(166 days)
No
The description focuses on the mechanical and physical properties of the catheter and aspiration system, with no mention of AI or ML for image analysis, decision support, or any other function.
Yes
The device is indicated for "revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease," which is a treatment for a medical condition.
No
This device is a reperfusion catheter system used to remove thrombus/clot from neurovasculature, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines physical components like catheters, tubing sets, and a pump, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The MantaRay Reperfusion Catheter system is designed to be used inside the human body to physically remove blood clots from blood vessels. It is an interventional device used for treatment, not for analyzing samples taken from the body.
- Intended Use: The intended use clearly states "revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease," which is a therapeutic procedure performed directly on the patient.
- Device Description: The description details a catheter designed for insertion into blood vessels, not for handling or analyzing biological specimens.
- Performance Studies: The performance studies involve bench testing, animal studies, and physician validation studies using simulated use models and animal models, all focused on the physical performance and safety of the device within a vascular system, not on the analysis of biological samples.
Therefore, based on the provided information, the MantaRay Reperfusion Catheter system is a therapeutic medical device used for interventional procedures, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The MantaRay Reperfusion Catheters, with the Imperative Care Aspiration Tubing Set and Imperative Care Aspiration Pump (or equivalent vacuum pump), are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
The Imperative Care Aspiration Tubing Set is intended to connect the Imperative Care Reperfusion Catheter to the canister of the Imperative Care Aspiration Pump and to allow the user to control the fluid flow.
Product codes (comma separated list FDA assigned to the subject device)
NRY
Device Description
The MantaRay Reperfusion Catheter is a single lumen, braid and coil reinforced, variable stiffness catheter that facilitates removal of thrombus/clot from the neurovasculature when connected to a vacuum source generated from the Imperative Care Aspiration Pump using the Imperative Care Aspiration Tubing. The MantaRay Reperfusion Catheter will be offered with various working lengths and nominal inner diameters (ID) and outer diameters (OD) as shown in Table 1 below.
The MantaRay Reperfusion Catheter is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers.
The distal section of the MantaRay Reperfusion Catheter has a hydrophilic coating to enhance tracking through the vasculature. The beveled distal tip allows for atraumatic tracking past vessel branches during insertion. A radiopaque marker provides the user with visual confirmation of the distal tip location under fluoroscopy.
The MantaRay Reperfusion Catheter is packaged with an accessory Rotating Hemostasis Valve (RHV). The RHV is designed to be attached to the proximal luer of the catheter and helps the user maintain hemostasis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries
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)
Bench and Lab (in-vitro) testing were conducted in order to evaluate the similarities and differences between the MantaRay Reperfusion Catheter with Imperative Care Aspiration Pump and Aspiration Tubing Set and the predicate Penumbra System. The largest and smallest diameter catheter sizes were tested for both the subject and predicate devices. The test results were reviewed and found to demonstrate that the differences between the subject and predicate devices do not significantly impact any performance parameters that would negatively affect the safety or effectiveness of the subject MantaRay Reperfusion Catheter used with the Imperative Care Aspiration Pump and Aspiration Tubing Set. These tests were performed per company approved protocols and test methods based primarily on catheter performance standard ISO 10555-1.
A series of subacute and chronic animal studies were conducted to evaluate the safe and effective use of the MantaRay Reperfusion Catheter with the Imperative Care Aspiration Pump and Aspiration Tubing Set in a porcine model. Testing included worst case positioning of the catheter in a "wedged" position, retrieval of various types of clots, and evaluation of various aspiration pressures. The predicate Penumbra System was used as a control device in all completed studies. The studies concluded that:
- All vessels treated with the MantaRay Reperfusion Catheters were patent, with no ● perforation, dissection or thrombosis following completion of the procedure.
- The subacute and chronic vascular response was histologically comparable between the MantaRay Reperfusion Catheter and predicate Penumbra System Reperfusion Catheter.
- . The subacute and chronic pathological findings were comparable between the MantaRay Reperfusion Catheter and predicate Penumbra System Reperfusion Catheter.
