(244 days)
Not Found
No
The document describes standard image processing and control functions, but there is no mention of AI, ML, or related concepts like deep learning, neural networks, or algorithms that learn from data.
Yes
The device aids in diagnostic and surgical procedures such as resecting, removing, and coagulating tissue (e.g., myomas, polyps), and performing therapeutic procedures in hysteroscopy and cystoscopy, which are direct medical interventions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is used "during diagnostic and surgical procedures" for various applications like hysteroscopy and cystoscopy, and also "for the purpose of performing diagnostic and surgical procedures."
No
The device description explicitly states the system includes hardware components such as a Controller with integrated fluid management, a dual peristaltic pump, a sterile single-use disposable Scope with a CMOS sensor and light source, a bipolar Radiofrequency (RF) energy delivery system, and mechanical Disposable Resecting Devices with integrated motors. The performance studies also include hardware-related testing like functional testing for all components, dimensional inspection, electrical safety, and biocompatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Aveta System 2.0 is used within the body (in vivo) for visualization, fluid management, and surgical procedures (resecting, removing, and coagulating tissue) directly on the anatomical site. It facilitates the physician's actions during the procedure.
- Lack of Specimen Analysis: The description focuses on direct visualization, fluid control, and tissue manipulation within the body. There is no mention of analyzing specimens collected from the patient.
The device is an endoscopic system used for diagnostic and surgical procedures performed directly on the patient's internal anatomy.
N/A
Intended Use / Indications for Use
AVETA SYSTEM 2.0: USING BIPOLAR RF DEVICE:
-Hysteroscopy:
Aveta System 2.0 for Hysteroscopy: The Aveta System 2.0 is intended for intrauterine use by trained gynecologists to permit viewing of the cervical canal and the uterine cavity, provide liquid distension of the volume differential between the irrigation fluid flowing into and out of the uterus during diagnostic and surgical procedures to resect, remove and coagulate tissue such as submucous myomas, endometrial polyps, adhesions and retained products of conception using a bipolar resecting device.
USING MECHANICAL RESECTING DEVICES:
-Hysteroscopy:
The Aveta System 2.0 is intended for intrauterine use by trained gynecologists to permit viewing of the cervical canal and the uterine cavity, provide liquid distension of 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 2.0 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 (comma separated list FDA assigned to the subject device)
HIH, HIG, FAJ
Device Description
The Aveta System 2.0 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 2.0 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. Controller 2.0 provides continuous monitoring of the cavity pressure to the set pressure. For hysteroscopy, it also monitors the volume differential between saline inflow and outflow from the uterus (fluid deficit). Controller 2.0 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. The Controller 2.0 provides bipolar Radiofrequency (RF) energy to deliver to the Aveta Glo Disposable RF Device for CUT and COAG functions. For operative hysteroscopy procedures, the Aveta System also includes sterile, mechanical Disposable Resecting Device (available in various configurations, see below) powered by an integrated motor in the device handset. The resecting device (RF or mechanical) 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CMOS sensor, and light source in Endoscope
Anatomical Site
cervical canal and the uterine cavity, lower urinary tract, including the bladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained gynecologists
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
- Functional Testing: Cut and coagulation, aspiration, irrigation, pressure control
- Dimensional Inspection and Testing
- Functional Testing for all components of the system
- Controller
- Weight accuracy
- Pressure accuracy and control
- Suction
- Mechanical Resecting Devices
- Motor speed
- Oscillation
- RF Device
- CUT
- COAG
- Controller
- Functional Testing for all components of the system
- Simulated Use: Tissue resection, regulation of cavity pressure, imaging, CUT, COAG
- Comparative Testing
- Biocompatibility Evaluation per ISO 10993-1 and testing for the Bipolar Resecting Device (GLO). No new testing performed on other components. 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 Edition 3.1(or AMD2:2020), IEC 60601-1-2: Edition 4.1(or AMD1:2020), IEC 60601-2-18 and IEC 62304 Edition 1.1:2015-06
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.
Not Found
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.
