(56 days)
· Merlin Aspiration Catheter
As a part of the Merlin Aspiration System, the Merlin Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi in the peripheral arterial system.
· High Flow Tubing
As a part of the Merlin Aspiration System, the High Flow Tubing is indicated to connect the guide catheter to an aspiration pump.
The Merlin Aspiration System is comprised of two devices:
- Merlin Aspiration Catheter
- High Flow Tubing
The Merlin Aspiration Catheter is introduced through a guide catheter or long sheath into the peripheral vasculature and guided over a guidewire to the site of primary occlusion. The Merlin Aspiration Catheter is used in conjunction with an aspiration pump, which is connected to High Flow Tubing. These devices are visible under fluoroscopy.
Merlin Aspiration Catheter
The Merlin Aspiration Catheter consists of single lumen, coiled construction, variable stiffness shaft with radiopaque markers on distal and proximal end of the catheter portion for angiographic visualization. The Merlin Aspiration Catheter is identical in design to the MIVI Q Distal Access Catheter (K192558).
High Flow Tubing
The MIVI High Flow Tubing is a sterilized and disposable (onetime use) product consisting of high-pressure PVC tubing with end fittings and an on/off switch. The MIVI High Flow Tubing connects an aspiration pump to a reperfusion catheter, providing a means for introducing vacuum during procedures. The MIVI High Flow Tubing has a flow valve that allows the physician to start and stop the flow of aspiration.
The provided text describes the MIVI Merlin Aspiration System and its premarket notification (K213771) to the FDA, demonstrating substantial equivalence to a predicate device. However, the document does not contain specific acceptance criteria, reported device performance (in quantitative metrics), human reader studies, or detailed information about the ground truth establishment in the manner typically associated with studies proving device performance against acceptance criteria for AI/ML-based devices.
The provided text focuses on the mechanical and material performance of a medical device (aspiration catheter and tubing), not an AI/ML diagnostic or therapeutic device. Therefore, the questions related to AI/ML device testing (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to the content provided.
The document instead provides information about engineering bench testing, animal testing, and biocompatibility, which are standard for physical medical devices.
Here's a summary of the information that is available, formatted to address the relevant parts of your request, and explicitly stating where information is not applicable (N/A) based on the nature of the device described:
Acceptance Criteria and Device Performance (for a physical medical device)
1. Table of Acceptance Criteria and Reported Device Performance
For this physical medical device, the "acceptance criteria" are implied by the "established criteria" that the device was tested against. The "reported device performance" is simply that the device "Met established criteria" for each test. Specific quantitative criteria and performance values are not provided in this summary.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Merlin Aspiration Catheter | ||
| Coating Particulate Testing | Met established criteria | Met established criteria |
| Coating Adhesion | Met established criteria | Met established criteria |
| Coating Uniformity | Met established criteria | Met established criteria |
| Surface Integrity | Met established criteria | Met established criteria |
| Tip Inspection | Met established criteria | Met established criteria |
| Liquid Leakage under Pressure | Met established criteria | Met established criteria |
| Dimensional Verification | Met established criteria | Met established criteria |
| Kink Resistance | Met established criteria | Met established criteria |
| Push/Track | Met established criteria | Met established criteria |
| Suction Flow Rate | Met established criteria | Met established criteria |
| System Introduction / Aspiration of Thromboemboli | Met established criteria | Met established criteria |
| Tensile Strength-Push Wire | Met established criteria | Met established criteria |
| Tensile Strength-Distal Section | Met established criteria | Met established criteria |
| Catheter Torque Testing | Met established criteria | Met established criteria |
| Catheter Burst Testing | Met established criteria | Met established criteria |
| High Flow Tubing | ||
| Dimensional Verification | Met established criteria | Met established criteria |
| Vacuum Pressure | Met established criteria | Met established criteria |
| Flow Rate | Met established criteria | Met established criteria |
| Degree of Collapse | Met established criteria | Met established criteria |
| Simulated Use | Met established criteria | Met established criteria |
| Leak Test | Met established criteria | Met established criteria |
| Distal Male Luer Tubing Tensile Strength | Met established criteria | Met established criteria |
| Female Luer Tubing Tensile Strength | Met established criteria | Met established criteria |
| Proximal Male to Tubing Tensile Strength | Met established criteria | Met established criteria |
| Connector to Tubing Tensile Strength | Met established criteria | Met established criteria |
Information for AI/ML Device Evaluation (Not Applicable for this Device)
The following points are primarily relevant for AI/ML-based medical devices, which the Merlin Aspiration System is not. Therefore, specific details for these points are Not Applicable (N/A) based on the provided text. The device is a physical aspiration system, and its evaluation focuses on mechanical performance, biocompatibility, and animal testing.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This device is a physical medical device (aspiration system), not an AI/ML device that uses a "test set" of data in the common sense for diagnostic or prognostic purposes. Performance was evaluated through bench testing and animal testing.
