(240 days)
No
The summary describes standard image processing and fluid management functionalities, with no mention of AI, ML, or related concepts.
Yes.
The device is intended for "diagnostic and surgical procedures to resect and remove tissue such as submucous myomas, endometrial polyps and retained products of conception," and for "various diagnostic and therapeutic procedures" which indicates it performs therapeutic functions.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the Aveta System and its components are intended for "viewing," "examination," and performing "diagnostic procedures" of the cervical canal, uterine cavity, and lower urinary tract/bladder.
No
The device description clearly outlines multiple hardware components including a Controller with integrated fluid management, a dual peristaltic pump, sterile single-use disposable scopes, and sterile mechanical disposable resecting devices. The performance studies also include testing of these hardware components.
Based on the provided information, the Aveta System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is a medical device intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This includes reagents, calibrators, control materials, kits, instruments, apparatus, equipment, and software.
- Aveta System's Intended Use: The Aveta System is intended for intrauterine and lower urinary tract use to permit viewing and perform surgical procedures (resection and removal of tissue). It involves direct visualization and physical intervention within the body.
- Lack of Specimen Examination: The system does not examine specimens derived from the human body in vitro. While it helps in visualizing and removing tissue, the diagnostic information is derived from the visual examination in vivo and potentially subsequent histological examination of the removed tissue (which would be a separate process, not part of the Aveta System's function).
- Focus on Visualization and Intervention: The core function of the Aveta System is to provide visualization and facilitate surgical procedures within the body, not to analyze biological samples outside the body.
Therefore, the Aveta System falls under the category of a surgical or endoscopic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
HIH, HIG, FAJ
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 following components: Aveta Controller and Footswitch, Aveta Hysteroscope/Aveta Cystoscope (Aveta Pearl Disposable Hysteroscope, Aveta Coral Disposable Hysteroscope, Aveta Opal Disposable Hysteroscope, Aveta Coral Disposable Cystoscope), Aveta Fluid Management Accessory, Aveta Disposable Resecting Device (Aveta Wave+ Disposable Resecting Device, 3.9mm (DRD-Wave+), Aveta Max Disposable Resecting Device, 3.9mm (DRD-Max), Aveta Disposable Resecting Device, 3.9 (DRD-3.9), Aveta Flex Disposable Resecting Device, 2.9mm (DRD-Flex), Aveta Smol Disposable Resecting Device, 2.9mm (DRD-Smol), Aveta Disposable Resecting Device, 2.9 and (DRD-2.9), Aveta Auto Disposable Resecting Device (AUTO)), Aveta Disposable Resecting Handset (DRH), Aveta Reusable Resecting Handset (RRH), and Additional Aveta System Components / Accessories (Waste Management Accessory, Waste Bag (6L), Aveta Reusable Cable, Opal, Roll Stand with Drape Pump, Monitor).
The Controller displays image/video and procedural information on an external monitor, enables visualization functions, controls fluid management (irrigation and aspiration), monitors and maintains cavity pressure and intrauterine pressure, monitors fluid deficit (for hysteroscopy), provides ON/OFF function for the Resecting Device, and powers resecting handsets and disposable resecting devices.
The disposable scopes (hysteroscopes and cystoscopes) provide visualization of the cervical canal and uterine cavity or lower urinary tract/bladder, respectively; offer conduits for fluid inflow and outflow; and provide working channels for operative instruments.
The Fluid Management Accessory contains a membrane for pressure monitoring/control and provides conduits for saline irrigation and waste aspiration.
The Disposable Resecting Devices mechanically resect and remove tissue under suction. Some models include a motor in the handle for oscillating the resection tip.
The Disposable Resecting Handset and Reusable Resecting Handset include motors for the oscillation of the resection tip when used with certain disposable resecting devices.
Additional accessories include a Waste Management Accessory to collect tissue and waste fluid, a Waste Bag, a Reusable Cable for connection, a Roll Stand with Drape Pump, and a commercially available surgical monitor.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical canal, uterine cavity, lower urinary tract, bladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained gynecologists; Not found for care setting, but implies clinical use.
