(81 days)
No
The document does not mention AI, ML, or any related concepts in the device description, intended use, or performance studies.
Yes
The device is indicated for the "removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature," which is a therapeutic intervention.
No
Explanation: The device is described as a thrombectomy system and aspirator for removing emboli and thrombi, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it includes physical components like catheters, dilators, and an aspirator, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature." This describes a therapeutic procedure performed directly on the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is described as a "Mechanical Thrombectomy System" designed to "remove fresh soft emboli, debris, and thrombi from the peripheral vasculature." This further reinforces its role in a therapeutic intervention.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's health status
In summary, the VentiV 7Fr – 12Fr MP Mechanical Thrombectomy System and VentiV Mechanical Aspirator are devices used for a therapeutic procedure (removing blockages from blood vessels), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The VentiV 7Fr – 12Fr MP Mechanical Thrombectomy System and VentiV Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature. .
Product codes
OEZ
Device Description
The VentiV Mechanical Thrombectomy System devices are single-use, sterile, short-term use medical devices designed to remove fresh soft emboli, debris, and thrombi from the peripheral vasculature. The System includes (1) VentiV Mechanical Aspirator and (1) VentiV 7Fr - 12Fr catheters and dilators.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels in the peripheral vasculature. Catheters are used in the peripheral vasculature via the patient's legs, arms, or chest
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 testing in this submission confirms the subject device passes simulated use tracking, simulated aspiration, and simulated thrombectomy in the peripheral vasculature with test units accelerated aged up to 3-years. Accordingly, non-clinical testing confirms the subject device meets specifications, intended use, demonstration of claims, and equivalence to predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K101497, K122958, K181463, K210627, K221914, K240957
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
March 24, 2025
Control Medical Technology, Inc. / dba VentiV Scientific % Spencer Walker CEO/ Founder Peak Regulatory Consulting 370 South 300 East Salt Lake City, Utah 84111
Re: K250013
Trade/Device Name: VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B. V30-ASP) Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: OEZ Dated: December 31, 2024 Received: January 2, 2025
Dear Spencer Walker:
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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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-devices/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
2
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. O'CONNELL -S
O'CONNELL -S Date: 2025.03.24 09:57:51
-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
3
Indications for Use
510(k) Number (if known) K250013
Device Name
VentiV 7Fr -12Fr MP Mechanical Thrombectorny System (VS7-MP60S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP)
Indications for Use (Describe)
The VentiV 7Fr – 12Fr MP Mechanical Thrombectomy System and VentiV Mechanical Aspirator are indicated for the removal of fresh soft emboli 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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4
510(K) SUMMARY
(21 CFR 807.92)
GENERAL INFORMATION
| Submitter: | Control Medical Technology, Inc. dba VentiV Scientific |
|---|---|
| Contact Person: | Spencer Walker, MSc. – Regulatory Affairs |
| Peak Regulatory Consulting | |
| 370 South 300 East | |
| Salt Lake City, UT 84111 | |
| (801) 708-2238 | |
| Spencer@peakregulatory.com | |
| Trade Names: | VentiV 7Fr – 12Fr MP Mechanical Thrombectomy System |
| (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, | |
| VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, | |
| 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F- | |
| MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP) | |
| Common Name of | |
| Device | Thrombectomy Catheter and/or Embolectomy Catheter |
| Classification Name: | Embolectomy Catheter |
| 21 CFR §870.5150, Product Code QEZ | |
| Device Class: | Class II |
| Primary Predicate | |
| Device: | 510(k) No.: K200871 |
| Model: Aspire MAX 7 - 11F Mechanical Thrombectomy System and | |
| Aspire Mechanical Aspirator | |
| Manufacture: Control Medical Technology, Inc. | |
| Classification: QEZ | |
| Reference Devices: | 510(k) No.: K101497 |
| Model: Delivery Sheath, Model Adelante Breezeway | |
| Manufacturer: Integer / Oscor Inc. | |
| Classification: DYB | |
| 510(k) No.: K122958 | |
| Model: Delivery Sheath, Model Adelante Breezeway | |
| Manufacturer: Integer / Oscor Inc. | |
| Classification: DYB |
5
510(k) No.: K181463 Model: DuraSheath Introducer Sheath System Manufacturer: Heraeus / Contract Medical International GmbH Classification: DYB
510(k) No.: K210627 Model: Breezeway II Manufacturer: Integer / Oscor Inc. Classification: DYB
510(k) No.: K221914 Model: Catapult Guide Sheath Manufacturer: Heraeus /Contract Medical International GmbH Classification: DYB
510(k) No.: K240957 Model: Catapult Guide Sheath Manufacturer: Heraeus /Contract Medical International GmbH Classification: DYB
Device Description:
The VentiV Mechanical Thrombectomy System devices are single-use, sterile, short-term use medical devices designed to remove fresh soft emboli, debris, and thrombi from the peripheral vasculature. The System includes (1) VentiV Mechanical Aspirator and (1) VentiV 7Fr - 12Fr catheters and dilators.
