(63 days)
No
The device description and intended use focus on the physical characteristics and function of a balloon guide catheter. There is no mention of AI, ML, or any software-driven analytical capabilities. The performance studies reference predicate devices and clinical trials related to the catheter's physical use, not AI/ML performance.
No
The device facilitates the insertion and guidance of other catheters and provides temporary vascular occlusion; it does not directly treat a disease or condition.
No
The device is a guide catheter used to facilitate the insertion and guidance of other intravascular catheters and for temporary vascular occlusion during angiographic procedures. It is an interventional device, not a diagnostic one.
No
The device description clearly details a physical catheter with a balloon, lumens, and a hub, 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 describes a device used in vivo (within the body) for facilitating the insertion and guidance of catheters and providing temporary vascular occlusion during angiographic procedures. IVDs are used in vitro (outside the body) to examine specimens derived from the human body.
- Device Description: The description details a physical catheter designed to be inserted into blood vessels. This is consistent with an in vivo medical device, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
The device is a medical device used for interventional procedures within the vascular system.
N/A
Intended Use / Indications for Use
The Concentric Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for the Merci Retriever.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Concentric Balloon Guide Catheter are coaxial-lumen, braid-reinforced, variable stiffness catheters designed for use in facilitating the insertion and quidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. A radiopaque marker on the distal end facilitates angiographic visualization. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic procedures. A bifurcated luer hub on the proximal end allows attachments for flushing, inflation and aspiration. Balloon Guide Catheter dimensions and maximum recommended balloon inflation volume are indicated on product label. If indicated on product label, a dilator is provided. The Balloon Guide Catheter is identical to K010954 and K021899.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and neuro vascular systems
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 Balloon Guide Catheter is identical to K010954 and K021899 and there were no design changes. For this 510k, Concentric Medical referenced the bench testing, biocompatibility and sterility information in K010954 and K021899. The safety and effectiveness of the Balloon Guide Catheter was also demonstrated by referencing the MERCI and Multi MERCI clinical trials in (K070521 and K082034).
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.
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
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
510(K) Summary
General Information
| Trade Name | Concentric Balloon Guide Catheter |
|---|---|
| Common Name | Percutaneous Catheter |
| Classification | Percutaneous Catheter, 21CFR 870.1250 - Class II |
| Submitter | Concentric ® Medical, Inc. |
| 301 E. Evelyn Avenue | |
| Mountain View, CA 94041 | |
| Tel 650-938-2100 | |
| Fax 650-938-2700 | |
| Contact | Kirsten Valley |
| Senior Vice President, Technology and Regulatory Affairs |
Predicate Device
Concentric Balloon Guide Catheters (K010954 and K021899).
Device Description
The Concentric Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters designed for use in facilitating the insertion and quidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. A radiopaque marker on the distal end facilitates angiographic visualization. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic procedures. A bifurcated luer hub on the proximal end allows attachments for flushing, inflation and aspiration. Balloon Guide Catheter dimensions and maximum recommended balloon inflation volume are indicated on product label. If indicated on product label, a dilator is provided. The Balloon Guide Catheter is identical to K010954 and K021899.
Indications for Use
The Concentric Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for the Merci Retriever.
Technological Characteristics
The Concentric Balloon Guide Catheter has the same technological characteristics as the predicate device. The device design, materials used, function, physical properties and composition have not been changed. Specifically, the device is coaxial-lumen, braid-reinforced, variable stiffness catheter with a radiopaque marker on the distal end. A soft, compliant balloon is mounted on the distal end. A bifurcated luer hub on the proximal end allows attachments for flushing, inflation and aspiration.
Testing Summary
The Balloon Guide Catheter is identical to K010954 and K021899 and there were no design changes. For this 510k, Concentric Medical referenced the bench testing, biocompatibility and sterility information in K010954 and K021899. The safety and effectiveness of the Balloon Guide Catheter was also demonstrated by referencing the MERCI and Multi MERCI clinical trials in (K070521 and K082034).
NOV 1 7 2010
1
Summary of Substantial Equivalence
.
.
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The Concentric Balloon Guide Catheters are substantially equivalent to the predicate device with regard to device design, intended use, and patient population. As a result, the Concentric Balloon Guide Catheter is as safe and effective as the predicate device.
2
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing its wings or body.
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 East Evelyn Avenue Mountain View, CA 94041
Re: K102657
Trade/Device Name: Concentric Balloon Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 14, 2010 Received: September 15, 2010
NOV 1 7 2010
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. 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.
3
Page 2 - Ms. Kristen Valley
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 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/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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Esa A. Rhmbr
Melvin R. Robinson
Malvina B. Eydelman, M Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
INDICATIONS FOR USE
| 510(k) Number (if known): | This application K102657 | NOV 17 2010 |
|---|---|---|
| Device Name: | Concentric Balloon Guide Catheter | |
| Indications for Use: | The Concentric Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for the Merci Retriever. |
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)
JEFFREY Toy
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K102657