The ROVO Mechanical Thrombectomy Device is indicated for the removal of soft emboli and thrombi from vessels in the peripheral vasculature. It consists of a ROVO Driver, a ROVO Locking Aspiration Syringe, and a ROVO Catheter. The ROVO Driver handpiece was designed to work with an off-the-shelf catheter manufactured by Merit Medical Systems, Inc (K121051 and K132409) and an off-the-shelf locking aspiration syringe (K163597) also manufactured by Merit Medical Systems, Inc. Both the catheter and syringe are private labeled with the ROVO system name.

The ROVO Catheter is maneuvered under fluoroscopic observation to the location of the target thromboemboli utilizing the surgeon's preferred vascular access procedure. Once in the desired location, the ROVO Driver handpiece with the ROVO Locking Syringe is attached to the catheter. Squeezing of the handpiece rotates the distal tip of the ROVO Driver. This rotation ensures the thromboemboli is loosened and the catheter tip is fully exposed to the vessel to completely capture and aspirate the thromboemboli. Rotation does not happen when the trigger is released. Aspiration of the emboli/thrombi happens upon release of the Locking Syringe, independent of the catheter rotation. During aspiration, the surgeon can continue to pull the trigger and move the catheter as needed to capture the target thromboemboli.

AI/ML Overview

The provided text describes a medical device called the ROVO Mechanical Thrombectomy Device and its 510(k) clearance. However, it does not include information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of AI/ML or diagnostic accuracy, as your specific questions imply (e.g., effect size of human readers with AI, standalone algorithm performance, ground truth establishment for test/training sets).

This document focuses on the substantial equivalence of a physical medical device (mechanical thrombectomy device) to existing predicate devices, primarily through non-clinical performance data and a comparison of technological characteristics. Clinical testing was explicitly stated as not necessary for the determination of substantial equivalence in this context.

Therefore, many of your requested details regarding AI/ML device performance and testing methodology cannot be extracted from this document.

Here's what can be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document lists various non-clinical tests performed on the device components but does not provide specific acceptance criteria or quantitative performance results for these tests. It only states that these tests were "evaluated for" or "completed by Merit Medical Systems".

Acceptance Criteria (Implied from tests performed)	Reported Device Performance
Shelf-Life Validation	Evaluated / Completed
Particulate Testing	Evaluated / Completed
Biological Evaluation per ISO 10993-1:2018	Evaluated / Completed
Small-bore Connector Testing per ISO 80369-7:2021 (Dimensional Req., Leakage by Pressure Decay, Subatmospheric Pressure Air Leakage, Stress Cracking, Resistance to Separation from Axial Load Test, Resistance to Separation from Unscrewing, Resistance to Overriding)	Evaluated / Completed
Trackability	Evaluated / Completed
Torque Transmission	Evaluated / Completed
Kink Resistance	Evaluated / Completed
Air Leak Resistance	Evaluated / Completed
Tensile Strength	Evaluated / Completed
Mechanical Testing on Handpiece	Evaluated / Completed
Packaging per ISO 11607-1:2020	Evaluated / Completed
Sterilization per AAMI and ISO standards	Evaluated / Completed
Rotational Safety	Evaluated / Completed
Simulated Use Testing	Evaluated / Completed

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The document focuses on non-clinical engineering and biological tests, not data from human subjects or retrospective/prospective studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. "Ground truth" in the context of expert consensus or pathology is relevant for diagnostic or AI/ML-driven devices, which this is not.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided for the same reasons as above.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done, as explicitly stated: "Clinical testing was not necessary for the determination of substantial equivalence." This device is a mechanical thrombectomy device, not an AI-assisted diagnostic tool.

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

This is not an AI/ML or algorithm-based device, so a standalone algorithm performance study was not conducted.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

No "ground truth" of this nature was established, as the device's substantial equivalence was determined through non-clinical performance testing and comparison to predicate devices, not through diagnostic accuracy studies.

