← Product Code [SAB](/submissions/SU/subpart-e%E2%80%94surgical-devices/SAB) · DEN230025

# MIRA Surgical System (DEN230025)

_Virtual Incision · SAB · Feb 23, 2024 · General, Plastic Surgery · DENG_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/SAB/DEN230025

## Device Facts

- **Applicant:** Virtual Incision
- **Product Code:** [SAB](/submissions/SU/subpart-e%E2%80%94surgical-devices/SAB.md)
- **Decision Date:** Feb 23, 2024
- **Decision:** DENG
- **Submission Type:** Direct
- **Regulation:** 21 CFR 878.4962
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
- **Attributes:** Therapeutic

## Intended Use

The MIRA Surgical System is a miniaturized robotic assisted surgery device indicated for the mobilization of the colon in adults at least 5'0" (1.52 m) tall and having a weight of at least 100 lbs (45.36 kg) who are undergoing minimally invasive colectomy procedures. It is intended to assist in the visualization of tissues and provide accurate and precise control of surgical instruments to grasp, retract, and dissect while maintaining hemostasis with electrocautery during manipulation of tissues. It is for prescription use only and is to be used by trained physicians in any operating room environment.

## Device Story

Miniaturized robotic-assisted surgery system; table-mounted; provides visualization and instrument control for grasping, retracting, and dissecting tissues; utilizes electrocautery for hemostasis. Used in operating rooms by trained physicians. System includes software-controlled electromechanical arms inserted into body cavity. Provides precise instrument manipulation to assist surgeon during minimally invasive colectomy. Benefits include robotic assistance for complex surgical tasks; requires mandatory device-specific training program for users and facilities.

## Clinical Evidence

Clinical performance testing required as a special control. Premarket clinical data evaluated for safety and effectiveness. Postmarket clinical validation performance testing required to include diverse demographic groups and specific disease etiologies (e.g., irritable bowel disease) to confirm performance is not inferior to premarket study results.

## Technological Characteristics

Table-mounted miniaturized electromechanical surgical system; software-controlled; includes patient/device interfaces and electromechanical arms for instrument control. Features include electrocautery capability. Requires biocompatibility, sterility, and pyrogenicity testing for patient-contacting components. Subject to electromagnetic compatibility, electrical, thermal, and mechanical safety testing.

## Regulatory Identification

The MIRA Surgical System is a miniaturized robotic assisted surgery device indicated for the mobilization of the colon in adults at least 5'0" (1.52 m) tall and having a weight of at least 100 lbs (45.36 kg) who are undergoing minimally invasive colectomy procedures. It is intended to assist in the visualization of tissues and provide accurate and precise control of surgical instruments to grasp, retract, and dissect while maintaining hemostasis with electrocautery during manipulation of tissues.

## Special Controls

In combination with the general controls of the FD&C Act, the table mounted miniaturized electromechanical surgical system is subject to the following special controls:

(1) Data obtained from premarket clinical performance validation testing and postmarket surveillance acquired under anticipated conditions of use must demonstrate that the device performs as intended in the intended patient population, unless FDA determines based on the totality of the information provided for premarket review that data from postmarket surveillance is not required.

(i) Data provided from (1) must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in a variety of disease etiologies relevant to the device intended use. The test data set must include data acquired from a patient population that is representative of the intended patient population.

(ii) Objective performance measures (i.e., rate and number of conversions to open surgery, rate of device related adverse events and their severity, cause, and outcomes) must be reported with relevant descriptive or developmental performance measures.

(2) Animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must evaluate:

(i) All surgical tasks pertinent to the device’s intended use, demonstrating the device can accurately and precisely control attached surgical instruments without excess of adverse events, device and not-device related.

(ii) Acute and chronic histopathology and gross examination of the affected organs and surrounding tissue.

(3) 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.

(4) 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.

(5) Human factors validation testing must be performed and must demonstrate that the device/user interfaces of the system support safe use in all use environments.

(6) 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 (1) of this section and any necessary modifications to the labeling to accurately reflect outcomes based upon the post-market surveillance data collected under paragraph (1) of this section.

(7) 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;

A. Instrument reliability;

B. Thermal effects on tissue;

C. User-device interface performance;

D. Workspace access testing; and

E. Performance testing with compatible devices.

(8) Software verification, validation, and hazard analysis must be performed.
(9) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(10) Performance data must demonstrate the sterility of all patient-contacting device components.
(11) 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.
(12) Performance data must validate the reprocessing instructions for the reusable components of the device.
(13) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(14) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(15) The device manufacturer must submit a report to the 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.

## Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

February 23, 2024

Virtual Incision
Florence Beck
VP Clinical and Regulatory Affairs
2125 Transformation Drive, Suite 1300
Lincoln, Nebraska 68508

Re: DEN230025
Trade/Device Name: MIRA Surgical System
Regulation Number: 21 CFR 878.4962
Regulation Name: Table mounted miniaturized electromechanical surgical system
Regulatory Class: Class II
Product Code: SAB
Dated: April 10, 2023
Received: April 11, 2023

Dear Florence Beck:

The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your De Novo request for classification of the MIRA Surgical System, a prescription device under 21 CFR Part 801.109 with the following indications for use:

The MIRA Surgical System is a miniaturized robotic assisted surgery device indicated for the mobilization of the colon in adults at least 5'0" (1.52 m) tall and having a weight of at least 100 lbs (45.36 kg) who are undergoing minimally invasive colectomy procedures.

