The Cantata® 2.9 Microcatheters are intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures including neuro, peripheral, or coronary use.

Device Description

The Cantata 2.9 Microcatheters are braided microcatheters with hydrophilic coating, designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures including neuro, peripheral, or coronary use. The devices include one radiopaque marker band to assist in fluoroscopic visualization of the catheter during use. The catheters are available in 2.9 French shafts and are available in 100, 110, 135, and 150 centimeter lengths. The devices are compatible with a 0.038 inch (0.97 millimeters) diameter angiographic catheter and can accept 0.018 inch (0.46 millimeters) and 0.021 inch (0.53 millimeters) diameter wire guides.

AI/ML Overview

The provided text describes performance testing for the Cantata® 2.9 Microcatheter. This is a medical device, not an AI/ML algorithm, therefore most of the requested information about AI model specifics (training set, experts, MRMC studies, etc.) is not applicable.

Here's the information that can be extracted relevant to the performance of the Cantata® 2.9 Microcatheter:

Acceptance Criteria and Device Performance

Test	Acceptance Criteria	Reported Device Performance
Air Leakage Testing	Device does not exhibit air leakage during proper clinical use.	Testing showed that the catheter does not exhibit air leakage during proper clinical use. Device met the predetermined acceptance criteria.
Liquid Leakage Testing	Device shall not leak liquid during proper clinical use.	Testing shows that the catheter shall not leak liquid during proper clinical use. Testing demonstrated that the device met the predetermined acceptance criteria.
Tensile Testing	The resulting force required to break the shaft was greater than 5 Newtons (in conformance with ISO 10555-1:1995).	Testing showed that under proper clinical use of the device the peak load value shall be greater than 5 Newtons. In conformance with ISO 10555-1:1995, the predetermined acceptance criteria were met.
Kink Radius Testing	Kink radius of the device is ≤ 3 millimeters.	Testing showed that under proper clinical use the kink radius of the device is ≤ 3 millimeters. Testing demonstrated that the device met the predetermined acceptance criteria.
Dynamic Failure Pressure Testing	Device can withstand a pressure of 1000 pounds per square inch without signs of failure (leaking, rupture, or swelling of the shaft greater than twice the original diameter).	Testing demonstrated that under proper clinical use the device can withstand a pressure of 1000 pounds per square inch without signs of failure. Testing demonstrated that the device met the predetermined acceptance criteria.
Injection Pressures and Flow Rate Testing	(No explicit acceptance criteria stated; test is for characterization)	Injection pressures and flow rates of the device were characterized.
Embolic Particle Size Testing	Device can deliver embolic particles in the 710 – 1000 micron range without complete blockage of the lumen.	The device can deliver embolic particles in the 710 – 1000 micron range.
Ancillary Device Compatibility Testing	Device is compatible with a standard microwire guide and a 0.038 inch inner diameter angiographic catheter when advanced through a simulated tortuosity fixture.	Device is compatible with a Standard micro wire guide and a 0.038 inch diameter angiographic catheter.
Evaluation of Device in an Animal Model	The device and compatible device/embolization medium must receive an acceptable rating in terms of preparation, introduction, pushability, trackability, and radiopacity.	The device and the compatible device/embolization medium must receive an acceptable rating in terms of preparation, introduction, pushability, trackability, and radiopacity. (Implies performance met, as it's stated as a requirement that was met according to the conclusion).
Trackability Testing	Device is able to be consistently tracked to the location of the internal carotid artery siphon.	Testing showed that the device is able to be consistently tracked to the location of the internal carotid artery siphon. Testing demonstrated that the device met the predetermined acceptance criteria.
Cytotoxicity – ISO MEM Elution Assay	Test article scores 0 for lysis (same as negative and cell control) at 24, 48, and 72 ± 4 hours.	Non-cytotoxic (Test article scored a 0 for lysis at 24, 48, and 72 ± 4 hours).
Sensitization	Test article does not elicit a sensitization response greater than '0' for normal saline extract and cottonseed oil extract.	The test article did not elicit a sensitization response (Normal saline extract and cottonseed oil extract had a sensitization response of '0' under valid test conditions).
Intracutaneous Reactivity	Differences in the mean test and control scores of the extract dermal observations were less than 1.0.	The requirements of the ISO Intracutaneous Reactivity Test have been met (Differences in the mean test and control scores of the extract dermal observations were less and 1.0).
Systemic Toxicity	No clinical signs consistent with toxicity observed in test article treated animals at any observation periods.	The requirements of the ISO Acute System Injection Test have been met (None of the test article treated animals were observed with clinical signs consistent with toxicity at any of the observations periods).
Hemolysis	Non-hemolytic (Implicit; based on industry standards for medical devices in contact with blood).	Non-hemolytic (Test article exhibited an Average Blank Corrected % Hemolytic Index of % (same as blank control)).
Complement Activation	(No specific acceptance criteria provided, test is for characterization/comparison)	Under conditions of the C3a assay the test article and the comparison article activation at 2.1% and 3.5%, respectively, of the normalized C3a concentration produced by CVF. (No ranges or levels established as acceptable were explicitly mentioned in the "Conclusions" column).
Partial Thromboplastin Time	Minimal-activator of intrinsic coagulation pathway (Implicit; based on safety standards for blood-contacting devices, indicating it doesn't significantly activate clotting).	Minimal-activator of intrinsic coagulation pathway (Test article had an average clotting time of 297.0 seconds, which is 99% of the negative control).

