(70 days)
No
The summary describes image processing but does not mention AI, ML, or related concepts like neural networks, training sets, or performance metrics typically associated with AI/ML algorithms.
Yes
Explanation: The device is described as being used for "diagnostic and surgical procedures to resect and remove tissue such as submucous myomas, endometrial polyps and retained products of conception," and also mentions "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." Resecting and removing tissue are therapeutic actions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Aveta System is used "during diagnostic and surgical procedures." Additionally, the "Device Description" mentions that "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." These statements confirm its use in diagnostic contexts.
No
The device description explicitly mentions hardware components like the Aveta Controller, Aveta Fluid Management Accessory, Aveta Handswitch, Aveta Scale, Waste Management Bags, saline bags, external monitor, Aveta Reusable Resecting Handset, Aveta Disposable Resecting Handset, and Aveta Disposable Resecting Device. It also mentions a CMOS sensor and light source in the hysteroscope. This is not a software-only device.
Based on the provided information, the Aveta System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for intrauterine use by trained gynecologists to view the cervical canal and uterine cavity, provide liquid distension, and monitor fluid volume during diagnostic and surgical procedures. This involves direct interaction with the patient's body and is focused on visualization and fluid management within the uterus.
- Device Description: The description details a system with a controller, fluid management accessories, handswitches, scales, and resecting handpieces. These are all components used for performing procedures directly on the patient.
- Lack of In Vitro Testing: An IVD device is designed to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. The Aveta System does not perform any such testing on specimens.
- Focus on Procedure and Visualization: The system's primary functions are visualization (through the hysteroscope and image processing) and fluid management during a procedure. These are not diagnostic tests performed on samples.
While the system is used for "diagnostic procedures," this refers to the physician using the visualization capabilities to diagnose conditions within the uterus, not the device itself performing an in vitro diagnostic test.
Therefore, the Aveta System is a surgical and diagnostic imaging system used for procedures within the body, not an IVD device.
N/A
Intended Use / Indications for Use
The Aveta System is intended for intrauterine use by trained gynecologists to permit viewing of the cervical canal and the uterine cavity, provide liquid distension of the uterus and monitor the volume differential between the irrigation fluid flowing into and out of the uterus during diagnostic and surgical procedures to resect and remove tissue such as submucous myomas, endometrial polyps and retained products of conception.
Product codes (comma separated list FDA assigned to the subject device)
HIH, HIG
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.
Mentions image processing
Hysteroscopic image / video processing / storing recorded images
CMOS sensor, and light source in Aveta Disposable Hysteroscope with image processing by the Aveta Controller
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intrauterine (cervical canal and the uterine cavity)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained gynecologists / office or operating room setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Sharon Andrews Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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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 180
San Jose, CA 95129 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Csaba Truckai
President & CEO
Mobile: (415) 215-7233 Fax: (408) 418-4815
Office: (408) 471-4877
csabat@hermesinnovations.com |
| Date Prepared: | 30 September 2019 |
II. Product Classification
| Device Name: | Aveta System | |
|---|---|---|
| Common Name: | Hysteroscope | Subject Device |
| Regulation: | 21 CFR 884.1690 | |
| Regulation Name: | Hysteroscope and accessories | |
| Class: | II | |
| Product Code: | HIH | |
| Additional Product Codes: | HIG (21 CFR 884.1700) |
III. Predicate Device Information
| Predicate Devices | Manufacturer | Predicate Device Names | 510(k)# | Clearance Date |
|---|---|---|---|---|
| Predicate Device | Meditrina, Inc. | Aveta System | K190372 | May 16, 2019 |
The predicate has not been a subject of a design related recall.
IV. Device Description
The modified Aveta System is used by physicians in an office or operating room setting. The Aveta Controller acts as the hub of the system. For diagnostic procedures, the Aveta Fluid Management Accessory, the Aveta Handswitch, the Aveta Scale, the Waste Management Bags, saline bags and an external monitor are all connected to the Aveta Controller. The inflow and outflow of the fluid management accessory are connected to the corresponding ports of a compatible hysteroscope. For therapeutic procedures, the Aveta Reusable Resecting Handset or the Aveta Disposable Resecting Handset are connected to the Aveta Controller for powering the Aveta Disposable Resecting Device. Provided in Table 1 are additional details on the components of the modified Aveta System.