8. The sample size for the training set

This information is not applicable and not provided, as this is not an AI/ML device.

9. How the ground truth for the training set was established

This information is not applicable and not provided, as this is not an AI/ML device.

Summary

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March 31, 2023

2MG, Inc % Kelli Anderson Principal Consultant Tech2Med. LLC 6450 Old Darby Trl NE Ada, Michigan 49301

Re: K220780

Trade/Device Name: ROVO Mechanical Thrombectomy Device Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: February 24, 2023 Received: February 24, 2023

Dear Kelli Anderson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-

542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Gregory W. Digitally signed by
Gregory W. Gregory W. O'connell -S ○'connell -S Date: 2023.03.31
04'00'

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220780

Device Name ROVO Mechanical Thrombectomy Device

Indications for Use (Describe)

The ROVO Mechanical Thrombectory Device is indicated for the removal and thrombi from vessels in the peripheral vasculature.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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(a)(1). Submitted By:	2MG, Inc176 Nanagosa TrailSuttons Bay, MI 49682United States of America
Contact Person:	Kelli AndersonPrincipal Regulatory ConsultantOffice – (574) 527-9214
Date:	March 16, 2022
(a)(2). Proprietary Name:	Rovo Mechanical Thrombectomy Device
Common Name(s):	Peripheral Mechanical Thrombectomy with Aspiration
Classification Name:	21 CFR 870.5150: Embolectomy catheter
Regulatory Class:Product Code:	Class IIQEW
(a)(3). Primary Predicate Device:Secondary Predicate Device:Reference Devices:	K113757 – Aspire MAX Aspiration CatheterK202218 - Zelante DVT ClotHunter Helical Rotation DeviceK121051 and K132409 - Merit Medical Concierge Catheters

(a)(4). Device Description

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Page 2 / 3 K220780

(a)(5). Indications for Use

The ROVO Mechanical Thrombectomy Device is indicated for the removal of soft emboli and thrombi from vessels in the peripheral vasculature.

(a)(6). Technological Characterizes

The subject devices included in ROVO Mechanical Thrombectomy Device are similar to predicate devices in material, size, and have the similar indications for use.

(b)(1). Substantial Equivalence: - Non-Clinical Evidence Performance Data

2MG has leveraged testing completed by Merit Medical Systems for the general performance, sterility and packaging of the compatible Concierge Catheter (K121051 and K132409). Overall performance of the ROVO Driver in combination with the off-the-shelf catheter and syringe components were evaluated for:

Shelf-Life Validation
Particulate Testing ●
Biological Evaluation per ISO 10993-1:2018 ●
. Small-bore Connector Testing per ISO 80369-7:2021
- Dimensional Requirements O
- Leakage by Pressure Decay O
- Subatmospheric Pressure Air Leakage O
- O Stress Cracking per ISO 80369-20
- o Resistance to Separation from Axial Load Test
- Resistance to Separation from Unscrewing O
- Resistance to Overriding O
Trackability ●
Torque Transmission ●
Kink Resistance ●
Air Leak Resistance ●
Tensile Strength
Mechanical Testing on Handpiece ●
Packaging per ISO 11607-1:2020
Sterilization per AAMI and ISO standards ●
Rotational Safety ●
Simulated Use Testing ●

(b)(2). Substantial Equivalence: - Clinical Evidence

Clinical testing was not necessary for the determination of substantial equivalence.

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(b)(3). Substantial Equivalence - Conclusions

The ROVO Mechanical Thrombectomy Device utilizes an off-the-shelf catheter and aspiration syringe from Merit Medical Systems, Inc.. Based on the indications for use, technological characteristics, and safety and performance testing, the ROVO Mechanical Thrombectomy Device has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the Aspire MAX Aspiration Catheter (K113757), the ZelanteDVT ClotHunter Helical Rotation Device (K202218) and the Concierge Guiding Catheter (K121051 and K132409).

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).