It is intended to assist in the visualization of tissues and provide accurate and precise control of surgical instruments to grasp, retract, and dissect while maintaining hemostasis with electrocautery during manipulation of tissues.

It is for prescription use only and is to be used by trained physicians in any operating room environment.

FDA concludes that this device should be classified into Class II. This order, therefore, classifies the MIRA Surgical System, and substantially equivalent devices of this generic type, into Class II under the generic name table mounted miniaturized electromechanical surgical system.

FDA identifies this generic type of device as:

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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DEN230025 - Florence Beck
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Table mounted miniaturized electromechanical surgical system. A table mounted miniaturized electromechanical surgical system is a software-controlled electromechanical system with surgical table mounted patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures where the software-controlled electromechanical device's miniaturized and compact size allows the effective element of the system to be inserted into the body cavity and use surgical instruments attached to the electromechanical arms.

Section 513(f)(2) of the Food, Drug and Cosmetic Act (the FD&C Act) was amended by section 607 of the Food and Drug Administration Safety and Innovation Act (FDASIA) on July 9, 2012. This law provides two options for De Novo classification. First, any person who receives a "not substantially equivalent" (NSE) determination in response to a 510(k) for a device that has not been previously classified under the Act may request FDA to make a risk-based classification of the device under section 513(a)(1) of the Act. On December 13, 2016, the 21st Century Cures Act removed a requirement that a De Novo request be submitted within 30 days of receiving an NSE determination. Alternatively, any person who determines that there is no legally marketed device upon which to base a determination of substantial equivalence may request FDA to make a risk-based classification of the device under section 513(a)(1) of the Act without first submitting a 510(k). FDA shall, within 120 days of receiving such a request, classify the device. This classification shall be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the Federal Register announcing the classification.

On April 11, 2023, FDA received your De Novo requesting classification of the MIRA Surgical System. The request was submitted under section 513(f)(2) of the FD&C Act. In order to classify the MIRA Surgical System into class I or II, it is necessary that the proposed class have sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the De Novo request, FDA has determined that, for the previously stated indications for use, the MIRA Surgical System can be classified in class II with the establishment of special controls for class II. FDA believes that class II (special) controls provide reasonable assurance of the safety and effectiveness of the device type. The identified risks and mitigation measures associated with the device type are summarized in the following table:

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DEN230025 - Florence Beck
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|  Risks to Health | Mitigation Measures  |
| --- | --- |
|  Electrical fault, electromagnetic interference, mechanical fault, or system malfunction resulting in injury to patient or delay of treatment. | Clinical performance testing
Postmarket surveillance
Animal performance testing
Non-clinical performance testing
Annual reporting
Human factors testing
Electrical safety testing
Electromagnetic compatibility testing
Software verification and validation and hazard analysis
Labeling  |
|  Use error leading to:
• Re-operation
• Hematoma
• Injury to surrounding organ structures | Clinical performance testing
Postmarket surveillance
Animal performance testing
Training
Annual reporting
Human factors testing
Labeling  |
|  Infection | Clinical performance testing
Postmarket surveillance
Animal performance testing
Sterilization validation
Reprocessing validation
Biocompatibility testing
Shelf-life validation
Pyrogenicity testing
Labeling  |
|  Adverse tissue reaction | Postmarket surveillance
Biocompatibility evaluation
Pyrogenicity testing  |

In combination with the general controls of the FD&C Act, the table mounted miniaturized electromechanical surgical system is subject to the following special controls:

(1) Data obtained from premarket clinical performance validation testing and postmarket surveillance acquired under anticipated conditions of use must demonstrate that the device performs as intended in the intended patient population, unless FDA determines based on the totality of the information provided for premarket review that data from postmarket surveillance is not required.

(i) Data provided from (1) must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in a variety of disease etiologies relevant to

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DEN230025 - Florence Beck
Page 4

the device intended use. The test data set must include data acquired from a patient population that is representative of the intended patient population.

(ii) Objective performance measures (i.e., rate and number of conversions to open surgery, rate of device related adverse events and their severity, cause, and outcomes) must be reported with relevant descriptive or developmental performance measures.

(2) Animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must evaluate:

(i) All surgical tasks pertinent to the device’s intended use, demonstrating the device can accurately and precisely control attached surgical instruments without excess of adverse events, device and not-device related.

(ii) Acute and chronic histopathology and gross examination of the affected organs and surrounding tissue.

(3) 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.

(4) 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.

(5) Human factors validation testing must be performed and must demonstrate that the device/user interfaces of the system support safe use in all use environments.