A user validation study was developed and conducted per recommendations in the FDA guidance document titled "Applying Human Factors and Usability Engineering to Medical Devices ". As part of the study, active US physicians experienced in interventional neuroradiology and neurovascular surgery were asked to complete clot retrieval procedures under fluoroscopic visualization in a tortuous neurovascular simulated use model using both the subject MantaRay Reperfusion Catheter with the Imperative Care Aspiration Pump and Aspiration Tubing Set and the predicate Penumbra System. The order in which each physician tested the subject and predicate devices was randomized to reduce bias. The results of the clot retrieval procedures for the subject and predicate devices were analyzed and compared. The analysis found no significant differences between the subject and predicate devices that would negatively impact safety or effectiveness.
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.
K152541, K1424581, K090752, K113163
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
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1
510(k) Summary
A. Submitter Information
Submitter's Name: Address:
Telephone: Email: Contact Person: Date of Preparation:
B. Subject Device
Proprietary Name: Common/Usual Name: Classification Name: Product Code:
C. Primary Predicate Device
Proprietary Name: Manufacturer: 510(k) #'s:
Imperative Care Inc. 1359 Dell Avenue Campbell, CA 95008 248-496-0198 JWolenberg@imperativecare.com Jake Wolenberg October 31, 2018
MantaRay (071, 055, 045, 035) Reperfusion Catheters; Imperative Care Aspiration Tubing Set Catheter, Thrombus Retriever Catheter, Percutaneous NRY per 21 C.F.R. 870.1250
| Predicate Device Model | Corresponding 510(k) |
|---|---|
| ACE68 | K152541, K1424581 |
| 5MAX | K090752 |
| 4MAX | K113163 |
| 3MAX | K113163 |
Common/Usual Name: Classification Name: Product Code:
Catheter, Thrombus Retriever Catheter, Percutaneous NRY per 21 C.F.R. 870.1250
1 The Penumbra System ACE68 Reperfusion Catheter was cleared under K142458 with an Indications for Use in the internal carotid artery (ICA) only. In K152541, animal study data was submitted showing that the catheters were safe to use in a "wedged" position and Indications for Use for the same Penumbra System ACE68 Reperfusion Catheter design was expanded to include the ICA, M1, M2, vertebral, and basilar arteries.
2
Device Description: D.
The MantaRay Reperfusion Catheter is a single lumen, braid and coil reinforced, variable stiffness catheter that facilitates removal of thrombus/clot from the neurovasculature when connected to a vacuum source generated from the Imperative Care Aspiration Pump using the Imperative Care Aspiration Tubing. The MantaRay Reperfusion Catheter will be offered with various working lengths and nominal inner diameters (ID) and outer diameters (OD) as shown in Table 1 below.
| Product Name | Model | Distal
Diameter | | Proximal
Diameter | | Nominal Usable | Hydrophilic
Coating |
|------------------------|------------|--------------------|--------|----------------------|--------|-----------------|------------------------|
| (Used Throughout 510k) | Number | Inner | Outer | Inner | Outer | Catheter Length | Length |
| 0.071" ID MantaRay | ICRC071137 | 0.071" | 0.083" | 0.071" | 0.083" | 137 cm | 35cm |
| 0.055" ID MantaRay | ICRC055137 | 0.055" | 0.069" | 0.067" | 0.080" | 137 cm | 35cm |
| 0.045" ID MantaRay | ICRC045144 | 0.045" | 0.060" | 0.064" | 0.080" | 144 cm | 65cm |
| 0.035" ID MantaRay | ICRC035158 | 0.035" | 0.051" | 0.047" | 0.060" | 158 cm | 90cm |
Table 1: MantaRay Reperfusion Catheter Sizes
The MantaRay Reperfusion Catheter is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers.
The distal section of the MantaRay Reperfusion Catheter has a hydrophilic coating to enhance tracking through the vasculature. The beveled distal tip allows for atraumatic tracking past vessel branches during insertion. A radiopaque marker provides the user with visual confirmation of the distal tip location under fluoroscopy.
The MantaRay Reperfusion Catheter is packaged with an accessory Rotating Hemostasis Valve (RHV). The RHV is designed to be attached to the proximal luer of the catheter and helps the user maintain hemostasis.
3
In addition to the supplied accessories discussed above, the adjunctive devices and supplies listed below are intended to be used with the MantaRay Reperfusion Catheter. All of these accessories are also commonly used with the predicate Penumbra System.
