(200 days)
Not Found
No
The description focuses on mechanical and software control for instrument positioning and gravity compensation, without mentioning learning, adaptation, or data-driven decision-making characteristic of AI/ML.
No
The device aids the surgeon in holding and positioning instruments, which is a supportive rather than a direct therapeutic function. It does not treat or diagnose a disease.
No
The device is described as assisting surgeons in manipulating and maintaining instrument position during laparoscopic surgical procedures, compensating for gravitational force. It does not perform any diagnostic function such as detecting, diagnosing, or characterizing a disease or condition.
No
The device description explicitly states that the Moon Maestro System utilizes both software and hardware, and the performance studies include validation of hardware components like motors, brakes, and electrical systems.
Based on the provided information, the Maestro System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Maestro System is "intended to hold and position laparoscopic instruments during laparoscopic surgical procedures." This describes a device used during a surgical procedure to manipulate tools, not a device used to examine specimens in vitro (outside of the body) to diagnose a condition.
- Device Description: The description focuses on the mechanical and software aspects of supporting and positioning surgical instruments. It doesn't mention any analysis of biological samples or patient data for diagnostic purposes.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers
The Maestro System is a surgical assist device designed to aid the surgeon in manipulating instruments during a procedure.
N/A
Intended Use / Indications for Use
The Maestro System is intended to hold and position laparoscopes and laparoscopic instruments during laparoscopic surgical procedures.
Product codes
FQO
Device Description
The Moon Maestro System 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Design validation testing included the following:
- Positional reach and trocar accommodation
- Payload capacity
- System cart stability
- Single fault condition
- Force measurement accuracy
- Brake hold
- Electrical insulation
- LED status
- Drape integrity
- Emergency stop
- Software validation
- Electrical safety
- EMC
- Sterilization validation
- Gravity compensation accuracy
- Coupler performance
- Cadaver testing
- Human factors testing
All testing had passed in accordance with the pre-specified success criteria, international standards or FDA guidances.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4960 Operating tables and accessories and operating chairs and accessories.
(a)
Identification. Operating tables and accessories and operating chairs and accessories are AC-powered or air-powered devices, usually with movable components, intended for use during diagnostic examinations or surgical procedures to support and position a patient.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
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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 seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
December 2, 2022
Moon Surgical % Michael Daniel President Daniel & Daniel Consulting 340 Jones Lane Gardnerville, Nevada 89460
Re: K221410
Trade/Device Name: Maestro Platform Regulation Number: 21 CFR 878.4960 Regulation Name: Operating Tables And Accessories And Operating Chairs And Accessories Regulatory Class: Class I Product Code: FQO Dated: November 2, 2022 Received: November 3, 2022
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 (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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Carr -S
for Long Chen, PhD 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
2
Indications for Use
510(k) Number (if known) K221410
Device Name Maestro System
Indications for Use (Describe)
The Maestro System is intended to hold and position laparoscopic instruments during laparoscopic surgical procedures.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary (K221410)
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number: K221410
Applicant Information:
| Date Prepared: | November 28th, 2022 |
|---|---|
| Name: | Moon Surgical |
| Address: | 7/11 Blvd Haussmann |
| 75009 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): | Table, Operating-Room, AC-Powered |
| Product Code/ Regulation: | FQO 21 CFR 878.4960 |
| Classification: | Class I |
Predicate Device:
ENDEX Endoscopic Positioning System (K936308)
Subject Device Description
The Moon Maestro System 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.
Subject Device Intended Use / Indications for Use
The Maestro System is intended to hold and position laparoscopes and laparoscopic instruments during laparoscopic surgical procedures.
Predicate Device and Subject Device Comparison
The table below compares the Maestro System to the predicate device.
4
| ASPECT | ANDRONIC DEVICES LTD.
