(29 days)
Not Found
No
The summary describes a physical medical device (microcatheter) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device description and intended use indicate it is an accessory for placement of fluids or other devices for diagnostic and/or therapeutic procedures, but it does not independently provide therapy itself.
Yes.
The "Intended Use / Indications for Use" section explicitly states "during diagnostic and/or therapeutic procedures."
No
The device description clearly outlines physical components like a shaft, radiopaque marker, luer hub, and hydrophilic coating, indicating it is a hardware device, not software-only.
No, 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 direct intervention or delivery, not for testing samples outside the body.
- Device Description: The description details a catheter with a shaft, marker, and hub, designed for insertion into blood vessels. This is consistent with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing conditions by examining samples in vitro (outside the living organism).
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device is used in vivo (within the living organism) 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 consists of a single lumen, braided, variable stiffness shaft with a radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has 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.
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).
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
IJUL 30 2009
General Information
| Trade Name | Concentric Microcatheter |
|---|---|
| Common Name | Diagnostic Intravascular Catheter |
| Classification | 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 | |
| Contact | Kirsten Valley |
| Senior Vice President, Technology & Regulatory Affairs |
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.
Predicate Device
Concentric Microcatheter, K003086
Device Description
The Modified Concentric Microcatheter consists of a single lumen, braided, variable stiffness shaft with a radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use.
Materials
All materials used in the manufacture of the Modified Concentric Microcatheter are suitable for the intended use of the device and have been used in numerous previously cleared products.
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.
Summary of Substantial Equivalence
The Modified Concentric Microcatheter is substantially equivalent to the predicate device with regard to device design, intended use, patient population and anatomical site. Any differences in technological characteristics between the Moditied Concentric Microcatheter and the predicate device do not raise any new issues of safety or effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 30 2009
Concentric Medical % Ms. Kirsten Valley 301 East Evelyn Avenue Mountain View. California 94041
Re: K091961
Trade/Device Name: Modified Concentric Microcatheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: June 29, 2009 Received: July 1, 2009
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, 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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing
2
Page 2-Ms. Kirsten Valley
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/ResourcesforYou/Industry/default.htm.
Singerely yours,
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Concentric Medical, Inc. Special 510(k): Device Modification Concentric Microcatheter
INDICATIONS FOR USE
510(k) Number (if known):
This application - K091961
Modified Concentric Microcatheter
Device Name:
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 801.109) AND/OR
Over-The-Counter Use (Optional Format 1-2-96)
(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_Kog
I d