(379 days)
No
The device description and performance studies focus on mechanical aspects and compatibility with existing components, with no mention of AI/ML algorithms or data processing.
Yes
Explanation: The device is indicated for the removal of thrombi from vessels, which is a therapeutic intervention aimed at treating a medical condition.
No
Explanation: The device is described as a "Mechanical Thrombectomy Device" used for the "removal of soft emboli and thrombi." Its function is to physically remove blockages from vessels, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly outlines physical components: a ROVO Driver, a ROVO Locking Aspiration Syringe, and a ROVO Catheter. The performance studies also detail testing on these physical components (e.g., mechanical testing on handpiece, trackability, torque transmission).
Based on the provided information, the ROVO Mechanical Thrombectomy Device is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- ROVO Device Function: The ROVO device is a mechanical tool used within the body (in the peripheral vasculature) to physically remove blood clots (thrombi). It does not analyze or test bodily fluids or tissues outside the body.
- Intended Use: The intended use clearly states "removal and thrombi from vessels in the peripheral vasculature," which is a therapeutic intervention, not a diagnostic test.
- Device Description: The description details a mechanical system for aspiration and rotation within the vessel, not a system for analyzing biological samples.
- Input: The input is fluoroscopic observation, which is an imaging modality used to guide the device's placement, not a biological sample.
Therefore, the ROVO Mechanical Thrombectomy Device is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The ROVO Mechanical Thrombectory Device is indicated for the removal and thrombi from vessels in the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
QEW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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
- Leakage by Pressure Decay
- Subatmospheric Pressure Air Leakage
- Stress Cracking per ISO 80369-20
- Resistance to Separation from Axial Load Test
- Resistance to Separation from Unscrewing
- Resistance to Overriding
- 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
Clinical Evidence
Clinical testing was not necessary for the determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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
2
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) | |
|---|---|
| ------------------------------------------------- | -- |
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, Inc
176 Nanagosa Trail
Suttons Bay, MI 49682
United States of America |
|----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kelli Anderson
Principal Regulatory Consultant
Office – (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 II
QEW |
| (a)(3). Primary Predicate Device:
Secondary Predicate Device:
Reference Devices: | K113757 – Aspire MAX Aspiration Catheter
K202218 - Zelante DVT ClotHunter Helical Rotation Device
K121051 and K132409 - Merit Medical Concierge Catheters |
(a)(4). Device Description
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.
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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.
5
(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).