The Anovo Surgical System is an endoscopic instrument control system that is intended to assist in the accurate control of the Instrument ARMS during single site, natural orifice transvaginal and transabdominal benign laparoscopic-assisted surgical procedures listed below. The Anovo Surgical System is indicated for use in adult patients. It is intended to be used by trained physicians in an operating room environment.

The representative uses of the Anovo Surgical System are indicated for the following benign procedures:

Total benign hysterectomy with salpingo-oophorectomy
Total benign hysterectomy with salpingectomy
Total benign hysterectomy
Salpingectomy
Oophorectomy
Adnexectomy
Ovarian cyst removal
Ventral hernia

Device Description

The Anovo™ Surgical System is a mountable electromechanical surgical system used in single-site surgical procedures through a transvaginal or transabdominal access point. The system consists of two (2) Anovo™ Instrument ARMS, Anovo™ Surgeon Console, Anovo™ Robotic Control Unit, and accessories (Anovo™ Pedestal, Anovo™ Access Kit and Anovo™ Sterile Drape for Robotic Control Unit).

The Instrument ARMS are connected to the RCU, which is attached to the Pedestal. The physician sits at the Anovo™ Surgeon Console and controls the Instrument ARMS by manipulating the ARMS Controllers. While manipulating the Instrument ARMS, the physician views the surgical site through a standard OR visualization system using a laparoscopic camera inserted through an abdominal port and views the main user interface at the Anovo™ Surgical System Surgeon Console. The Anovo™ Surgical System Surgeon Console is located outside of the sterile zone.

The system is designed to be used with an Electrosurgical Generator. The Anovo™ Surgical System is operated in conjunction with standard commercially available laparoscopic surgery visualization systems.

AI/ML Overview

The provided text describes the Anovo Surgical System and includes information about its performance evaluation, but it does not explicitly list pre-defined acceptance criteria in a table format with corresponding device performance values for each criterion. Instead, it presents the results of various studies that collectively aim to demonstrate the device's safety and effectiveness for its expanded indications, particularly for ventral hernia repair.

However, based on the information provided, we can infer some criteria and reported performance:

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit acceptance criteria are not tabulated in the document, I will infer them from the reported study objectives and outcomes.

Acceptance Criterion (Inferred from Study Objectives)	Reported Device Performance
Clinical Performance (Primary Endpoint):
No instances of conversion to open surgery.	Met: No instances of conversion to open surgery were observed for all 30 subjects.
No instances of conversion to laparoscopy approach.	Met: No instances of conversion to laparoscopy approach were observed for all 30 subjects.
Clinical Safety (Intraoperative):
No Adverse Events (AEs).	Met: 0% intraoperative AEs (intraoperative).
No Adverse Device Events (ADEs).	Met: 0% intraoperative ADEs (intraoperative).
No Serious Adverse Events (SAEs).	Met: 0% intraoperative SAEs (intraoperative).
Clinical Safety (Postoperative/Perioperative):
No Adverse Device Events (ADEs).	Met: 0% ADEs (postoperative).
No Serious Adverse Events (SAEs).	Met: 0% SAEs (postoperative).
Complications (not device related) within acceptable limits.	Reported: 3.33% complications (post-procedure) - indicated as "Not device related." One wound seroma reported, also "not device related."
Adverse Events (not device related) within acceptable limits.	Reported: 16.66% AEs (post-procedure) - indicated as "Not device related."
Clinical Efficacy (Secondary Endpoints):
100% Procedure completion.	Met: 30 (100%) procedure completion.
No unplanned surgical activities.	Met: None reported.
No additional ports used.	Met: None reported.
Acceptable Average Operative Time.	Reported: 64.1 minutes (range 33-124). (No specific criterion was given for what is "acceptable" but the inference is that this range was acceptable).
No bowel injury.	Met: 0 bowel injuries.
No surgical site infection.	Met: 0 surgical site infections.
Acceptable blood loss.	Reported: 0 blood loss. (No specific criterion was given for what is "acceptable" but 0 is excellent).
Acceptable length of hospital stays.	Reported: 1 day (range 1-2). (No specific criterion was given for what is "acceptable" but this is a very short stay, implying acceptance).
No mortality.	Met: 0% mortality.
Cadaver Study Performance:
Successful access and reach of anatomical structures.	Met: Anovo™ Surgical System can successfully access and reach anatomical structures during execution of transabdominal laparoscopic ventral hernia procedures.
Ability to perform all surgical tasks.	Met: Anovo™ Surgical System can perform all surgical tasks to complete transabdominal laparoscopic ventral hernia repair.
Met specific requirements related to clinical compatibility, performance, and safety.	Met: Anovo™ Surgical System met all predefined specific requirements related to transabdominal clinical compatibility, performance, and safety.
Human Factors/Usability Performance:
Support safe and effective use by representative users.	Met: Demonstrated that the Anovo™ Surgical System supports safe and effective use by representative users during the performance of laparoscopic transabdominal general surgery procedures.
All relevant use-related risks found acceptable.	Met: Analysis of results demonstrated all relevant use-related risks were found to be acceptable and there is no residual use-related risk.
Bench Testing Performance:
Design output meets design input requirements.	Met: Bench testing demonstrates that the subject device's design output meets the design input requirements (mechanical and functional verification).
Software Performance:
Compliance with IEC 62304 and FDA Guidance.	Met: Software development process and testing performed according to IEC 62304 and FDA's Guidance for Industry and FDA Staff "Content of Premarket Submissions for Device Software Functions."
Cybersecurity Performance:
Assurance of integrity and security.	Met: Implements robust security controls to safeguard the integrity and security of the system's operation, and tested in compliance with FDA Guidance: Cybersecurity in Medical Devices and section 524B of the FD&C Act.
Electrical Safety and EMC:
Compliance with relevant IEC standards.	Met: Testing conducted in accordance with IEC 60601-1, IEC 60601-1-6, IEC 60601-1-2, and IEC 60601-2-2.
Biocompatibility:
Compliance with ISO 10993-1.	Met: All patient-contacting components classified and evaluated per ISO 10993-1:2018 and FDA guidance.
Sterilization:
Effectiveness, consistency, and reproducibility of sterilization processes.	Met: Sterilization validation study conducted to demonstrate the effectiveness, consistency, and reproducibility of the EtO and Steam sterilization processes for the Instrument ARM and Access Kit respectively.

