K Number

Device Name

CANTATA(R) 2.9 MICROCATHETER

Manufacturer

COOK, INC.

Date Cleared

2014-02-20

(248 days)

Product Code

KRA DQY

Regulation Number

870.1210

Intended 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.

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K101450

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical characteristics and performance testing of a microcatheter, with no mention of AI or ML capabilities.

Therapeutic

No.
The device is described as a microcatheter intended for diagnostic and interventional procedures, used to access small vessels. While it may be used in interventional procedures, its primary function as described is for access and delivery rather than directly providing a therapeutic effect itself (e.g., delivering a drug, ablating tissue, or performing a corrective action). It acts as a tool or conduit for a procedure, not a therapeutic device in its own right in this context.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the microcatheters are intended for "diagnostic and interventional procedures." Additionally, the "Device Description" reiterates their design for "diagnostic and interventional procedures." While they also have interventional uses, the diagnostic aspect makes them a diagnostic device.

SaMD (Software as a Medical Device)

The device description clearly details a physical medical device (braided microcatheters with hydrophilic coating, radiopaque marker band, specific dimensions) and performance studies related to physical properties and biological interactions, not software functionality.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for "diagnostic and interventional procedures including neuro, peripheral, or coronary use." This describes a device used within the body for visualization and treatment, not for testing samples outside the body.
Device Description: The description details a physical catheter designed to be inserted into blood vessels. This is consistent with an interventional medical device, not an IVD.
Input Imaging Modality: The device relies on "Fluoroscopic visualization," which is an imaging technique used to view structures inside the body in real-time. IVDs typically do not involve real-time imaging of the patient's internal anatomy.
Anatomical Site: The device is used in "Small vessel or superselective anatomy including neuro, peripheral, or coronary use," which are locations within the human body. IVDs analyze samples taken from the body (like blood, urine, tissue), not the body itself.

IVD devices are designed to perform tests on samples taken from the human body to provide information about a person's health status. This device is a tool used during medical procedures within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

KRA, DQY

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Small vessel or superselective anatomy (neuro, peripheral, or coronary use)

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)

The following tests were performed:
Air Leakage Testing: Test article is loaded with de-aerated processed water and subjected to a negative pressure after occluding the lumen. Visual inspection for air bubbles is subsequently conducted for fifteen seconds. Conclusion: Testing showed that the catheter does not exhibit air leakage during proper clinical use. Device met the predetermined acceptance criteria.

Liquid Leakage Testing: Test article is loaded with processed water and subjected to a pressure of 300 kPa to 320 kPa after occluding the lumen. Visual inspection for air bubbles is subsequently conducted for a minimum of 30 seconds. Conclusion: 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: A uniaxial tensile load was applied to evaluate all four durometer transition zones of the test article shaft to ensure the resulting force required to break the shaft was greater than 5 Newtons. Conclusion: 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: The distal segment of the test article shaft was passed through a kink radius fixture to create a loop in the device. Both end of the device were then slowly pulled to close the loop until a kink was formed in the shaft. This process was recorded by an image analysis system which was used to determine the radius of the loop immediately prior to kinking. Conclusion: Testing showed that under proper clinical use the kink radius of the device is

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).

Summary

Image /page/0/Picture/0 description: The image shows a logo for Cook Medical. The word "COOK" is in large, bold, sans-serif font at the top of the logo. Below "COOK" is the word "MEDICAL" in a smaller, bolder, sans-serif font. The logo is black and white.

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

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 and
subjected to a negative
pressure after occluding the
lumen. Visual inspection for
air bubbles is subsequently
conducted for fifteen seconds.	Testing showed that the
catheter does not exhibit air
leakage during proper clinical
use. Device met the
predetermined acceptance
criteria.
Liquid Leakage Testing	Test article is loaded with
processed water and subjected
to a pressure of 300 kPa to
320 kPa after occluding the
lumen. Visual inspection for
air bubbles is subsequently
conducted for a minimum of
30 seconds.	Testing shows that the catheter
shall not leak liquid during
proper clinical use. Testing
demonstrated that the device
met the predetermined
acceptance criteria.
Table I Cantata 2.9 Microcatheter Test Data (continued)
Tensile Testing	A uniaxial tensile load was
applied to evaluate all four
durometer transition zones of
the test article shaft to ensure
the resulting force required to
break the shaft was greater
than 5 Newtons.	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	The distal segment of the test
article shaft was passed
through a kink radius fixture
to create a loop in the device.
Both end of the device were
then slowly pulled to close the
loop until a kink was formed
in the shaft. This process was
recorded by an image analysis
system which was used to
determine the radius of the
loop immediately prior to
kinking.	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	Test articles are subjected to a
dynamic flow of saline at
1000 psi +50 psi / 0 psi and
examined for 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	Test article are subjected to
dynamic flow or various
injection fluids at given
pressure steps. The fluid
through the lumen of the
device during injection is
measure and divided by the
time that the pressure was
applied to create a flow rate.	Injection pressures and flow
rates of the device were
characterized.

Embolic Particle Size Testing	Embolic particles are prepared
and delivered through the
device per their corresponding
Instructions for Use. Failure is
considered to have occurred if
the lumen of the device is
completely blocked during
delivery and the entire batch
of particles cannot be
delivered.	The device can deliver
embolic particles in the 710 –
1000 micron range.
Ancillary Device
Compatibility Testing	The device was advanced over
a standard microwire guide
and through a 0.038" inner
diameter angiographic catheter
placed in a simulated
tortuosity fixture to ensure
device compatibility.	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 was qualitatively
evaluated for performance
criterion of preparation,
introduction, pushability,
trackability, and radiopacity in
an animal model.	The device and the compatible
device/embolization medium
must receive an acceptable
rating in terms of preparation,
introduction, pushability,
trackability, and radiopacity.
Trackability Testing	The device was inserted
through an angiographic
catheter and tracked over a
micro wire guide through a
model of the internal carotid
artery. Testing was considered
successful if the device was
able to be successfully tracked
to 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	When scoring lysis, the test
article score a 0 (same as
negative and cell control) at
24, 48, and 72 ± 4 hours.	Non-cytotoxic
Table 1 Cantata 2.9 Microcatheter Test Data (continued)
Sensitization	None of the negative animals
challenged with the control
vehicle, or the animals
challenged with the test article
extracts were observed with a
sensitization response great
then '0'. The normal saline
extract and cottonseed oil
extract of the test material had
a sensitization response of '0'
under valid test conditions.	The test article did not elicit a
sensitization response
Intracutaneous Reactivity	The differences in the mean
test and control scores of the
extract dermal observations
were less and 1.0	The requirements of the ISO
Intracutaneous Reactivity Test
have been met
Systemic Toxicity	None of the test article treated
animals were observed with
clinical signs consistent with
toxicity at any of the
observations periods.	The requirements of the ISO
Acute System Injection Test
have been met
Hemolysis	Test article exhibited an
Average Blank Corrected %
Hemolytic Index of % (same
as blank control)	Non-hemolytic
Complement Activation	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
Partial Thromboplastin Time	The test article had an average
clotting time 297.0 seconds
(99% of the negative control)	Minimal-activator of intrinsic
coagulation pathway

Table 1 Cantata® 2.9 Microcatheter Test Data

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

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

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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