(6) 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 (1) of this section and any necessary modifications to the labeling to accurately reflect outcomes based upon the post-market surveillance data collected under paragraph (1) of this section.

(7) 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;

A. Instrument reliability;

B. Thermal effects on tissue;

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DEN230025 - Florence Beck
Page 5

C. User-device interface performance;
D. Workspace access testing; and
E. Performance testing with compatible devices.

(8) Software verification, validation, and hazard analysis must be performed.
(9) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(10) Performance data must demonstrate the sterility of all patient-contacting device components.
(11) 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.
(12) Performance data must validate the reprocessing instructions for the reusable components of the device.
(13) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(14) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(15) The device manufacturer must submit a report to the 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.

In order to satisfy special control (1) above, FDA has determined that you must collect and report postmarket surveillance data acquired under anticipated conditions of use to demonstrate that the device performs as intended when used to analyze data from the intended patient population. Specifically, you must conduct postmarket clinical validation performance testing of the MIRA Surgical System device in patients from demographic groups representative of the U.S. population, to include populations who had limited representation in the premarket study (e.g., African American, Asian, etc.) or had conditions such as irritable bowel disease.

FDA expects that the postmarket clinical validation performance testing will include a clinically and statistically justified study sample size to confirm that performance of the device in postmarket use is not inferior to the performance observed in the pre-market study for the studied subgroup(s) or the overall population. The study should enroll a representative range of subjects with overrepresentation of patient demographics not present in the premarket data set. The study should also include patients with a diversity of disease etiologies, such as irritable bowel disease as this population is expected to be included in the device patient population.

Within 30 days of receipt of this order, you must submit a complete study protocol for your study as described above. FDA expects to work with you to approve your study protocol within 60 days of this order. Your submission should be clearly labeled as a "De Novo Postmarket Study Protocol" and submitted to the Agency as specified below. Please reference the De Novo number above to facilitate processing. If there are multiple protocols being finalized after granting of this De Novo request, please submit each protocol as a separate submission, identified by their unique study name(s).

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DEN230025 - Florence Beck
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From the date of study protocol approval, you must meet the following timelines:

- First subject enrolled within 12 months
- 20% of subjects enrolled within 24 months
- 50% of subjects enrolled within 36 months
- 100% of subjects enrolled within 48 months

In addition, you must submit separate periodic reports on the progress of the study as follows:

- Postmarket study progress reports annually (12 months), from the date of the granted De Novo letter, unless otherwise specified by FDA.
- If any enrollment milestones are not met, you must begin submitting enrollment status reports every 6 months in addition to your annual postmarket study progress reports, until FDA notifies you otherwise.
- Submit the final postmarket study report three (3) months from study completion (i.e., last subject’s last follow-up date).

Each postmarket study report should be submitted to the Agency as specified below, identified as a “De Novo Postmarket Study Report” in accordance with how the study is identified above, and bearing the applicable De Novo reference number.

Be advised that failure to comply with any special control requirement, including the initiation, enrollment, completion, and reporting per the postmarket surveillance data requirements outlined above, may result in the adulteration and misbranding of your device.

In addition, this is a prescription device and must comply with 21 CFR 801.109.

Although this letter refers to your product as a device, please be aware that some granted products may instead be combination products. If you have questions on whether your product is a combination product, contact CDRHProductJurisdiction@fda.hhs.gov.

Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device type. FDA has determined premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device type and, therefore, the device is not exempt from the premarket notification requirements of the FD&C Act. Thus, persons who intend to market this device type must submit a premarket notification containing information on the table mounted miniaturized electromechanical surgical system they intend to market prior to marketing the device.

Please be advised that FDA’s decision to grant this De Novo request does not mean that FDA has made a determination that your device complies with other requirements of the FD&C Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the FD&C Act’s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)

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DEN230025 - Florence Beck
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regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and if applicable, the electronic product radiation control provisions (Sections 531-542 of the FD&C Act; 21 CFR 1000-1050).

A notice announcing this classification order will be published in the Federal Register. A copy of this order and supporting documentation are on file in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852 and are available for inspection between 9 a.m. and 4 p.m., Monday through Friday.

As a result of this order, you may immediately market your device as described in the De Novo request, subject to the general control provisions of the FD&C Act and the special controls identified in this order.

For comprehensive regulatory information about medical devices and radiation-emitting products, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-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).

All required documents should be submitted, unless otherwise specified, to the address below and should reference the above De Novo number to facilitate processing.

De Novo Postmarket Surveillance
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Control Center – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

Alternatively, documents can be submitted electronically through the CDRH Portal. For more information on the CDRH Portal, please visit https://www.fda.gov/medical-devices/industry-medical-devices/send-and-track-medical-device-premarket-submissions-online-cdrh-portal.

If you have any questions concerning the contents of the letter, please contact Francisco Delgado at 301-796-0084.

Sincerely,

Clarence W. Murray III -S

For Binita Ashar, M.D., M.B.A., F.A.C.S.
Director
OHT4: Office of Surgical
and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

---

**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/SAB/DEN230025](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/SAB/DEN230025)

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