(85 days)
Not Found
No
The document describes a physical medical device (a catheter) and its intended use for guiding other catheters. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
The device facilitates the insertion and guidance of other catheters or serves as a diagnostic angiographic catheter, rather than directly treating a condition.
Yes
The "Intended Use / Indications for Use" section states: "It may also be used as a diagnostic angiographic catheter."
No
The device description clearly outlines physical components like a braided shaft, radiopaque marker, luer hub, and hydrophilic coating, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a guide catheter for facilitating the insertion and guidance of other catheters into blood vessels, and potentially for diagnostic angiography. This is an in vivo use, meaning it is used within a living organism.
- Device Description: The description details a physical catheter designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests on samples taken from the body, not to be inserted into the body for direct intervention or imaging.
N/A
Intended Use / Indications for Use
The HD Guide Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary or neuro vascular systems. It may also be used as a diagnostic anqiographic catheter.
Product codes
DQY
Device Description
The HD Guide Catheter 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 coaling to reduce friction during use. A rotating hemostatic valve with side-arm adapter is provided with each catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, coronary or 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
The results of verification and validation conducted on the HD Guide Catheter demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
- 6 2009
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
General Information
| Trade Name | HD 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 | Laraine Pangelina |
| Director, Regulatory Affairs |
Intended Use
The HD Guide Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary or neuro vascular systems. It may also be used as a diagnostic anqiographic catheter.
Predicate Device
HD Guide Catheter, K080583
Device Description
The HD Guide Catheter 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 coaling to reduce friction during use. A rotating hemostatic valve with side-arm adapter is provided with each catheter.
Materials
All materials used in the manufacture of the HD Guide Catheter 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 HD Guide Catheter 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 HD Guide Catheter 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 HD Guide Catheter and the predicate device do not raise any new issues of safety or effectiveness.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal is circular and contains an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" are written around the eagle in a circular fashion.
Public Health Service
MAY - 6 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Concentric Medical c/o Ms. Laraine Pangalina Director, Regulatory Affairs 301 East Evelyn Avenue Mountain View, CA 94041
Re: K090335
Trade/Device Name: Concentric HD Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: April 16, 2009 Received: April 20, 2009
Dear Ms. Pangalina:
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
2
Page 2 - Ms. Laraine Pangalina
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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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/cdrh/industry/support/index.html.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
.
| 510(k) Number (if known): | This application |
|---|---|
| Device Name: | HD Guide Catheter |
| Indications for Use: | The HD Guide Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary or neuro vascular systems. It may also be used as a diagnostic angiographic catheter. |
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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 GDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | 5/5/09 |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K090335 |