(90 days)
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.
The Aveta System is an integrated system which allows for visualization of the cervical canal and the uterine cavity for the purpose of performing diagnostic and operative hysteroscopic procedures. The system includes a Controller with integrated fluid management which incorporates a dual peristaltic pump design to control the continuous inflow and outflow of saline to provide fluid distention of the uterine cavity. The Controller provides continuous monitoring of the intrauterine pressure to the set pressure, as well as monitoring of the volume differential between saline inflow from the uterus. The Controller connects to a sterile, single use Disposable Hysteroscope via a Reusable Hysteroscope Handset that allows visualization of the cervical canal and the uterine cavity and displays the images obtained from the hysteroscope on a standard monitor. For operative procedures, the Aveta System includes a sterile, mechanical Disposable Resecting Device powered by a motorized, Reusable Resecting Handset which is inserted through the sterile hysteroscope working channel to resect and remove endometrial polyps, submucous myomas and retained products of conception under suction.
The provided text describes the 510(k) premarket notification for the Aveta System but does not contain specific acceptance criteria or detailed study results with performance metrics that would typically be found in a clinical study report. The document focuses on demonstrating substantial equivalence to a predicate device.
However, it does list various performance data types that were provided in support of the substantial equivalence determination. Based on these, we can infer the types of acceptance criteria that would have been used, even if the specific numerical thresholds are not explicitly stated.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
As the document is a 510(k) summary, specific numerical acceptance criteria and detailed performance results are not provided. However, the "Performance Data" section (Page 10) lists the types of tests performed, which inherently implies associated acceptance criteria for each. Without the actual study reports, the exact performance values are unknown.
| Test Category | Inferred Acceptance Criteria Type | Reported Device Performance (as per document) |
|---|---|---|
| Software Verification & Validation | Adherence to IEC 62304:2006, functionality, and safety requirements (e.g., no critical software bugs found). | "Software Verification and Validation Testing performed per IEC 62304:2006 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."" (Implies successful completion and compliance) |
| System Integrity | Withstanding specified operating pressures without failure. | "System withstands operating pressures" (Implies successful completion) |
| Functional Testing (Cut, Coagulation, Aspiration, Irrigation, Pressure Control) | Device operates as intended for each function, meeting specified performance parameters (e.g., flow rates, pressure accuracy, tissue resection capability). | "Functional Testing: Cut and coagulation, aspiration, irrigation, pressure control" (Implies successful completion, device functions as intended) |
| Dimensional Inspection & Testing | Adherence to specified dimensions and tolerances. | "Dimensional Inspection and Testing" (Implies successful completion) |
| Functional Testing for all components | Each component functions reliably and as designed. | "Functional Testing for all components of the system" (Implies successful completion) |
| Maximum LED Tip Temperature | Temperature within safe limits to prevent tissue damage. | "Maximum LED Tip Temperature" (Implies successful completion, temperature within safe limits) |
| Fluid Deficit Limit Verification | Accurate measurement and control of fluid deficit within specified safety margins. | "Fluid Deficit Limit Verification testing" (Implies successful verification) |
| Simulated Use (Tissue Resection, Cavity Pressure, Imaging) | Effective tissue resection, stable cavity pressure, clear imaging for diagnostic and operative procedures. | "Simulated Use: Tissue resection, regulation of cavity pressure, imaging" (Implies successful performance in simulated scenarios) |
| Comparative Testing to Predicate (Pressure Control, Fluid Deficit, Fluid Control, Durability) | Performance of the Aveta System is comparable or superior to the predicate device in these aspects. | "Comparative testing to predicate for pressure control, fluid deficit, fluid control and durability." (Implies the Aveta System performs comparably or is substantially equivalent to the predicate in these aspects, justifying the 510(k) clearance) |
| Biocompatibility Testing | Compliance with ISO 10993-1:2009/(R)2013, indicating no adverse biological reactions. | "Biocompatibility Testing per ISO 10993-1:2009/(R)2013." (Implies successful compliance) |
| Sterilization Validation | Compliance with ISO 11135:2014 and ISO 11137-1/-2/-3:2013, ensuring sterility assurance level. | "Sterilization Validation per ISO 11135:2014 and ISO 11137-1/-2/-3:2013." (Implies successful validation, ensuring sterility) |
| Packaging Validation | Compliance with ASTM D4169:2016, ensuring product integrity during shipping and storage. | "Packaging Validation per ASTM D4169:2016." (Implies successful validation) |
| Accelerated Aging | Compliance with ASTM F1980:2016, demonstrating shelf life stability. | "Accelerated Aging per ASTM F1980:2016." (Implies successful demonstration of shelf life) |
| Electrical Safety & EMC | Compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-18 standards. | "Electrical Safety & EMC: In accordance with IEC 60601-1:2005, IEC 60601-1-2:2014 and IEC 60601-2-18:2009." (Implies successful compliance with these standards) |
| Usability Testing | Compliance with FDA guidance and IEC 62366:2015, ensuring safe and effective human-device interaction. | "Usability Testing per FDA guidance and IEC 62366:2015" (Implies successful completion, ensuring usability and safety as per standards) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided document. The listed tests are primarily engineering and bench testing, as well as simulated use. No information is given regarding human subject test sets or the number of cases.
