(144 days)
Predecessor device: K113260
No
The description focuses on the physical characteristics and intended use of a microcatheter, with no mention of AI or ML capabilities. The performance studies are related to the physical properties and simulated use of the device.
No.
The device description states it is used for "selective placement of fluids and/or other devices or agents" for "diagnostic and/or therapeutic procedures," meaning it is a delivery tool and not the therapeutic agent itself.
No.
The device is used to place other devices or agents, which can then be used for diagnostic procedures. The device itself does not perform diagnostics.
No
The device description clearly describes a physical catheter with a shaft, lumen, hub, and coating, indicating it is a hardware device, not software-only.
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 a device used to test samples outside the body to diagnose conditions.
- Device Description: The description details a catheter designed for insertion into blood vessels. This is consistent with an interventional device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
In summary, the device is an interventional medical device used for delivering substances or other devices within the vascular system, which is distinct from an in vitro diagnostic device used for testing samples outside 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 (comma separated list FDA assigned to the subject device)
DQO, DQY and KRA
Device Description
The Modified Concentric Microcatheter is a line extension to the existing Concentric Microcatheter, cleared under K113260. Like the predicate device, the Modified Concentric Microcather is a single-lumen, braided shaft, 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. The Modified Concentric Microcatheter differs from its predicate in that it has smaller shaft diameters and a longer effective shaft length. Device dimensions and configuration are shown on the product label. A rotating hemostasis valve with side-arm adapter is provided with each microcatheter.
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 test methods applied were similar to those previously submitted for the predicate Concentric Microcatheter.
Specifically, the following tests were performed on the proposed device:
Design verification testing:
- 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.
In addition, dimensional verification testing was performed as part of design verification tests for the proposed device.
Design validation testing:
- Radiopacity Testing - the visibility of the device under fluoroscopy was successfully evaluated.
- Design Validation Simulated Use Testing – testing was performed in a porcine model to confirm that the proposed device meets its intended use.
The Modified Concentric Microcatheter uses the same materials and processes as the predicate device. Biocompatibility and sterilization tests were performed on the predicate device; results for all tests met the pre-determined acceptance criteria and apply to the Modified Concentric Microcatheter.
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
§ 870.1200 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
Concentric Medical, Inc. Traditional 510(k) Submission, K131437
5. 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, DQY and KRA | |
| Submitter: | Concentric Medical, Inc. | |
| 301 E. Evelyn Avenue | ||
| Mountain View, CA 94041 | ||
| Tel 650-938-2100 | ||
| Fax 650-237-5230 | ||
| Facility Registration #2954917 | OCT 1 1 2013 | |
| Contact: | Christina Rowe | |
| Manager, Regulatory Affairs | ||
| Date Prepared: | September 6, 2013 | |
| Predicate Device: | Concentric Microcatheter (K113260) |
Device Description
The Modified Concentric Microcatheter is a line extension to the existing Concentric Microcatheter, cleared under K113260. Like the predicate device, the Modified Concentric Microcather is a single-lumen, braided shaft, 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. The Modified Concentric Microcatheter differs from its predicate in that it has smaller shaft diameters and a longer effective shaft length. Device dimensions and configuration are shown on the product label. A rotating hemostasis valve with side-arm adapter is provided with each 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.
1
Concentric Medical, Inc. Traditional 510(k) Submission, K131437
Technological Characteristics
The Modified Concentric Microcatheter has the same technological characteristics as compared to the predicate device (K113260). The Modified Concentric Microcatheter differs from the predicate device in that its shaft diameters are smaller and its effective shaft length is longer. The device design, materials used, function, physical properties and composition have not been changed. A comparison of the subject device with predicate device is summarized in the table below.
| Feature | Results |
|---|---|
| Indications for Use | Same |
| Device Description | Same except smaller shaft diameters and longer |
| effective shaft length | |
| Target Population | Same |
| Accessory Devices Provided | Same |
| Materials | Same |
| Labeled shaft outer diameter | Smaller (2.4F vs. 2.7F) |
| Labeled shaft inner diameter | Smaller (.017" vs. .021") |
| Overall Length | Longer (157 cm vs. 150 cm) |
| Packaging Materials and | |
| Configuration | Same |
| Sterilization Method | Same |
| How Supplied | Same |
Product Feature Comparison of Subject Device with Predicate Device
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 test methods applied were similar to those previously submitted for the predicate Concentric Microcatheter.
Specifically, the following tests were performed on the proposed device:
Design verification testing:
- 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.
2
Concentric Medical, Inc. Traditional 510(k) Submission, K131437
In addition, dimensional verification testing was performed as part of design verification tests for the proposed device.
Design validation testing:
- . Radiopacity Testing - the visibility of the device under fluoroscopy was successfully evaluated.
- . Design Validation Simulated Use Testing – testing was performed in a porcine model to confirm that the proposed device meets its intended use.
The Modified Concentric Microcatheter uses the same materials and processes as the predicate device. Biocompatibility and sterilization tests were performed on the predicate device; results for all tests met the pre-determined acceptance criteria and apply to the Modified Concentric Microcatheter.
Summary of Substantial Equivalence
The Modified Concentric Microcatheter is substantially equivalent to the predicate device with regard to device design, materials, 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 as safe, as effective, and performs as well as or better than the legally marketed device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G6U9 Silver Spring, MD 20993-0002
October 11, 2013
Concentric Medical, Inc. c/o Ms. Christina Rowe Manager. Regulatory Affairs 301 E. Evelyn Ave. Mountain View, CA 94041
Rc: K131437
Trade/Device Name: Modified Concentric Microcatheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO, DQY and KRA Dated: September 9, 2013 Received: September 10, 2013
Dear Ms. Rowe:
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 ar any Federal statutes and regulations administered by other Federal agencies. You must or any vith 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized abstract image of an eagle or bird with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird image.
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Page 2 – Ms. Christina Rowe
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 Biometries/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.
Sincercly yours.
Joyce M. Whang -S
for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K131437
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 (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(Please Do NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Joyce M. Whang -S
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