- For animal testing: 8 animals (porcine carotid, renal, and subclavian vasculature). This is prospective testing in an animal model.
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)
- N/A. Ground truth establishment for a "test set" of data points is not relevant for the physical device performance testing described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Not relevant for the type of device testing described.
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
- N/A. This is a physical medical device, not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. For the bench testing, the "ground truth" would be established engineering specifications and physical measurements. For animal testing, it would be direct observation of the device's performance in vivo concerning safety and effectiveness in removing emboli/thrombi.
8. The sample size for the training set
- N/A. This device is not an AI/ML product developed using a training set.
9. How the ground truth for the training set was established
- N/A. Not applicable as there is no training set for this physical device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
January 27, 2022
MIVI Neurovascular, Inc. Janel Hurtado Regulatory Affairs Director 6545 City West Parkway Eden Prairie, Minnesota 55443
Re: K213771
Trade/Device Name: Merlin Aspiration System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEZ Dated: November 24, 2021 Received: December 2, 2021
Dear Janel Hurtado:
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.
{1}------------------------------------------------
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 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 (QS) 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 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 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 O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
Device Name Merlin Aspiration System
Indications for Use (Describe)
· Merlin Aspiration Catheter
As a part of the Merlin Aspiration System, the Merlin Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi in the peripheral arterial system.
· High Flow Tubing
As a part of the Merlin Aspiration System, the High Flow Tubing is indicated to connect the guide catheter to an aspiration pump.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(K) SUMMARY
| Date Prepared: January 24, 2022 | ||||
|---|---|---|---|---|
| Table 1. General Information | ||||
| 510(k) Submitter | Contact | |||
| MIVI Neuroscience, Inc. | Janel Hurtado | |||
| 6545 City West Parkway | Regulatory Affairs Director | |||
| Eden Prairie, MN 55344 | Email: jhurtado@mivineuro.com | |||
| General Information | ||||
| Trade Name | Merlin Aspiration System | |||
| Common Name | Catheter, Embolectomy | |||
| Classification | Percutaneous catheter; 21 CFR 870.5150 (Class II) | |||
| Information | ProCode: QEZ | |||
| Panel: Cardiovascular | ||||
| Predicate | Penumbra INDIGOTM Aspiration System (K161523) | |||
| Device | ||||
| Reference | MIVI Q Distal Access Catheter (K192558) | |||
| Device |
Device Description
The Merlin Aspiration System is comprised of two devices:
- Merlin Aspiration Catheter
- High Flow Tubing
The Merlin Aspiration Catheter is introduced through a guide catheter or long sheath into the peripheral vasculature and guided over a guidewire to the site of primary occlusion. The Merlin Aspiration Catheter is used in conjunction with an aspiration pump, which is connected to High Flow Tubing. These devices are visible under fluoroscopy.
