(206 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon guide catheter, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device is a guide catheter used to facilitate the insertion and guidance of other intravascular catheters and to provide temporary vascular occlusion, rather than directly treating a condition.
No
The device is described as a guide catheter for facilitating the insertion and guidance of other intravascular catheters and for temporary vascular occlusion. Its function is interventional, not diagnostic.
No
The device description clearly outlines physical components such as a catheter, balloon, radiopaque marker, and luer hub. The performance studies also detail testing on physical properties like tensile strength, leak testing, and biocompatibility, indicating a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Concentric Balloon Guide Catheter is a device used within the body to facilitate the insertion and guidance of other catheters and to provide temporary vascular occlusion. It is a surgical/interventional tool, not a diagnostic test performed on a sample.
- Intended Use: The intended use clearly describes a procedure performed in vivo (within a living organism), not a test performed in vitro (in a lab setting).
- Device Description: The description details the physical characteristics and function of a catheter used for navigation and occlusion within blood vessels.
- Performance Studies: The performance studies focus on the physical and mechanical properties of the catheter and its biocompatibility, not on the accuracy or reliability of a diagnostic test.
Therefore, based on the provided information, the Concentric Balloon Guide Catheter is a medical device used for interventional procedures, not an In Vitro Diagnostic.
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 Retrieval devices.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Concentric Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters designed for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. A radiopaque marker is included on the distal end for 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.
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 same performance standards and specifications as those previously submitted in the predicate device 510(k) submission are applicable. No additional verification testing was required for the change to the indications statement requested in this submission. The results of verification and validation conducted on the predicate device remain applicable. Specifically, the device meets the predetermined specifications for the following tests:
- Tensile Testing .
- . Leak Testing
- . Dimensional Testing
- . Torque Testing
- Kink Resistance
- . Simulated Use
- . Biocompatibility Testing
- . Balloon Fatique
- . Inflation/Deflation Testing
To confirm the biocompatibility of the new colorant, the following testing was successfully performed:
- Hemolysis, Direct Contact Method ●
- Hemolysis, Extract Method ●
- . Cytotoxicity - ISO MEM Elution
Based on conformance with these test requirements, the Concentric Balloon Guide Catheter is as safe and effective as the legally marketed predicate device.
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
§ 870.1250 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
KJ2404
510(K) Summary
General Information
| Trade Name
Common Name
Classification | Concentric Balloon Guide Catheter
Percutaneous Catheter
Percutaneous Catheter, 21CFR 870.1250 - Class II |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Owner | 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 |
| Date Prepared | August 4, 2011 |
Predicate Device
Concentric Balloon Guide Catheters (K102657)
Device Description
The Concentric Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters designed for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. A radiopaque marker is included on the distal end for 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.
Indications for Use
The modified Indications for Use are as follows:
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 Retrieval devices.
The modification to the indications does not impact the intended therapeutic use of the device. As a result, the safety and effectiveness of the device are not impacted when used as indicated.
Technological Characteristics
The Concentric Balloon Guide Catheter has the same technological characteristics as the predicate device. A colorant has been added to the dilator. Apart from this minor modification, the device design, materials used, function, physical properties and composition have not been changed.
Testing Summary
The same performance standards and specifications as those previously submitted in the predicate device 510(k) submission are applicable. No additional verification testing was required for
1
the change to the indications statement requested in this submission. The results of verification and validation conducted on the predicate device remain applicable. Specifically, the device meets the predetermined specifications for the following tests:
- Tensile Testing .
- . Leak Testing
- . Dimensional Testing
- . Torque Testing
- Kink Resistance
- . Simulated Use
- . Biocompatibility Testing
- . Balloon Fatique
- . Inflation/Deflation Testing
To confirm the biocompatibility of the new colorant, the following testing was successfully performed:
- Hemolysis, Direct Contact Method ●
- Hemolysis, Extract Method ●
- . Cytotoxicity - ISO MEM Elution
Based on conformance with these test requirements, the Concentric Balloon Guide Catheter is as safe and effective as the legally marketed predicate device.
Summary of Substantial Equivalence
The Concentric Balloon Guide Catheters are substantially equivalent to the predicate device with regard to device design, intended use, and patient population.
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-like symbol with three parallel lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Concentric Medical, Inc. c/o Regulatory Technology Services, LLC Mr. Mark Job Responsible Third Party Official 1394 25th Street NW Buffalo, MN 55313
Re: K112404
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: February 28, 2012 Received: February 29, 2012
Dear Mr. Job:
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.
MAR 1 5 2012
3
Page 2 - Mr. Mark Job
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 forth in the quality systems (OS) 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE: STATEMENT
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Indications for Use:
Concentric Balloon Guide Catheter
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 Retrieval devices.
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)
Quyñ Hoang
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K112404