(126 days)
Not Found
No
The device description and summary of performance studies describe a mechanical catheter for thrombus removal and do not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for the "removal/aspiration of fresh, soft emboli and thrombi," which is a direct treatment of a medical condition.
No
The device is indicated for the removal/aspiration of emboli and thrombi, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines physical components like a catheter shaft, radiopaque marker, luer hub, and a rotating hemostatic valve, 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 is the "removal/aspiration of fresh, soft emboli and thrombi from vessels in the arterial system." This is a therapeutic procedure performed directly on the patient's body, not a test performed on a sample of bodily fluid or tissue in vitro (outside the body).
- Device Description: The description details a catheter designed for physical intervention within the arterial system.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a therapeutic tool used for physical intervention.
N/A
Intended Use / Indications for Use
The HD Guide Catheter is indicated for the removal/aspiration of fresh, soft emboli and thrombi from vessels in the arterial system.
Product codes (comma separated list FDA assigned to the subject device)
QEZ, DXE
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 coating 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
vessels in the arterial system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 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 (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
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
May 20, 2021
Concentric Medical, Inc. Kirsten Valley Senior VP, Technology & Regulatory Affairs 301 E. Evelyn Ave. Mountain View, California 94041
Re: K091703
Trade/Device Name: HD Guide Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ
Dear Kirsten Valley:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 14, 2009. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices. (301) 796-6075. Gregory. Oconnell(@FDA.HHS.gov.
Sincerely,
Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2021.05.20 09:42:07 -04'00'
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Concentric Medical C/O Ms. Kirsten Valley Sr. Vice President, Technology & Regulatory Affairs 301 East Evelyn Ave. Mountain View, CA 94041
Re: K091703
OCT 1 4 2009
Trade Name: Concentric HD Guide Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: DXE Dated: September 18, 2009 Received: September 21, 2009
Dear Ms. Valley:
We have reviewed your Section 510(k) prematket 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. Kirsten Valley
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/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.
una R-kuhner
Image /page/2/Picture/7 description: The image shows a handwritten symbol or signature. It appears to be a combination of curved and straight lines, possibly representing initials or a stylized mark. The symbol is positioned next to the word "Bra", which is followed by the word "Dir" on the next line, and then "Dir" again on the following line.
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 STATEMENT
INDICATIONS FOR USE
| 510(k) Number (if known): | This application K091703 |
|---|---|
| Device Name: | HD Guide Catheter |
| Indications for Use: | The HD Guide Catheter is indicated for the |
| removal/aspiration of fresh, soft emboli and | |
| thrombi from vessels in the arterial system. |
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)
Duna D. Archer
(Division Sign-Off) (Division Sign off)
Division of Cardiovascular Devices
510(k) Number_Kogi703
8
4
510(K) SUMMARY
General Information
| Trade Name | HD Guide Catheter | |
|---|---|---|
| Common Name | Embolectomy Catheter | |
| Classification | Embolectomy Catheter, 21CFR 870.5150 - Class II | |
| Submitter | Concentric® Medical, Inc. | |
| 301 E. Evelyn Avenue | ||
| Mountain View, CA 94041 | ||
| Tel 650-938-2100 | ||
| Fax 650-938-2700 | OCT 1 4 2009 | |
| Contact | Kirsten Valley | |
| Senior Vice President, Technology and Regulatory Affairs |
Intended Use
The HD Guide Catheter is indicated for the removal/aspiration of fresh, soft emboli and thrombi from vessels in the arterial system.
Predicate Device
QuickCat Extraction Catheter (K073519).
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 coating 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, and patient population. Any differences in technological characteristics between the HD Guide Catheter and the predicate device do not raise any new issues of safety or effectiveness.