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.

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.

AI/ML Overview

This document describes the premarket notification (510(k) summary) for the MantaRay Reperfusion Catheters and Imperative Care Aspiration Tubing Set. The study primarily relies on a "substantial equivalence" argument by comparing the subject device to a predicate device (Penumbra System Reperfusion Catheter) through various bench, lab, and animal tests, rather than a standalone clinical study demonstrating a specific clinical outcome or a multi-reader, multi-case study for human-AI improvement.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a comprehensive table (Table 4) detailing various test attributes and their corresponding specifications, which serve as acceptance criteria. The "Results" column in this context indicates that all tests passed or met these specifications, demonstrating the device's performance.

Test Attribute	Acceptance Criteria (Specification)	Reported Device Performance (Results from document)
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.	Passed (Demonstrated)
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.	Passed (Demonstrated)
Flexibility and Kink Resistance	There shall be no kinking of shaft (permanent deformation) after simulated use.	Passed (No kinking)
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.	Passed (Demonstrated)
Guidewire compatibility	The catheters shall be able to be delivered over the guidewire size indicated in the product labeling.	Passed (Demonstrated)
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.	Passed (Demonstrated)
Luer compatibility	Devices and accessories shall be compatible with standard syringe luer fittings per ISO 80369-7.	Passed (Compatible)
Accessory compatibility	Devices shall be compatible with the accessory RHV.	Passed (Compatible)
Visual	Free of kinks, breaks, separation or particulate (greater than 0.25mm²). No exposed metal.	Passed (Free of defects)
Dimensional	All defined catheter dimensions are within the specified tolerances.	Passed (Within tolerances)
Catheter Bond Strength	The catheter shall have sufficient bond strengths to remain intact throughout a procedure.	Passed (Sufficient bond strength)
Flowrate - positive (forward) pressure	The catheter lumen shall allow for a minimum flowrate comparable to competitive products.	Passed (Comparable flowrate)
Flowrate – vacuum pressure	The flowrate under a vacuum shall be similar to or greater than competitive devices.	Passed (Similar or greater flowrate)
Freedom from Leakage – positive pressure	No liquid leakage from the hub or catheter shaft at 46psi for 30 seconds.	Passed (No leakage)
Freedom from Leakage – negative pressure	No air leakage into a 20cc syringe when vacuum pulled for 15 seconds.	Passed (No leakage)
Burst Pressure	Catheter does not burst under pressures that could be seen when performing contrast injections with a standard 10cc syringe.	Passed (Did not burst)
Catheter Torque Strength	No separation of any portion of the catheter when rotated at least two (2) full rotations (720 degrees).	Passed (No separation)
Lumen Integrity	The catheter lumen shall not collapse under vacuum.	Passed (Did not collapse)
Kink Resistance	There shall be no kinking of the catheter shaft (permanent deformation) after wrapping around anatomically relevant bend radii.	Passed (No kinking)
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.	Passed (Comparable flexibility)
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.	Passed (Acceptable particulate)
Coating - lubricity	Coating must be lubricious and maintain a minimum lubricity over 15 test cycles.	Passed (Lubricious, maintained lubricity)
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.	Passed (No visible corrosion)
Radiopacity	The radiopaque marker on the catheter can be seen under fluoroscopy during use.	Passed (Visible under fluoroscopy)
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.	Passed (Comparable vacuum force)
Aspiration Volume	The volume of fluid aspirated when using the catheter should be comparable to the predicate devices.	Passed (Comparable aspiration volume)

Biocompatibility Test Summary (Table 5)