Merlin Aspiration Catheter
The Merlin Aspiration Catheter consists of single lumen, coiled construction, variable stiffness shaft with radiopaque markers on distal and proximal end of the catheter portion for angiographic visualization. The Merlin Aspiration Catheter is identical in design to the MIVI Q Distal Access Catheter (K192558).
| Table 2: Device Information | |
|---|---|
| Device Description | Model Number |
| Merlin Aspiration Catheter, 3F | M3-36 |
| Merlin Aspiration Catheter, 4F | M4-43 |
{4}------------------------------------------------
| Merlin Aspiration Catheter, 5F | M5-57 |
|---|---|
| Merlin Aspiration Catheter, 6F | M6-69 |
| High Flow Tubing | HFT 110 |
High Flow Tubing
The MIVI High Flow Tubing is a sterilized and disposable (onetime use) product consisting of high-pressure PVC tubing with end fittings and an on/off switch. The MIVI High Flow Tubing connects an aspiration pump to a reperfusion catheter, providing a means for introducing vacuum during procedures. The MIVI High Flow Tubing has a flow valve that allows the physician to start and stop the flow of aspiration.
Intended Use / Indications
● Merlin Aspiration Catheter
As a part of the Merlin Aspiration System, the Merlin Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombus in the peripheral arterial system.
- High Flow Tubing ●
As a part of the Merlin Aspiration System, the High Flow Tubing is indicated to connect the guide catheter to an aspiration pump.
Substantial Equivalence Comparison
Table 3 compares the substantial equivalence of the subject, predicate and reference devices.
| Table-3: Comparison with Predicate Device | |||
|---|---|---|---|
| Feature | Subject DeviceMerlin AspirationSystem | Predicate DeviceINDIGO AspirationSystem | Reference DeviceMIVI Q Distal AccessCatheter |
| 510(k) Holder &Manufacturer | MIVI Neuroscience, Inc. | Penumbra, Inc. | MIVI Neuroscience, Inc. |
| 510(k)# | K213771 | K161523 | K192558 |
| Product Code | QEZ | QEW | DQY |
| Regulatory Class | Class II | ||
| Regulatory Number | 21 CFR 870.5150 | ||
| Regulatory Name | Percutaneous Catheter | ||
| Indications / Intended Use / Principle of Operation | |||
| Indications / IntendedUse | Merlin AspirationCatheterAs a part of the MerlinAspiration System, theMerlin Aspiration | INDIGO AspirationCathetersand SeparatorsAs part of the PenumbraEmbolectomy AspirationSystem | Q Distal Access Catheter isindicated for use withcompatible guide catheters infacilitating the insertionand guidance ofmicrocatheters into a selected |
| Table-3: Comparison with Predicate Device | |||
| Feature | Subject DeviceMerlin AspirationSystem | Predicate DeviceINDIGO AspirationSystem | Reference DeviceMIVI Q Distal AccessCatheter |
| Catheter is indicated forthe removal of fresh, softemboli and thrombus inthe peripheral arterialsystems.High Flow TubingAs a part of the MerlinAspiration System, theHFT 110 High FlowTubing is indicated toconnect the guidecatheter to an aspirationpump. | (INDIGOTM AspirationSystem),the INDIGO AspirationCathetersand Separators areindicated forthe removal of fresh, softemboliand thrombi from vesselsof theperipheral arterial andvenoussystems.INDIGO AspirationTubingAs part of the PenumbraEmbolectomy AspirationSystem(INDIGOTM AspirationSystem),the INDIGO SterileAspirationTubing is indicated toconnect theINDIGO AspirationCatheters tothe Penumbra PumpMAX.Penumbra Pump MAXThe Penumbra PumpMAX isindicated as a vacuumsource forthe Penumbra AspirationSystem. | blood vessel in theperipheral, coronary andneuro vascular systems. | |
| Aspiration Catheter | |||
| Tip | Straight | Straight | Straight |
| Marker band | Radiopaque | Radiopaque | Radiopaque |
| Catheter Coating | Hydrophilic | Hydrophilic | Hydrophilic |
