(126 days)
Not Found
No
The description focuses on the physical characteristics and performance of a microcatheter, with no mention of AI or ML capabilities. The performance studies are based on physical and biocompatibility testing, not algorithmic performance.
No
The device is described as being used during diagnostic and/or therapeutic procedures for the placement of fluids or other devices, but it is not inherently therapeutic itself.
Yes
The device is indicated for use during diagnostic procedures, meaning it plays a role in gathering information for diagnosis.
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 and biocompatibility of the hardware.
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 "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 interventional procedures, not for testing samples outside the body.
- Device Description: The description details a catheter designed for insertion into blood vessels, with features like a lumen for fluid/agent delivery, a luer hub for connection, radiopacity for visualization, and a hydrophilic coating for ease of use. These are characteristics of an invasive medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to facilitate procedures within the body.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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. The same test methods were applied as those previously submitted for the predicate Concentric Microcatheter. Specifically, the following tests were performed on the proposed device:
- 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. .
- 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.
- . Coating Testing - the durability and lubricity of the device coating was successfully evaluated.
- . Radiopacity - the visibility of the device under fluoroscopy was successfully evaluated.
- Particulate Testing the amount and size of particles that are released from the device . during simulated clinical use were successfully evaluated.
The following biocompatibility tests were performed on the device; results for all tests met the predetermined acceptance criteria.
- . Sensitization/Maximization
- Cytotoxicity .
- Intracutaneous Reactivity .
- Systemic Toxicity/Systemic Injection Test .
- Systemic Toxicity/Rabbit Pyrogen Test .
- Hemocompatibility/Hemolysis .
- Hemocompatibility/Complement Activation ◆
- . Hemocompatibility/in vivo Thrombogenicity
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
MAR - 9 2012
510(k) Summary
| Trade Name: | Modified Concentric Microcatheter |
|---|---|
| Common Name: | Diagnostic Intravascular Catheter |
| Classification Name: | Diagnostic Intravascular Catheter, 21CFR 870.1200 - Class II |
| Product Code: | DQO |
| 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 | |
| Predicate Device: | Concentric Microcatheter (K111619) |
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 predicate device (K111619). Both have braided shafts with varying durometers of polymer along the length for optimal flexibility.
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. The same test methods were applied as those previously submitted for the predicate Concentric Microcatheter. Specifically, the following tests were performed on the proposed device:
- Kink Resistance the device's ability to withstand kinking when flexed was successfully evaluated.
1
Image /page/1/Picture/0 description: The image contains handwritten text. The text at the top reads "K113260". Below that, the text reads "p.2 of 2". The handwriting is in black ink.
- 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. .
- 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.
- . Coating Testing - the durability and lubricity of the device coating was successfully evaluated.
- . Radiopacity - the visibility of the device under fluoroscopy was successfully evaluated.
- Particulate Testing the amount and size of particles that are released from the device . during simulated clinical use were successfully evaluated.
The following biocompatibility tests were performed on the device; results for all tests met the predetermined acceptance criteria.
- . Sensitization/Maximization
- Cytotoxicity .
- Intracutaneous Reactivity .
- Systemic Toxicity/Systemic Injection Test .
- Systemic Toxicity/Rabbit Pyrogen Test .
- Hemocompatibility/Hemolysis .
- Hemocompatibility/Complement Activation ◆
- . Hemocompatibility/in vivo Thrombogenicity
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 lines forming its body and head, and two curved lines representing its legs. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the left side of the eagle.
Public Health Service
MAR - 9 2012
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Concentric® Medical, Inc. c/o Ms. Kirsten Valley Vice President, Technology & Regulatory Affairs 301 East Evelyn Avenue Mountain View, CA 94041
Re: K113260
Trade/Device Name: Modified Concentric Microcatheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: DOO Dated: March 1, 2012 Received: March 5, 2012
Dear Ms. Valley:
We have reviewed vour 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.
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
3
(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 (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/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 (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
M. A. Wilhelm
C / 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): | K113260 |
| 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_ (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)
Ms. Villeheni
(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular Devices
16119260 510(k) Number_
Page 1 of 1