(Predicate) | MOON SURGICAL (Subject
Device) | COMPARISON |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | ENDEX | Maestro | N/A |
| 510(k) Number | K936308 | K221410 | N/A |
| Product Code /
Regulation | FQO / 878.4960
Table Operating-room, AC-
Powered | FQO / 878.4960
Table Operating-room, AC-
Powered. | Previous "Operating
table" related codes are
now all Class I 510(k)
exempt. |
| Brief Description | The ENDEXEndoscopic
Positioning System is an
electrically actuated, air or
nitrogen-powered devicewith
movablecomponents intended
forlaparoscopicsurgical
procedures tosupport and
position laparoscopic
instruments. Its major
components consist of the
Endoscopic Positioner
(consisting of the Positioning
Arm and Table Module),
Control Unit,Scope Driver
(formerly called the
Instrument Positioning
Effector), Grasper Holder
(formerly called the
Instrument Holding Effector),
Arm Release Button, Scope
Driver ControlFootswitch,
ScopeDriverControl Hand
switch, and High-Pressure
Hose. | The Moon Surgical Maestro device
is an electrically actuated device
with movable components intended
for laparoscopic surgical procedures
to support and position laparoscopic
instruments.
Its major components consist of the
Surgical Base, Surgical Arms,
Control Unit, Instrument Coupling,
and Control Station | Predicate is electrically
actuated pneumatic and
software driven
mechanical system.
The subject device is
strictly electrically
actuated and utilizes
software to maintain
instrument position by
compensating for
gravity. |
| Intended Use /
Indications for Use | Intended to hold and position
laparoscopes and laparoscopic
instruments in laparoscopic
cholecystectomies and
advanced laparoscopic
surgical procedures. | The Maestro System is intended to
hold and position laparoscopes and
laparoscopic instruments during
laparoscopic surgical procedures. | Substantially
Equivalent (SE) |
| Mechanism of Action
(System Actuation /
Positioning) | The ENDEX Endoscopic
Positioner "remains locked
when the gas source is applied
and has a positioner unlock
control button that permits the
surgeon to easily unlock and
reposition the device without
compromising the sterility of
the surgical field." | The Moon Maestro System utilizes
DC motors to compensate for
gravitational forces applied to
laparoscopic instruments. Software
and hardware are designed to
maintain instrument position.
Surgeon control is achieved by
grasping the handle of conventional
laparoscopic tools and moving the | The predicate has two
(2) operating modes.
One locks the
instrument arm/holder
in the location desired
by surgeon and the
second mode allows
motor driven endoscope |
| Table 1 - Comparison between subject and predicate device | |||
|---|---|---|---|
| ----------------------------------------------------------- | -- | -- | -- |
5
| ASPECT | ANDRONIC DEVICES LTD.
(Predicate) | MOON SURGICAL (Subject
Device) | COMPARISON |
|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The ENDEX Scope Driver is
an electrically powered device
for translating the position of
laparoscopic surgical
instruments. Both instruments
and endoscope positions can
be adjusted
electromechanically via motor
driven polymer "rollers"
making contact with the
endoscope or instrument
shafts. | tool to the desired position. Once
surgeon hand force is removed, the
Maestro system reverts to
maintenance of the specified
location including orientation.
Unlike the predicate, there is no
motorized movement of
instruments. Only maintenance of
position. | or instrument
positioning. |
| Platform / Mechanism
of stable attachment of
arms | Aluminum jointed arms are
clamped to operating table rail
or base via mechanical screw
clamps. | Jointed arms are attached to stages
located on a portable base that can
be locked in position. The bases are
locked in position during system
use. | SE |
| Method of instrument
attachment | Mechanical clamp | Mechanical clamp around
laparoscopic instrument and
magnetic attachment to arm | SE |
| Mechanisms involved
in physical positioning | Jointed arms locked in place
via nitrogen or air. The
pneumatic lock and unlock
states are controlled via
electrical switches in either
hand or foot switch locations.
Endoscope and Instruments
are held in place against
gravity force by metallic
jointed arms.