- Guidewires
- Support/Diagnostic Catheters ●
- Introducer Sheaths ●
Imperative Care will offer an Aspiration Pump and Tubing that can be used with the MantaRay Reperfusion Catheter (referred to as Imperative Care Aspiration Pump and Imperative Care Aspiration Tubing). The Imperative Care Aspiration Pump and Tubing will be packaged and sold separately from the MantaRay Reperfusion Catheter.
The Imperative Care Aspiration Pump was cleared under K180115 and the Imperative Care Aspiration Tubing is a part of this 510(k) submission. The Imperative Care Aspiration Pump (K180115) and Aspiration Tubing are manufactured for Imperative Care by Taiwan Biomaterial Co., Ltd. (TWBM). The MantaRay Reperfusion Catheter has been tested with and verified to perform as intended when used in conjunction with the Imperative Care Aspiration Pump and Tubing.
4
Indications for Use: E.
The MantaRay Reperfusion Catheters, with the Imperative Care Aspiration Tubing Set and Imperative Care Aspiration Pump (or equivalent vacuum pump), are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
The Imperative Care Aspiration Tubing Set is intended to connect the Imperative Care Reperfusion Catheter to the canister of the Imperative Care Aspiration Pump and to allow the user to control the fluid flow.
Predicate Comparison: F.
The predicate device for the MantaRay Reperfusion Catheter is the Penumbra System Reperfusion Catheter (ACE68, 5MAX, 4MAX, and 3MAX). The Penumbra System Reperfusion Catheter was selected as the predicate device as it has the same intended use and similar catheter designs as the subject MantaRay Reperfusion Catheter.
There are multiple catheter sizes in the predicate device product family that were cleared over a series of 510(k) submissions, as indicated in Table 2 below. Each of the MantaRay Reperfusion Catheter sizes was designed to correspond to one of the predicate Penumbra System Reperfusion Catheter sizes.
| Subject
Device Model | Distal Inner
Diameter x
Working Length | Corresponding
Predicate
Device Model | Distal Inner
Diameter x
Working Length | Predicate
Device
510(k) |
|-------------------------|----------------------------------------------|--------------------------------------------|----------------------------------------------|-------------------------------|
| 0.071" ID MantaRay | 0.071" x 137cm | ACE68 | 0.068" x 132cm | K152541
K1424582 |
| 0.055" ID MantaRay | 0.055" x 137cm | 5MAX | 0.054" x 132cm | K090752 |
| 0.045" ID MantaRay | 0.045" x 144cm | 4MAX | 0.041" x 139cm | K113163 |
| 0.035" ID MantaRay | 0.035" x 158cm | 3MAX | 0.035" x 153cm | K113163 |
Table 2: Subject and Predicate Device Models
Table 3 presented below provides a comparison of the similarities and differences between the subject MantaRay Reperfusion Catheters and the predicate Penumbra System Reperfusion Catheters. Bench and lab testing was conducted as appropriate to evaluate any differences that were identified.
2 The Penumbra System ACE68 Reperfusion Catheter was cleared under K142458 with an Indications for Use in the internal carotid artery (ICA) only. In K152541, animal study data was submitted showing that the catheters were safe to use in a "wedged" position and Indications for Use for the same Penumbra System ACE68 Reperfusion Catheter design was expanded to include the ICA, M1, M2, vertebral, and basilar arteries.
5
The comparison between the subject and predicate devices found that the MantaRay Reperfusion Catheter is substantially equivalent to the predicate Penumbra System Reperfusion Catheter, and that there are no new safety or effectiveness concerns. This conclusion is based on all devices sharing the same intended use, basic technology characteristics, and performance characteristics, as demonstrated through bench, lab, and animal testing.