Test	Acceptance Criteria	Results
Cytotoxicity: ISO MEM Elution	Sample extracts must yield cell lysis grade 2 or lower.	Pass, Non-cytotoxic
Cytotoxicity: ISO MTT Assay	The percentage of cells exhibiting lysis should be similar for all test devices.	Pass, No Significant Differences
Sensitization: Magnusson-Kligman Method	Test Group shall yield Grade < 1 score on Magnusson and Kligman scale (provided control Grade < 1).	Pass, Non-Sensitizing
Irritation: ISO Intracutaneous Irritation	The difference in the mean test article and mean control score must be grade 1.0 or lower.	Pass, Non-Irritant
Systemic Toxicity: ISO Materials Mediated	Sample Extracts must not cause a total rise in body temperature of $\ge$ 0.5°C.	Pass, Non-pyrogenic
Pyrogen Systemic Toxicity: ISO Acute	Sample extracts must not cause the following: > 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
Systemic Injection Test Hemocompatibility	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.
Complement Activation Hemocompatibility	Sample extracts must be nonhemolytic ( $\le$ 2% hemolytic index).	Pass, Non-hemolytic
Hemolysis (Direct Contact Method)	Sample extracts must be nonhemolytic ( $\le$ 2% hemolytic index).	Pass, Non-hemolytic
Hemolysis (Extract Method)	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.
Standard In vivo Thrombogenicity	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.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Description: The document focuses on bench, lab (in-vitro), and animal testing for substantial equivalence. There isn't a "test set" in the traditional clinical trial sense with human patient data.
Sample Size:
- Bench and Lab Testing: The largest and smallest diameter catheter sizes for both the subject and predicate devices were tested for the various performance attributes. The exact number of units per test is not specified, but the testing was conducted per "company approved protocols and test methods based primarily on catheter performance standard ISO 10555-1."
- Animal Studies: Performed in a porcine model. The number of animals used is not specified directly for the main animal study, but the thrombogenicity test was "Performed in duplicate."
- Biocompatibility Testing: Guinea pigs and rabbits were used for sensitization and irritation tests, respectively. Mice were used for acute systemic injection tests. The number of animals per test is not explicitly stated in the summary table.
- Physician Validation Study: Active US physicians experienced in interventional neuroradiology and neurovascular surgery were recruited. The number of physicians is not specified.
Data Provenance: Not explicitly stated as country of origin of the data. All studies were conducted to support a US FDA 510(k) submission, implying they meet US regulatory standards. The animal and lab tests are pre-clinical. The physician validation study involved "US physicians." The nature of these studies is prospective as they were designed specifically to evaluate the device.

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)

Bench and Lab Testing: The "ground truth" for these tests are the defined engineering specifications (acceptance criteria) and physical measurements. These are established by engineering standards (e.g., ISO 10555-1) and internal company protocols. No external "experts" in the sense of clinical specialists are mentioned for establishing ground truth for these quantifiable measures.
Animal Studies: The evaluation of vascular response and pathological findings was "histologically comparable" to the predicate device. This implies assessment by experts (likely veterinary pathologists), but their number and specific qualifications are not detailed.
Physician Validation Study: "Active US physicians experienced in interventional neuroradiology and neurovascular surgery" participated. They performed clot retrieval procedures, and their performance/feedback constituted the evaluation. Their number and years of experience are not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

There is no mention of an adjudication method in the context of expert consensus or dispute resolution for a "test set" of clinical cases. The various performance tests are against defined specifications or compared to a predicate device in controlled environments.
For the physician validation study, the "results... were analyzed and compared," implying a statistical comparison rather than an expert adjudication process for ground truth.

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

No MRMC comparative effectiveness study was done in the context of AI assistance. This document describes a medical device (catheter and aspiration system), not an AI device for diagnostic imaging or interpretation.
The Physician Validation Study (Section L) involved physicians performing procedures with both the subject and predicate devices, demonstrating usability and comparable performance, but it was not a comparative effectiveness study designed to measure the improvement of human readers with AI assistance. It was a usability/performance study for a physical medical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device described, the MantaRay Reperfusion Catheter and Aspiration Tubing Set, is a physical medical device (catheter system) for mechanical thrombectomy, not an algorithm, AI, or software-only device. Its performance is inherently tied to human use (human-in-the-loop) and the mechanical action of aspiration.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Bench and Lab Testing: Engineering specifications, physical measurements, and performance against industry standards (e.g., ISO 10555-1).
Animal Studies: Histological analysis of vascular response and pathological findings; direct observation of successful revascularization, absence of perforation, dissection, or thrombosis. Comparison to the predicate device served as the control.
Biocompatibility Testing: Standardized biological test methods (e.g., ISO 10993-x series) with defined pass/fail criteria.
Physician Validation Study: Direct observation of procedural success in a simulated model (clot retrieval), and comparison of performance metrics between the subject and predicate devices.

8. The sample size for the training set

This question is not applicable as the studies described are for regulatory clearance of a physical medical device. There is no mention of machine learning or an "AI" component requiring a training set in the document.

9. How the ground truth for the training set was established

This question is not applicable, as there is no "training set" for an AI or machine learning model in this submission.

Summary

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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.

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Device Description: D.

Product Name	Model	DistalDiameter		ProximalDiameter		Nominal Usable	HydrophilicCoating
(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

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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.

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Indications for Use: E.

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.

SubjectDevice Model	Distal InnerDiameter xWorking Length	CorrespondingPredicateDevice Model	Distal InnerDiameter xWorking Length	PredicateDevice510(k)
0.071" ID MantaRay	0.071" x 137cm	ACE68	0.068" x 132cm	K152541K1424582
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.