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 21, 2023
Meditrina, Inc. Csaba Truckai President & CEO 1190 Saratoga Avenue, Suite 180 San Jose, CA 95129
Re: K223813
Trade/Device Name: Aveta System 2.0 Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and Accessories Regulatory Class: II Product Code: HIH, HIG, FAJ Dated: July 28, 2023 Received: July 31, 2023
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 (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 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 Roberts -S
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) K223813
Device Name Aveta System 2.0
Indications for Use (Describe) AVETA SYSTEM 2.0: USING BIPOLAR RF DEVICE:
-Hysteroscopy:
Aveta System 2.0 for Hysteroscopy: The Aveta System 2.0 is intended for intrauterine use by trained gynecologists to permit viewing of the cervical canal and the uterine cavity, provide liquid distension of the volume differential between the irrigation fluid flowing into and out of the uterus during diagnostic and surgical procedures to resect, remove and coagulate tissue such as submucous myomas, endometrial polyps, adhesions and retained products of conception using a bipolar resecting device.
USING MECHANICAL RESECTING DEVICES:
-Hysteroscopy:
The Aveta System 2.0 is intended for intrauterine use by trained gynecologists to permit viewing of the cervical canal and the uterine cavity, provide liquid distension of 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 2.0 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
K223813 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: | 16 August 2023 |
II. Product Classification
| Device Name: | Aveta System 2.0 | |
|---|---|---|
| Common Name: | Hysteroscope | |
| Regulation: | 21 CFR 884.1690 | |
| Regulation Name: | Hysteroscope and accessories; | |
| Hysteroscopic insufflator | ||
| Endoscope and accessories | Subject Device | |
| Class: | II | |
| Product Code: | HIH | |
| Additional Product Codes: | HIG, FAJ |
III. Predicate Device Information
| Predicate Devices | Manufacturer | Predicate Device Names | 510(k)# | Clearance Date |
|---|---|---|---|---|
| Predicate #1 | ||||
| (PRIMARY | ||||
| PREDICATE) | Meditrina, Inc. | Aveta System, Aveta | ||
| Disposable Hysteroscope | ||||
| (Pearl/Opal/Coral), Aveta | ||||
| Disposable Cystoscope (Coral) | K213171 | May 26, 2022 | ||
| Predicate #2 | ||||
| (Secondary Predicate) | Gynecare, Inc. | Scuba (Gynecare Versapoint) | ||
| System | K962482 | November 1, | ||
| 1996 |
Predicate has not been a subject of a design related recall.
IV. Device Description
The Aveta System 2.0 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 2.0 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. Controller 2.0 provides continuous monitoring of the cavity pressure to the set pressure. For hysteroscopy, it also monitors the volume differential between saline inflow and outflow from the uterus (fluid deficit). Controller 2.0 connects to a sterile,
5
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. The Controller 2.0 provides bipolar Radiofrequency (RF) energy to deliver to the Aveta Glo Disposable RF Device for CUT and COAG functions. For operative hysteroscopy procedures, the Aveta System also includes sterile, mechanical Disposable Resecting Device (available in various configurations, see below) powered by an integrated motor in the device handset. The resecting device (RF or mechanical) 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 2.0 Components and their Functions |
|---|
| ---------------------------------------------------------- |
| Aveta System 2.0 Component | Functions Performed |
|---|---|
| Aveta Controller 2.0 | |
| and Footswitch (includes single | |
| pedal or dual pedal 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 Disposable Resecting Devices for oscillation at a preset speed for | |
| mechanical resection function of Disposable Resecting Device. | |
| • Provides power to the Drape Pump. | |
| • Provides bi-polar RF energy to the tissue via the GLO Disposable RF Device. | |
| Aveta Disposable Hysteroscope | |
| (Coral, Pearl and Opal) and | |
| Aveta Coral Disposable | |
| Cystoscope | |
| Collectively, they are called | |
| Aveta Disposable Scope or just | |
| 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 | |
| • For Coral and Pearl hysteroscopes, 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 2.0. | |
| Aveta Disposable Resecting | |
| Devices (DRDH-Wave+, | |
| DRDH-Flex, DRDH-Smol, | |
| DRDH-AUTO and DRDH- | |
| AUTO-5Fr) | • Mechanically resects and removes tissue under suction |
| o DRDH-Wave+, DRDH-Flex, DRDH-Smol, AUTO and AUTO-5Fr includes motor in | |
| the device handle to oscillate resection tip for the DRDHs and to rotate the resection tip | |
| for Auto and Auto-5Fr. | |
