Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a system for hysteroscopic procedures with fluid management and visualization. While it mentions image processing, there is no mention of AI, ML, or related concepts like training/test sets for algorithmic development. The performance studies focus on system functionality, safety, and comparison to predicates, not on the performance of an AI/ML algorithm.

Therapeutic

Yes
The device is used for diagnostic procedures (viewing the cervical canal and uterine cavity) and surgical procedures (tissue resection and removal), which are therapeutic interventions.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the system is intended for "viewing... during diagnostic and surgical procedures." This indicates it has a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly outlines multiple hardware components including a Controller with integrated fluid management, a Disposable Hysteroscope, a Reusable Hysteroscope Handset, a Disposable Resecting Device, and a Reusable Resecting Handset. The performance studies also include testing of hardware aspects like electrical safety, biocompatibility, and sterilization.

IVD (In Vitro Diagnostic)

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 permit viewing of the cervical canal and the uterine cavity, provide liquid distension of the uterus and monitor the volume differential... during diagnostic and surgical procedures to resect and remove tissue". This describes a device used within the body for visualization, fluid management, and tissue removal, not for testing samples outside the body.
Device Description: The description details a system with a hysteroscope, fluid management, and a resecting device. These are all components used for direct intervention and visualization within the uterus.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples in vitro), reagents, or performing tests on samples outside the body. The image processing is for visualizing the internal anatomy, not for analyzing images of in vitro samples.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Aveta System's function is to directly visualize and operate within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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

HIH, HIG

Device Description

The Aveta System is an integrated system which allows for visualization of the cervical canal and the uterine cavity for the purpose of performing diagnostic and operative hysteroscopic procedures. The Aveta System consists of the components listed in Table 1. The system includes a Controller with integrated fluid management which incorporates a dual peristaltic pump design to control the continuous inflow and outflow of saline to provide fluid distention of the uterine cavity. The Controller provides continuous monitoring of the intrauterine pressure to the set pressure, as well as monitoring of the volume differential between saline inflow from the uterus. The Controller connects to a sterile, single use Disposable Hysteroscope via a Reusable Hysteroscope Handset that allows visualization of the cervical canal and the uterine cavity and displays the images obtained from the hysteroscope on a standard monitor. For operative procedures, the Aveta System includes a sterile, mechanical Disposable Resecting Device powered by a motorized, Reusable Resecting Handset which is inserted through the sterile hysteroscope working channel to resect and remove endometrial polyps, submucous myomas and retained products of conception under suction.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CMOS sensor, Fiberoptic image guide

Anatomical Site

cervical canal and the uterine cavity

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

The following performance data have been provided in support of the substantial equivalence determination.

Software Verification and Validation Testing performed per IEC 62304:2006 and . documentation provided per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Other Tests were performed pre pre-specified test protocols which included:
- Integrity: System withstands operating pressures o
- Functional Testing: Cut and coagulation, aspiration, irrigation, pressure control o
- Dimensional Inspection and Testing O
- Functional Testing for all components of the system o
- Maximum LED Tip Temperature O
- Fluid Deficit Limit Verification testing O
- Simulated Use: Tissue resection, regulation of cavity pressure, imaging O
- Comparative testing to predicate for pressure control, fluid deficit, fluid control and O durability.
- Biocompatibility Testing per ISO 10993-1:2009/(R)2013. O
- Sterilization Validation per ISO 11135:2014 and ISO 11137-1/-2/-3:2013. O
- Packaging Validation per ASTM D4169:2016. O
- Accelerated Aging per ASTM F1980:2016. O
- Electrical Safety & EMC: In accordance with IEC 60601-1:2005, IEC 60601-1-O 2:2014 and IEC 60601-2-18:2009.
- Usability Testing per FDA guidance and IEC 62366:2015 O

Key Metrics

Not Found

Predicate Device(s)

K152143, K123732, K132015

Reference Device(s)

K123151

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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 logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

May 16, 2019

Meditrina, Inc. Csaba Truckai President & CEO 1601 S. De Anza Blvd, Suite 165 Cupertino, CA 95014

Re: K190372

Trade/Device Name: Aveta System Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: Class II Product Code: HIH, HIG Dated: February 14, 2019 Received: February 15, 2019

Dear Csaba Truckai:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

1

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Sharon M. Andrews Assistant Division Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K190372