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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 ReperfusionCatheter (Predicate Device)
FDA ProductClassification	Class II, NRY, 21 CFR 870.1250	Same
Intended Use	Revascularization of patients withacute ischemic stroke.	Same
ConditionSupplied	Sterile and Single Use	Same
SterilizationMethod	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, andatraumatic	Square edge, soft, flexible, andatraumatic
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.
PackagedAccessories	Rotating Hemostasis Valve (RHV)	Rotating Hemostasis Valve (RHV)Peelable Catheter IntroducerSteam Shaping Mandrel
PackagingConfiguration	The catheter is placed in a protectivepolyethylene tube and then mounted,along with the accessories, onto apolyethylene packaging card.The packaging card is inserted into aTyvek® pouch which is then sealed.The sealed pouch and IFU are placed in	Same
Device Attribute	MantaRay Reperfusion Catheter(Subject Device)	Penumbra System ReperfusionCatheter (Predicate Device)
Key DeviceComponents	Imperative Care Aspiration PumpImperative Care Aspiration Tubing Set	Penumbra Pump MAXPenumbra Hi-Flow Tubing
Critical Aspiration Pump Performance Requirements
AspirationPressure	-20 inHg to max vacuum	-20 inHg to max vacuum
Flowrate (Air)	0 to 23 LPM	0 to 23 LPM
IEC 60601Compliance	Pump is compliant with electricalsafety standards.	Pump is compliant with electricalsafety standards.
Critical Aspiration Tubing Requirements
Tubing ID	0.110" Minimum	0.110" Minimum
Tubing Length	112"	112"
Flow ControlMechanism	Flow Control Switch	Flow Control Switch

Table 3: Subject and Predicate Device Comparison

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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 retractedper the IFU within a simulated neurological model withoutincurring any damage to the catheter.
Clot Retrieval	The catheter will be able to be delivered in a clinically relevantmodel and used to effectively aspirate clots with the aspirationpump and aspiration tubing set when placed at appropriatelocations based on the size of the catheter.
Flexibility and KinkResistance	There shall be no kinking of shaft (permanent deformation) aftersimulated use.
Compatibility with otherdevices (external)	The catheters shall be able to be delivered through the minimumintroducer sheath or guide catheter size indicated in the productlabeling.
Guidewire compatibility	The catheters shall be able to be delivered over the guidewire sizeindicated in the product labeling.
Interventional devicecompatibility (internal)	The catheters shall be able to accommodate other interventionaldevices (e.g., support catheter, diagnostic catheter) up to themaximum size indicated in the product labeling.
Luer compatibility	Devices and accessories shall be compatible with standard syringeluer 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 than0.25mm²). No exposed metal.
Dimensional	All defined catheter dimensions are within the specifiedtolerances.
Catheter Bond Strength	The catheter shall have sufficient bond strengths to remain intactthroughout a procedure.
Flowrate - positive(forward) pressure	The catheter lumen shall allow for a minimum flowratecomparable to competitive products.
Flowrate – vacuumpressure	The flowrate under a vacuum shall be similar to or greater thancompetitive devices.
Freedom from Leakage– positive pressure	No liquid leakage from the hub or catheter shaft at 46psi for 30seconds
Freedom from Leakage– negative pressure	No air leakage into a 20cc syringe when vacuum pulled for 15seconds.
Burst Pressure	Catheter does not burst under pressures that could be seen whenperforming contrast injections with a standard 10cc syringe.
Catheter TorqueStrength	No separation of any portion of the catheter when rotated at leasttwo (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 (permanentdeformation) after wrapping around anatomically relevant bendradii.
Flexibility	The flexibility of the catheter tip shall be comparable tocompetitive products and allow for easily tracking the device tothe desired target anatomy.
Coating - Particulate	The amount of particulate matter that comes off the hydrophilic-coated shaft during simulated use testing shall be determined andcompared to competitive products and techniques.
Coating - lubricity	Coating must be lubricious and maintain a minimum lubricity over15 test cycles.
Test Attribute	Specification
Corrosion Resistance	No visible corrosion present on devices after saline immersionfollowed by 30 minutes in boiling water followed by 48 hours in37°C water bath.
Radiopacity	The radiopaque marker on the catheter can be seen underfluoroscopy during use.
Vacuum Force atCatheter Tip	The vacuum force at the tip of the catheter should be comparableto the vacuum force at the tip of the predicate devices.
Aspiration Volume	The volume of fluid aspirated when using the catheter should becomparable to the predicate devices.

Table 4: Tests and Performance Specifications

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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.