| Aveta System
Component | Device
Characteristics | Materials; Patient
Contact and Contact
Duration* | Functions Performed |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Aveta Controller with
Integrated Fluid
Management (P/N
212-002) | Non-sterile, reusable,
used outside the
sterile field | No patient contact | · Hysteroscopic image / video processing /
storing recorded images
• Fluid Management with irrigation and
aspiration functions |
| Aveta System
Component | Device
Characteristics | Materials; Patient
Contact and Contact
Duration* | Functions Performed |
| | | | • Controls saline inflow and outflow for
insufflation of the uterine cavity for
visualization
• Monitors and maintains intrauterine
pressure to set pressure
• Monitors volume differential (fluid
deficit)
• Controls Mechanical Resecting Device
oscillation (Preset speed)
• Displays image/video and procedural
information on external monitor |
| Aveta Fluid
Management
Accessory (P/N 205-
023) | Sterile (EO), single
use, used in the sterile
field | Polymers (PVC, ABS);
indirect patient contact
for limited duration. | • Provides conduits/lumens for fluid
inflow and outflow
• Provides membrane in fluid inflow line
to enable intrauterine pressure
monitoring/control using pressure
transducer in Controller
• Includes cassette for proper connection
with Controller pumps |
| Aveta Disposable
Resecting Device
(P/N 204-003) | Sterile (Gamma),
single use, used in the
sterile field | Stainless steel,
polymers (ABS); direct
contact with patient for
limited duration. | • Mechanically resects and removes tissue
under suction |
| Aveta Disposable
Resecting Handset
(P/N 211-001) | Sterile (Gamma),
single use, used in the
sterile field | Stainless steel, ABS;
No patient contact | • Includes motor to provide oscillation of
resection tip |
| Aveta Reusable
Resecting Handset
(P/N 211-001) | Non-sterile, reusable,
cleaned and steam
sterilized prior to each
use | Stainless steel,
polymers; No patient
contact | • Includes motor to provide oscillation of
resection tip |
| Additional Aveta
System Components
/ Accessories
• Monitor
• Waste
Management Kit
(P/N 205-001)
• Waste Scale Bag
(P/N 205-003)
• Aveta Scale (P/N
212-020)
• Aveta Roll Stand
(P/N 200-020)
• Aveta Handswitch
(P/N 218-002) | • Non-sterile, reusable
• Non-sterile, single
use
• Non-sterile, single
use
• Reusable, outside
the sterile field
• Reusable, outside
the sterile field
• Reusable, outside
the sterile field | (No patient contact
with any of the
additional accessories)
• Non-sterile, reusable
• Non-sterile, single
use
• Polymer
• Stainless steel,
hardware
• Stainless steel,
hardware
• ABS, hardware | • Displays image, procedural parameters
and notifications
• Collects tissue for pathology and stores
the outflow fluid waste
• Collects waste fluid from patient drape
• Measures waste fluid / leaked fluid lost
from cervix / hysteroscope
• Mounts Controller and Monitor
• Provides user interface for intrauterine
set pressure, fluid deficit limit
adjustments and different flow modes. |
Table 1. Modified Aveta System Components
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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 available | ||
| hysteroscope or the AVETA CONTROLLER) | Endoscope Functions | |
| (performed by AVETA CONTROLLER) | ||
| Visualization and | ||
| Image Processing | If using commercially available hysteroscope | |
| accessories: | ||
| Regular Optics with CCD sensor, Light Source and | ||
| Camera Controller from compatible device | ||
| If using Aveta Disposable Hysteroscope: | ||
| Identical to predicate (Aveta controller) | CMOS sensor, and light source in Aveta Disposable | |
| Hysteroscope with image processing by the Aveta | ||
| Controller | ||
| Image and | ||
| Procedural | ||
| Parameter Display | If using commercially available hysteroscope | |
| accessories: | ||
| External Camera Controller connects to an external | ||
| commercially available Monitor and displays | ||
| images. | ||
| If using Aveta Disposable Hysteroscope: | ||
| Identical to predicate (Aveta Controller) | Aveta Controller connects to a commercially | |
| available external Monitor for diagnostic and | ||
| operative information; Screen displays cavity | ||
| pressure, fluid deficit with graphical user interface. | ||
| Fluid Management Functions (performed by AVETA CONTROLLER) | ||
| Controller: | No change from cleared device | As in K190372 |
| OTHER COMPONENTS (BESIDES CONTROLLER) | ||
| HYSTEROSCOPE |
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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 Management | ||
| Control Functions: | Aveta Handswitch Aveta Disposable Hysteroscope included in K190372 | Aveta Disposable Hysteroscope 510(k) Cleared per K190372 |
| AVETA FLUID MANAGEMENT ACCESSORY | ||
| Device: | No change from cleared device | As in K190372 |
| AVETA DISPOSABLE RESECTING DEVICE | ||
| Device: | No change from cleared device | As in K190372 |
| AVETA DISPOSABLE RESECTING HANDSET | ||
| Device: | No change from cleared device | As in K190372 |
| SYSTEM ACCESSORIES | ||
| AVETA HANDSWITCH | ||
| How Provided | Non-critical component (Non-sterile, Reusable, used outside the sterile field) | Not included in K190372 |
| Function | Provides user a means to control the fluid management functions | Fluid management functions controlled by cleared |
| Aveta Disposable Hysteroscope. | ||
| Cleaning/ Disinfection | Same as that for cleared Aveta System (predicate). | Validated (per AAMI TIR 12 and AAMI TIR 30) |
| instructions in IFU | ||
| AVETA WASTE MANAGEMENT KIT | ||
| Device: | No change from cleared device | As in K190372 |
| AVETA WASTE SCALE BAG | ||
| Device: | No change from cleared device | As in K190372 |
| AVETA ROLL STAND | ||
| Device: | No change from cleared device | As in K190372 |
| MONITOR | ||
| Device: | No change from cleared device | As in K190372 |
| AVETA SCALE | ||
| Subject Device | PREDICATE Device | |
| 510k# | K191958 | K190372 |
| Manufacturer: | Meditrina Inc. | Meditrina Inc. |
| Device Names | Aveta System | Aveta System |
| Device: | No change from cleared device | As in K190372 |
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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).