| o The motor in the device handle for AUTO and AUTO-5Fr also provides suction by | |
| peristaltic action and are only for use with the pressurized saline bag. | |
| Aveta Glo Disposable RF | |
| Device, 7Fr. | • Performs bipolar resection (RF CUT) and removes tissue under suction and coagulates |
| (RF COAG) tissue to reduce or eliminate bleeding and improve visibility. | |
| Additional Aveta System | |
| Components / Accessories | |
| • Waste Management Accessory | |
| • Waste Bag (6L) | |
| • Roll Stand with Drape Pump | |
| • Monitor | • Collects tissue for pathology, stores the outflow fluid waste, collects fluid from the |
| patient's under-buttocks drape | |
| • Part of Waste Management Accessory | |
| • 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 |
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V. Indications for Use
There is no difference in the indications for use for the Aveta System 2.0 (subject device) when compared to the indications of the predicate devices. f Indiantions for U
| Comparison of Indications for Use | |
|---|---|
| Device | Indications For Use |
| Aveta System 2.0 | |
| (Subject Device) | AVETA SYSTEM 2.0: |
| USING BIPOLAR RF DEVICE: | |
| -Hysteroscopy: | |
| Aveta System 2.0 for Hysteroscopy: The Aveta System 2.0 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, remove and coagulate tissue such as submucous myomas, endometrial polyps, adhesions and | |
| retained products of conception using a bipolar resecting device. | |
| USING MECHANICAL RESECTING DEVICES: | |
| -Hysteroscopy: | |
| The Aveta System 2.0 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 2.0 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 | |
| Aveta System | |
| (Predicate Device #1) | urinary tract, including the bladder. When combined with accessory instruments, the Cystoscope allows the user to |
| perform various diagnostic and therapeutic procedures. | |
| 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. | |
| Scuba (Gynecare | |
| Versapoint) | |
| System | |
| (Predicate Device #2) | The Scuba (Gynecare Versapoint) System is intended for tissue cutting, vaporization and desiccation as required or |
| encountered in gynecologic hysteroscopic electrosurgical procedures for excision of intrauterine myomas and | |
| polyps, lysis of intrauterine adhesions, and excision of uterine septa. |
The indications for use for the subject Aveta System 2.0 is similar to the indications for use for primary Predicate #1 (Aveta System) and Predicate #2 (Scuba (Gynecare Versapoint) System)).
7
VI. Comparison of Technological Characteristics with the Predicate Device
Aveta System 2.0 and the predicate system have the same or similar technological characteristics in terms of basic operating principle and basic design features with minor differences.
Technological Comparison of Aveta System 2.0 with Predicate Devices
| | Subject Device | PREDICATE #1
Primary Predicate | PREDICATE #2
Secondary Predicate | | | |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|--|--|--|
| 510k# | K223813 | K213171 | K962482 | | | |
| Manufacturer: | Meditrina Inc. | Meditrina Inc. | Gynecare, Inc. | | | |
| Device Names | Aveta System 2.0 | Aveta System
Aveta Hysteroscope
Aveta Cystoscope | Scuba (Gynecare Versapoint) System | | | |
| CONTROLLER FUNCTIONS | | | | | | |
| | | Hysteroscope /Cystoscope Functions | | | | |
| Visualization and
Image Processing | CMOS sensor, and light source in
Endoscope with image processing by the
Controller | CMOS sensor, and light
source in Endoscope with
image processing by the
Controller | N/A | | | |
| 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. | NA | | | |
| Fluid Management Functions | | | | | | |
| Fluid Distension | Continuous flow of saline/fluid | Continuous flow of saline/fluid | NA | | | |
| Irrigation for
Distension | Peristaltic pump with dual pressure sensors
for irrigation of fluids | Peristaltic pump with dual
pressure sensors for irrigation
of fluids | NA | | | |
| Aspiration of bodily
fluids and tissue | Integrated Peristaltic pump for aspiration. | Integrated Peristaltic pump for
aspiration. | NA | | | |
| 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 | NA | | | |
| Set Pressure Range | Hysteroscopy:
30-120 mmHg
Cystoscopy:
30-60mmHg | Hysteroscopy:
30-120 mmHg
Cystoscopy:
30-60mmHg | NA | | | |
| Set Pressure User
Adjustments | Allows user to increase/decrease the set
pressure | Allows user to
increase/decrease the set
pressure | NA | | | |
| 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:
Reverse rotation of irrigation
peristaltic pump at 75mmHg | NA | | | |
| Fluid Deficit
Measurement | YES | YES | NA | | | |
| Flow Rate | 180-500 mL/min preset fixed flow rates | 180-500 mL/min preset fixed
flow rates | NA | | | |
8
Meditrina, Inc.