| Device Attribute | MantaRay Reperfusion Catheter
(Subject Device) | Penumbra System Reperfusion
Catheter (Predicate Device) |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| FDA Product
Classification | Class II, NRY, 21 CFR 870.1250 | Same |
| Intended Use | Revascularization of patients with
acute ischemic stroke. | Same |
| Condition
Supplied | Sterile and Single Use | Same |
| Sterilization
Method | Ethylene Oxide (EtO), SAL 10-6 | Same |
| Inner Diameter
(Distal) | 0.035" – 0.071" | 0.035" – 0.068" |
| Outer Diameter
(Distal) | 0.051" – 0.083" | 0.050" – 0.084" |
| Inner Diameter
(Proximal) | 0.047" – 0.071" | 0.043" – 0.068" |
| Outer Diameter
(Proximal) | 0.060" – 0.083" | 0.062" – 84 |
| Effective Length | 137 - 158cm | 132 - 160cm |
| Tip Design | Beveled edge, soft, flexible, and
atraumatic | Square edge, soft, flexible, and
atraumatic |
| Coating | Surmodics Hydrophilic coating | Surmodics Hydrophilic coating |
| Materials | Commonly used medical grade plastics
& metals with hydrophilic coating. | Commonly used medical grade plastics
& metals with hydrophilic coating. |
| Packaged
Accessories | Rotating Hemostasis Valve (RHV) | Rotating Hemostasis Valve (RHV)
Peelable Catheter Introducer
Steam Shaping Mandrel |
| Packaging
Configuration | The catheter is placed in a protective
polyethylene tube and then mounted,
along with the accessories, onto a
polyethylene packaging card.
The packaging card is inserted into a
Tyvek® pouch which is then sealed.
The sealed pouch and IFU are placed in | Same |
| Device Attribute | MantaRay Reperfusion Catheter
(Subject Device) | Penumbra System Reperfusion
Catheter (Predicate Device) |
| Key Device
Components | Imperative Care Aspiration Pump
Imperative Care Aspiration Tubing Set | Penumbra Pump MAX
Penumbra Hi-Flow Tubing |
| Critical Aspiration Pump Performance Requirements | | |
| Aspiration
Pressure | -20 inHg to max vacuum | -20 inHg to max vacuum |
| Flowrate (Air) | 0 to 23 LPM | 0 to 23 LPM |
| IEC 60601
Compliance | Pump is compliant with electrical
safety standards. | Pump is compliant with electrical
safety standards. |
| Critical Aspiration Tubing Requirements | | |
| Tubing ID | 0.110" Minimum | 0.110" Minimum |
| Tubing Length | 112" | 112" |
| Flow Control
Mechanism | Flow Control Switch | Flow Control Switch |
Table 3: Subject and Predicate Device Comparison
6
7
Performance Data Supporting Substantial Equivalence: G.
Bench and Lab (in-vitro) testing were conducted in order to evaluate the similarities and differences between the MantaRay Reperfusion Catheter with Imperative Care Aspiration Pump and Aspiration Tubing Set and the predicate Penumbra System. The largest and smallest diameter catheter sizes were tested for both the subject and predicate devices.
The test results were reviewed and found to demonstrate that the differences between the subject and predicate devices do not significantly impact any performance parameters that would negatively affect the safety or effectiveness of the subject MantaRay Reperfusion Catheter used with the Imperative Care Aspiration Pump and Aspiration Tubing Set.
A summary of the tests and performance specifications that were evaluated is presented in Table 4. These tests were performed per company approved protocols and test methods based primarily on catheter performance standard ISO 10555-1.