2. Sample Size Used for the Test Set and Data Provenance

Clinical Study (Test Set):
- Sample Size: 30 subjects (N=30).
- Data Provenance: Multi-center, single-arm, prospective study. Conducted in two sites outside the United States (Belgium and Israel).
Cadaver Study (Test Set):
- The document does not specify the sample size (number of cadavers) used for this study.
- Data Provenance: Not specified, but generally cadaver studies are retrospective use of donated human remains.
Human Factors Study (Test Set):
- The document mentions "Representative users" but does not specify the number of users in the sample size.
- Data Provenance: Conducted in a "simulated OR environment."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not explicitly state the number of experts used to establish a "ground truth" in the traditional sense (e.g., for diagnostic accuracy).
For the Clinical Study: The "ground truth" is derived from the actual surgical outcomes, complications, operative times, etc., observed by the surgical teams and follow-up clinicians at the study sites. These would be trained physicians in an operating room environment, as the device is intended for use by "trained physicians."
For the Cadaver Study: The "ground truth" of successful access, reach, and task completion would have been assessed by experienced surgeons or surgical residents performing the procedures on the cadavers.
For Human Factors: The "ground truth" for usability and safety was established by "representative users" (presumably surgeons or surgical staff) performing predefined critical tasks and experts evaluating use-related risks.

4. Adjudication Method for the Test Set

The document does not specify an explicit adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth, as would be common for diagnostic imaging studies where agreement on subtle findings might be required.
For the Clinical Study, outcomes like conversion rates, adverse events, and procedure completion are generally objective metrics observed and recorded by the treating physicians and study coordinators/monitors, rather than requiring an explicit adjudication process for interpreting findings.
The complications and adverse events were categorized as "not device related," implying a clinical judgment was made (presumably by the investigators/clinicians at the sites or a clinical events committee), but no formal adjudication committee or process is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

No, an MRMC comparative effectiveness study was not done.
This device is an electromechanical surgical system (robotics system), not an AI-based diagnostic imaging tool that would involve "human readers" interpreting images. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable in this context. The study focused on the performance of the surgical system itself.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

This question is not applicable to the Anovo Surgical System. As a surgical robot, it inherently requires a "human-in-the-loop" (the surgeon operating the console). There is no "algorithm-only" performance for such a device; its function is always to assist the surgeon. The "standalone" performance if considered would be the system's mechanical and software reliability in performing the surgeon's commands, which is assessed through bench testing and software validation.