- Data Provenance: The tests are indicated as performance data provided in support of substantial equivalence, which typically means the testing was conducted by Meditrina, Inc. (the manufacturer) or a contracted lab. The country of origin for the data is not specified, but the context implies it was generated to meet US FDA requirements. The data is prospective in the sense that Meditrina, Inc. generated it specifically for this premarket notification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The tests performed are primarily related to device function, safety, and performance against engineering specifications, rather than clinical diagnostic accuracy requiring ground truth established by experts. "Simulated Use" might involve experts, but the details are not given.
4. Adjudication Method for the Test Set
- This information is not provided in the document. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where expert consensus is needed to establish ground truth for diagnostic decisions. The tests listed are not typically subject to such adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not explicitly mentioned or described. The document states "Comparative testing to predicate for pressure control, fluid deficit, fluid control and durability." This refers to technical performance comparisons between the devices, not a clinical study assessing human reader performance with and without AI assistance. The Aveta System appears to be a medical device for hysteroscopy procedures with integrated fluid management and resection capabilities, not primarily an AI-driven diagnostic imaging interpretation device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
- The Aveta System is a medical device for hysteroscopy, not an AI algorithm. Therefore, a standalone algorithm-only performance assessment, as it pertains to AI/machine learning, is not applicable and was not performed. The "Software Verification and Validation Testing" addresses the software component of the device, but this is distinct from AI-specific standalone performance.
7. The Type of Ground Truth Used
- For the engineering and functional tests, the "ground truth" would be the engineering specifications, regulatory standards (e.g., ISO, IEC, ASTM), and the expected physical or electrical outcomes of the device's operation.
- For "Simulated Use" tests, the ground truth might come from established clinical protocols or expert assessment of the simulation's success.
- For "Comparative testing to predicate," the predicate device's established performance would serve as a benchmark or "ground truth" for comparison.
- Pathology or outcomes data are not explicitly mentioned as ground truth sources for the performance data presented here, although tissue resection is mentioned, implying that the resected tissue would eventually be sent for pathology in actual clinical use.
