(26 days)
Not Found
No
The device description and performance studies focus on the physical properties and functionality of a microcatheter, with no mention of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is used to place fluids or other devices for diagnostic and/or therapeutic procedures, but it is not itself a therapeutic agent. It is an accessory device.
No
The device is a microcatheter used for selective placement of fluids or other devices during diagnostic or therapeutic procedures, not for making a diagnosis itself.
No
The device description clearly describes a physical catheter with a lumen, braiding, coating, and a luer hub, indicating it is a hardware device. The performance studies also focus on physical properties like kink resistance and tensile strength.
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 the "selective placement of fluids and/or other devices or agents into the peripheral, coronary and neuro vasculature during diagnostic and/or therapeutic procedures." This describes a device used within the body for procedural purposes, not for testing samples outside the body to diagnose conditions.
- Device Description: The description details a catheter designed for insertion into blood vessels. This aligns with an interventional or therapeutic device, not an IVD which typically involves reagents, test strips, or instruments for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on testing in vitro.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device is used in vivo (within the living body) for procedural purposes.
N/A
Intended Use / Indications for Use
The Modified Concentric Microcatheter is indicated for use in the selective placement of fluids and/or other devices or agents into the peripheral, coronary and neuro vasculature during diagnostic and/or therapeutic procedures.
Product codes
DQO
Device Description
The Modified Concentric Microcatheter is a single lumen, braided, variable stiffness catheter designed for use in the selective placement of fluids and/or other devices or agents into the peripheral, coronary and neuro vasculature during diagnostic and/or therapeutic procedures. A luer hub on the proximal end of the shaft enables connection to the rotating hemostasis valve included in the package. The radiopaque shaft and distal marker facilitate fluoroscopic visualization. The catheter shaft is coated with a hydrophilic coating to reduce friction during use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, coronary and neuro vasculature
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
The results of verification and validation conducted on the Modified Concentric Microcatheter demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device. Specifically, the following tests were performed: . Kink Resistance - the device's ability to withstand kinking when flexed was successfully evaluated. . Leak Resistance – the device's leak resistance when subjected to both high pressure and vacuum was successfully evaluated. . Flexibility Testing - the device's ability to navigate tight bends was successfully evaluated. . Flow Testing - the device's ability to infuse fluids was succesfully evaluated. . Tensile Testing - the device's mechanical integrity under tensile loads was successfully evaluated. . Torque Testing - the device's mechanical integrity when subjected to torsion was successfully evaluated. The materials on the Modified Concentric Microcatheter are the same as the predicate device. As a result, the following biocompatibility tests were leveraged. . Hemocompatibilty/Coagulation . Cytotoxicity . Systemic Toxicity . Hemocompatibility/Hematology . Sensitization . Irritation/Intracutaneous Reactivity . Pyrogen/Sytem.Toxicity
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
510(k) Summary
| Trade Name: | Modified Concentric Microcatheter |
|---|---|
| Common Name: | Diagnostic Intravascular Catheter |
| Classification Name: | Diagnostic Intravascular Catheter, 21CFR 870.1200 – Class II |
| Submitter | Concentric® Medical, Inc. |
| 301 E. Evelyn Avenue | |
| Mountain View, CA 94041 | |
| Tel 650-938-2100 | |
| Fax 650-237-5230 | |
| Facility Registration #2954917 |
Contact: Kirsten Valley, Senior Vice President, Technology and Regulatory Affairs |
| Predicate Device | Concentric Microcatheter (K091961) |
Device Description
The Modified Concentric Microcatheter is a single lumen, braided, variable stiffness catheter designed for use in the selective placement of fluids and/or other devices or agents into the peripheral, coronary and neuro vasculature during diagnostic and/or therapeutic procedures. A luer hub on the proximal end of the shaft enables connection to the rotating hemostasis valve included in the package. The radiopaque shaft and distal marker facilitate fluoroscopic visualization. The catheter shaft is coated with a hydrophilic coating to reduce friction during use.
Intended Use
The Modified Concentric Microcatheter is indicated for use in the selective placement of fluids and/or other devices or agents into the peripheral, coronary and neuro vasculature during diagnostic and/or therapeutic procedures.
Technological Characteristics
The Modified Concentric Microcatheter has the same technological characteristics as the K091961 predicate device. The device design, materials used, function, physical properties and composition have not been changed.
Testing Summary
The results of verification and validation conducted on the Modified Concentric Microcatheter demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device. Specifically, the following tests were performed:
1
- . Kink Resistance - the device's ability to withstand kinking when flexed was successfully evaluated.
- . Leak Resistance – the device's leak resistance when subjected to both high pressure and vacuum was successfully evaluated.
- . Flexibility Testing - the device's ability to navigate tight bends was successfully evaluated.
- . Flow Testing - the device's ability to infuse fluids was succesfully evaluated.
- . Tensile Testing - the device's mechanical integrity under tensile loads was successfully evaluated.
- . Torque Testing - the device's mechanical integrity when subjected to torsion was successfully evaluated.
The materials on the Modified Concentric Microcatheter are the same as the predicate device. As a result, the following biocompatibility tests were leveraged.
- . Hemocompatibilty/Coagulation
- . Cytotoxicity
- Systemic Toxicity .
- Hemocompatibility/Hematology .
- . Sensitization
- Irritation/Intracutaneous Reactivity .
- . Pyrogen/Sytem.Toxicity
Summary of Substantial Equivalence
The Modified Concentric Microcatheter is substantially equivalent to the predicate device with regard to device design, intended use, and patient population. The results of verification and validation conducted on the Modified Concentric Microcatheter demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Concentric Medical, Inc. c/o Ms. Kristen Valley Senior Vice President, Technology and Regulatory Affairs 301 E. Evelyn Avenue Mountain View, CA 94041
JUL - 6 2011
Re: KI11619
Trade/Device Name: Modified Concentric Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Catheter, Intravascular, Diagnostic Regulatory Class: Class II Product Code: DQO Dated: June 9, 2011 Received: June 10, 2011
Dear Ms. Valley:
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. Iisting 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
3
Page 2 – Ms. Kristen Valley
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/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/ReportalProblem/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/Resourcesfor You/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
4
Statement of Indications for Use
INDICATIONS FOR USE
| 510(k) Number (if known): | This application K111619 |
|---|---|
| Device Name: | Modified Concentric Microcatheter |
| Indications for Use: | The Modified Concentric Microcatheter is |
| indicated for use in the selective placement of | |
| fluids and/or other devices or agents into the | |
| peripheral, coronary and neuro vasculature | |
| during diagnostic and/or therapeutic | |
| procedures. |
Prescription Use __X (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| (Division Sign-Off) |
| Division of Cardiovascular Devices |
510(k) Number_(SII) 61) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------