(81 days)
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.
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.
Based on the provided text, the device in question is the VentiV 7Fr - 12Fr MP Mechanical Thrombectomy System. This is a medical device, not an AI/ML powered device, therefore no acceptance criteria related to AI/ML device performance (like sensitivity, specificity, AUC, human reader studies etc.) are mentioned.
The information provided describes the regulatory submission for premarket notification (510(k)) of a medical device, asserting its substantial equivalence to a legally marketed predicate device. The document details the physical and functional characteristics of the device and how they compare to the predicate, as well as the non-clinical testing performed.
Therefore, the specific information requested in the prompt about acceptance criteria and study proving AI/ML device performance (e.g., acceptance criteria for AI performance metrics, sample size for test sets, expert adjudication, MRMC studies, standalone AI performance, ground truth establishment for AI models, training set details) is not applicable to this document as it pertains to a mechanical medical device, not an AI/ML powered one.
However, I can extract the general acceptance criteria and the type of study performed to prove this mechanical device meets its intended use, based on the non-clinical testing conducted.
Acceptance Criteria and Study for the VentiV 7Fr - 12Fr MP Mechanical Thrombectomy System
Given that the device is a mechanical thrombectomy system and not an AI/ML powered device, the "acceptance criteria" discussed in this document relate to the performance and safety of the physical device compared to its predicate, rather than AI-specific metrics. The "study" refers to non-clinical bench testing.
1. Table of Acceptance Criteria (Implied) and Reported Device Performance (Non-Clinical)
While an explicit, quantifiable table of acceptance criteria for performance metrics is not provided in a format typical for AI/ML devices, the document states that all necessary verification steps met "pre-determined acceptance criteria" to demonstrate substantial equivalence. The reported performance refers to the device passing simulated use tests.
| Acceptance Criteria (Implied through Substantial Equivalence and Testing) | Reported Device Performance (Non-Clinical Testing) |
|---|---|
| Intended Use Equivalence: Comparable to predicate in removing fresh soft emboli and thrombi from peripheral vasculature. | Same intended use as the predicate.Same indications for use as the predicate. |
| Fundamental Scientific Technology Equivalence: Operates on the same principle as the predicate. | Same fundamental scientific technology (over-the-wire intravascular catheters, aspiration for thrombectomy).Same operating principle (manual syringe action to create vacuum). |
| Material Properties Equivalence: Materials are comparable to the predicate for safe and effective use. | Same material properties as the predicate. |
| Performance Specifications Equivalence: Meets similar functional specifications as the predicate. | Same performance specifications as the predicate.Same maximum vacuum potential (-760mmHg, -1ATM, -14.69PSI). |
| Physical Design Equivalence: Catheter dimensions, tip shape, aspiration lumen, guidewire compatibility are within comparable ranges to the predicate. | Catheter Shaft OD: Added 12Fr (predicate 7-11Fr). Otherwise, 7Fr-11Fr are same.Usable Lengths: Range expanded to 60-100cm (predicate 60-90cm).Tip Shape: Multipurpose (predicate Straight).Aspiration Lumen Shape: Round (Same).Guidewire: 0.035" (Same).Integrated Radiopaque Marker: Yes (Same). |
| Sterilization and Packaging Equivalence: Uses similar methods for sterilization and packaging. | Sterilization: ETO (Same).Packaging: Catheter in Hoop and Tyvek Tray (Same). |
| Biocompatibility: Meets established biocompatibility standards. | Biocompatibility: ISO 10993 compliant (Same). |
| Simulated Use Performance: Successfully tracks, aspirates in simulated peripheral vasculature. | Device "passes simulated use tracking, simulated aspiration, and simulated thrombectomy in the peripheral vasculature." |
| Accelerated Aging Performance: Performs as intended after accelerated aging. | Device "passes..." tests with accelerated aging up to 3-years. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document mentions "non-clinical testing" and refers to "test units" without specifying precise numerical sample sizes. This typically refers to a number of physical device units tested in a lab setting.
- Data Provenance: The data is generated from non-clinical bench testing rather than patient data. Therefore, concepts like "country of origin of the data," "retrospective," or "prospective" are not applicable. It's laboratory-generated data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. As this is a mechanical device, there is no "ground truth" established by experts in the context of image interpretation or clinical diagnosis. The "ground truth" for performance is based on direct physical measurements, simulations, and engineering specifications.
4. Adjudication Method for the Test Set:
- Not Applicable. There is no "adjudication" in the sense of reconciling expert opinions for a test set, as this is bench testing of a physical device. Performance is objectively measured against specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study is not mentioned because this is a mechanical device, not an AI/ML diagnostic system intended to assist human readers with interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not Applicable. This is a mechanical medical device, not an algorithm, so independent algorithmic performance is not relevant.
7. The Type of Ground Truth Used:
- For this mechanical device, the "ground truth" for performance and substantial equivalence is established through:
- Bench Testing: Direct physical measurements, engineered simulations (e.g., simulated vessels, simulated thrombi), and performance against predefined engineering specifications.