| Test Attribute | Specification |
|---|---|
| Delivery, Compatibility, | |
| and Retraction | |
| (Trackability) | The catheter shall be able to be delivered, deployed, and retracted |
| per the IFU within a simulated neurological model without | |
| incurring any damage to the catheter. | |
| Clot Retrieval | The catheter will be able to be delivered in a clinically relevant |
| model and used to effectively aspirate clots with the aspiration | |
| pump and aspiration tubing set when placed at appropriate | |
| locations based on the size of the catheter. | |
| Flexibility and Kink | |
| Resistance | There shall be no kinking of shaft (permanent deformation) after |
| simulated use. | |
| Compatibility with other | |
| devices (external) | The catheters shall be able to be delivered through the minimum |
| introducer sheath or guide catheter size indicated in the product | |
| labeling. | |
| Guidewire compatibility | The catheters shall be able to be delivered over the guidewire size |
| indicated in the product labeling. | |
| Interventional device | |
| compatibility (internal) | The catheters shall be able to accommodate other interventional |
| devices (e.g., support catheter, diagnostic catheter) up to the | |
| maximum size indicated in the product labeling. | |
| Luer compatibility | Devices and accessories shall be compatible with standard syringe |
| luer fittings per ISO 80369-7. | |
| Accessory compatibility | Devices shall be compatible with the accessory RHV. |
| Test Attribute | Specification |
| Visual | Free of kinks, breaks, separation or particulate (greater than |
| 0.25mm²). No exposed metal. | |
| Dimensional | All defined catheter dimensions are within the specified |
| tolerances. | |
| Catheter Bond Strength | The catheter shall have sufficient bond strengths to remain intact |
| throughout a procedure. | |
| Flowrate - positive | |
| (forward) pressure | The catheter lumen shall allow for a minimum flowrate |
| comparable to competitive products. | |
| Flowrate – vacuum | |
| pressure | The flowrate under a vacuum shall be similar to or greater than |
| competitive devices. | |
| Freedom from Leakage | |
| – positive pressure | No liquid leakage from the hub or catheter shaft at 46psi for 30 |
| seconds | |
| Freedom from Leakage | |
| – negative pressure | No air leakage into a 20cc syringe when vacuum pulled for 15 |
| seconds. | |
| Burst Pressure | Catheter does not burst under pressures that could be seen when |
| performing contrast injections with a standard 10cc syringe. | |
| Catheter Torque | |
| Strength | No separation of any portion of the catheter when rotated at least |
| two (2) full rotations (720 degrees). | |
| Lumen Integrity | The catheter lumen shall not collapse under vacuum. |
| Kink Resistance | There shall be no kinking of the catheter shaft (permanent |
| deformation) after wrapping around anatomically relevant bend | |
| radii. | |
| Flexibility | The flexibility of the catheter tip shall be comparable to |
| competitive products and allow for easily tracking the device to | |
| the desired target anatomy. | |
| Coating - Particulate | The amount of particulate matter that comes off the hydrophilic- |
| coated shaft during simulated use testing shall be determined and | |
| compared to competitive products and techniques. | |
| Coating - lubricity | Coating must be lubricious and maintain a minimum lubricity over |
| 15 test cycles. | |
| Test Attribute | Specification |
| Corrosion Resistance | No visible corrosion present on devices after saline immersion |
| followed by 30 minutes in boiling water followed by 48 hours in | |
| 37°C water bath. | |
| Radiopacity | The radiopaque marker on the catheter can be seen under |
| fluoroscopy during use. | |
| Vacuum Force at | |
| Catheter Tip | The vacuum force at the tip of the catheter should be comparable |
| to the vacuum force at the tip of the predicate devices. | |
| Aspiration Volume | The volume of fluid aspirated when using the catheter should be |
| comparable to the predicate devices. |
Table 4: Tests and Performance Specifications
8
9
In addition to the above tests which support that the MantaRay Reperfusion Catheter performs as intended when used in conjunction with the Imperative Care Aspiration Pump and Aspiration Tubing Set, Imperative Care also confirmed that performance testing has been completed for the Imperative Care Aspiration Pump (K180115) and Imperative Care Aspiration Tubing Set individually. Testing completed for the Imperative Care Aspiration Pump is summarized in K180115. Testing for the Imperative Care Aspiration Tubing includes: connector compatibility, lumen collapse resistance, flow control switch functionality, freedom from leakage, and tensile strength.
10
Biocompatibility Testing: H.
Biocompatibility testing was performed on all direct patient contacting components of the MantaRay Reperfusion Catheter. This testing was conducted to ensure that the components and raw materials used in the proposed MantaRay Reperfusion Catheter, as well as the manufacturing processes and sterilization processes result in a biocompatible product. All biocompatibility tests were conducted pursuant to 21 CFR Part 58, Good Laboratory Practices, ISO 10993-1, and per the recommendations in FDA guidance document titled: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
As the MantaRay Reperfusion Catheter is in direct contact with circulating blood and the average length of an endovascular procedure is typically less than 2 hours, the test devices were evaluated for the tests recommended in the patient contact category: External communicating device, blood path direct, limited contact duration.