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)
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:
- Integrity: System withstands operating pressures
- Dimensional Inspection and Testing
- Functional Testing for all components of the system:
- Controller: Weight accuracy, Pressure accuracy and control, Suction, Fluid Deficit
- Scopes: Optical testing, Leak and flow rate, Maximum LED Tip Temperature
- Resecting Devices: Motor/Oscillation speed
- 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 durability.
- Biocompatibility Evaluation per ISO 10993-1 (No new testing performed. No change in materials from the cleared device).
- Sterilization Validation per ISO 11135 and ISO 11137-1/-2/-3.
- Packaging Validation per ASTM D4169.
- Accelerated Aging per ASTM F1980
- Electrical Safety & EMC: In accordance with IEC 60601-1:2005, IEC 60601-1-2:2014 and IEC 60601-2-18:2009.
Key results: Not specified beyond "The differences outlined were evaluated through performance testing to demonstrate safety and effectiveness of the Aveta System." and "Bench testing supports the subject device is as safe and effective for its proposed indications for use as the predicate device."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
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 seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.
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.
1
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
2
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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3
K213171 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
Email: csabat@hermesinnovations.com
Phone: 415-215-7233
Fax: 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 insufflators
Endoscope 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 Device
Names | 510(k)# | Clearance Date |
|---------------------|------------------|--------------------------------------|---------|-----------------|
| PREDICATE
DEVICE | Meditrina, Inc. | Aveta System | K190372 | May 16, 2019 |
| Reference Device | UVision360, Inc. | Luminelle DTx
Hysteroscopy 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
4
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 Components
| Aveta System Component | Functions Performed |
|---|---|
| Aveta Controller | |
| and Footswitch | • Displays image/video and procedural information on external |
| monitor. | |
| • 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 uterine | |
| cavity or lower urinary tract with the bladder for visualization. | |
| • Monitors and maintains intrauterine pressure or lover urinary | |
| tract 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 Resecting | |
| Devices with Handsets for oscillation at a preset speed for | |
| mechanical 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 Cystoscope | |
| Collectively, they are called Aveta | |
| Disposable Scope or Endoscope. | • Hysteroscope: Visualization of cervical canal and uterine cavity |
| • Cystoscope: Visualization of the lower urinary tract including | |
| the bladder | |
| • Provides conduits/lumens for fluid inflow and outflow | |
| • Provides conduit (working channel) for operative instruments | |
| for operative procedures | |
| • Provides user interface for intrauterine or urethral cavity set | |
| pressure 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 or |
| urethral cavity pressure monitoring/control using pressure | |
| transducer in Controller | |
| • Provides conduits for irrigation of saline and aspiration of waste. | |
| • Provides FMA Cassette with tubing for peristaltic pump | |
| functions of Aveta Controller. |
Table 1 Aveta System Components
5
| Aveta System Component | Functions Performed |
|---|---|
| Aveta Disposable Resecting Device: | |
| • Aveta Wave+ Disposable Resecting | |
| Device, 3.9mm (DRD-Wave+) | |
| • Aveta Max Disposable Resecting | |
| Device, 3.9mm (DRD-Max) | |
| • Aveta Disposable Resecting Device, | |
| 3.9 (DRD-3.9) | |
