(90 days)
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No
The document describes an electromechanical surgical system for controlling instruments and does not mention any AI or ML components or capabilities.
No.
The device is an endoscopic instrument control system that assists surgeons in performing procedures, rather than directly treating a condition itself.
No
The device is described as an "endoscopic instrument control system" intended to assist in surgical procedures. Its purpose is to control instrument arms during surgery, not to diagnose a condition or disease.
No
The device description explicitly states the system consists of hardware components including Instrument ARMS, a Surgeon Console, a Robotic Control Unit Assembly, and System Accessories. While software is mentioned in the performance studies, it is part of a larger electromechanical system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- Device Description and Intended Use: The Anovo Surgical System is described as an "endoscopic instrument control system" and an "electromechanical surgical system" used to assist in controlling surgical instruments during surgical procedures performed inside the body (in vivo). Its intended use is for specific surgical procedures like hysterectomy and salpingo-oophorectomy.
The device's function is to manipulate surgical instruments within the body during surgery, not to perform diagnostic tests on samples taken from the body.
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 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
Product codes
QNM
Device Description
The Anovo™ Surgical System Model 6Ne is an electromechanical surgical system for transluminal approaches used in single-site benign hysterectomy and salpingo-oophorectomy surgical procedures through a transvaginal access point. The system consists of two (2) Instrument ARMS, a Surgeon Console, a Robotic Control Unit Assembly, and System Accessories (Sterile Drape, Vaginal Access Kit, Cables, and Pedestal). During clinical use, surgeons operate the Instrument ARMs from the Surgeon Console with a compatible and FDA-cleared third-party standard laparoscope (transumbilical) and visual guidance system.
Anovo™ Surgical System 6Ne, including Anovo™ Surgeon Console 6Ne and Anovo™ Robotic Control Unit 6Ne, is an additional enhanced configuration of the Anovo™ 6N, with Anovo™ Surgeon Console 6N and Anovo™ Robotic Control Unit 6N ("Predicate Device") that was the subject of a De Novo request (DEN190022). There are no differences in the system instruments and accessories compared to the Anovo™ 6N, and the Surgeon Console and Robotic Control Unit Model 6Ne will be offered with the same Instrument and accessories.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
transvaginal access point
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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing: Bench testing demonstrates that the subject device's design output meets the design input requirements. The testing conducted consisted of dimensional measurements and 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 6Ne implements robust security controls to safeguard the integrity and security of the system's operation. 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 80601-2-77 (basic safety and essential performance of robotically assisted surgical equipment), IEC 60601-1-2 (Electromagnetic disturbances), IEC 60601-4-2 (Electromagnetic Immunity), and IEC 60601-2-2 (high-frequency surgical equipment).
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 US Surgeons evaluated the Anovo™ Surgical System 6Ne usage in a simulated OR environment by performing predefined critical tasks after a training session. The Human Factor Usability Validation demonstrated that the Anovo™ Surgical System 6Ne supports safe and effective use by representative users during the performance of transvaginal laparoscopic-assisted surgical 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.
Pre-Clinical Cadaver Study: Momentis has performed design validation of the in female cadaver models to ensure that the Anovo™ Surgical System 6Ne meets its safety and performance requirements. The validation was performed by conducting procedures according to its intended use in an operating room environment. A female cadaver model was chosen for this study as it simulates the human anatomy and allows evaluation of system's ability to access and reach the relevant anatomical regions and structures during surgical procedures that are part of the Indications for Use. The study consisted of performing transvaginal laparoscopic-assisted surgical procedures on five (5) Cadavers by two (2) trained Surgeons. Following each procedure, the operating surgeon evaluated various features related to the System's performance and surgical tasks. The results were analyzed and demonstrated that the Anovo™ Surgical System model 6Ne can successfully perform all surgical tasks to complete transvaginal laparoscopic-assisted surgical procedures. The Anovo™ Surgical System 6Ne met all the predefined specific requirements related to clinical compatibility, performance, and safety.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Hominis Surgical System DEN190022
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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October 21, 2024
Momentis Surgical Ltd. Maya Leib Shlomo VP Qa/ra 6 Yoni Netanyahu Street Or Yehuda, 6037604 Israel
Re: K242157
Trade/Device Name: Anovo Surgical System (Model 6Ne) Regulation Number: 21 CFR 878.4961 Regulation Name: Mountable Electromechanical Surgical System For Transluminal Approaches Regulatory Class: Class II Product Code: QNM Dated: July 23, 2024 Received: July 23, 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: 2024.10.21 08:41:09 -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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Anovo Surgical System (Model 6Ne)
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 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
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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:
Device &
Classification
Name: | July 23, 2024
Anovo™ Surgical System Model 6Ne
Mountable Electromechanical Surgical System for Transluminal Approachs
Product Code QNM, Class 2 |
| Predicate Device: | Hominis Surgical System DEN190022 |
| Description: | The Anovo™ Surgical System Model 6Ne is an electromechanical surgical system for transluminal approaches used in single-site benign hysterectomy and salpingo-oophorectomy surgical procedures through a transvaginal access point. The system consists of two (2) Instrument ARMs, a Surgeon Console, a Robotic Control Unit Assembly, and System Accessories (Sterile Drape, Vaginal Access Kit, Cables, and Pedestal). During clinical use, surgeons operate the Instrument ARMs from the Surgeon Console with a compatible and FDA-cleared third-party standard laparoscope (transumbilical) and visual guidance system.