Study Information (Non-AI Device)

Sample size used for the test set and the data provenance: Not explicitly stated for each test in terms of a "test set" for an algorithm. These are physical device tests. Sample sizes would refer to the number of physical devices or animal subjects used, which is not detailed beyond "test article(s)" or "animal model." The provenance is internal testing by Cook Incorporated, a U.S. company. The studies are prospective in nature, as they involve testing newly manufactured devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these physical and biocompatibility tests is established through standardized methodologies and objective measurements, not expert consensus on interpretations.
Adjudication method for the test set: Not applicable. Test results are objective measurements against predetermined physical or biological criteria.
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: Not applicable. This is not an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
The type of ground truth used:
- Physical Properties: Objective measurements against engineering specifications (e.g., force in Newtons, pressure in kPa/psi, diameter in mm, radius in mm).
- Biocompatibility: Established ISO standards and direct biological response (e.g., lysis score, sensitization response, observation of toxicity, hemolytic index, clotting time).
- Functional Performance: Qualitative and quantitative assessment of device behavior in simulated environments (e.g., tracking through a tortuosity fixture, ability to deliver particles) or animal models (e.g., preparation, introduction, pushability, trackability, radiopacity).
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary

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510(K) Summary

COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA 812.339.2235 touring 800,457,4500 WWW.COOKMEDICAL.COM

Cantata® 2.9 Microcatheter

Cook Incorporated

Bloomington, IN 47404 Jennifer A. Richardson, MA

(812) 339-2235 ext. 2370

jennifer.richardson@cookmedical.com

750 Daniels Way

Submitter Information:

Applicant: Address:

Contact: Email: Contact Phone Number: Contact Fax Number:

Date Prepared:

December 24, 2013

(812) 332-0281

Device Information:

Trade Name: Common Name: Classification Name: Cantata® 2.9 Microcatheter Continuous Flush Catheter Catheter, Continuous Flush KRA (21 CFR §870.1210)

Purpose of Submission:

The purpose of this submission is to expand the offering of COOK Inc. Cantata® Microcatheters to include a 2.9 French, 0.027 inch (0.69 millimeters) inner diameter microcatheter. The 2.9 French Cantata® Microcatheter will complement the existing 2.5 French and 2.8 French Cantata Microcatheters.

Indications for Use:

The Cantata 2.9 Microcatheters are intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures including neuro, peripheral, or coronary use.

Predicate Device:

The Cantata 2.9 Microcatheters are identical in terms of intended use, principles of operation, and technological characteristics to the predicate devices. The device, subject of this submission, is substantially equivalent to the Cantata® Microcatheters cleared under 510(k) number K101450.

K131772

FEB 20 2014

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K 131772 - Cantata® 2.9 Microcatheter 510(k) Summary 24 December 2013

Comparison to Predicate Device:

It has been demonstrated that the Cantata® 2.9 Microcatheters are comparable to the predicate device. The predicate devices and the device subject of this submission are intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures including neuro, peripheral, or coronary use. The predicate and proposed devices are completely identical in terms of overall design and indications for use. .

Device Description:

Test Data:

The following tests were performed to demonstrate that the Cantata® 2.9 Microcatheters met applicable design and performance requirements and supports a determination of substantial equivalence.

Test	Methodology	Conclusions
Air Leakage Testing	Test article is loaded with de-aerated processed water andsubjected to a negativepressure after occluding thelumen. Visual inspection forair bubbles is subsequentlyconducted for fifteen seconds.	Testing showed that thecatheter does not exhibit airleakage during proper clinicaluse. Device met thepredetermined acceptancecriteria.
Liquid Leakage Testing	Test article is loaded withprocessed water and subjectedto a pressure of 300 kPa to320 kPa after occluding thelumen. Visual inspection forair bubbles is subsequentlyconducted for a minimum of30 seconds.	Testing shows that the cathetershall not leak liquid duringproper clinical use. Testingdemonstrated that the devicemet the predeterminedacceptance criteria.
Table I Cantata 2.9 Microcatheter Test Data (continued)
Tensile Testing	A uniaxial tensile load wasapplied to evaluate all fourdurometer transition zones ofthe test article shaft to ensurethe resulting force required tobreak the shaft was greaterthan 5 Newtons.	Testing showed that underproper clinical use of thedevice the peak load valueshall be greater than 5Newtons. In conformancewith ISO 10555-1:1995, thepredetermined acceptancecriteria were met.
Kink Radius Testing	The distal segment of the testarticle shaft was passedthrough a kink radius fixtureto create a loop in the device.Both end of the device werethen slowly pulled to close theloop until a kink was formedin the shaft. This process wasrecorded by an image analysissystem which was used todetermine the radius of theloop immediately prior tokinking.	Testing showed that underproper clinical use the kinkradius of the device is ≤ 3millimeters. Testingdemonstrated that the devicemet the predeterminedacceptance criteria.
Dynamic Failure PressureTesting	Test articles are subjected to adynamic flow of saline at1000 psi +50 psi / 0 psi andexamined for leaking, rupture,or swelling of the shaft greaterthan twice the originaldiameter.	Testing demonstrated thatunder proper clinical use thedevice can withstand apressure of 1000 pounds persquare inch without signs offailure. Testing demonstratedthat the device met thepredetermined acceptancecriteria.
Injection Pressures and FlowRate Testing	Test article are subjected todynamic flow or variousinjection fluids at givenpressure steps. The fluidthrough the lumen of thedevice during injection ismeasure and divided by thetime that the pressure wasapplied to create a flow rate.	Injection pressures and flowrates of the device werecharacterized.