| • Aveta Flex Disposable Resecting | |
| Device, 2.9mm (DRD-Flex) | |
| • Aveta Smol Disposable Resecting | |
| Device, 2.9mm (DRD-Smol) | |
| • Aveta Disposable Resecting Device, | |
| 2.9 and (DRD-2.9) | |
| • Aveta Auto Disposable Resecting | |
| Device (AUTO) | • Mechanically resects and removes tissue under suction |
| • DRD-2.9 and DRD-3.9 require use of DRH or RRH for | |
| oscillation of resection tip | |
| • DRD-Wave+, DRD-Max, DRD-Flex, DRD-Smol, AUTO | |
| include motor in the device handle to oscillate resection tip | |
| • The motor in the device handle for AUTO also provides | |
| suction by peristaltic action and is only for use with the | |
| pressurized 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 waste |
| and collects fluid from the patient's under-buttocks drape. | |
| • Part of Waste Management Accessory. | |
| • Provides connection from the hysteroscope pigtail outside the | |
| sterile field to the Controller. | |
| • Roll Stand mounts the monitor and Controller for the system | |
| Drape Pump transfers collected waste fluid from drape to Waste | |
| Bag. | |
| • Commercially available surgical monitor. Displays image, | |
| procedural parameters and notifications. |
6
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 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 | |
| (Subject Device) | 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 | |
| (Subject Device) | 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. | |
| Aveta System | |
| (Predicate Device – K190372) | 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. | |
| UVision360 Luminelle DTx | |
| Hysteroscopy System | |
| (Reference Device – K181909) | Hysteroscopy: The LUMINELLE DTx Hysteroscopy System is used to permit |
| direct viewing of the cervical canal and uterine cavity for the purpose of performing | |
| diagnostic and surgical procedures. | |
| Note: Hysteroscopes are used as tools to access the uterine cavity and are not, in and | |
| of 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 pain | |
| Generally recognized indications for operative hysteroscopy include: | |
| • Directed endometrial biopsy | |
| • Polypectomy | |
| • Submucous myomectomy | |
| • Transection of intrauterine adhesions | |
| Device | Indications For Use |
| • Endometrial ablation | |
| Cystoscopy: The LUMINELLE DTx Hysteroscopy 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. |
Comparison of Indications for Use
7
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 | PRIMARY
Predicate
Device | Reference Device | | |
|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| 510k# | K213171 | K190372 | K191958 | K192100 | K181909 |
| Manufacturer: | Meditrina Inc. | Meditrina, Inc. | | | UVision360 |
| Device Names | Aveta System
Aveta Hysteroscope
Aveta Cystoscope | Aveta System | Aveta System | Aveta Disposable
Hysteroscope | Luminelle DTx
Hysteroscopy
System |
| CONTROLLER FUNCTIONS | | | Hysteroscope Functions | | |
| Visualization
and Image
Processing | CMOS sensor, and
light source in
Endoscope with
image processing by
the Controller | CMOS sensor,
and light source
in Hysteroscope
with image
processing by
the Controller | N/A
(Used in combination with
hysteroscope and accessories
of the commercial 3rd party
hysteroscope) | CMOS sensor, and
light source in
Hysteroscope with
image processing
by the Controller | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate. |
| Viewing
Functions | Controller connects
to a commercially
available external
Monitor and
displays image from
the cavity, plays
tone, displays cavity
pressure, fluid
deficit with
graphical user
interface. | Controller
connects to a
commercially
available external
Monitor and
displays image
from the cavity,
plays tone,
displays cavity
pressure, fluid
deficit with
graphical user
interface. | Controller connects to a
commercially available
external Monitor and
plays tone, displays
cavity pressure, fluid
deficit with graphical
user interface but
doesn't display image
from cavity. | Controller
connects to a