7. The Type of Ground Truth Used

Clinical Study: The ground truth for the clinical study was based on clinical outcomes and observations during and after surgery, including:
- Procedure completion (objective observation).
- Conversion rates (objective observation).
- Occurrence and type of adverse events, adverse device events, and serious adverse events (clinical diagnosis/observation).
- Operative time (objective measurement).
- Blood loss (objective measurement/estimation).
- Hospital stay duration (objective record).
- Mortality (objective record).
- These are forms of outcomes data and expert clinical observation/diagnosis.
Cadaver Study: The ground truth was based on direct observation and assessment by surgeons of the device's ability to access, reach, and perform tasks on anatomical structures within the cadaveric model. This is a form of expert observation/assessment in a simulated setting.
Human Factors Study: The ground truth for usability and safety was established by observing "representative users" interacting with the system and experts identifying and assessing use-related risks. This is based on expert observation and assessment of user performance and risk analysis.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of device performance validation testing for the Anovo Surgical System for its expanded indications.
For electro-mechanical systems, the "training" typically refers to the engineering design, simulation, and bench testing phases where parameters are refined and models are iterated, but not in the same sense as an AI model's training data.
The "training" of the physicians using the system in the human factors study is mentioned, but this is user training, not data training for an algorithm.

9. How the Ground Truth for the Training Set Was Established

As a "training set" for an algorithm or data-driven model is not mentioned in this submission, this question is not applicable. The validation studies (clinical, cadaver, human factors, bench, software, etc.) are evaluating the final device's performance against its design requirements and safety/effectiveness goals, not training an underlying model.

Summary

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October 2, 2024

Momentis Surgical Ltd. Maya Leib Shlomo VP Qa/ra 6 Yoni Netanyahu Street Or Yehuda, 6037604 Israel

Re: K241907

Trade/Device Name: Anovo Surgical System (model 6N) Regulation Number: 21 CFR 878.4961 Regulation Name: Mountable Electromechanical Surgical System For Transluminal Approaches Regulatory Class: Class II Product Code: QNM Dated: June 30, 2024 Received: July 1, 2024

Dear Maya Leib Shlomo:

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 (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 (QS) 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 -Trumbore -S Date: 2024.10.02
15:03:01 -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)

K241907

Device Name

Anovo Surgical System (model 6N)

Indications for Use (Describe)

The representative uses of the Anovo Surgical System are indicated for the following benign procedures:

· Total benign hysterectomy with salpingo-oophorectomy
· Total benign hysterectomy with salpingectomy
· Total benign hysterectomy
· Salpingectomy
· Oophorectomy
· Adnexectomy
· Ovarian cyst removal
· Ventral hernia

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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Submitter	Momentis Surgical Ltd.6 Yoni Netanyahu St.Or Yehuda, Israel 6037604
Contact Person:	Maya Leib Shlomo, VP of QA/RAMaya.leib@momentissurgical.comTel.: 972-5-088-52822
Date:	June 30, 2024
Device &Classification Name:	Anovo™ Surgical SystemMountable Electromechanical Surgical System for Transluminal ApproachesProduct Code QNM, Class 2
Predicate Device:Reference Device:	Hominis Surgical System DEN190022Anovo™ Pedestal K232146
Description:	The Anovo™ Surgical System is a mountable electromechanical surgical systemused in single-site surgical procedures through a transvaginal or transabdominalaccess point. The system consists of two (2) Anovo™ Instrument ARMS, Anovo™Surgeon Console, Anovo™ Robotic Control Unit, and accessories (Anovo™Pedestal, Anovo™ Access Kit and Anovo™ Sterile Drape for Robotic Control Unit).
	The Instrument ARMS are connected to the RCU, which is attached to the Pedestal.The physician sits at the Anovo™ Surgeon Console and controls the InstrumentARMS by manipulating the ARMS Controllers. While manipulating the InstrumentARMS, the physician views the surgical site through a standard OR visualizationsystem using a laparoscopic camera inserted through an abdominal port and viewsthe main user interface at the Anovo™ Surgical System Surgeon Console. TheAnovo™ Surgical System Surgeon Console is located outside of the sterile zone.
	The system is designed to be used with an Electrosurgical Generator. The Anovo™Surgical System is operated in conjunction with standard commercially availablelaparoscopic surgery visualization systems.
Indications for Use:	The Anovo™ Surgical System is an endoscopic instrument control system that isintended to assist in the accurate control of the Instrument ARMS during single site,natural orifice transvaginal and trans-abdominal benign laparoscopic-assistedsurgical procedures listed below. The Anovo™ Surgical System is indicated for usein adult patients. It is intended to be used by trained physicians in an operating roomenvironment.
	The representative uses of the Anovo™ Surgical System are indicated for thefollowing benign procedures:
	• Total benign hysterectomy with salpingo-oophorectomy• Total benign hysterectomy with salpingectomy• Total benign hysterectomy• Salpingectomy• Oophorectomy• Adnexectomy