Aveta System 2.0,
K223813 Page 5 of 7
| Subject Device | PREDICATE #1 | PREDICATE #2 | |
|---|---|---|---|
| Primary Predicate | Secondary Predicate | ||
| 510k# | K223813 | K213171 | K962482 |
| Manufacturer: | Meditrina Inc. | Meditrina Inc. | Gynecare, Inc. |
| Device Names | Aveta System 2.0 | Aveta System | |
| Aveta Hysteroscope | |||
| Aveta Cystoscope | Scuba (Gynecare Versapoint) System | ||
| Resection Functions | |||
| Mechanical | |||
| Resecting Device | Connects to the Controller 2.0 by an | ||
| electrical connection to provide motor | |||
| control with a preset fixed motor | |||
| rotation/oscillation speed. | Connects to the Controller by | ||
| an electrical connection to | |||
| provide motor control with a | |||
| preset fixed motor | |||
| rotation/oscillation speed. | N/A | ||
| Bipolar RF Device | Cut and Coagulate tissue when active | ||
| electrode is extended and powered by | |||
| controller, only when activated by the | |||
| dual footswitch | NA | Cut and Coagulate Uterine tissue when | |
| active electrode is extended and | |||
| powered by controller | |||
| RF CUT, COAG | |||
| Power Waveform | |||
| and frequency | Bipolar | ||
| CUT 110 W @ 150Ω | |||
| COAG 55W @ 150Ω | |||
| quasi sinusoidal waveform | |||
| 205 kHz | N/A | Bipolar | |
| CUT 200W @ 160Ω | |||
| COAG 125W @ 160Ω | |||
| variable amplitude sinusoid waveform | |||
| varying between | |||
| 340kHz and 450kHz | |||
| DISPOSABLE HYSTEROSCOPE/CYSTOSCOPE | |||
| Irrigation and | |||
| Aspiration Lumens | Independent sterile saline | ||
| irrigation and aspiration | |||
| lumens | Independent sterile saline | ||
| irrigation and aspiration | |||
| lumens | NA | ||
| Insertion OD | Pearl Hysteroscope: 5.7mm | ||
| Coral Hysteroscope: 4.6mm | |||
| Opal Hysteroscope: 4.6mm | |||
| Coral Cystoscope: 4.6mm | Pearl Hysteroscope: 5.7mm | ||
| Coral Hysteroscope: 4.6mm | |||
| Opal Hysteroscope: 4.6mm | |||
| Coral Cystoscope: 4.6mm | NA | ||
| Working Length | Pearl Hysteroscope: 216mm | ||
| Coral Hysteroscope: 206mm | |||
| Opal Hysteroscope: 206mm | |||
| Coral Cystoscope: 206mm | Pearl Hysteroscope: 216mm | ||
| Coral Hysteroscope: 206mm | |||
| Opal Hysteroscope: 206mm | |||
| Coral Cystoscope: 206mm | NA | ||
| Illumination | LEDs (Light Emitting Diode) | LEDs (Light Emitting Diode) | NA |
| Working Channel | Pearl Hysteroscope: 4.0mm | ||
| Coral Hysteroscope: 3.0mm | |||
| Opal Hysteroscope: 3.0mm | |||
| Coral Cystoscope: | |||
| 3.0mm | Pearl Hysteroscope: 4.0mm | ||
| Coral Hysteroscope: 3.0mm | |||
| Opal Hysteroscope: 3.0mm | |||
| Coral Cystoscope: | |||
| 3.0mm | NA | ||
| Camera | Digital CMOS Camera | Digital CMOS Camera | NA |
| RESECTION SYSTEM | |||
| Disposable Resecting Devices (DRD, DRDH, AUTO, AUTO-5Fr), Disposable RF Device (GLO) | |||
| Cutting Window | DRDH-Wave+: | ||
| 8mm | |||
| DRDH-Flex: | |||
| 7mm | |||
| DRDH-Smol: | |||
| 7mm | |||
| AUTO: | |||
| 8mm | |||
| AUTO-5Fr: | |||
| 8mm | |||
| GLO: N/A (no cutting window) | DRDH-Wave+: | ||
| 8mm | |||
| DRDH-Max: | |||
| 11mm | |||
| DRD-3.9: | |||
| 10mm | |||
| DRDH-Flex: | |||
| 7mm | |||
| DRDH-Smol: | |||
| 7mm | |||
| DRD-2.9: | |||
| 7mm | |||
| AUTO: | |||
| 8mm | NA | ||
| Tip / Electrode | |||
| Material | Stainless steel | Stainless steel | Metal (Gynecare Proprietary) |
| Subject Device | PREDICATE #1 | ||
