Who is the manufacturer of Maestro Platform?

Moon Surgical filed the 510(k) submission for Maestro Platform (K221410).

What is the FDA product code for Maestro Platform?

FQO. It is classified under 21 CFR 878.4960 as a Class 1 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Maestro Platform?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Maestro Platform?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Maestro Platform

Q: What are the predicate devices for Maestro Platform?

ENDEX Endoscopic Positioning System (K936308).

K221410 · Moon Surgical · FQO · Dec 2, 2022 · General, Plastic Surgery

Device Facts

Record ID	K221410
Device Name	Maestro Platform
Applicant	Moon Surgical
Product Code	FQO · General, Plastic Surgery
Decision Date	Dec 2, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4960
Device Class	Class 1

Intended Use

The Maestro System is intended to hold and position laparoscopes and laparoscopic instruments during laparoscopic surgical procedures.

Device Story

Maestro System is an electro-mechanical surgical support platform used in the operating room. It consists of a surgical base, jointed arms, control unit, instrument coupling, and control station. The device supports surgeons by manipulating and maintaining the position of laparoscopic instruments. Input is provided by the surgeon manually grasping and moving conventional laparoscopic tools. The system uses DC motors to compensate for gravitational forces acting on the instruments. When the surgeon releases the tool, the system maintains the specific position and orientation. It does not perform motorized movement of instruments. The system provides status feedback via LEDs and a graphical touch screen. In the event of a system fault, brakes engage on the motorized axes to prevent arm motion. The device benefits the patient by providing stable instrument positioning during surgery, reducing the physical burden on the surgical team.

Clinical Evidence

Bench testing only. Validation included positional reach, payload capacity, system stability, force measurement accuracy, brake hold, electrical safety, EMC, sterilization validation, gravity compensation accuracy, and coupler performance. Human factors and cadaver testing were also performed. All tests met pre-specified success criteria.

Technological Characteristics

Electrically actuated system with jointed arms. Components: surgical base, arms, control unit, instrument coupling, control station. Uses DC motors for gravity compensation. Connectivity: touch screen graphical interface. Sterilization: steam for coupling devices; drape used as sterility barrier. Software: real-time system performance monitoring with redundant encoders on motorized axes; velocity, acceleration, current, and torque limits.

Indications for Use

Indicated for holding and positioning laparoscopes and laparoscopic instruments during laparoscopic surgical procedures.

Regulatory Classification

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.

Predicate Devices

ENDEX Endoscopic Positioning System (K936308)

Related Devices

K240598 — Maestro System (REF100) · Moon Surgical · Jun 3, 2024
K250984 — Maestro System (REF100) · Moon Surgical · Jun 27, 2025
K242323 — Maestro System (REF100) · Moon Surgical · Mar 14, 2025
K243968 — Revolve Surgical System · Revolve Surgical, Inc. · Oct 3, 2025
K223673 — Surgeon Controlled Arm · Levita Magnetics International Corp · Aug 4, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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.