commercially
available external
Monitor and
displays image
from the cavity
and plays tone. | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate. |
| Fluid Management Functions | | | | | |
| Fluid
Distension | Continuous flow of
saline/fluid | Continuous flow
of saline/fluid | YES | N/A | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate. |
| | Subject Device | PRIMARY
Predicate
Device | Reference Device | | |
| 510k# | K213171 | K190372 | K191958 | K192100 | K181909 |
| Manufacturer: | Meditrina Inc. | Meditrina, Inc. | | | UVision360 |
| Device Names | Aveta System
Aveta Hysteroscope
Aveta Cystoscope | Aveta System | Aveta System | Aveta Disposable
Hysteroscope | Luminelle DTx
Hysteroscopy
System |
| Irrigation for
Distension | Peristaltic pump
with dual pressure
sensors for irrigation
of fluids | Peristaltic pump
with dual pressure
sensors for
irrigation of fluids | Peristaltic pump with
dual pressure sensors for
irrigation of fluids | N/A | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate. |
| Aspiration of
bodily fluids
and tissue | Integrated Peristaltic
pump for aspiration. | Integrated
Peristaltic pump
for aspiration. | Integrated Peristaltic
pump for aspiration. | N/A | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate. |
| Intrauterine
Pressure
Measurements | Obtains two
independent,
intrauterine pressure
measurement by
sensing pressure of
the irrigation tube | Obtains two
independent,
intrauterine
pressure
measurement by
sensing pressure
of the irrigation
tube | Obtains two
independent, intrauterine
pressure measurement
by sensing pressure of
the irrigation tube | N/A | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate. |
| Set Pressure
Range | Hysteroscopy:
30-120 mmHg
Cystoscopy:
30-60mmHg | Hysteroscopy:
30-120 mmHg
Cystoscopy: N/A | Hysteroscopy:
30-120 mmHg
Cystoscopy: N/A | N/A | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate. |
| Set Pressure
User
Adjustments | Allows user to
increase/decrease the
set pressure | Allows user to
increase/decrease
the set pressure | Allows user to
increase/decrease the
set pressure | N/A | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate. |
| Pressure Relief
for
overpressure
risk mitigation | Hysteroscopy:
Reverse rotation of
irrigation peristaltic
pump at 150mmHg
Cystoscopy:
Reverse rotation of
irrigation peristaltic
pump at 75mmHg | Hysteroscopy:
Reverse rotation
of irrigation
peristaltic pump at
150mmHg
Cystoscopy: N/A | Hysteroscopy:
Reverse rotation of
irrigation peristaltic pump
at 150mmHg
Cystoscopy: N/A | N/A | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate. |
| Fluid Deficit
Measurement | YES | YES | YES | N/A | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate. |
| Flow Rate | 180-500 mL/min
preset fixed flow
rates | 180-500 mL/min
preset fixed flow
rates | 180-500 mL/min preset
fixed flow rates | N/A | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate. |
| | Subject Device | PRIMARY
Predicate
Device | Reference Device | | |
| 510k# | K213171 | K190372 | K191958 | K192100 | K181909 |
| Manufacturer: | Meditrina Inc. | Meditrina, Inc. | | UVision360 | |
| Device Names | Aveta System
Aveta Hysteroscope
Aveta Cystoscope | Aveta System | Aveta System | Aveta Disposable
Hysteroscope | Luminelle DTx
Hysteroscopy
System |
| Mechanical
Resecting
Device | Connects to the
Resecting Handset
by an electrical
connection to
provide motor
control with a preset
fixed motor
rotation/oscillation
speed. | Connects to the
Resecting
Handle by an
electrical
connection to
provide motor
control with a
user adjustable
motor
oscillation
speed. | Connects to the
Resecting Handle by an
electrical connection to
provide motor control
with a user adjustable
motor oscillation speed. | Connects to the
Resecting Handle
by an electrical
connection to
provide motor
control with a user
adjustable motor
oscillation speed. | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate. |
| SCOPE | | | | | |
| | | | Disposable Hysteroscope/Cystoscope | | |
| Irrigation and