Device Name Aveta System

Indications for Use (Describe)

The Aveta System is intended for intrauterine use by trained gynecologists to permit viewing of the cervical canal and the uterine cavity, provide liquid distension of the uterus and monitor the volume differential between the irrigation fluid flowing into and out of the uterus during diagnostic and surgical procedures to resect and remove tissue such as submucous myomas, endometrial polyps and retained products of conception.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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K190372: 510(k) Summary

I. Submitter Information

| Submitter name: | Meditrina, Inc.
1601 S. De Anza Blvd, Suite 165
Cupertino, CA 95014 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Csaba Truckai
President & CEO
Mobile: (415) 215-7233
Office: (408) 471-4877
Fax: (408) 609-3342
csabat@hermesinnovations.com |
| Date Prepared: | 14 February 2019 |

II. Product Classification

Device Name:	Aveta System
Common Name:	Hysteroscope	Subject Device
Regulation:	21 CFR 884.1690
Regulation Name:	Hysteroscope and accessories
Class:	II
Product Code:	HIH
Additional Product Codes:	HIG

III. Predicate Device Information

Predicate Devices	Manufacturer	Predicate Device Names
PREDICATE
DEVICE (System)
( see NOTE 1 )	Smith & Nephew
(Truclear
Morcellation
System)	Truclear Operative
Hysteroscope 5C and
Sheath 5C	K152143	September 2, 2015
		Hysteroscopic Fluid
Management System
( see NOTE 2 )	K123732	April 4, 2013
		Truclear Morcellator
System and Truclear
Morcellators	K132015	March 18, 2005

NOTE 1: The Smith & Nephew Truclear Morcellation System (Controller, Hysteroscope and Fluid Management System) was originally cleared under K031787 as a system. Since the original

clearance each system component has been modified per the 510(k) clearances noted above. NOTE 2: Originally cleared as IUR Fluid Management System / Hysteroscopy Pump HM6 by W.O.M. World of Medicine AG under K123732.

Predicate has not been a subject of a design related recall.

IV. Device Description

The Aveta System is an integrated system which allows for visualization of the cervical canal and the uterine cavity for the purpose of performing diagnostic and operative hysteroscopic procedures.

4

The Aveta System consists of the components listed in Table 1. The system includes a Controller with integrated fluid management which incorporates a dual peristaltic pump design to control the continuous inflow and outflow of saline to provide fluid distention of the uterine cavity. The Controller provides continuous monitoring of the intrauterine pressure to the set pressure, as well as monitoring of the volume differential between saline inflow from the uterus. The Controller connects to a sterile, single use Disposable Hysteroscope via a Reusable Hysteroscope Handset that allows visualization of the cervical canal and the uterine cavity and displays the images obtained from the hysteroscope on a standard monitor. For operative procedures, the Aveta System includes a sterile, mechanical Disposable Resecting Device powered by a motorized, Reusable Resecting Handset which is inserted through the sterile hysteroscope working channel to resect and remove endometrial polyps, submucous myomas and retained products of conception under suction.

Aveta System Component	Functions Performed
Aveta Controller with Integrated
Fluid Management	• Hysteroscopic image / video processing / storing recorded images
• Fluid Management with irrigation and aspiration functions
• 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 Disposable Hysteroscope
(with tubing and fluid management
cassette)	• Visualization of uterine cavity
• 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
• Provides conduit for Disposable Resecting Device for operative
hysteroscopy
• Provides user interface for intrauterine set pressure and fluid deficit
limit adjustments, and recording of images
Aveta Reusable Hysteroscope
Handset
Aveta Disposable Resecting Device
Aveta Reusable Resecting Handset	• Mechanically resects and removes tissue under suction
• Includes motor to provide oscillation of resection tip
Additional Aveta System
Components / Accessories
• Monitor
• Waste Management Kit
• Scale
• Roll Stand	• Displays image, procedural parameters and notifications
• Collects tissue for pathology and stores the outflow fluid waste
• Measures waste fluid / leaked fluid lost from cervix / hysteroscope
• Mounts Controller and Monitor