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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: ISOMEM* Elution	ISO 10993-5	Test device extracted inMEM 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: ISOMTT* Assay	ISO 10993-5	Test device extracted inMTT* Assay Media at 37 ± 1°C for 24 ± 2 hours	The percentage of cells exhibiting lysis should be similar for all test devices.	Pass, NoSignificantDifferences
Sensitization:Magnusson-Kligman Method, 2extracts	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 < 1 score on Magnusson and Kligman scale (provided control Grade < 1).	Pass, Non-Sensitizing
Test	Test Method	ExtractionMethods/Conditions	Acceptance Criteria	Results
Irritation: ISOIntracutaneousIrritation Test	ISO 10993-10	Rabbits are injected withextracts of test device.Injection sitesexamined/scored at $24 \pm 2$ ,$48 \pm 2$ and $72 \pm 2$ hours afterinjections.	The difference in themean test article andmean control score mustbe grade 1.0 or lower.	Pass, Non-Irritant
Systemic Toxicity:ISO MaterialsMediated RabbitPyrogen	ISO 10993-11:2006	Test device extracted in0.9% NS and injected in themarginal ear vein. Rectaltemperatures recorded priorto injection and every 30 minuntil 1-3 hours post injection.Extracts were prepared at 50$\pm 2$ °C for $72 \pm 2$ hours	Sample Extracts must notcause a total rise inbody temperature of $\geq$0.5°C.	Pass, Non-pyrogenic
Systemic Toxicity:ISO AcuteSystemic InjectionTest	ISO 10993-11	Mice are injected withextracts of test device.Animals are observed forsigns of toxicity immediatelyafter injection, $4 \pm 0.75$ , $24 \pm$$2, 48 \pm 2$ and $72 \pm 2$ hoursafter injections. Bodyweights are measured priorto injection and on all 3 days.Extracts were prepared in0.9% NS * and Sesame Oil at$50 \pm 2$ °C for $72 \pm 2$ hours.	Sample extracts must notcause the following:• > 10% weight loss in 3or more test animals• Mortality of 2 or moretest animals• Toxic signs such asconvulsions andprostration in 2 or moretest animals	Pass, Non-Toxic
Hemocompatibility:ComplementActivation	ISO 10993-4ASTM F756	Preformed in vitro using aprepared EnzymeImmunoassay (EIA) kit. Thiskit will detect the presence ofspecific complementenzymes.Test device incubated inserum at $37\pm 2$ °C and testedfor C3a and SC5b at 0.5, 1,and 1.5 hours.	The concentrations of C3aand SC5b-9 in the testdevices are statisticallysimilar to the predicatedevice (Penumbra NeuronMax 6F Catheter) andstatistically lower than thepositive control for allexposure times.	Pass, NoSignificantDifferencesThe test device hadstatistically similaror lowerconcentrations thanthe predicate andnegative controls.
Test	Test Method	ExtractionMethods/Conditions	Acceptance Criteria	Results
Hemocompatibility:Hemolysis (DirectContact Method)	ASTM F 756ISO 10993-4	Test device extracted inPBS* and diluted blood at 37$\pm$ 2°C for 3 $\pm$ 5 minutes.Test device exposed to bloodcell suspension.% hemolysis is measured.	Sample extracts must benonhemolytic ( $\le$ 2%hemolytic index).	Pass, Non-hemolytic
Hemocompatibility:Hemolysis (ExtractMethod)	ASTM F 756ISO 10993-4	Test device extracted in PBSat 50 $\pm$ 2°C for 72 $\pm$ 2 hours.Extract exposed to blood cellsuspension. % hemolysis ismeasured.	Sample extracts must benonhemolytic ( $\le$ 2%hemolytic index).	Pass, Non-hemolytic
Standard In vivoThrombogenicity,Ovine JugularNAVI (ISO)	ISO 10993-4:2002	Performed in duplicate. Testand control device are placedin alternate sides of thejuggler vein. The devices areimplanted and remains inplace 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, MinimalThrombogenicPotentialThe test device had less thrombogenic potential than the control device.

Table 5: Biocompatibility Test Summarv

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*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.

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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 infractional, half and full cycles.	PASS	All positive controls in each cycle readpositive.
Fractional cycle requirements:	PASS
1) IPCDs must be equal or less difficult tosterilize than the EPCDs2) The IPCDs and EPCDs may show growthafter 7 days with the EPCD required to beequal or more EtO resistant.3) Product Sterility testing must show nogrowth in all samples.4) Bacteriostasis/Fungistasis testing mustshow that the product is not inhibitory forgrowth.		1) IPCDs showed growth after 7 days.2) EPCDs were equal or more EtOresistant than the IPCDs.3) The devices did not show anygrowth when tested per the methodsin ISO 11737-2.4) Bacteriostasis/Fungistasis Testingshowed product is not inhibitory togrowth when tested per the methodsin ISO 11737-2.
Half cycle requirements:1) The IPCDs must show no growth after 7days2) EPCD are expected to show no growthafter 7 days. A few positives are allowedby ISO 11135.	PASS	1) IPCDs showed no growth after 7days.2) EPCDs showed no growth after 7days.
Full cycle requirements:1) 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 VisualInspection	ASTM F1886Imperative CareTM00071	Pass	Pass
Pouch Integrity Test -Gross Leak Detection	ASTM F2096	Pass	Pass
Pouch Seal Strength– Peel Strength	ASTM F88	Pass	Pass
Label Integrity	Imperative CareTM00071	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

Regulation Number and Section

§ 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).