(220 days)
Not Found
No
The 510(k) summary describes a physical medical device (microcatheter) and its performance testing, with no mention of software, image processing, AI, ML, or related concepts.
No.
The microcatheter is designed for diagnostic and interventional procedures, which are not explicitly therapeutic treatments in themselves, but rather tools often used for or in preparation for therapeutic interventions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "designed for use in ... diagnostic and interventional procedures".
No
The device description clearly describes a physical medical device (infusion catheter) with specific dimensions and materials, and the performance studies focus on physical properties and biocompatibility. There is no mention of software as the primary or sole component.
Based on the provided information, the Cantata™ Microcatheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's for "diagnostic and interventional procedures including neuro, peripheral, or coronary use" in small vessels. This describes a device used within the body for procedures, not for testing samples outside the body.
- Device Description: The description details a physical catheter designed for infusion and navigation within vessels. This is consistent with an interventional device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), reagents, or any other components typically associated with in vitro testing.
- Performance Studies: The performance studies focus on the physical and biological properties of the catheter itself (tensile strength, burst pressure, biocompatibility, etc.), which are relevant to an interventional device. They do not involve evaluating the accuracy or performance of a diagnostic test.
In summary, the Cantata™ Microcatheter is an interventional medical device used for procedures within the body, not an IVD used for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Cantata™ Microcatheter is designed 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
Device Description
The Cantata™ Microcatheter is an infusion catheter with a hydrophilic coating, designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures. The device is available in 2.5 and 2.8 French shafts and is available in 100, 110, 135, and 150 cm lengths. The device is supplied sterile and intended for one-time use.
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 Cantata™ Microcatheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were:
- Tensile strength
- Static burst pressure
- Kink radius
- Coating durability and lubricity
- Biocompatibility
a. Cytotoxicity
b. Sensitization, Maximization
c. Intracutaneous
d. Systemic Toxicity
e. Hemolysis
f. Pyrogen
g. Complement Activation
h. ASTM Partial Thromboplastin Time - Shelf life
- Endotoxin/bioburden
- Particulate Testing
A rationale based upon the geometry, conditions of use and the materials that interact with the blood was submitted to support the omission of the in vivo thrombogenicity testing.
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use.
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.
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.
Not Found
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
§ 870.1210 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).
0
Special 510(k) Premarket Notification CantataTM Microcatheter COOK INCORPORATED
510(k) Summary
K101450
DEC 300 2010 .
Submitted By:
Mironda Carpenter Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 812.339.2235
22 December 2010
Device:
Trade Name: Proposed Classification: Cantata™ Microcatheter Catheter, Continuous Flush KRA
Indications for Use:
The Cantata™ Microcatheter is designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures including neuro, peripheral, or coronary use.
Predicate Devices:
The Cantata™ Microcatheter is identical in terms of intended use and technological characteristics and similar in terms of material with the predicate MiraFlex®18 Microcatheter cleared under 510(k) number K060224 and the MiraFlex® High Flow Microcatheter cleared under 510(k) number K080737. The change involves a conversion from the current hydrophilic coating to a differently formulated hydrophilic coating.
Device Description:
The Cantata™ Microcatheter is an infusion catheter with a hydrophilic coating, designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures. The device is available in 2.5 and 2.8 French shafts and is available in 100, 110, 135, and 150 cm lengths. The device is supplied sterile and intended for one-time use.
1
Substantial Equivalence:
The Cantata™ Microcatheter is substantially equivalent to the predicate MiraFlex®18 Microcatheter cleared under 510(k) number K060224 and MiraFlex® High Flow Microcatheter cleared under 510(k) number K080737.
Test Data:
The Cantata™ Microcatheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were:
-
- Tensile strength
-
- Static burst pressure
-
- Kink radius
-
- Coating durability and lubricity
-
- Biocompatibility
- a. Cytotoxicity
- b. Sensitization, Maximization
- c. Intracutaneous
- d. Systemic Toxicity
- e. Hemolysis
- f. Pyrogen
- g. Complement Activation
- h. ASTM Partial Thromboplastin Time
-
- Shelf life
-
- Endotoxin/bioburden
-
- Particulate Testing
A rationale based upon the geometry, conditions of use and the materials that interact with the blood was submitted to support the omission of the in vivo thrombogenicity testing.
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized eagle with three stripes forming its wing, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Cook Incorporated c/o Ms. Mironda Carpenter Regulatory Affairs Specialist 750 Daniels Wav P.O. Box 489 Bloomington. IN 47402
DEC 3 0 2010
Re: K101450
Trade/Device Name: Cantata™ Microcatheter Common Name: Catheter, Continuous Flush Regulation Number: 21 CFR 870.1210 Regulatory Class: II Product Code: KRA Dated: December 17, 2010 Received: December 20, 2010
Dear Ms. Carpenter:
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.
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Page 2 - Ms. Mironda Carpenter
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 forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Special 510(k) Premarket Notification Cantata™M Microcatheter COOK INCORPORATED 21-May-2010
Indications for Use
DEC 3 0 2010
510(k) Number (if known): _ Kl (0145D
Device Name: Cantata™ Microcatheter
The Cantata™ Microcatheter is designed for use in small vessel or Indications for Use: superselective anatomy for diagnostic and interventional procedures including neuro, peripheral, or coronary use.
Prescription Use X (Per 21 CFR 801 Subpart D) OR
Over-the-Counter Use (Per 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
diovascular Devices
510(k) Number : K101450
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