveta System, Aveta Hysteroscope, Aveta Cystoscope Traditional 510(k) Premarket Notification
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Aveta System, Aveta Hysteroscope, Aveta Cystoscope Traditional 510(k) Premarket Notification
The differences outlined were evaluated through performance testing to demonstrate safety and effectiveness of the Aveta System.
VII. Performance Data
The following performance data have been provided in support of the substantial equivalence determination.
- Software Verification and Validation Testing performed per IEC 62304 and . documentation provided per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- Other Tests were performed per approved test protocols which included: .
- o Integrity: System withstands operating pressures
- Dimensional Inspection and Testing O
- O Functional Testing for all components of the system
- . Controller
- Weight accuracy
- Pressure accuracy and control
- Suction
- . Fluid Deficit
- I Scopes
- Optical testing ●
- Leak and flow rate
- Maximum LED Tip Temperature ●
- l Resecting Devices
- Motor/Oscillation speed ●
- . Controller
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O
.
Traditional 510(k) Premarket Notification
- Fluid Management Accessory .
- Leak and flow rate
- Simulated Use: Tissue resection, regulation of cavity pressure, imaging
- Comparative testing to predicate for pressure control, fluid deficit, fluid control and O durability.
- Biocompatibility Evaluation per ISO 10993-1 (No new testing performed. No change O in materials from the cleared device).
- Sterilization Validation per ISO 11135 and ISO 11137-1/-2/-3. O
- Packaging Validation per ASTM D4169. O
- O Accelerated Aging per ASTM F1980
- Electrical Safety & EMC: In accordance with IEC 60601-1:2005, IEC 60601-1-O 2:2014 and IEC 60601-2-18:2009.
VIII. Conclusions
The modified Aveta System, Aveta Hysteroscope and the Aveta Cystoscope are substantially equivalent to the cleared predicate i.e., Aveta System based on the same intended use, technological characteristics and principles of operation. Bench testing supports the subject device is as safe and effective for its proposed indications for use as the predicate device.
§ 884.1690 Hysteroscope and accessories.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.