| Guidewirecompatibility | Yes | Yes | Yes |
| Catheter Sizes | 3F, 4F, 5F, 6F | 3.4F, 5F, 6F, 8F | 3F, 4F, 5F, 6F |
| Table-3: Comparison with Predicate Device | |||
| Feature | Subject DeviceMerlin AspirationSystem | Predicate DeviceINDIGO AspirationSystem | Reference DeviceMIVI Q Distal AccessCatheter |
| Total Length (cm) | 148cm,135cm,130cm,130cm | 150cm, 132cm, 135cm, 85cm | 148cm,135cm,130cm,130cm |
| Catheter Biomaterials | Patient contactingmaterials are listed inTable 11-3 in Section11.7 | Biocompatible,commonly utilized forinterventional devices | Same as Merlin AspirationCatheter |
| Principle of Operation | The principle of operationis for removal of fresh,soft emboli and thrombiin the peripheral arterialsystem, using anendovascularapproach, underfluoroscopy.Contrast is often usedduring catheterplacement. | The principle of operationis for removal of fresh,soft emboli and thrombiin the peripheral arterialand venous system, usingan endovascularapproach, underfluoroscopy. Contrast isoften used during catheterplacement. | Used to endovascularly insertand guide microcathetersunder fluoroscopyduring diagnostic and/ortherapeutic procedures forpatients with arterialdisease or damage |
| Aspiration Tubing | |||
| Materials | The materials list isprovided in listed inTable 11-3 in Section11.7 | Biocompatible,commonly utilized forinterventional devices | N/A |
| Inner Diameter (ID) | 0.110 +/- .003 inches | 0.071"- 0.110" [1.8mm –2.8mm] | N/A |
| Length | 112 +/- 3 inches | 112.0 [284.5cm] | N/A |
| Principle of Operation | The High Flow Tubing isa suction tube used topass fluids from acatheter to a retentioncanister based on vacuumapplied by a pump. It isconnected between acommercially availableaspiration catheter and achosen source ofvacuum. | Tubing consists of a shorttubing segment with aninline filter, andconnectors on each end tofacilitate attachment tothe pump's vacuum port.The tubing is providedpre-attached to thecanister reservoir lid. | N/A |
| Accessories / Packaging / Sterilization / Shelf Life / Labeling | |||
| Provided Accessories | Not provided with anyaccessories. | Torque Device andIntroducer Sheath | Not provided with anyaccessories |
| Table-3: Comparison with Predicate Device | |||
| Feature | Subject DeviceMerlin AspirationSystem | Predicate DeviceINDIGO AspirationSystem | Reference DeviceMIVI Q Distal AccessCatheter |
| Required Accessories | 9F Rotatinghemostasisvalve Y-Connector 8F guidecatheter / 6Fguide sheath 90-95 cm in length(RequiredAccessory) | None | 9F Rotatinghemostasis valve Y-Connector 8F guide catheter /6F guide sheath 90-95 cm in length(RequiredAccessory) |
| Package Configuration | Catheter inserted in aplastic tube, mounted onan insert card, and sealedin a pouch. Sealed pouchpackaged in carton alongwith Instructions for Use.High Flow Tubing isplaced in a sealed,labeled Tyvek pouchpackaged in a labeledbox. | Commonly utilized forinterventional devices | Catheter inserted in a plastictube, mounted on an insertcard, and sealed in a pouch.Sealed pouch packaged incarton along with Instructionsfor Use. |
| Sterile & Non-pyrogenic? | Yes | ||
| Sterilization Method | Ethylene Oxide (EO) | ||
| Shelf Life | 3 years | ||
| Single use | Yes | Yes | Yes |
| Labeling | Proposed IFU | Current IFU | Current IFU |
{5}------------------------------------------------
{6}------------------------------------------------
{7}------------------------------------------------
Performance Testing
Bench Testing
The Merlin Aspiration System is identical to the MIVI Q Distal Access Catheter (K192558), which has been evaluated through risk analysis and design verification testing, which confirmed the device met design specifications.