Anovo™ Surgical System 6Ne, including Anovo™ Surgeon Console 6Ne and Anovo™ Robotic Control Unit 6Ne, is an additional enhanced configuration of the Anovo™ 6N, with Anovo™ Surgeon Console 6N and Anovo™ Robotic Control Unit 6N ("Predicate Device") that was the subject of a De Novo request (DEN190022). There are no differences in the system instruments and accessories compared to the Anovo™ 6N, and the Surgeon Console and Robotic Control Unit Model 6Ne will be offered with the same Instrument and accessories. |
| 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 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 |
| Comparison of
Technological
Characteristics: | The Anovo™ Surgical System Model 6Ne is based on the authorized
Anovo™ Surgical System Model 6N (“predicate device” DEN190022) and,
therefore they are technologically similar. Both systems include a Surgeon
Console, Robotic Control Unit, Instrument ARMs, and accessories. The
Instrument ARM and accessories compatible with the Model 6N are also
compatible with the Model 6Ne System.
Anovo™ Surgical System Model 6Ne improves the user interface by
incorporating enhanced controllers into the Surgeon Console and
introducing new features including clutching, annotation, antegrade for better
hand posture, and haptic feedback that indicate the surgeon to maintain the
ARMs Controllers within the Instrument ARMs Range of Motion. Those
modifications were for user experience, and they do not impact the key
functionalities of the device. |
| Performance
Evaluation: | The following performance testing was conducted to demonstrate
substantial equivalence to the predicate device: |
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Bench Testing
Bench testing demonstrates that the subject device's design output meets the design input requirements. The testing conducted consisted of dimensional measurements and 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 6Ne implements robust security controls to safeguard the integrity and security of the system's operation. 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 80601-2-77 (basic safety and essential performance of
6
robotically assisted surgical equipment), IEC 60601-1-2 (Electromagnetic disturbances), IEC 60601-4-2 (Electromagnetic Immunity), and IEC 60601-2-2 (high-frequency surgical equipment).
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 US Surgeons evaluated the Anovo™ Surgical System 6Ne usage in a simulated OR environment by performing predefined critical tasks after a training session.
The Human Factor Usability Validation demonstrated that the Anovo™ Surgical System 6Ne supports safe and effective use by representative users during the performance of transvaginal laparoscopic-assisted surgical 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.
Pre-Clinical Cadaver Study
Momentis has performed design validation of the in female cadaver models to ensure that the Anovo™ Surgical System 6Ne meets its safety and performance requirements. The validation was performed by conducting procedures according to its intended use in an operating room environment.
A female cadaver model was chosen for this study as it simulates the human anatomy and allows evaluation of system's ability to access and reach the relevant anatomical regions and structures during surgical procedures that are part of the Indications for Use.
The study consisted of performing transvaginal laparoscopic-assisted surgical procedures on five (5) Cadavers by two (2) trained Surgeons. Following each procedure, the operating surgeon evaluated various features related to the System's performance and surgical tasks. The results were analyzed and demonstrated that the Anovo™ Surgical System model 6Ne can successfully perform all surgical tasks to complete transvaginal laparoscopic-assisted surgical procedures.
The Anovo™ Surgical System 6Ne met all the predefined specific requirements related to clinical compatibility, performance, and safety.
Conclusion: The Anovo™ Surgical System Model 6Ne is substantially equivalent to the predicate device. The device has the same intended uses and indications for use as the predicate. The subject device has similar technological characteristics and principles of operation as the predicate device. The technological differences between the Anovo™ Surgical System 6Ne and
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its predicate device do not raise different questions of safety or effectiveness. Furthermore, the same type of non-clinical testing was performed to demonstrate the safety and effectiveness of the predicate device which also addressed the verification and validation of the subject device. No additional risks were identified in the completed testing. In addition, the subject device appropriately addresses all of the special controls in the existing classification regulation. Therefore, the Anovo™ Surgical System 6Ne is substantially equivalent to its predicate device.