Aspiration
Lumens | Independent sterile
saline irrigation and
aspiration lumens | Independent
sterile saline
irrigation and
aspiration lumens | N/A | Independent
sterile saline
irrigation and
aspiration lumens | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate. |
| Insertion OD | Pearl Hysteroscope:
5.7mm
Coral Hysteroscope:
4.6mm
Opal Hysteroscope:
4.6mm
Coral Cystoscope:
4.6mm | 5.5 mm | N/A | 5.5 mm | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate. |
| Working
Length | Pearl Hysteroscope:
216mm
Coral Hysteroscope
206mm
Opal Hysteroscope
206mm
Coral Cystoscope:
206mm | 224mm | N/A | 224mm | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate. |
| Illumination | LEDs
(Light Emitting
Diode) | LEDs
(Light Emitting
Diode) | N/A | LEDs
(Light Emitting
Diode) | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate. |
| Working
Channel | Pearl Hysteroscope:
4.0mm
Coral Hysteroscope:
3.0mm
Opal Hysteroscope:
3.0mm
Coral Cystoscope:
3.0mm | 3.5mm | N/A | 3.5mm | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate. |
| | Subject Device | PRIMARY
Predicate
Device | Reference Device | | |
| 510k# | K213171 | K190372 | K191958 | K192100 | K181909 |
| Manufacturer: | Meditrina Inc. | Meditrina, Inc. | | UVision360 | |
| Device Names | Aveta System
Aveta Hysteroscope
Aveta Cystoscope | Aveta System | Aveta System | Aveta Disposable
Hysteroscope | Luminelle DTx
Hysteroscopy
System |
| Camera | Digital CMOS
Camera | Digital CMOS
Camera | N/A | Digital CMOS
Camera | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate. |
| Cutting
Window | DRD-Wave+: 8mm
DRD-Max: 11mm
DRD-3.9: 10mm
DRD-Flex: 7mm
DRD-Smol: 7mm
DRD-2.9: 7mm
AUTO: 8mm | 8 mm | N/A | N/A | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate. |
| Blade Material | Stainless steel | Stainless steel | N/A | N/A | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate. |
| Working
Length | DRD-Wave+: 339mm
DRD-Max: 339mm
DRD-3.9: 328mm
DRD-Flex: 339mm
DRD-Smol: 339mm
DRD-2.9: 328mm
AUTO: 318mm | 328 mm | N/A | N/A | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate. |
| Insertion OD | DRD-Wave+: 3.9mm
DRD-Max: 3.9mm
DRD-3.9: 3.9mm
DRD-Flex: 2.9mm
DRD-Smol: 2.9mm
DRD-2.9: 2.9mm
AUTO: 2.9mm | 3.4 mm | N/A | N/A | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate. |
| Rotational
Speed | 3000RPM | 2000RPM | N/A | N/A | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate. |
| Suction
Assisted
Resection? | YES | YES | N/A | N/A | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate. |
| Disposable (Sterile) and Reusable (Steam Sterilizable) Resecting Handset | | | | | |
| | Subject Device | PRIMARY
Predicate
Device | Reference Device | | |
| 510k# | K213171 | K190372 | K191958 | K192100 | K181909 |
| Manufacturer: | Meditrina Inc. | Meditrina, Inc. | UVision360 | | |
| Device Names | Aveta System
Aveta Hysteroscope
Aveta Cystoscope | Aveta System | Aveta System | Aveta Disposable
Hysteroscope | Luminelle DTx
Hysteroscopy
System |
| Resection
Mechanism | Mechanical | Mechanical | N/A | N/A | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate. |
| User Controls | Handset Controls | Handset Controls | N/A | N/A | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate. |
| Mechanical
Connection | Locks Disposable
Resecting Device | Locks
Disposable
Resecting
Device | N/A | N/A | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate. |
| Rotational
Speed | 2000 RPM
(pre-set - not user
adjustable) | 2000 RPM
(pre-set - not
user adjustable) | N/A | N/A | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate. |
Technological Comparison of Aveta System with Predicate System
8
Aveta System, Aveta Hysteroscope, Aveta Cystoscope Traditional 510(k) Premarket Notification
9
Aveta System, Aveta Hysteroscope, Aveta Cystoscope Traditional 510(k) Premarket Notification
10
Aveta System, Aveta Hysteroscope, Aveta Cystoscope Traditional 510(k) Premarket Notification
11
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
12
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.