- Regulatory Standards: Compliance with relevant international standards (e.g., ISO 10993 for biocompatibility) and FDA guidance for medical device testing.
- Predicate Device Performance: The predicate device itself serves as a "ground truth" benchmark for demonstrating substantial equivalence in function and safety.
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI/ML device that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.
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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
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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
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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
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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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510(K) SUMMARY
(21 CFR 807.92)
GENERAL INFORMATION
| Submitter: | Control Medical Technology, Inc. dba VentiV Scientific |
|---|---|
| Contact Person: | Spencer Walker, MSc. – Regulatory AffairsPeak Regulatory Consulting370 South 300 EastSalt Lake City, UT 84111(801) 708-2238Spencer@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 ofDevice | Thrombectomy Catheter and/or Embolectomy Catheter |
| Classification Name: | Embolectomy Catheter21 CFR §870.5150, Product Code QEZ |
| Device Class: | Class II |
| Primary PredicateDevice: | 510(k) No.: K200871Model: Aspire MAX 7 - 11F Mechanical Thrombectomy System andAspire Mechanical AspiratorManufacture: Control Medical Technology, Inc.Classification: QEZ |
| Reference Devices: | 510(k) No.: K101497Model: Delivery Sheath, Model Adelante BreezewayManufacturer: Integer / Oscor Inc.Classification: DYB |
| 510(k) No.: K122958Model: Delivery Sheath, Model Adelante BreezewayManufacturer: Integer / Oscor Inc.Classification: DYB |
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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
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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 MechanicalThrombectomy System | ||
|---|---|---|
| Predicate - K200871 (Control 7Fr –11Fr Mechanical ThrombectomySystem) | Subject Device - (VentiV 7Fr – 12Fr MPMechanical Thrombectomy System) | |
| Device Name | Control 7Fr - 11Fr Mechanical ThrombectomySystem | VentiV 7Fr - 12Fr MP MechanicalThrombectomy System |
| Classification Name | Aspiration Thrombectomy Catheter21 CFR §870.5150Product Code: QEZClass II | Same - No Change |
| Ind. for Use | The Control 7Fr - 11Fr MechanicalThrombectomy System and Control MechanicalAspirator are indicated for the removal of freshsoft emboli and thrombi from vessels in theperipheral vasculature. | The VentiV 7Fr - 12Fr MP MechanicalThrombectomy System and VentiV MechanicaAspirator are indicated for the removal of freshsoft emboli and thrombi from vessels in theperipheral vasculature. |
| Single Use | Yes | Same - No Change |
| Prescription (RxOnly) | Yes | Same - No Change |
| Anatomical Access | Catheters are used in the peripheralvasculature via the patient's legs, arms, orchest | Same - No Change |
| FundamentalScientificTechnology | Over-the-wire intravascular catheters areintroduced via percutaneous or open surgicaltechnique, advanced to a target thrombus,then an aspirator, syringe, or pump is attachedto the proximal end of the catheter, and theuser creates thrombectomy force to removethe soft fresh thrombus or emboli from thevessel. | Same - No Change |
| Aspirator | 30ml Control AspiratorFDA ClearedK072299, K113757, K131998, and K200871 | 30ml VentiV AspiratorFDA ClearedK072299, K113757, K131998, and K200871 |
| CompatibleCatheterComponent | Over-the-Wire7Fr – 11Fr Catheters | Over-the-Wire7Fr – 12Fr Catheters |
| Tip Shape | Straight | Multipurpose |
| Table 1: Substantial Equivalence Comparison Chart – VentiV 7Fr – 12Fr MP MechanicalThrombectomy System | ||
| Predicate - K200871 (Control 7Fr –11Fr Mechanical ThrombectomySystem) | Subject Device – (VentiV 7Fr – 12Fr MPMechanical Thrombectomy System) | |
| Aspiration LumenShape | 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 |
| AspirationLumens | Single | Same – No Change |
| Guidewire | 0.035" | Same – No Change |
| IntegratedRadiopaqueMarker | Yes | Same – No Change |
| Tip, Shaft &Dilator Bodycontact | Direct circulating blood <24h | Same – No Change |
| Hubs, liner,Aspirator valvesand tubing | Indirect <24h | Same – No Change |
| Syringe Action | Manual | Same – No Change |
| Syringe maximumVacuum Potential | -760mmHG-1ATM-14.69PSI | Same – No Change |
| Sterilization | ETO | Same – No Change |
| Packaging | Catheter in Hoop and Tyvek Tray | Same – No Change |
| Biocompatibility | ISO 10993 compliant | Same – No Change |
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Non-Clinical Testing
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.
Conclusion:
The subject device is substantially equivalent to the currently marketed predicate based on comparison of the device classification, fundamental scientific technology, basic operating principle, indication for use, technical characteristics, packaging, and sterilization methods. Testing confirms the suitability of Subject Device for its intended use.
§ 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).