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Ovarian cyst removal
· Ventral hernia

Comparison of Technological Characteristics:

With respect to technology, the Anovo™ Surgical System is the same as the predicate and reference Devices. The purpose of this submission was to expand the indication for use which was the treatment of Ventral Hernias in male and female patients.

Performance Evaluation:

The following performance testing was conducted to demonstrate substantial equivalence to the predicate and reference devices:

Pre-Clinical Cadaver Study

Cadaver testing demonstrated that the Anovo™ Surgical System can successfully access and reach anatomical structures during the execution of transabdominal laparoscopic ventral hernia procedure, perform all surgical tasks to complete transabdominal laparoscopic ventral hernia repair.

The Anovo™ Surgical System met all the predefined specific requirements related to transabdominal clinical compatibility, performance, and safety.

Human Factors

Human Factors and Usability Engineering Process was performed according to the requirements of:

ISO/IEC 62366-1:2015, Medical devices Application of usability ● engineering to medical devices.
Guidance for Industry and Food and Drug Administration Staff Applying . Human Factors and Usability Engineering to Medical Devices (February 3, 2016)

Representative users evaluated the Anovo™ Surgical System usage in simulated OR environment by performing predefined critical tasks after a training session.

The Human Factor Usability Validation demonstrated that the Anovo™ Surgical System supports safe and effective use by representative users during the performance of laparoscopic transabdominal general surgery procedures. The analysis of the results demonstrated that all relevant use-related risks were found to be acceptable and there is no residual use-related risk.

Clinical Study

A multi-center, single-arm, prospective study was performed to clinically assess the Anovo™ Surgical System for use in performing laparoscopic Ventral Hernia repair. The Clinical Study was performed in two sites outside the Unites States (in Belgium and Israel) and included 30 subjects undergoing ventral hernia repair. A summary of the baseline demographics for subjects is provided in Table 1.

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Variable Name	Ventral Hernia Study(N=30)
Age (years)
Min-Max (years)	22-79
Mean (SD)	50.8 (16.1)
Median	36
Lower/Upper bound 95% CI	44.8-56.9
Gender
Male	22 (73.3%)
Female	8 (26.7%)
BMI (kg/m²)
Min-Max (kg/m²)	18.9-36.2
Mean (SD)	26.2 (3.8)
Median	23.6
Lower/Upper bound 95% CI	24.8-27.6
Smoker
Current	6 (20%)
Former	7 (23.3%)
Never	17 (56.7%)
Alcohol Consumption
No	17 (56.7%)
Yes	13 (43.3%)
Race
African American or Hispanic	0
Not African American or Hispanic	30 (100%)

Table 1: Ventral Hernia Subject Demographics

The study included post-surgery safety visits: an in-clinic visit two weeks following the procedure, and one telephone follow-up, 4 weeks after the surgery.

The primary endpoint was successfully met as there were no instances of conversion to open surgery or to laparoscopy approach during the surgeries for all 30 subjects enrolled. All surgeries took place as expected. The data collected in this clinical investigation points to a favorable safety provide of the Anovo™ Surgical System in ventral hernia surqeries. No Adverse Event, Adverse Device Event or Serious Adverse Event intra-operatively. Postoperatively, there were no Adverse Device Event or Serious Adverse Event. The data collected reinforces the positive safety profile of Anovo™ Surgical System in ventral hernia repair surgeries.