A summary of the selected biocompatibility tests performed for the MantaRay Reperfusion Catheter is presented for reference below and on the following pages in Table 5. All test results passed, indicating that the MantaRay Reperfusion Catheter is biocompatible for its intended use.
| Test | Test Method | Extraction Methods/Conditions | Acceptance Criteria | Results |
|---|---|---|---|---|
| Cytotoxicity: ISO | ||||
| MEM* Elution | ISO 10993-5 | Test device extracted in | ||
| MEM with 5% serum at 37 ± 1°C for 24 ± 2 hours | Sample extracts must yield cell lysis grade 2 or lower. | Pass, Non- | ||
| cytotoxic | ||||
| Cytotoxicity: ISO | ||||
| MTT* Assay | ISO 10993-5 | Test device extracted in | ||
| MTT* Assay Media at 37 ± 1°C for 24 ± 2 hours | The percentage of cells exhibiting lysis should be similar for all test devices. | Pass, No | ||
| Significant | ||||
| Differences | ||||
| Sensitization: | ||||
| Magnusson- | ||||
| Kligman Method, 2 | ||||
| extracts | ISO 10993-10 | Guinea pigs exposed to test device extracts. Challenged sites observed for skin sensitization 24 ± 2 and 48 ± 2 hours after removal of extracts. | ||
| Extracts were prepared at 50 ± 2°C for 72 ± 2 hours. | Test Group shall yield Grade 10% weight loss in 3 | |||
| or more test animals | ||||
| • Mortality of 2 or more | ||||
| test animals | ||||
| • Toxic signs such as | ||||
| convulsions and | ||||
| prostration in 2 or more | ||||
| test animals | Pass, Non-Toxic | |||
| Hemocompatibility: | ||||
| Complement | ||||
| Activation | ISO 10993-4 | |||
| ASTM F756 | Preformed in vitro using a | |||
| prepared Enzyme | ||||
| Immunoassay (EIA) kit. This | ||||
| kit will detect the presence of | ||||
| specific complement | ||||
| enzymes. | ||||
| Test device incubated in | ||||
| serum at $37\pm 2$ °C and tested | ||||
| for C3a and SC5b at 0.5, 1, | ||||
| and 1.5 hours. | The concentrations of C3a | |||
| and SC5b-9 in the test | ||||
| devices are statistically | ||||
| similar to the predicate | ||||
| device (Penumbra Neuron | ||||
| Max 6F Catheter) and | ||||
| statistically lower than the | ||||
| positive control for all | ||||
| exposure times. | Pass, No | |||
| Significant | ||||
| Differences | ||||
| The test device had | ||||
| statistically similar | ||||
| or lower | ||||
| concentrations than | ||||
| the predicate and | ||||
| negative controls. | ||||
| Test | Test Method | Extraction | ||
| Methods/Conditions | Acceptance Criteria | Results | ||
| Hemocompatibility: | ||||
| Hemolysis (Direct | ||||
| Contact Method) | ASTM F 756 | |||
| ISO 10993-4 | Test device extracted in | |||
| PBS* and diluted blood at 37 | ||||
| $\pm$ 2°C for 3 $\pm$ 5 minutes. | ||||
| Test device exposed to blood | ||||
| cell suspension. | ||||
| % hemolysis is measured. | Sample extracts must be | |||
| nonhemolytic ( $\le$ 2% | ||||
| hemolytic index). | Pass, Non- | |||
| hemolytic | ||||
| Hemocompatibility: | ||||
| Hemolysis (Extract | ||||
| Method) | ASTM F 756 | |||
| ISO 10993-4 | Test device extracted in PBS | |||
| at 50 $\pm$ 2°C for 72 $\pm$ 2 hours. | ||||
| Extract exposed to blood cell | ||||
| suspension. % hemolysis is | ||||
| measured. | Sample extracts must be | |||
| nonhemolytic ( $\le$ 2% | ||||
| hemolytic index). | Pass, Non- | |||
| hemolytic | ||||
| Standard In vivo | ||||
| Thrombogenicity, | ||||
| Ovine Jugular | ||||
| NAVI (ISO) | ISO 10993- | |||
| 4:2002 | Performed in duplicate. Test | |||
| and control device are placed | ||||
| in alternate sides of the | ||||
| juggler vein. The devices are | ||||
| implanted and remains in | ||||
| place for 4 $\pm$ 0.5 hours. | The device must have similar or lesser thrombogenic potential after 4 hours in vivo when compared to a control device (Penumbra Neuron Max 6F Catheter). | Pass, Minimal | ||
| Thrombogenic | ||||
| Potential | ||||
| The test device had less thrombogenic potential than the control device. |
Table 5: Biocompatibility Test Summarv
11
12
*MEM=Minimal Essential Media,
MTT Assay = (3-(4,5-Dimethylthiazol-2-yl)-2,5-Diphenyltetrazolium Bromide)
NS = Normal Saline
PBS=Phosphate Buffered Saline
Imperative Care also confirmed that the Imperative Care Aspiration Tubing Set is biocompatible for its intended use. Biological evaluation of the aspiration tubing was conducted pursuant to 21 CFR Part 58, Good Laboratory Practices and following the recommendations in FDA guidance document titled: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". As the aspiration tubing does not have any patient contact, it was evaluated for the tests recommended for skin contacting devices to cover a worst-case scenario where the aspiration tubing may be handled by someone who isn't wearing gloves. All test results passed, indicating that the aspiration tubing is biocompatible for the intended use.