Table 1. Aveta System Components

5

V. Indications for Use

Comparison of Indications for Use
Device	Indications For Use
Aveta System
(Subject Device)	The Aveta Diagnostic and Therapeutic Hysteroscopy System is 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.
Predicate System Component:
Truclear™ Morcellator System
and Truclear™ Morcellators
(K152143)	For intrauterine use by trained gynecologists to hysteroscopically resect and
remove tissue such as submucous myomas, endometrial polyps and retained
products of conception.
Predicate System Component:
Hysteroscopic Fluid
Management System
(K123732)	To provide liquid distension of the uterus for diagnostic and operative
hysteroscopy, and to monitor the volume differential between the irrigation
fluid flowing into and out of the uterus.
Predicate System Component:
Truclear™ Operative
Hysteroscope 5C and Sheath 5C
(K132015)	To permit viewing of the cervical canal and uterine cavity for the purpose
of performing diagnostic and surgical procedures.

Comparison of Indications for Use

Although the subject device does not have identical indications compared to the individual predicate devices, the subject device has the same general intended use as each of the respective predicate components: 1) to permit viewing of the cervical canal and the uterine cavity during diagnostic and operative procedures, 2) to provide liquid distension of the uterus and monitor fluid volume differential, and 3) to resect and remove tissue such as submucous myomas, endometrial polyps, and retained products of conception. When comparing each component function of the subject device to the indications of the respective predicate components, the subject and predicate devices have the same intended use.

6

VI. Comparison of Technological Characteristics with the Predicate Device

Aveta System and the predicate system have similar technological characteristics in terms of basic operating principle and basic design features with minor differences.

Technological Comparison of Aveta System with Predicate System

| | Subject Device | Predicate Devices (System)
[Original K031787] | | | Reference Device | |
|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 510k# | TBD | K132015 | K123732 | K152143 | K123151 | |
| Manufacturer: | Meditrina Inc. | Smith and Nephew, Inc. | | | Endosee
Corporation
(Cooper Surgical) | |
| Device Names | Aveta System | Truclear™
Morcellator
System and
Truclear™
Morcellators | Hysteroscopic
Fluid
Management
System | Truclear™
Operative
Hysteroscope 5C
and Sheath 5C | Endosee®
U-Scope Model 8000 | |
| CONTROLLER FUNCTIONS | | | | | | |
| Hysteroscope Functions | | | | | | |
| Visualization
and Image
Processing | CMOS sensor and light
source in Hysteroscope
and image processed by
the Controller
microprocessor | N/A | N/A | Regular Optics
with CCD sensor
and light source
and camera;
images process by
Controller | CMOS sensor, and
light source in
Hysteroscope and
image processed by
internal
microprocessor in
reusable handset | |
| Viewing
Functions | Controller connects to
a separate Monitor for
diagnostic and
operative information;
Screen displays IU
pressure, fluid deficit
with graphical user
interface. | N/A | Pressure and
Fluid Deficit
data is
displayed on
the unit.
Image is
displayed on
the Monitor. | N/A | Monitor integrated in
the Reusable
Handset Camera | |
| Fluid Management Functions | | | | | | |
| Fluid
Distention | Continuous flow of
saline/fluid | N/A | Same | N/A | Saline inflow | |
| Irrigation for
Distention | Peristaltic pump with
dual pressure sensors
for irrigation of fluids | N/A | Same | N/A | N/A | |
| Aspiration | Peristaltic pump for
aspiration of fluids and
for resected tissue and
fluids | N/A | Facility
vacuum pump
provides
suction for
aspiration of
resected tissue
and fluids | N/A | N/A | |
| Intrauterine
Pressure
Measurements | Obtains two
independent
intrauterine pressure
measurements by
sensing pressure of the
irrigation tube | N/A | Same | N/A | N/A | |
| Set Pressure
Range | 30-120 mmHg | N/A | 15-120 mmHg | N/A | N/A | |
| Set Pressure
User
Adjustments | Allows user to
increase/decrease the
set pressure | N/A | Same | N/A | N/A | |
| | Subject Device | Predicate Devices (System)
[Original K031787 | | | Reference Device | |
| 510k# | TBD | K132015 | K123732 | K152143 | K123151 | |
| Manufacturer: | Meditrina Inc. | Smith and Nephew, Inc. | | | Endosee
Corporation
(Cooper Surgical) | |
| Device Names | Aveta System | Truclear™
Morcellator
System and
Truclear™
Morcellators | Hysteroscopic
Fluid
Management
System | Truclear™
Operative
Hysteroscope 5C
and Sheath 5C | Endosee®
U-Scope Model 8000 | |
| Pressure Relief
for
overpressure
risk mitigation | Reverse rotation of
irrigation peristaltic
pump at 150 mmHg | N/A | Same | N/A | N/A | |
| Over Pressure
Controls | Above 100 mmHg
requires positive action
by the user with two
presses to confirm
setting is intentional up
to 120 mmHg max.
Display Notification
appears. | N/A | Same | N/A | N/A | |
| User Pressure
Adjustments to
Set Pressure | 5 mmHg at a time up to
120 mmHg max. | N/A | Same | N/A | N/A | |
| Fluid Deficit
Measurement
(Weight based
measurement
which includes
aspirated fluid
and fluid
leaking from
cervix) | Obtains difference
between three
independent weight
measurement sensors to
determine the Fluid
Deficit: 1) Irrigation
minus 2) Aspiration
and 3) fluid lost from
cervix as measured by
scale | N/A | Obtains
difference
between two
independent
weight
measuring
sensors to
determine
Fluid Deficit | N/A | N/A | |
| Flow Rate | 180-500 mL/min preset
fixed flow rates | N/A | 30-
700mL/min
user adjustable | N/A | N/A | |
| Mechanical Resection Functions | | | | | | |
| Mechanical
Resecting
Device | Connects to the
Disposable or Reusable
Resecting Handset by
an electrical connection
to provide a dc motor
control with a preset
programmed motor
oscillation speed. | Same | N/A | N/A | N/A | |
| HYSTEROSCOPE SYSTEM | | | | | | |
| Disposable Hysteroscope | | | | | | |
| Irrigation and
Aspiration
Lumens | Independent sterile
saline irrigation and
aspiration lumens | N/A | N/A | Same | Independent sterile
irrigation lumen. No
aspiration lumen | |
| Insertion OD | 5.5 mm | N/A | N/A | 5.7 mm | Oval - 3.8mm x 4.6
mm | |
| Working
Length | 224 mm | N/A | N/A | 205 mm | 287 mm | |
| | Subject Device | Predicate Devices (System)
[Original K031787] | | | Reference Device | |
| 510k# | TBD | K132015 | K123732 | K152143 | K123151 | |
| Manufacturer: | Meditrina Inc. | Smith and Nephew, Inc. | | | Endosee
Corporation
(Cooper Surgical) | |
| Device Names | Aveta System | Truclear™
Morcellator
System and
Truclear™
Morcellators | Hysteroscopic
Fluid
Management
System | Truclear™
Operative
Hysteroscope 5C
and Sheath 5C | Endosee®
U-Scope Model 8000 | |
| Illumination | LEDs
(Light Emitting Diode) | N/A | N/A | Fiber optic | LED
(Light Emitting
Diode) | |
| Working
Channel | 3.5 mm working
channel | N/A | N/A | 3 mm working
channel | No working channel | |
| Camera | Digital CMOS Camera | N/A | N/A | Fiberoptic image
guide coupled to
External CCD
(not part of the
system) | Same | |
| Proximal
Connection (to
Camera and
Light
Controls) | Entire device including
the cable and handset is
sterile in one package | N/A | N/A | Mechanical
connection to the
reusable remote
camera head and
light cable | Electromechanical
connection at the
proximal end to
Reusable Handle | |
| Reusable Hysteroscope Handset | | | | | | |
| Image
Processing | Processes images
generated by the
Disposable
Hysteroscope CMOS
sensor | N/A | N/A | No images
processing
capabilities.
Images are
processed by the
external CCD
video camera
attached to
Endoscope eye
piece (not part of
the system) | Same | |
| User Controls | · Set Pressure Controls
• Fluid Deficit Limit
Controls
· Image capture
capability
· Mode Selection with
preprogrammed
flowrates for each
Mode | N/A | · Set Pressure
Controls
• Fluid
Deficit
Limit
Controls
· Flow Rate
Adjustment | · Light, Image
adjustments
and Image
Capture using
compatible
device | · Image capture
button.
· Increase
illumination
power button.
· ON/OFF button.
· Touch screen for
patient ID, time
set entry | |
| RESECTING SYSTEM | | | | | | |
| Disposable Resecting Device | | | | | | |
| Cutting
Window | 8 mm | 7 mm | N/A | N/A | N/A | |
| Blade Material | Stainless steel | Same | N/A | N/A | N/A | |
| Working
Length | 328 mm | 357 mm | N/A | N/A | N/A | |
| Insertion OD | 3.4 mm | 2.9 mm | N/A | N/A | N/A | |
| | Subject Device | Predicate Devices (System)
[Original K031787] | | | Reference Device | |
| 510k# | TBD | K132015 | K123732 | K152143 | K123151 | |
| Manufacturer: | Meditrina Inc. | Smith and Nephew, Inc. | | | Endosee
Corporation
(Cooper Surgical) | |
| Device Names | Aveta System | Truclear™
Morcellator
System and
Truclear™
Morcellators | Hysteroscopic
Fluid
Management
System | Truclear™
Operative
Hysteroscope 5C
and Sheath 5C | Endosee®
U-Scope Model 8000 | |
| Device
Rotation for
Resection | Rotatable distal portion
of the hub allows the
user to orient the
resection window
towards the target
tissue | Not rotatable.
User must turn
Resecting Handset
to orient window
direction for
resection | N/A | N/A | N/A | |
| Aspiration
During
Resection | Aspiration is provided
via peristaltic suction
pump | Aspiration
provided by
facility vacuum
pump | N/A | N/A | N/A | |
| Tissue
Collection | Tissue catch provided
for resected tissue
chips | Same | N/A | N/A | N/A | |
| Disposable (Sterile) and Reusable (Steam Sterilizable) Resecting Handset | | | | | | |
| Resection
Mechanism | Mechanical | Mechanical | N/A | N/A | N/A | |
| User Controls | Handset Controls | Foot Switch
Controls | N/A | N/A | N/A | |
| Mechanical
Connection | Locks Disposable
Resecting Device | Locks Disposable
Resecting Device | N/A | N/A | N/A | |
| Rotational
Speed | 1500 RPM
(pre-set - not user
adjustable) | 100 - 2500 RPM
(user adjustable) | N/A | N/A | N/A | |
| WASTE MANAGEMENT KIT | | | | | | |
| How Provided | Non-sterile, Single-Use | N/A | Facility
provided (Not
part of the
system). Non-
sterile, Single-
Use | N/A | N/A | |

7

Traditional 510(k) Premarket Notification

8

K190372
Aveta Systeme 6 of 8

Meditrina, Inc.

Traditional 510(k) Premarket Notification

9

Meditrina, Inc.

Traditional 510(k) Premarket Notification

The differences outlined were evaluated through performance testing to demonstrate safety and effectiveness of the Aveta System. The differences in technological characteristics do not raise different questions of safety and effectiveness

10

VII. Performance Data

The following performance data have been provided in support of the substantial equivalence determination.

Software Verification and Validation Testing performed per IEC 62304:2006 and . documentation provided per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Other Tests were performed pre pre-specified test protocols which included:
- Integrity: System withstands operating pressures o
- Functional Testing: Cut and coagulation, aspiration, irrigation, pressure control o
- Dimensional Inspection and Testing O
- Functional Testing for all components of the system o
- Maximum LED Tip Temperature O
- Fluid Deficit Limit Verification testing O
- Simulated Use: Tissue resection, regulation of cavity pressure, imaging O
- Comparative testing to predicate for pressure control, fluid deficit, fluid control and O durability.
- Biocompatibility Testing per ISO 10993-1:2009/(R)2013. O
- Sterilization Validation per ISO 11135:2014 and ISO 11137-1/-2/-3:2013. O
- Packaging Validation per ASTM D4169:2016. O
- Accelerated Aging per ASTM F1980:2016. O
- Electrical Safety & EMC: In accordance with IEC 60601-1:2005, IEC 60601-1-O 2:2014 and IEC 60601-2-18:2009.
- Usability Testing per FDA guidance and IEC 62366:2015 O

VIII. Conclusions

The Aveta System is substantially equivalent to the Smith and Nephew Truclear System based on the similarities in intended use / indications for use, as well as technological characteristics and principles of operation.

The performance testing provided in the subject premarket notification demonstrate that the Aveta System is as safe and effective as the predicate device for its proposed indications for use.