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The summary of the clinical investigation data is provided in Table 2

Secondary Endpoint	Intraoperative	Post-Procedure(Perioperative)	Follow-Up(through 6 weeks)
Procedure completion	30 (100%)	N/A	N/A
Conversion rate	None	N/A	N/A
Any additional ports used	None	N/A	N/A
Unplanned surgical activities	None	N/A	N/A
Average Operative Time(range) [minutes]	64.1 (33-124)	N/A	N/A
Complications [%]	0	3.33*	0
Adverse Events (AEs) [%]	0	16.66*	0
Serious Adverse Events(SAEs) [%]	0	0	0
Bowel injury [# of patients]	0	0	0
Wound Seroma [# of patients]	0	1*	0
Surgical Site Infection [# ofpatients]	0	0	0
Blood Loss	0	N/A	N/A
Average length of hospitalstays (range) [days]	N/A	1 (1-2)	N/A
Mortality [%]	0	0	0

Table 2: Summary of Secondary Endpoint Results

Not device related

In addition, the following performance testing were conducted on the predicate and reference devices:

Bench Testing

Bench testing demonstrates that the subject device's design output meets the design input requirements. The testing conducted consisted of mechanical and functional verification.

Software Testing

Software development process and software testing including verification and validation testing, were performed in according to the current version of IEC 62304 and FDA's Guidance for Industry and FDA Staff "Content of Premarket Submissions for Device Software Functions".

Cybersecurity

Anovo™ Surgical System implements robust security controls to safeguard the integrity and security of the system's operation.

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Cybersecurity testing was performed, and the information provided in this submission demonstrates compliance with section 524B of the FD&C Act consistent with current "FDA Guidance: Cybersecurity in Medical Devices -Quality System Considerations and Content of Premarket Submissions".

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical Safety and EMC testing was conducted using a third-party Accredited laboratory in accordance with the current versions of IEC 60601-1 (basic safety and essential performance), IEC 60601-1-6 (usability), IEC 60601-1-2 (Electromagnetic disturbances), and IEC 60601-2-2 (high-frequency surgical equipment).

Biocompatibility

The Anovo™ Surgical System contains direct and indirect patient-contacting components, including the Instrument ARM and Access Kit. All patient-contacting components were classified as "external communicating devices in contact with tissue/bone/dentine for limited duration (<24 hours)" per ISO 10993-1:2018, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process, and FDA's guidance document titled, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (September 2023).

Sterilization

The Anovo™ Instrument ARM is an EtO-Sterilized single-use component. The Anovo™ Access Kit is a steam-sterilized reusable component. Sterilization validation study was conducted to demonstrate the effectiveness, consistency, and reproducibility of the EtO and Steam sterilization processes.

Conclusion:

The Anovo™ Surgical System is substantially equivalent to the predicate and reference devices. The device has the same intended uses and similar indications for use as the predicate. The expanded indications are addressed with the same types of data as were used to support the predicate devices and the outcome of the performance evaluation (design validation, human factor and clinical trial) do not present any new risks. There are no differences in the technological characteristics of the device compared to the predicate. In addition, the device for the expanded indications appropriately addresses all of the special controls in the existing classification requlation. Therefore, the Anovo™ Surgical System to be substantially equivalent to treat Ventral Hernias.

Regulation Number and Section

§ 878.4961 Mountable electromechanical surgical system for transluminal approaches.

(a)
Identification. A mountable electromechanical surgical system for transluminal approaches is a software-controlled, patient bed- and/or operating table-mounted electromechanical surgical system with human/device interfaces that allows a qualified user to perform transluminal endoscopic or laparoscopic surgical procedures using surgical instruments attached to an electromechanical arm.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
(2) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(3) The device manufacturer must conduct and complete post-market surveillance, including an impact of the training program on user learning, behavior, and performance, in accordance with an FDA-agreed-upon protocol. The device manufacturer must submit post-market surveillance reports that contain current data and findings in accordance with the FDA-agreed-upon protocol.
(4) The device manufacturer must submit a report to FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling or device-specific use training program, which did not require submission of a premarket notification during the reporting period.
(5) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness of the device has not been evaluated for outcomes related to the treatment or prevention of cancer, including but not limited to risk reduction, overall survival, disease-free survival and local recurrence, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A detailed summary of the post-market surveillance data collected under paragraph (b)(3) of this section and any necessary modifications to the labeling to accurately reflect outcomes based upon the post-market surveillance data collected under paragraph (b)(3) of this section.
(6) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use.
(7) Human factors validation testing must be performed and must demonstrate that the user interfaces of the system support safe use in an operating room environment.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and precision;
(ii) System testing;
(iii) Instrument reliability;
(iv) Thermal effects on tissue;
(v) Human-device interface;
(vi) Mounting hardware testing;
(vii) Workspace access testing; and
(viii) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed. Software documentation must include an assessment of the impact of threats and vulnerabilities on device functionality and end users/patients as part of cybersecurity review.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.