13
L. Sterilization:
The MantaRay Reperfusion Catheter is sterilized using a validated EtO process with a sterility assurance level of 1x10 . The sterilization process was validated per the overkill method described recognized consensus standard ISO 11135, "Sterilization Of Health-Care Products -Ethylene Oxide - Requirements For The Development, Validation And Routine Control Of A Sterilization Process For Medical Devices." A summary of the completed testing is presented below in Table 6.
| Requirement/Acceptance Criteria | Results | Summary |
|---|---|---|
| Positive BI controls must be positive in | ||
| fractional, half and full cycles. | PASS | All positive controls in each cycle read |
| positive. | ||
| Fractional cycle requirements: | PASS | |
| 1) IPCDs must be equal or less difficult to | ||
| sterilize than the EPCDs |
- The IPCDs and EPCDs may show growth
after 7 days with the EPCD required to be
equal or more EtO resistant. - Product Sterility testing must show no
growth in all samples. - Bacteriostasis/Fungistasis testing must
show that the product is not inhibitory for
growth. | | 1) IPCDs showed growth after 7 days. - EPCDs were equal or more EtO
resistant than the IPCDs. - The devices did not show any
growth when tested per the methods
in ISO 11737-2. - Bacteriostasis/Fungistasis Testing
showed product is not inhibitory to
growth when tested per the methods
in ISO 11737-2. |
| Half cycle requirements: - The IPCDs must show no growth after 7
days - EPCD are expected to show no growth
after 7 days. A few positives are allowed
by ISO 11135. | PASS | 1) IPCDs showed no growth after 7
days. - EPCDs showed no growth after 7
days. |
| Full cycle requirements: - The IPCDs must show no growth after 7 | PASS | 1) IPCDs showed no growth after 7 |
| days | | days. |
| 2) Selected EPCD must show no growth after | | 2) EPCDs showed no growth after 7 |
| 7 days. | | days. |
| 3) Samples exposed to 2X sterilization cycle | | 3) Samples passed EtO residual testing |
| must pass EtO residual testing. | | at 0 hour aeration time point. |
Table 6: Sterilization Validation Summary
Imperative Care also confirmed that sterilization has been completed for the Imperative Care Aspiration Tubing Set, which is provided sterile via Ethylene Oxide (EtO) and with a sterility assurance level of 1x1066. The sterilization process was validated per the overkill and equivalence method described in recognized consensus standard ISO 11135: 2014, "Sterilization Of Health-Care Products - Ethylene Oxide - Requirements For The Development, Validation And Routine Control Of A Sterilization Process For Medical Devices." All requirements for EtO sterilization validation per the methods indicated in ISO 11135 were completed and all test results passed.
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J. Shelf Life and Packaging:
Accelerated aging testing based on ASTM F1980 was conducted to verify device, accessory, and packaging performance. A real time aging equivalent of 13 months was used for this testing and will allow for labeling of product with a 1-year shelf life.
All device component performance was verified by repeating a subset of the functional tests previously presented in Section G of this 510(k) summary.
