(63 days)
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.
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.
This document is a 510(k) premarket notification for a medical device called the "Concentric Balloon Guide Catheter." This type of submission is for demonstrating "substantial equivalence" to a predicate device, not for proving a device meets specific acceptance criteria through novel studies. Therefore, much of the requested information regarding acceptance criteria and performance studies for this specific device is not present in the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a table of acceptance criteria and reported device performance for the Concentric Balloon Guide Catheter. Instead, it relies on the principle of substantial equivalence to previously cleared devices (K010954 and K021899).
The "performance" described is that the device "is identical to K010954 and K021899 and there were no design changes." The submitter states, "The device design, materials used, function, physical properties and composition have not been changed."
Therefore, the "acceptance criteria" were essentially:
- Being identical in design, materials, function, physical properties, and composition to the predicate devices.
- Having the same Indications for Use as the predicate devices.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable for this 510(k) submission directly. This submission primarily relies on the identity to predicate devices.
- Data Provenance: The document states that Concentric Medical referenced "the bench testing, biocompatibility and sterility information in K010954 and K021899." It also referenced "the MERCI and Multi MERCI clinical trials in (K070521 and K082034)" to demonstrate safety and effectiveness.
- K010954 and K021899 (Predicate Devices): The details of the original testing for these devices (sample size, provenance) are not provided here.
- K070521 and K082034 (MERCI and Multi MERCI clinical trials): These are referenced for clinical trial data, implying the data would be prospective clinical data. However, the specific sample sizes for these trials as they relate to this specific 510(k) are not given. The trials are mentioned as supporting the safety and effectiveness in a broader sense, likely for the use case rather than the minute performance of this specific guide catheter in a dedicated study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This 510(k) does not describe a new study with ground truth established by experts for this specific device. It relies on equivalence to predicate devices and previously reviewed clinical trial data.
4. Adjudication method
Not applicable. No new study with adjudication is described for this device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No. This type of study is typically for evaluating diagnostic imaging algorithms with human readers. This 510(k) is for a physical medical device (catheter) and does not describe such a study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a catheter, not an algorithm.
7. The type of ground truth used
For the safety and effectiveness mentioned by referencing the MERCI and Multi MERCI clinical trials, the "ground truth" would likely be patient outcomes data (e.g., successful recanalization, functional independence, adverse event rates), established through clinical diagnoses, imaging, and follow-up in those trials. For the predicate device bench testing, the ground truth would be against engineering specifications for physical properties.
8. The sample size for the training set
Not applicable. This 510(k) is not for an AI/algorithm device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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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 AvenueMountain View, CA 94041Tel 650-938-2100Fax 650-938-2700 |
| Contact | Kirsten ValleySenior 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
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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.
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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.
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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
§ 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).