HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131

K091703 · Concentric Medical, Inc. · QEZ · Oct 14, 2009 · Cardiovascular

Device Facts

• Record ID: K091703
• Device Name: HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131
• Applicant: Concentric Medical, Inc.
• Product Code: QEZ · Cardiovascular
• Decision Date: Oct 14, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HD Guide Catheter is indicated for the removal/aspiration of fresh, soft emboli and thrombi from vessels in the arterial system.

Device Story

HD Guide Catheter is a single-lumen, braided, variable-stiffness shaft device used for aspiration of emboli and thrombi from the arterial system. Features include a distal radiopaque marker, proximal luer hub, and hydrophilic coating to reduce friction. Supplied with a rotating hemostatic valve with side-arm adapter. Operated by clinicians in a clinical setting to remove obstructions; device facilitates mechanical aspiration to restore blood flow.

Clinical Evidence

Bench testing only. Verification and validation results demonstrate the device performs as designed and is suitable for its intended use.

Technological Characteristics

Single-lumen, braided, variable-stiffness shaft; radiopaque distal marker; proximal luer hub; hydrophilic coating. Includes rotating hemostatic valve with side-arm adapter. Materials are biocompatible and previously cleared.

Indications for Use

Indicated for removal/aspiration of fresh, soft emboli and thrombi from arterial system vessels.

Regulatory Classification

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.

Predicate Devices

• QuickCat Extraction Catheter (K073519)

Submission Summary (Full Text)

{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. [phone]. 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 [phone] or [phone] 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<br>removal/aspiration of fresh, soft emboli and<br>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.<br>301 E. Evelyn Avenue<br>Mountain View, CA 94041<br>Tel [phone]<br>Fax [phone] | OCT 1 4 2009 |
| Contact | Kirsten Valley<br>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.