Testing includes:
| Table 4: Design Verification Testing | |||
|---|---|---|---|
| Merlin Aspiration Catheter | |||
| Test | Result | ||
| Coating Particulate Testing | Met established criteria | ||
| Coating Adhesion | Met established criteria |
{8}------------------------------------------------
| Coating Uniformity | Met established criteria |
|---|---|
| Surface Integrity | Met established criteria |
| Tip Inspection | Met established criteria |
| Liquid Leakage under Pressure | Met established criteria |
| Dimensional Verification | Met established criteria |
| Kink Resistance | Met established criteria |
| Push/Track | Met established criteria |
| Suction Flow Rate | Met established criteria |
| System Introduction / Aspiration of Thromboemboli | Met established criteria |
| Tensile Strength-Push Wire | Met established criteria |
| Tensile Strength-Distal Section | Met established criteria |
| Catheter Torque Testing | Met established criteria |
| Catheter Burst Testing | Met established criteria |
| High Flow Tubing | |
| Dimensional Verification | Met established criteria |
| Vacuum Pressure | Met established criteria |
| Flow Rate | Met established criteria |
| Degree of Collapse | Met established criteria |
| Simulated Use | Met established criteria |
| Leak Test | Met established criteria |
| Distal Male Luer Tubing Tensile Strength | Met established criteria |
| Female Luer Tubing Tensile Strength | Met established criteria |
| Proximal Male to Tubing Tensile Strength | Met established criteria |
| Connector to Tubing Tensile Strength | Met established criteria |
Animal Testing
The Animal Testing data was performed in the porcine carotid, renal, and subclavian vasculature of 8 animals to ensure that there are no new questions of safety and effectiveness.
Biocompatibility
The MIVI Merlin Aspiration System patient contacting materials are the same materials used in the currently marketed reference device with an identical bio-contact. There is no change to colorants between the subject and reference devices.
Sterilization
Each Merlin Aspiration Catheter and High Flow Tubing device meets EO and ECH limits specified in the ISO 10933-7 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals (2008).
The sterilization validation for Merlin Aspiration Catheter and High Flow tubing was validated in accordance with ISO 11135-1: 2014 Sterilization of healthcare product- Ethylene oxide -Part 1: Requirements for development validation and routine control of a sterilization process for medical devices (2014).
Shelf-life and Expiration Dating
{9}------------------------------------------------
The Merlin Aspiration System will be labeled with an expiration date of 3 years from the date of sterilization, which is same as predicate and reference devices. There is no change in materials used and this does not impact the shelf-life of the product.
Substantial Equivalence Summary and Conclusion
The Merlin Aspiration System and the predicate device, the INDIGO Aspiration System, have identical indications, principles of operation, and a comparable design, but the Merlin catheter is indicated only for peripheral arterial use. While there are technological differences between the Merlin Aspiration System and the predicate device which are related to exclusion of separators, product labeling, and size matrix (3-6F and 130-148 cm lengths for the Merlin catheter, 3.4-8F and 85-150 cm lengths for the INDIGO aspiration catheter, 0.110+/- 0.003 inches ID and 112+/-3 inches length for High Flow Tubing, 0.071-0.110 inches ID and 112.0 inches length for INDIGO Aspiration Tubing), the Merlin Aspiration catheter is identical to currently marketed Q Distal Access catheter reference device in design and materials, and the scope of the change includes an indication change and rebranding. Therefore, the Merlin Aspiration Catheter has been evaluated through risk analysis and design verification testing (DVT). The testing verified the device met the design specifications and is sufficiently robust and suitable for its intended use as the predicate device. Based on the predicate device comparison, risk assessment, and DVT information provided in this 510(k), the subject device has been shown to be appropriate for its intended use and is therefore considered substantially equivalent to the predicate device.
§ 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).