The ENDEX Scope Driver is
an electrically powered device
for translating the position of
laparoscopic surgical
instruments. Both instruments
and endoscope positions can
be adjusted
electromechanically via motor
driven polymer "rollers"
making contact with the
endoscope or instrument
shafts. Forward and backward
motion is controlled by
footswitch. | Electro-mechanical jointed arms
driven by internal motors that
follow the physician movements.
Unlike the predicate, there is no
motorized movement of
instruments. Only maintenance of
position. | SE - subject device is
more sophisticated in
design. However,
fundamental function
remains substantially
equivalent in terms of
intended use and
functions related to
positioning and holding
an endoscope and
instruments |
| Method of control | On/off switch for application
of pneumatic locking
mechanism. Joystick or foot
switch control of laparoscope | Direct manipulation of conventional
laparoscopic instrument handles.
Endoscope and Instrument positions
are unlocked via surgeon applied | SE - subject device is
more sophisticated in
design. However,
fundamental function |
| ASPECT | ANDRONIC DEVICES LTD.
(Predicate) | MOON SURGICAL (Subject
Device) | COMPARISON |
| | or laparoscopic instrument
movement.
Fundamental control is
achieved through electrical
switch unlock or release of
pneumatic pressure followed
by surgeon movement of
endoscope or instruments into
desired location followed by
electrical switch re-actuation
of pneumatic lock. | force to laparoscope or instrument
handles. This unlocking force is on
the order of magnitude of what
would be expected in holding or
repositioning the endoscope or
instruments themselves. The
endoscope or instruments are
repositioned as desired by the
surgeon. Once the surgeon releases
the instruments or scope the system
maintains the new position with
motor driven forces sufficient to
compensate for gravity. | remains substantially
equivalent in terms of
intended use and
functions related to
positioning and holding
an endoscope and
instruments. |
| Alarm and Warning
Condition Indicators | The Endex system has two
user indicators: the low-
pressure light and the scope
movement tone. The low-
pressure light illuminates
when supply gas pressure falls
below 100 psi. Recommended
supply pressure necessary for
optimal arm strength is 200
psi.
The scope or instrument
movement tone is activated
whenever the driver is moving
the scope or instrument. This
movement is controlled via
the footswitch. The volume is
adjustable and may be turned
off. | The Maestro has two primary LEDs
for communication to the surgeon.
These LEDs change colors and
pulse to communicate system status.
In the case of a critical system fault,
the LEDs will change to red.
The Maestro is also equipped with a
touch screen graphical interface.
This screen provides messages to
the operating room staff regarding
system state. | SE – subject device is
more sophisticated in
design. However,
fundamental function
remains substantially
equivalent in terms of
intended use and
functions related to
positioning and holding
an endoscope and
instruments. |
| Single Fault Tolerance | Visual supervision by surgeon | 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, current and
torque limits | SE |
| | | - Brakes engage if power is
removed | |
| Back-up fault response | None | Brakes engage on motorized axis in
the event of a fault state to prohibit
any arm motion | SE |
| ASPECT | ANDRONIC DEVICES LTD.
(Predicate) | MOON SURGICAL (Subject
Device) | COMPARISON |
| Maximum Applied
Load | 5 lbs "maximum force
generated by Scope Driver" | 4.4 lbs tested. | No exertion of force by
subject device |
| Sterilization Method | Steam | Steam (for coupling devices used to
attach laparoscopic instruments) | SE |
| Sterility barrier | Drape | Drape | SE |
6
7
Performance Testing
Design validation testing included the following:
- Positional reach and trocar accommodation ●
- Payload capacity
- System cart stability
- Single fault condition
- Force measurement accuracy ●
- Brake hold ●
- Electrical insulation
- LED status
- Drape integrity
- Emergency stop ●
- Software validation
- Electrical safety
- EMC
- Sterilization validation
- Gravity compensation accuracy
- Coupler performance ●
- . Cadaver testing
- Human factors testing ●
All testing had passed in accordance with the pre-specified success criteria, international standards or FDA guidances.
Conclusion
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 device.