8. The Sample Size for the Training Set
- This information is not applicable or not provided as the Aveta System is a hardware/software medical device, not an AI/machine learning system that requires a distinct "training set" for model development in the traditional sense. Software verification and validation are performed, but this is testing against specifications, not training a model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no mention of a "training set" in the context of AI/machine learning for this device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 16, 2019
Meditrina, Inc. Csaba Truckai President & CEO 1601 S. De Anza Blvd, Suite 165 Cupertino, CA 95014
Re: K190372
Trade/Device Name: Aveta System Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: Class II Product Code: HIH, HIG Dated: February 14, 2019 Received: February 15, 2019
Dear Csaba Truckai:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Sharon M. Andrews Assistant Division Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190372
Device Name Aveta System
Indications for Use (Describe)
The Aveta System is intended for intrauterine use by trained gynecologists to permit viewing of the cervical canal and the uterine cavity, provide liquid distension of the uterus and monitor the volume differential between the irrigation fluid flowing into and out of the uterus during diagnostic and surgical procedures to resect and remove tissue such as submucous myomas, endometrial polyps and retained products of conception.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K190372: 510(k) Summary
I. Submitter Information
| Submitter name: | Meditrina, Inc.1601 S. De Anza Blvd, Suite 165Cupertino, CA 95014 |
|---|---|
| Contact person: | Csaba TruckaiPresident & CEOMobile: (415) 215-7233Office: (408) 471-4877Fax: (408) 609-3342csabat@hermesinnovations.com |
| Date Prepared: | 14 February 2019 |
II. Product Classification
| Device Name: | Aveta System | |
|---|---|---|
| Common Name: | Hysteroscope | Subject Device |
| Regulation: | 21 CFR 884.1690 | |
| Regulation Name: | Hysteroscope and accessories | |
| Class: | II | |
| Product Code: | HIH | |
| Additional Product Codes: | HIG |
III. Predicate Device Information
| Predicate Devices | Manufacturer | Predicate Device Names | 510(k)# | Clearance Date |
|---|---|---|---|---|
| PREDICATEDEVICE (System)( see NOTE 1 ) | Smith & Nephew(TruclearMorcellationSystem) | Truclear OperativeHysteroscope 5C andSheath 5C | K152143 | September 2, 2015 |
| Hysteroscopic FluidManagement System( see NOTE 2 ) | K123732 | April 4, 2013 | ||
| Truclear MorcellatorSystem and TruclearMorcellators | K132015 | March 18, 2005 |
NOTE 1: The Smith & Nephew Truclear Morcellation System (Controller, Hysteroscope and Fluid Management System) was originally cleared under K031787 as a system. Since the original
clearance each system component has been modified per the 510(k) clearances noted above. NOTE 2: Originally cleared as IUR Fluid Management System / Hysteroscopy Pump HM6 by W.O.M. World of Medicine AG under K123732.
Predicate has not been a subject of a design related recall.
IV. Device Description
The Aveta System is an integrated system which allows for visualization of the cervical canal and the uterine cavity for the purpose of performing diagnostic and operative hysteroscopic procedures.
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The Aveta System consists of the components listed in Table 1. The system includes a Controller with integrated fluid management which incorporates a dual peristaltic pump design to control the continuous inflow and outflow of saline to provide fluid distention of the uterine cavity. The Controller provides continuous monitoring of the intrauterine pressure to the set pressure, as well as monitoring of the volume differential between saline inflow from the uterus. The Controller connects to a sterile, single use Disposable Hysteroscope via a Reusable Hysteroscope Handset that allows visualization of the cervical canal and the uterine cavity and displays the images obtained from the hysteroscope on a standard monitor. For operative procedures, the Aveta System includes a sterile, mechanical Disposable Resecting Device powered by a motorized, Reusable Resecting Handset which is inserted through the sterile hysteroscope working channel to resect and remove endometrial polyps, submucous myomas and retained products of conception under suction.
| Aveta System Component | Functions Performed |
|---|---|