Image /page/5/Figure/7 description: The image shows a medical device and its components. The device consists of a syringe-like instrument and three catheter-like components. The components are labeled as 'Luer Hub', 'Catheter', 'Marker Band', 'Dilator for 7-12F Catheters', and '11P Dilator'. The catheter is between 60cm to 100cm and 8F to 12F.
Image /page/5/Figure/8 description: The image shows the text "Figure 1: Representative image of the VentiV Mechanical Thrombectomy System and compatible devices." The text describes the image as a representative image of the VentiV Mechanical Thrombectomy System and compatible devices. The figure number is 1.
Indications for Use:
The VentiV 7Fr – 12Fr MP Mechanical Thrombectomy System is indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
Comparative Analysis:
It has been demonstrated that the VentiV 7Fr - 12Fr MP Mechanical Thrombectomy System is comparable to the predicate device in intended use, fundamental scientific technology, design, principles of operation and functional performance evaluations. The VentiV 7Fr - 12Fr MP Mechanical Thrombectomy System has been fully assessed within the VentiV Scientific Risk
6
Management and Design Controls systems. All necessary verification steps met pre-determined acceptance criteria to demonstrate substantial equivalence to the predicate device.
It has been demonstrated that the VentiV 7Fr – 12Fr MP Mechanical Thrombectomy System is comparable to the predicate device in the following manner:
- Same intended use ●
- Same indications for use
- Same fundamental scientific technology
- Same material properties
- . Same operating principle
- . Same performance specifications
- . Same patient-user interface
| Table 1: Substantial Equivalence Comparison Chart - VentiV 7Fr – 12Fr MP Mechanical
| Thrombectomy System | ||
|---|---|---|
| Predicate - K200871 (Control 7Fr – | ||
| 11Fr Mechanical Thrombectomy | ||
| System) | Subject Device - (VentiV 7Fr – 12Fr MP | |
| Mechanical Thrombectomy System) | ||
| Device Name | Control 7Fr - 11Fr Mechanical Thrombectomy | |
| System | VentiV 7Fr - 12Fr MP Mechanical | |
| Thrombectomy System | ||
| Classification Name | Aspiration Thrombectomy Catheter | |
| 21 CFR §870.5150 | ||
| Product Code: QEZ | ||
| Class II | Same - No Change | |
| Ind. for Use | The Control 7Fr - 11Fr Mechanical | |
| Thrombectomy System and Control Mechanical | ||
| Aspirator are indicated for the removal of fresh | ||
| soft emboli and thrombi from vessels in the | ||
| peripheral vasculature. | The VentiV 7Fr - 12Fr MP Mechanical | |
| Thrombectomy System and VentiV Mechanica | ||
| Aspirator are indicated for the removal of fresh | ||
| soft emboli and thrombi from vessels in the | ||
| peripheral vasculature. | ||
| Single Use | Yes | Same - No Change |
| Prescription (Rx | ||
| Only) | Yes | Same - No Change |
| Anatomical Access | Catheters are used in the peripheral | |
| vasculature via the patient's legs, arms, or | ||
| chest | Same - No Change | |
| Fundamental | ||
| Scientific | ||
| Technology | Over-the-wire intravascular catheters are | |
| introduced via percutaneous or open surgical | ||
| technique, advanced to a target thrombus, | ||
| then an aspirator, syringe, or pump is attached | ||
| to the proximal end of the catheter, and the | ||
| user creates thrombectomy force to remove | ||
| the soft fresh thrombus or emboli from the | ||
| vessel. | Same - No Change | |
| Aspirator | 30ml Control Aspirator | |
| FDA Cleared | ||
| K072299, K113757, K131998, and K200871 | 30ml VentiV Aspirator | |
| FDA Cleared | ||
| K072299, K113757, K131998, and K200871 | ||
| Compatible | ||
| Catheter | ||
| Component | Over-the-Wire | |
| 7Fr – 11Fr Catheters | Over-the-Wire | |
| 7Fr – 12Fr Catheters | ||
| Tip Shape | Straight | Multipurpose |
| Table 1: Substantial Equivalence Comparison Chart – VentiV 7Fr – 12Fr MP Mechanical | ||
| Thrombectomy System | ||
| Predicate - K200871 (Control 7Fr – | ||
| 11Fr Mechanical Thrombectomy | ||
| System) | Subject Device – (VentiV 7Fr – 12Fr MP | |
| Mechanical Thrombectomy System) | ||
| Aspiration Lumen | ||
| Shape | Round | Same – No Change |
| Catheter Shaft OD | 7Fr, 8Fr, 9Fr, 10Fr, 11Fr | 7Fr, 8Fr, 9Fr, 10Fr, 11Fr, 12Fr |
| Usable lengths | 60 – 90cm | 60cm to 100cm |
| Aspiration | ||
| Lumens | Single | Same – No Change |
| Guidewire | 0.035" | Same – No Change |
| Integrated | ||
| Radiopaque | ||
| Marker | Yes | Same – No Change |
| Tip, Shaft & | ||
| Dilator Body | ||
| contact | Direct circulating blood |