Embolic Particle Size Testing	Embolic particles are preparedand delivered through thedevice per their correspondingInstructions for Use. Failure isconsidered to have occurred ifthe lumen of the device iscompletely blocked duringdelivery and the entire batchof particles cannot bedelivered.	The device can deliverembolic particles in the 710 –1000 micron range.
Ancillary DeviceCompatibility Testing	The device was advanced overa standard microwire guideand through a 0.038" innerdiameter angiographic catheterplaced in a simulatedtortuosity fixture to ensuredevice compatibility.	Device is compatible with aStandard micro wire guide anda 0.038 inch diameterangiographic catheter.
Evaluation of Device in anAnimal Model	The device was qualitativelyevaluated for performancecriterion of preparation,introduction, pushability,trackability, and radiopacity inan animal model.	The device and the compatibledevice/embolization mediummust receive an acceptablerating in terms of preparation,introduction, pushability,trackability, and radiopacity.
Trackability Testing	The device was insertedthrough an angiographiccatheter and tracked over amicro wire guide through amodel of the internal carotidartery. Testing was consideredsuccessful if the device wasable to be successfully trackedto the internal carotid arterysiphon.	Testing showed that the deviceis able to be consistentlytracked to the location of theinternal carotid artery siphon.Testing demonstrated that thedevice met the predeterminedacceptance criteria.
Cytotoxicity – ISO MEMElution Assay	When scoring lysis, the testarticle score a 0 (same asnegative and cell control) at24, 48, and 72 ± 4 hours.	Non-cytotoxic
Table 1 Cantata 2.9 Microcatheter Test Data (continued)
Sensitization	None of the negative animalschallenged with the controlvehicle, or the animalschallenged with the test articleextracts were observed with asensitization response greatthen '0'. The normal salineextract and cottonseed oilextract of the test material hada sensitization response of '0'under valid test conditions.	The test article did not elicit asensitization response
Intracutaneous Reactivity	The differences in the meantest and control scores of theextract dermal observationswere less and 1.0	The requirements of the ISOIntracutaneous Reactivity Testhave been met
Systemic Toxicity	None of the test article treatedanimals were observed withclinical signs consistent withtoxicity at any of theobservations periods.	The requirements of the ISOAcute System Injection Testhave been met
Hemolysis	Test article exhibited anAverage Blank Corrected %Hemolytic Index of % (sameas blank control)	Non-hemolytic
Complement Activation	Under conditions of the C3aassay the test article and thecomparison article activationat 2.1% and 3.5%,respectively, of the normalizedC3a concentration producedby CVF	No ranges or levelsestablished as acceptable
Partial Thromboplastin Time	The test article had an averageclotting time 297.0 seconds(99% of the negative control)	Minimal-activator of intrinsiccoagulation pathway

Table 1 Cantata® 2.9 Microcatheter Test Data

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Table 1 Cantata® 2.9 Microcatheter Test Data (continued)

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Table 1 Cantata® 2.9 Microcatheter Test Data (continued)

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Table 1 Cantata® 2.9 Microcatheter Test Data (continued)

In conclusion, the results of these tests provide reasonable assurance that the device is as safe and as effective as the predicate devices, and support a determination of substantial equivalence.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W066-G609 Silver Spring, MD 20993-0002

February 20, 2014

Cook Inc. Ms. Jennifer A. Richardson Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47402

Re: K131772

Trade/Device Name: Cantata® 2.9 Microcatheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous flush catheter Regulatory Class: Class II Product Code: KRA, DQY Dated: June 14, 2013 Received: December 24, 2013

Dear Ms. Richardson:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Jennifer A. Richardson

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Joyce M. Whang -S

for Carl.

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K131772

Device Name Cantata® 2.9 Microcatheters

Indications for Use (Describe)

The Cantata® 2.9 Microcatheters are in small vessel or superselective anatomy for diagnostic and interventional procedures including neuro, peripheral, or coronary use.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED,

FOR FDA USE ONLY .. . Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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Regulation Number and Section

§ 870.1210 Continuous flush catheter.

(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).