| Aveta Controller with IntegratedFluid Management | • Hysteroscopic image / video processing / storing recorded images• Fluid Management with irrigation and aspiration functions• Controls saline inflow and outflow for insufflation of the uterinecavity 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 externalmonitor |
| Aveta Disposable Hysteroscope(with tubing and fluid managementcassette) | • Visualization of uterine cavity• Provides conduits/lumens for fluid inflow and outflow• Provides membrane in fluid inflow line to enable intrauterinepressure monitoring/control using pressure transducer in Controller• Includes cassette for proper connection with Controller pumps• Provides conduit for Disposable Resecting Device for operativehysteroscopy• Provides user interface for intrauterine set pressure and fluid deficitlimit adjustments, and recording of images |
| Aveta Reusable HysteroscopeHandset | |
| Aveta Disposable Resecting DeviceAveta Reusable Resecting Handset | • Mechanically resects and removes tissue under suction• Includes motor to provide oscillation of resection tip |
| Additional Aveta SystemComponents / Accessories• Monitor• Waste Management Kit• Scale• Roll Stand | • Displays image, procedural parameters and notifications• Collects tissue for pathology and stores the outflow fluid waste• Measures waste fluid / leaked fluid lost from cervix / hysteroscope• Mounts Controller and Monitor |
Table 1. Aveta System Components
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V. Indications for Use
| Comparison of Indications for Use | |
|---|---|
| Device | Indications For Use |
| Aveta System(Subject Device) | The Aveta Diagnostic and Therapeutic Hysteroscopy System is intendedfor intrauterine use by trained gynecologists to permit viewing of thecervical canal and the uterine cavity, provide liquid distension of the uterusand monitor the volume differential between the irrigation fluid flowinginto and out of the uterus during diagnostic and surgical procedures toresect and remove tissue such as submucous myomas, endometrial polypsand retained products of conception. |
| Predicate System Component: | |
| Truclear™ Morcellator Systemand Truclear™ Morcellators(K152143) | For intrauterine use by trained gynecologists to hysteroscopically resect andremove tissue such as submucous myomas, endometrial polyps and retainedproducts of conception. |
| Predicate System Component: | |
| Hysteroscopic FluidManagement System(K123732) | To provide liquid distension of the uterus for diagnostic and operativehysteroscopy, and to monitor the volume differential between the irrigationfluid flowing into and out of the uterus. |
| Predicate System Component: | |
| Truclear™ OperativeHysteroscope 5C and Sheath 5C(K132015) | To permit viewing of the cervical canal and uterine cavity for the purposeof performing diagnostic and surgical procedures. |
Comparison of Indications for Use
Although the subject device does not have identical indications compared to the individual predicate devices, the subject device has the same general intended use as each of the respective predicate components: 1) to permit viewing of the cervical canal and the uterine cavity during diagnostic and operative procedures, 2) to provide liquid distension of the uterus and monitor fluid volume differential, and 3) to resect and remove tissue such as submucous myomas, endometrial polyps, and retained products of conception. When comparing each component function of the subject device to the indications of the respective predicate components, the subject and predicate devices have the same intended use.
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VI. Comparison of Technological Characteristics with the Predicate Device
Aveta System and the predicate system have similar technological characteristics in terms of basic operating principle and basic design features with minor differences.
Technological Comparison of Aveta System with Predicate System
| Subject Device | Predicate Devices (System)[Original K031787] | Reference Device | ||||
|---|---|---|---|---|---|---|
| 510k# | TBD | K132015 | K123732 | K152143 | K123151 | |
| Manufacturer: | Meditrina Inc. | Smith and Nephew, Inc. | EndoseeCorporation(Cooper Surgical) | |||
| Device Names | Aveta System | Truclear™MorcellatorSystem andTruclear™Morcellators | HysteroscopicFluidManagementSystem | Truclear™OperativeHysteroscope 5Cand Sheath 5C | Endosee®U-Scope Model 8000 | |
| CONTROLLER FUNCTIONS | ||||||
| Hysteroscope Functions | ||||||
| Visualizationand ImageProcessing | CMOS sensor and lightsource in Hysteroscopeand image processed bythe Controllermicroprocessor | N/A | N/A | Regular Opticswith CCD sensorand light sourceand camera;images process byController | CMOS sensor, andlight source inHysteroscope andimage processed byinternalmicroprocessor inreusable handset | |
| ViewingFunctions | Controller connects toa separate Monitor fordiagnostic andoperative information;Screen displays IUpressure, fluid deficitwith graphical userinterface. | N/A | Pressure andFluid Deficitdata isdisplayed onthe unit.Image isdisplayed onthe Monitor. | N/A | Monitor integrated inthe ReusableHandset Camera | |
| Fluid Management Functions | ||||||
| FluidDistention | Continuous flow ofsaline/fluid | N/A | Same | N/A | Saline inflow | |
| Irrigation forDistention | Peristaltic pump withdual pressure sensorsfor irrigation of fluids | N/A | Same | N/A | N/A | |
| Aspiration | Peristaltic pump foraspiration of fluids andfor resected tissue andfluids | N/A | Facilityvacuum pumpprovidessuction foraspiration ofresected tissueand fluids | N/A | N/A | |
| IntrauterinePressureMeasurements | Obtains twoindependentintrauterine pressuremeasurements bysensing pressure of theirrigation tube | N/A | Same | N/A | N/A | |
| Set PressureRange | 30-120 mmHg | N/A | 15-120 mmHg | N/A | N/A | |
| Set PressureUserAdjustments | Allows user toincrease/decrease theset pressure | N/A | Same | N/A | N/A | |
| Subject Device | Predicate Devices (System)[Original K031787 | Reference Device | ||||
| 510k# | TBD | K132015 | K123732 | K152143 | K123151 | |
| Manufacturer: | Meditrina Inc. | Smith and Nephew, Inc. | EndoseeCorporation(Cooper Surgical) | |||
| Device Names | Aveta System | Truclear™MorcellatorSystem andTruclear™Morcellators | HysteroscopicFluidManagementSystem | Truclear™OperativeHysteroscope 5Cand Sheath 5C | Endosee®U-Scope Model 8000 | |
| Pressure Reliefforoverpressurerisk mitigation | Reverse rotation ofirrigation peristalticpump at 150 mmHg | N/A | Same | N/A | N/A | |
| Over PressureControls | Above 100 mmHgrequires positive actionby the user with twopresses to confirmsetting is intentional upto 120 mmHg max.Display Notificationappears. | N/A | Same | N/A | N/A | |
| User PressureAdjustments toSet Pressure | 5 mmHg at a time up to120 mmHg max. | N/A | Same | N/A | N/A | |
| Fluid DeficitMeasurement(Weight basedmeasurementwhich includesaspirated fluidand fluidleaking fromcervix) | Obtains differencebetween threeindependent weightmeasurement sensors todetermine the FluidDeficit: 1) Irrigationminus 2) Aspirationand 3) fluid lost fromcervix as measured byscale | N/A | Obtainsdifferencebetween twoindependentweightmeasuringsensors todetermineFluid Deficit | N/A | N/A | |
| Flow Rate | 180-500 mL/min presetfixed flow rates | N/A | 30-700mL/minuser adjustable | N/A | N/A | |
| Mechanical Resection Functions | ||||||
| MechanicalResectingDevice | Connects to theDisposable or ReusableResecting Handset byan electrical connectionto provide a dc motorcontrol with a presetprogrammed motoroscillation speed. | Same | N/A | N/A | N/A | |
| HYSTEROSCOPE SYSTEM | ||||||
| Disposable Hysteroscope | ||||||
| Irrigation andAspirationLumens | Independent sterilesaline irrigation andaspiration lumens | N/A | N/A | Same | Independent sterileirrigation lumen. Noaspiration lumen | |
| Insertion OD | 5.5 mm | N/A | N/A | 5.7 mm | Oval - 3.8mm x 4.6mm | |
| WorkingLength | 224 mm | N/A | N/A | 205 mm | 287 mm | |
| Subject Device | Predicate Devices (System)[Original K031787] | Reference Device | ||||
| 510k# | TBD | K132015 | K123732 | K152143 | K123151 | |
| Manufacturer: | Meditrina Inc. | Smith and Nephew, Inc. | EndoseeCorporation(Cooper Surgical) | |||
| Device Names | Aveta System | Truclear™MorcellatorSystem andTruclear™Morcellators | HysteroscopicFluidManagementSystem | Truclear™OperativeHysteroscope 5Cand Sheath 5C | Endosee®U-Scope Model 8000 | |
| Illumination | LEDs(Light Emitting Diode) | N/A | N/A | Fiber optic | LED(Light EmittingDiode) | |
| WorkingChannel | 3.5 mm workingchannel | N/A | N/A | 3 mm workingchannel | No working channel | |
| Camera | Digital CMOS Camera | N/A | N/A | Fiberoptic imageguide coupled toExternal CCD(not part of thesystem) | Same | |
| ProximalConnection (toCamera andLightControls) | Entire device includingthe cable and handset issterile in one package | N/A | N/A | Mechanicalconnection to thereusable remotecamera head andlight cable | Electromechanicalconnection at theproximal end toReusable Handle | |
| Reusable Hysteroscope Handset | ||||||