Packaging and sterile barrier integrity through transportation has been verified for the packaging configuration used for the MantaRay Reperfusion Catheter. Aging testing has also been performed that supports the sterile barrier integrity following 13 months of accelerated aging. A summary of the completed packaging test is presented below in Table 7.
| Test | Test Method | T0 Results
(Pass/Fail) | 1-Year Shelf Life Results
(Pass/Fail) |
|------------------------------------------------|------------------------------------------|---------------------------|------------------------------------------|
| Packaging Visual
Inspection | ASTM F1886
Imperative Care
TM00071 | Pass | Pass |
| Pouch Integrity Test -
Gross Leak Detection | ASTM F2096 | Pass | Pass |
| Pouch Seal Strength
– Peel Strength | ASTM F88 | Pass | Pass |
| Label Integrity | Imperative Care
TM00071 | Pass | Pass |
Table 7: Packaging Validation Summary
Imperative Care also confirmed that shelf life testing and packaging validation has been completed for the Imperative Care Aspiration Tubing Set. Accelerated aging testing based on ASTM F1980 was conducted to verify performance of the aspiration tubing and the packaging. A real time aging equivalent of 24 months was used for this testing and will allow for labeling of the aspiration tubing with a 23 month shelf life.
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K. Animal Studies
A series of subacute and chronic animal studies were conducted to evaluate the safe and effective use of the MantaRay Reperfusion Catheter with the Imperative Care Aspiration Pump and Aspiration Tubing Set in a porcine model. Testing included worst case positioning of the catheter in a "wedged" position, retrieval of various types of clots, and evaluation of various aspiration pressures. The predicate Penumbra System was used as a control device in all completed studies. The studies concluded that:
- All vessels treated with the MantaRay Reperfusion Catheters were patent, with no ● perforation, dissection or thrombosis following completion of the procedure.
- The subacute and chronic vascular response was histologically comparable between the MantaRay Reperfusion Catheter and predicate Penumbra System Reperfusion Catheter.
- . The subacute and chronic pathological findings were comparable between the MantaRay Reperfusion Catheter and predicate Penumbra System Reperfusion Catheter.
Physician Validation Study L.
A user validation study was developed and conducted per recommendations in the FDA guidance document titled "Applying Human Factors and Usability Engineering to Medical Devices ". As part of the study, active US physicians experienced in interventional neuroradiology and neurovascular surgery were asked to complete clot retrieval procedures under fluoroscopic visualization in a tortuous neurovascular simulated use model using both the subject MantaRay Reperfusion Catheter with the Imperative Care Aspiration Pump and Aspiration Tubing Set and the predicate Penumbra System. The order in which each physician tested the subject and predicate devices was randomized to reduce bias.
The results of the clot retrieval procedures for the subject and predicate devices were analyzed and compared. The analysis found no significant differences between the subject and predicate devices that would negatively impact safety or effectiveness.
M. Conclusions:
Where differences were identified between the subject MantaRay Reperfusion Catheter with the Imperative Care Aspiration Pump and Aspiration Tubing Set and the predicate Penumbra System, a risk assessment was completed to determine if the difference would result in new safety or effectiveness concerns regarding the use of the device. As appropriate, testing (bench, lab, and animal) was conducted to support this assessment.
Based on the results of the conducted risk assessments and associated testing, it is concluded that MantaRay Reperfusion Catheters with the Imperative Care Aspiration Pump and Aspiration Tubing Set is substantially equivalent to the predicate Penumbra System and that there are no new safety or effectiveness concerns associated with the identified differences. This conclusion was determined based on the fact that the subject and predicate devices share the same intended use, basic technology characteristics, and equivalent performance characteristics, as confirmed through bench, lab, and animal testing.
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Image /page/16/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
April 17, 2019
Imperative Care Inc. Jake Wolenberg Regulatory Affairs Manager 1359 Dell Avenue Campbell, California 95008
Re: K183043
Device Name: MantaRay (071, 055, 045, 035) Reperfusion Catheters; Imperative Care Aspiration Tubing Set Regulation Number: 21 CFR 870.1250
Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: March 15, 2019 Received: March 18, 2019
Dear Jake Wolenberg:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure