(220 days)
Yes
The summary explicitly mentions "The ML model was trained and tuned" and "ScoPilot Vision Performance" which implies the use of machine learning for image processing to enable the "seamlessly follow a desired instrument tip" feature.
Yes
The device is a surgical support system intended to hold, position, and manipulate laparoscopic instruments during surgical procedures, which directly aids in medical diagnosis, treatment, or prevention of disease.
No
The device is described as a system to hold and position laparoscopes and laparoscopic instruments during surgical procedures, assisting surgeons in manipulating and maintaining instrument position. It helps maintain a specified tool position and instrument tip location, and the ScoPilot feature allows the laparoscope to follow a desired instrument tip. The intended use and device description do not mention diagnosis of disease or conditions.
No
The device description explicitly states it is a "2-arm system which utilizes software and hardware" and mentions hardware components like motors and arms. The performance studies also include hardware-related testing such as "Payload Capacity," "Force Accuracy," and "System Endurance."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "hold and position laparoscopes and laparoscopic instruments during laparoscopic surgical procedures." This describes a surgical assist device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the mechanical and software aspects of manipulating surgical instruments and a laparoscope during surgery. It does not mention analyzing biological samples or providing diagnostic information.
- Input Imaging Modality: While it uses video from a laparoscope, this video is used for navigation and positioning during surgery, not for analyzing biological characteristics of a sample.
- Anatomical Site: The lack of an anatomical site is consistent with a surgical instrument positioning system, as it can be used in various laparoscopic procedures. IVDs typically specify the type of sample or anatomical site from which the sample is derived.
- Intended User / Care Setting: The intended user is "Surgeons during laparoscopic surgical procedures," which aligns with a surgical device. IVDs are often used in laboratories or by healthcare professionals for diagnostic purposes.
In summary, the Maestro System is a surgical assist device designed to aid surgeons in manipulating instruments and a laparoscope during laparoscopic procedures. Its function is mechanical and navigational, not diagnostic based on the analysis of biological samples.
No
The provided input does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
The Maestro System is intended to hold and position laparoscopes and laparoscopic instruments during laparoscopic surgical procedures.
Product codes
QZB
Device Description
The Moon Maestro System is a 2-arm system which utilizes software and hardware to provide support to surgeons for manipulating and maintaining instrument position. Motors compensate for gravitational force applied to laparoscopic instruments, while surgeon control is not affected. Conventional laparoscopic tools are exclusively controlled and maneuvered by the surgeon, who grasps the handle of the surgical laparoscopic instrument and moves it freely until the instrument is brought to the desired position. Once surgeon hand force is removed, the Maestro system reverts to maintenance of the specified tool position and instrument tip location. This 510(k) is being submitted to implement the ScoPilot feature. ScoPilot is an on-demand, optional, ease-of-use feature of the Maestro System, allowing the laparoscope which is attached to a Maestro Arm to seamlessly follow a desired instrument tip. The surgeon remains in control of laparoscope positioning, without having to disengage from the instrument in their hand, helping maintain surgical flow and focus.
Mentions image processing
Image processing algorithms that enable the detection of all surgical tools within the displayed video image and when commanded by the surgeon, follow the movement of the chosen tool.
The Image Processing Algorithm continuously detects the coordinates of the surgical tools within the video image. Additionally, it calculates the transformation matrix, which correlates to the laparoscope's movement from image to image
Mentions AI, DNN, or ML
Machine Learning methodology used to develop software algorithm responsible for identifying tool tip. Once developed, this software algorithm is fixed and static and added to the rest of the system software.
The ML model was trained and tuned through a K-fold cross-tuning process to optimize hyperparameters, until it reached our predefined performance requirements.
Input Imaging Modality
Video image from the laparoscope camera unit.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons performing laparoscopic surgical procedures.
Description of the training set, sample size, data source, and annotation protocol
The ML model was trained and tuned through a K-fold cross-tuning process to optimize hyperparameters.
Description of the test set, sample size, data source, and annotation protocol
An independent testing dataset containing videos was used to verify that the model performance (lower bound of the 95%CI for AP and AR) is compliant with our specification when using data including brands unseen during training/tuning.
Summary of Performance Studies
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions" and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions". Software testing included testing the software modifications made to implement the new ScoPilot features. This includes detection and tracking of specified instrument tips, generation of motion trajectories, safety limits and detection of malformed inputs at a video and frame level.
Design verification testing included Payload Capacity, Malformed Input, Force Accuracy, Drape Integrity, Emergency Stop, Hold Position Accuracy, IFU Inspection, Positioning Guidance & Collision Detection, ScoPilot Motion Performance, System Positioning Accuracy, Bedside Joint Control Accuracy, End to End Workflow, Design Inspection, System Setup, System Latency, Electro-Cautery Compatibility, ScoPilot Latency, ScoPilot End to End, ScoPilot IFU Inspection, System Endurance, ScoPilot Vision Performance, ScoPilot Malformed Input, Cybersecurity, Coupler Performance, Electrical safety and electromagnetic compatibility (EMC).
Design validation testing included Human factors testing and Cadaver testing.
Key Metrics
AP (Average Precision) and AR (Average Recall) were used to evaluate model performance after ML model training and tuning.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services - USA seal. To the right of the seal is the FDA logo in blue. The logo includes the words "U.S. FOOD & DRUG ADMINISTRATION".
March 14, 2025
Moon Surgical % Michael Daniel Consultant Daniel & Daniel Consulting P.O. Box 129 Minden, Nevada 89423
Re: K242323
Trade/Device Name: Maestro System (REF100) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: QZB Dated: January 14, 2025 Received: January 15, 2025
Dear Michael Daniel:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
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assistance/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,
Digitally signed by Mark Mark Trumbore -S Date: 2025.03.14 15:18:19 Trumbore -S -04'00' Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Maestro System (REF100)
Indications for Use (Describe)
The Maestro System is intended to hold and position laparoscopes and laparoscopic instruments during laparoscopic surgical 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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Image /page/4/Picture/0 description: The image shows the logo for Moon Surgical. The logo features a stylized depiction of a moon, with the upper portion shaded to represent craters or lunar features. Below the moon graphic, the word "MOON" is written in a simple, sans-serif font, with the word "SURGICAL" appearing beneath it in a smaller font size.
510(k) Number: K242323
Applicant Information:
| Date Prepared: | March 10, 2025 |
|---|---|
| Name: | Moon Surgical |
| Address: | 9 rue d'Enghien |
| 75010 Paris France | |
| Contact Person: | Michael A Daniel, Consultant |
| madaniel@clinregconsult.com | |
| Mobile Number: | (415) 407-0223 |
| Device Information: | |
| Device Trade Name: | Maestro System |
| Common Name: | Maestro System |
- Classification Name(s): Endoscope And Accessories
- Product Code/ Regulation: QZB 21 CFR 876.1500
- Classification: Class II
Predicate Device:
Maestro System, Moon Surgical SAS (K240598)
- Autolap System, Medical Surgery Technologies, Ltd. (K152848)
Subject Device Description
The Moon Maestro System is a 2-arm system which utilizes software and hardware to provide support to surgeons for manipulating and maintaining instrument position. Motors compensate for gravitational force applied to laparoscopic instruments, while surgeon control is not affected. Conventional laparoscopic tools are exclusively controlled and maneuvered by the surgeon, who grasps the handle of the surgical laparoscopic instrument and moves it freely until the instrument
5
is brought to the desired position. Once surgeon hand force is removed, the Maestro system reverts to maintenance of the specified tool position and instrument tip location. This 510(k) is being submitted to implement the ScoPilot feature. ScoPilot is an on-demand, optional, ease-of-use feature of the Maestro System, allowing the laparoscope which is attached to a Maestro Arm to seamlessly follow a desired instrument tip. The surgeon remains in control of laparoscope positioning, without having to disengage from the instrument in their hand, helping maintain surgical flow and focus.
Subject Device Intended Use / Indications for Use
The Maestro System is intended to hold and position laparoscopes and laparoscopic instruments during laparoscopic surgical procedures.
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Image /page/6/Picture/0 description: The image shows the logo for Moon Surgical. The logo consists of a stylized image of a moon with some craters on the surface. Below the moon image, the word "MOON" is written in a simple sans-serif font, and below that, the word "SURGICAL" is written in a smaller font.
510(k) summary
Predicate Device and Subject Device Comparison
The table below compares the Maestro System to the predicate devices.
| ASPECT | MOON SURGICAL (Subject
Device) | MOON SURGICAL (Primary
predicate Device) | MST - MEDICAL SURGERY
TECHNOLOGIES LTD
(Secondary predicate device) | COMPARISON |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Device Name | Maestro System | Maestro System | Autolap System | N/A |
| 510(k) Number | Not yet assigned | K221410 | K152848 | N/A |
| Product Code / | QZB / 876.1500 Endoscope | FQO / 878.4960 | GCJ / 876.1500 | Identical to 2nd |
| Regulation | And Accessories | Table Operating-room, Ac-
Powered. | Endoscope And Accessories | predicate |
| Brief
Description | The Moon Surgical Maestro
device is an electrically actuated
device with movable
components intended for
laparoscopic surgical procedures
to support and position
laparoscopic instruments. | Same | The Autolap system is a compact
image guided laparoscope
manipulator that is designed to
hold and position the
laparoscope during laparoscopic
surgery. Its role is to hold and
move the laparoscope under the
direct control of surgeon. | Substantially
equivalent |
| Intended Use /
Indications for
Use | The Maestro System is intended
to hold and position laparoscopic
Instruments during laparoscopic
surgical procedures. | Same | [The Autolap is used] for the
purpose of holding and
controlling the movement of a
standard laparoscope or rigid
endoscope for General
laparoscopic, Gynecologic and
Urologic procedures | Substantially
equivalent |
| Technological characteristics | | | | |
| System basic
components | Two motorized Arms that
hold and position the
laparoscope and/or
laparoscopic instruments | Same | A motorized Arm that holds
and positions the laparoscope
(the Autolap ARM)
A control unit that controls the | Substantially
equivalent |
| ASPECT | MOON SURGICAL (Subject
Device) | MOON SURGICAL (Primary
predicate Device) | MST - MEDICAL SURGERY
TECHNOLOGIES LTD
(Secondary predicate device) | COMPARISON |
| | Two stages, supporting and
positioning the arms
A Control Unit that controls
the movements of the arms
Instrument Coupling
A User interface for system
setup and feature selection | | movements of the ARM
A positioning unit connecting
the Arm to the operation bed
rail on either side
A hand-controlled Command
Unit that enables the surgeon
to move the laparoscope to
his/her chosen target location
Instrument coupling | |
| Method of
instrument
attachment | Mechanical clamp around
laparoscopic instrument and
mechanical attachment to arm | Same | Same | Identical |
| Mechanisms
involved in
physical
positioning | Electro-mechanical jointed
arms driven by internal
motors that follow the
physician movements. | Same | Same | Identical |
| Method of
control | Movement of the laparoscope is
enabled only upon applied force
to the instrument handle.
Endoscope can optionally be
controlled by selected handheld
instruments with Endoscope
following instrument tip. | Movement of the laparoscope is
enabled only upon applied force
to the instrument handle. | Movement of the laparoscope is
enabled only upon pressing the
button on the joystick command
or the Manual Activation Button
or be guided by the movement of
a designated tool within the field
of view. | Substantially
equivalent |
| Endoscope
Movement | Manual Control
Control algorithm applying
motor current for instrument
motion triggered by physician
direct movement
Instrument Based Control | Manual Control
Control algorithm applying
motor current for instrument
motion triggered by physician
direct movement | Manual Control
Control algorithm applying
motor current for instrument at
motion triggered by physician
direct movement | Substantially
equivalent |
| ASPECT | MOON SURGICAL (Subject
Device) | MOON SURGICAL (Primary
predicate Device) | MST - MEDICAL SURGERY
TECHNOLOGIES LTD
(Secondary predicate device) | COMPARISON |
| | Image processing algorithms that
enable the detection of all
surgical tools within the
displayed video image and when
commanded by the surgeon,
follow the movement of the
chosen tool. | | Instrument Based Control
image processing algorithms that
enable the detection of all
surgical tools within the
displayed video image and when
commanded by the surgeon,
follow the movement of the
chosen tool.
Joystick control
indirect instrument movement
communicated via RF signal. | |
| Video Image
Handling | The video image is transferred
from the laparoscope camera
unit, through the frame
grabber, to the Image
Processing Algorithm | N/A | The video image is transferred
from the laparoscope camera
unit, through the frame
grabber, to the Image
Processing Algorithm | Substantially
equivalent |
| Image
Processing
Algorithm | The Image Processing
Algorithm continuously
detects the coordinates of the
surgical tools within the video
image. Additionally, it
calculates the transformation
matrix, which correlates to the
laparoscope's movement from
image to image | N/A | The Image Processing
Algorithm continuously
detects the coordinates of the
surgical tools within the video
image. Additionally, it
calculates the transformation
matrix, which correlates to the
laparoscope's movement from
image to image | Substantially
equivalent |
| Instrument tip
identification | Machine Learning
methodology used to develop | N/A | Computer Vision
methodology used to develop | Substantially
equivalent |
| ASPECT | MOON SURGICAL (Subject
Device) | MOON SURGICAL (Primary
predicate Device) | MST - MEDICAL SURGERY
TECHNOLOGIES LTD
(Secondary predicate device) | COMPARISON |
| software
algorithm
development
method | software algorithm
responsible for identifying
tool tip. Once developed, this
software algorithm is fixed
and static and added to the
rest of the system software. | | software algorithm
responsible for identifying
tool tip. Once developed, this
software algorithm is fixed
and static and added to the rest
of the system software. | |
| Alarm and
Warning
Condition
Indicators | The arms and lighthouse of the
Maestro System are equipped
with eight LEDs that convey
information about the system's
status and conditions.
If necessary, alerts,
notifications, and fault
messages or graphics are
displayed on the Touchscreen
simultaneously to indicate the
system's current status. | Same | Alerts, notifications, and fault
messages are displayed on the
screen to indicate the system's
current status. | Substantially
equivalent |
| Single Fault
Tolerance | Automatic System
Performance Monitoring in
real-time with multiple fault
tiers + visual supervision by
surgeon via LED indicating
system status.
Examples include:
- Redundant encoders on
motorized axes - Velocity, acceleration, | Same | Searching redacted 510(k) for
"single fault" of "fault" does
not yield useful information.
Moon Surgical does not know
about their design in this
regard other than the
following:
"Motor current limitation -
applying relatively heavy
weight on the ARM will cause | Substantially
equivalent |
| ASPECT | MOON SURGICAL (Subject
Device) | MOON SURGICAL (Primary
predicate Device) | MST - MEDICAL SURGERY
TECHNOLOGIES LTD
(Secondary predicate device) | COMPARISON |
| | current and torque limits
Brakes engage if power is
removed | | the motors' currents to rise
above a pre-defined threshold.
As a response the system will
electronically shutdown the
motors and no motorized
movement will be enabled." | |
| Back-up fault
response | Brakes engage on motorized
axis in the event of a fault
state to prohibit any arm
motion | Same | No information | Substantially
equivalent |
| Maximum
Applied Load | 4.4 lbs tested. | Same | 600 grams | Substantially
equivalent |
| Compatible
with | 5mm and 10mm laparoscopes
and laparoscopic instruments
5mm and 10mm laparoscopes
for Scopilot | 5mm and 10mm laparoscopes
and laparoscopic instruments | 5mm and 10mm laparoscopes | Substantially
equivalent |
| Sterilization
Method | Ethylene Oxide (EtO) – for
coupling devices used to
attach laparoscopic
instruments | Same | Ethylene Oxide (EtO) | Substantially
equivalent |
| Sterility barrier | Drape | Drape | Drape | Identical |
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Image /page/11/Picture/0 description: The image shows the logo for Moon Surgical. The logo features a stylized image of a moon or globe at the top, with the word "MOON" in large, sans-serif font below it. Underneath "MOON" is the word "SURGICAL" in a smaller, sans-serif font.
510(k) summary
Testing Performed
Testing described in this 510(k) consisted of verification of the Scopilot input requirements and product specifications. All requirements were validated. Design verification testing included the following:
- Payload Capacity
- Malformed Input
- Force Accuracy
- · Drape Integrity
- · Emergency Stop
- Hold Position Accuracy
- · IFU Inspection
- Positioning Guidance & Collision Detection
- · ScoPilot Motion Performance
- System Positioning Accuracy
- Bedside Joint Control Accuracy
- End to End Workflow
- · Design Inspection
- · System Setup
- · System Latency
- Electro-Cautery Compatibility
- · ScoPilot Latency
- ScoPilot End to End
- ScoPilot IFU Inspection
- · System Endurance
- ScoPilot Vision Performance
- ScoPilot Malformed Input
- · Cybersecurity
- Coupler Performance
- · Electrical safety and electromagnetic compatibility (EMC)
Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket
12
Submissions for Device Software Functions" and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions". Software testing included testing the software modifications made to implement the new ScoPilot features. This includes detection and tracking of specified instrument tips, generation of motion trajectories, safety limits and detection of malformed inputs at a video and frame level.
ScoPilot Validation testing
The ML model was trained and tuned through a K-fold cross-tuning process to optimize hyperparameters, until it reached our predefined performance requirements. An independent testing dataset containing videos was used to verify that the model performance (lower bound of the 95%CI for AP and AR) is compliant with our specification when using data including brands unseen during training/tuning.
Design validation testing included the following:
- · Human factors testing
- · Cadaver testing
Summary
Based upon the Intended Use, Indications for Use, product technical information, performance evaluation, and standards compliance provided in this premarket notification, the Maestro System has been shown to be substantially equivalent to the cited predicate devices.