| ImageProcessing | Processes imagesgenerated by theDisposableHysteroscope CMOSsensor | N/A | N/A | No imagesprocessingcapabilities.Images areprocessed by theexternal CCDvideo cameraattached toEndoscope eyepiece (not part ofthe system) | Same | |
| User Controls | · Set Pressure Controls• Fluid Deficit LimitControls· Image capturecapability· Mode Selection withpreprogrammedflowrates for eachMode | N/A | · Set PressureControls• FluidDeficitLimitControls· Flow RateAdjustment | · Light, Imageadjustmentsand ImageCapture usingcompatibledevice | · Image capturebutton.· Increaseilluminationpower button.· ON/OFF button.· Touch screen forpatient ID, timeset entry | |
| RESECTING SYSTEM | ||||||
| Disposable Resecting Device | ||||||
| CuttingWindow | 8 mm | 7 mm | N/A | N/A | N/A | |
| Blade Material | Stainless steel | Same | N/A | N/A | N/A | |
| WorkingLength | 328 mm | 357 mm | N/A | N/A | N/A | |
| Insertion OD | 3.4 mm | 2.9 mm | N/A | N/A | N/A | |
| Subject Device | Predicate Devices (System)[Original K031787] | Reference Device | ||||
| 510k# | TBD | K132015 | K123732 | K152143 | K123151 | |
| Manufacturer: | Meditrina Inc. | Smith and Nephew, Inc. | EndoseeCorporation(Cooper Surgical) | |||
| Device Names | Aveta System | Truclear™MorcellatorSystem andTruclear™Morcellators | HysteroscopicFluidManagementSystem | Truclear™OperativeHysteroscope 5Cand Sheath 5C | Endosee®U-Scope Model 8000 | |
| DeviceRotation forResection | Rotatable distal portionof the hub allows theuser to orient theresection windowtowards the targettissue | Not rotatable.User must turnResecting Handsetto orient windowdirection forresection | N/A | N/A | N/A | |
| AspirationDuringResection | Aspiration is providedvia peristaltic suctionpump | Aspirationprovided byfacility vacuumpump | N/A | N/A | N/A | |
| TissueCollection | Tissue catch providedfor resected tissuechips | Same | N/A | N/A | N/A | |
| Disposable (Sterile) and Reusable (Steam Sterilizable) Resecting Handset | ||||||
| ResectionMechanism | Mechanical | Mechanical | N/A | N/A | N/A | |
| User Controls | Handset Controls | Foot SwitchControls | N/A | N/A | N/A | |
| MechanicalConnection | Locks DisposableResecting Device | Locks DisposableResecting Device | N/A | N/A | N/A | |
| RotationalSpeed | 1500 RPM(pre-set - not useradjustable) | 100 - 2500 RPM(user adjustable) | N/A | N/A | N/A | |
| WASTE MANAGEMENT KIT | ||||||
| How Provided | Non-sterile, Single-Use | N/A | Facilityprovided (Notpart of thesystem). Non-sterile, Single-Use | N/A | N/A |
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Traditional 510(k) Premarket Notification
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K190372
Aveta Systeme 6 of 8
Meditrina, Inc.
Traditional 510(k) Premarket Notification
{9}------------------------------------------------
Meditrina, Inc.
Traditional 510(k) Premarket Notification
The differences outlined were evaluated through performance testing to demonstrate safety and effectiveness of the Aveta System. The differences in technological characteristics do not raise different questions of safety and effectiveness
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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 62304:2006 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 pre pre-specified test protocols which included:
- Integrity: System withstands operating pressures o
- Functional Testing: Cut and coagulation, aspiration, irrigation, pressure control o
- Dimensional Inspection and Testing O
- Functional Testing for all components of the system o
- Maximum LED Tip Temperature O
- Fluid Deficit Limit Verification testing O
- Simulated Use: Tissue resection, regulation of cavity pressure, imaging O
- Comparative testing to predicate for pressure control, fluid deficit, fluid control and O durability.
- Biocompatibility Testing per ISO 10993-1:2009/(R)2013. O
- Sterilization Validation per ISO 11135:2014 and ISO 11137-1/-2/-3:2013. O
- Packaging Validation per ASTM D4169:2016. O
- Accelerated Aging per ASTM F1980:2016. O
- Electrical Safety & EMC: In accordance with IEC 60601-1:2005, IEC 60601-1-O 2:2014 and IEC 60601-2-18:2009.
- Usability Testing per FDA guidance and IEC 62366:2015 O
VIII. Conclusions
The Aveta System is substantially equivalent to the Smith and Nephew Truclear System based on the similarities in intended use / indications for use, as well as technological characteristics and principles of operation.
The performance testing provided in the subject premarket notification demonstrate that the Aveta System is as safe and effective as the predicate device for its proposed indications for use.
§ 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.