(93 days)
Anovo™ Pedestal K232146
No
The document describes a robotic surgical system controlled by a physician and does not mention any AI or ML capabilities for image processing, decision support, or autonomous control.
No.
The device is an endoscopic instrument control system that assists surgeons in performing procedures, rather than directly providing therapy itself.
No
The Anovo Surgical System is an endoscopic instrument control system intended to assist in surgical procedures by controlling instrument arms. Its purpose is to facilitate surgery, not to diagnose medical conditions.
No
The device description explicitly lists multiple hardware components including Instrument ARMS, Surgeon Console, Robotic Control Unit, and accessories, and the performance studies include testing of these hardware components (e.g., mechanical and functional verification, electrical safety, biocompatibility, sterilization).
Based on the provided information, the Anovo Surgical System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Anovo Surgical System Function: The Anovo Surgical System is an endoscopic instrument control system used to assist in performing surgical procedures within the body. It manipulates surgical instruments based on the physician's control and visualization of the surgical site.
- Lack of Specimen Analysis: The description of the Anovo Surgical System does not mention any analysis of biological specimens. Its function is entirely focused on controlling surgical instruments during the procedure itself.
Therefore, the Anovo Surgical System falls under the category of a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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
Product codes
QNM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
transvaginal and transabdominal
Indicated Patient Age Range
adult patients
Intended User / Care Setting
trained physicians in an operating room environment.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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. 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.
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: 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 (
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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.
1
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
2
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
3
Indications for Use
Submission Number (if known)
Device Name
Anovo Surgical System (model 6N)
Indications for Use (Describe)
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
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/RA
Maya.leib@momentissurgical.com
Tel.: 972-5-088-52822 |
| Date: | June 30, 2024 |
| Device &
Classification Name: | Anovo™ Surgical System
Mountable Electromechanical Surgical System for Transluminal Approaches
Product Code QNM, Class 2 |
| Predicate Device:
Reference Device: | Hominis Surgical System DEN190022
Anovo™ Pedestal K232146 |
| 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. |
| Indications for Use: | 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 trans-abdominal 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 |
5
- 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.
6
| 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.
7
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 [# of
patients] | 0 | 0 | 0 |
| Blood Loss | 0 | N/A | N/A |
| Average length of hospital
stays (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.
8
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 (