(70 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 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.
The provided text is a 510(k) summary for the Meditrina Aveta System (K191958). It describes a device that assists gynecologists in hysteroscopic procedures. This document primarily focuses on demonstrating substantial equivalence to a predicate device (K190372) rather than detailed acceptance criteria and study results for device performance in terms of diagnostic or therapeutic accuracy, as would be expected for an AI/ML powered device.
Therefore, many of the requested items (acceptance criteria for AI performance, sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, ground truth details) are not applicable or not provided in this specific 510(k) document, as it concerns a physical medical device and its accessories, not an AI/ML algorithm.
However, I can extract the available information related to the device's functional performance:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Functional) | Reported Device Performance |
|---|---|
| Handswitch controls function as expected (Pressure and Flow Control). | Functional Testing demonstrated Handswitch controls function as expected. |
| Regulation of cavity pressure demonstrated in a model uterine system. | Demonstrated with TruClear 8.0 and Myosure XL hysteroscopes in various operational modes. Results met specifications. |
2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to a functional performance test in a model uterine system, not a clinical data set for an AI algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this was functional testing, not an expert-driven ground truth assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This document does not describe an AI-powered device or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the functional testing, the "ground truth" was likely the expected physical and operational parameters (e.g., maintaining a set pressure, consistent flow control) within the model uterine system.
8. The sample size for the training set: Not applicable. No AI/ML training set is mentioned.
9. How the ground truth for the training set was established: Not applicable.
Summary of the study conducted to prove the device meets acceptance criteria:
The study conducted involved non-clinical performance testing to evaluate the modified Aveta System.
- Study Type: Functional testing and simulated use with a model uterine system.
- Key Tests:
- Functional Testing with Aveta Handswitch: Verified that the Handswitch's pressure control and flow control functions operated as expected.
- Simulated Use with Compatible Hysteroscopes: The device's ability to regulate cavity pressure was demonstrated using two commercially available hysteroscopes (Hologic MyoSure XL and Covidien TruClear 8.0) within a model uterine system. This was performed across various operational modes (diagnostic, therapeutic).
- Results: The results of these tests demonstrated that the subject device met its specifications.
- Conclusion: The non-clinical performance testing confirmed that the differences in the modified Aveta System (inclusion of Aveta Handswitch and compatibility with third-party hysteroscopes) did not raise new questions of safety and effectiveness, and the device performs as safely and effectively as its predicate.
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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
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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
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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) | ||
|---|---|---|
| ☑ 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) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ||
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K191958: 510(k) Summary
I. Submitter Information
| Submitter name: | Meditrina, Inc.1190 Saratoga Avenue, Suite 180San Jose, CA 95129 |
|---|---|
| Contact person: | Csaba TruckaiPresident & CEOMobile: (415) 215-7233 Fax: (408) 418-4815Office: (408) 471-4877csabat@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 SystemComponent | DeviceCharacteristics | Materials; PatientContact and ContactDuration* | Functions Performed |
|---|---|---|---|
| Aveta Controller withIntegrated FluidManagement (P/N212-002) | Non-sterile, reusable,used outside thesterile field | No patient contact | · Hysteroscopic image / video processing /storing recorded images• Fluid Management with irrigation andaspiration functions |
| Aveta SystemComponent | DeviceCharacteristics | Materials; PatientContact and ContactDuration* | Functions Performed |
| • Controls saline inflow and outflow forinsufflation of the uterine cavity forvisualization• Monitors and maintains intrauterinepressure to set pressure• Monitors volume differential (fluiddeficit)• Controls Mechanical Resecting Deviceoscillation (Preset speed)• Displays image/video and proceduralinformation on external monitor | |||
| Aveta FluidManagementAccessory (P/N 205-023) | Sterile (EO), singleuse, used in the sterilefield | Polymers (PVC, ABS);indirect patient contactfor limited duration. | • Provides conduits/lumens for fluidinflow and outflow• Provides membrane in fluid inflow lineto enable intrauterine pressuremonitoring/control using pressuretransducer in Controller• Includes cassette for proper connectionwith Controller pumps |
| Aveta DisposableResecting Device(P/N 204-003) | Sterile (Gamma),single use, used in thesterile field | Stainless steel,polymers (ABS); directcontact with patient forlimited duration. | • Mechanically resects and removes tissueunder suction |
| Aveta DisposableResecting Handset(P/N 211-001) | Sterile (Gamma),single use, used in thesterile field | Stainless steel, ABS;No patient contact | • Includes motor to provide oscillation ofresection tip |
| Aveta ReusableResecting Handset(P/N 211-001) | Non-sterile, reusable,cleaned and steamsterilized prior to eachuse | Stainless steel,polymers; No patientcontact | • Includes motor to provide oscillation ofresection tip |
| Additional AvetaSystem Components/ Accessories• Monitor• WasteManagement Kit(P/N 205-001)• Waste Scale Bag(P/N 205-003)• Aveta Scale (P/N212-020)• Aveta Roll Stand(P/N 200-020)• Aveta Handswitch(P/N 218-002) | • Non-sterile, reusable• Non-sterile, singleuse• Non-sterile, singleuse• Reusable, outsidethe sterile field• Reusable, outsidethe sterile field• Reusable, outsidethe sterile field | (No patient contactwith any of theadditional accessories)• Non-sterile, reusable• Non-sterile, singleuse• Polymer• Stainless steel,hardware• Stainless steel,hardware• ABS, hardware | • Displays image, procedural parametersand notifications• Collects tissue for pathology and storesthe outflow fluid waste• Collects waste fluid from patient drape• Measures waste fluid / leaked fluid lostfrom cervix / hysteroscope• Mounts Controller and Monitor• Provides user interface for intrauterineset pressure, fluid deficit limitadjustments and different flow modes. |
Table 1. Modified Aveta System Components
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*: 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.
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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 availablehysteroscope or the AVETA CONTROLLER) | Endoscope Functions(performed by AVETA CONTROLLER) | |
| Visualization andImage Processing | If using commercially available hysteroscopeaccessories:Regular Optics with CCD sensor, Light Source andCamera Controller from compatible deviceIf using Aveta Disposable Hysteroscope:Identical to predicate (Aveta controller) | CMOS sensor, and light source in Aveta DisposableHysteroscope with image processing by the AvetaController |
| Image andProceduralParameter Display | If using commercially available hysteroscopeaccessories:External Camera Controller connects to an externalcommercially available Monitor and displaysimages.If using Aveta Disposable Hysteroscope:Identical to predicate (Aveta Controller) | Aveta Controller connects to a commerciallyavailable external Monitor for diagnostic andoperative information; Screen displays cavitypressure, 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 |
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| 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 ManagementControl 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 clearedAveta 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 |
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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:
- 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).
§ 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.