| Primary Predicate | PREDICATE #2 | ||
| Secondary Predicate | |||
| 510k# | K223813 | K213171 | K962482 |
| Manufacturer: | Meditrina Inc. | Meditrina Inc. | Gynecare, Inc. |
| Device Names | Aveta System 2.0 | Aveta System | |
| Aveta Hysteroscope | |||
| Aveta Cystoscope | Scuba (Gynecare Versapoint) System | ||
| Working Length | DRDH-Wave+: | ||
| 339mm | |||
| DRDH-Flex: | |||
| 339mm | |||
| DRDH-Smol: | |||
| 339mm | |||
| AUTO: | |||
| 318mm | |||
| AUTO-5Fr: | |||
| 318 mm | |||
| GLO: | |||
| 339mm | DRDH-Wave+: | ||
| 339mm | |||
| DRDH-Max: | |||
| 339mm | |||
| DRD-3.9: | |||
| 328mm | |||
| DRDH-Flex: | |||
| 339mm | |||
| DRDH-Smol: | |||
| 339mm | |||
| DRD-2.9: | |||
| 328mm | |||
| AUTO: | |||
| 318mm | Twizzle Tip: 360mm | ||
| Insertion OD | DRDH-Wave+: | ||
| 3.9mm | |||
| DRDH-Flex: | |||
| 2.9mm | |||
| DRDH-Smol: | |||
| 2.9mm | |||
| AUTO: | |||
| 2.9mm | |||
| AUTO-5Fr: | |||
| 1.67mm | |||
| GLO: | |||
| 2.33mm | DRDH-Wave+: | ||
| 3.9mm | |||
| DRDH-Max: | |||
| 3.9mm | |||
| DRD-3.9: | |||
| 3.9mm | |||
| DRDH-Flex: | |||
| 2.9mm | |||
| DRDH-Smol: | |||
| 2.9mm | |||
| DRD-2.9: | |||
| 2.9mm | |||
| AUTO: | |||
| 2.9mm | NA | ||
| Rotational Speed | DRDH-Wave+: | ||
| 5,000 rpm | |||
| DRDH-Flex: | |||
| 10,000 rpm | |||
| DRDH-Smol: | |||
| 3,000 rpm | |||
| AUTO: | |||
| 3,000 rpm | |||
| AUTO-5Fr: | |||
| 3,000 rpm | DRDH-Wave+: | ||
| 3,000rpm | |||
| DRDH-Max: | |||
| 3,000rpm | |||
| DRD-3.9: | |||
| 3,000rpm | |||
| DRDH-Flex: | |||
| 3,000rpm | |||
| DRDH-Smol: | |||
| 3,000rpm | |||
| DRD-2.9: | |||
| 3,000rpm | |||
| AUTO: | |||
| 3,000rpm | NA | ||
| Suction Assisted | |||
| Resection | YES | YES | NA |
9
Aveta System 2.0,
Traditional 510(k) Premarket Notification
The differences outlined were evaluated through performance testing to demonstrate safety and effectiveness of the Aveta System 2.0.
VII. Performance Data
o
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 o
- Functional Testing: Cut and coagulation, aspiration, irrigation, pressure control o
- Dimensional Inspection and Testing o
- Functional Testing for all components of the system
- . Controller
- . Weight accuracy
- Pressure accuracy and control
- Suction ●
- Mechanical Resecting Devices
- . Motor speed
- . Oscillation
- I RF Device
- . Controller
- Functional Testing for all components of the system
■
- CUT .
- . COAG
10
- Simulated Use: Tissue resection, regulation of cavity pressure, imaging, CUT, COAG O
- Comparative Testing O
- Biocompatibility Evaluation per ISO 10993-1 and testing for the Bipolar Resecting Device o (GLO). No new testing performed on other components. No change in materials from the cleared device.
- Sterilization Validation per ISO 11135 and ISO 11137-1/-2/-3. O
- Packaging Validation per ASTM D4169. O
- Accelerated Aging per ASTM F1980 O
- Electrical Safety & EMC: In accordance with IEC 60601-1 Edition 3.1(or AMD2:2020), O IEC 60601-1-2: Edition 4.1(or AMD1:2020), IEC 60601-2-18 and IEC 62304 Edition 1.1:2015-06
VIII. Conclusions
The Aveta System 2.0, is substantially equivalent to the cleared predicates based on the same intended use, technological characteristics and principles of operation. Bench testing supports the subject device is as safe and effective as the predicate device for its proposed indications for use.