REFLOW ASPIRATION CATHETER

K123482 · Volcano Corporation · QEZ · Apr 29, 2013 · Cardiovascular

Device Facts

• Record ID: K123482
• Device Name: REFLOW ASPIRATION CATHETER
• Applicant: Volcano Corporation
• Product Code: QEZ · Cardiovascular
• Decision Date: Apr 29, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ReFLOW Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary, carotid and peripheral vasculature.

Device Story

ReFLOW Aspiration Catheter is an embolectomy device used to remove fresh, soft emboli and thrombi from coronary, carotid, and peripheral vessels. The device consists of a catheter shaft and hub, available in 6F and 7F diameters with a 150cm length. It is operated by a clinician in a clinical setting. The device functions via aspiration; the clinician navigates the catheter to the site of the thrombus and applies suction to remove the material. This process restores blood flow, potentially improving patient outcomes by reducing vessel occlusion. The device is a manual tool and does not involve electronic processing or automated decision-making.

Clinical Evidence

Bench testing only. Testing included dimensional verification, visual inspection, particulate evaluation, tensile strength (tube-to-stopcock, tube-to-luer, RX notch, hub-to-shaft, loading tool), liquid leak pressure, wall integrity, guidewire loading, torque strength, coating adhesion, kink resistance, liquid aspiration leak, aspiration flow rate, and simulated use thromboemboli aspiration. Biocompatibility testing included cytotoxicity, intracutaneous, systemic toxicity, sensitization, material-mediated pyrogen, hemolysis (ASTM and in vitro), complement activation (C3a, SC5-b), partial thromboplastin time, in vivo thromboresistance, and Limulus Amebocyte Lysate testing.

Technological Characteristics

Embolectomy catheter; 150cm length; 6F and 7F diameters; consists of catheter shaft and hub. Biocompatibility testing performed per ASTM standards for hemolysis. Manual aspiration mechanism. No electronic components or software.

Indications for Use

Indicated for removal of fresh, soft emboli and thrombi from coronary, carotid, and peripheral vasculature. No specific age or gender restrictions provided.

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

• Lumen Medical Xtract Aspiration Catheter

Submission Summary (Full Text)

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July 27, 2020

Volcano Corporation Brian Park Sr.Regulatory Specialist 3661 Valley Center Dr Suite 200 San Diego, California 92130

Re: K123482

Trade/Device Name: ReFLOW Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ

Dear Brian Park:

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 April 29, 2013. Specifically, FDA is updating this SE Letter 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], [e-mail].

Sincerely,

Image /page/0/Figure/9 description: The image shows the name "Gregory W. O'connell -S" in a large, bold font. The text is black and appears to be part of a document or title. The background is plain, with a watermark visible.

Digitally signed by Gregory W. O'connell -S Date: 2020.07.27 07:55:58

Gregory O'Connell Assistant Director Plaque Modification Devices Team 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

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 29, 2013

Volcano Corporation Brian Park, Senior Regulatory Affairs Specialist 3661 Valley Centre Drive, Suite 200 San Diego, CA 92130

Re: K123482

Trade/Device Name: ReFLOW Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: April 25, 2013 Received: April 26, 2013

Dear Mr. Park:

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.

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

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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

## Matthew G. Hillebrenner

for

Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use Statement

#### 510(k) Number K123482

Page 1 of 1

Device Name ReFLOW® Aspiration Catheter

Indications for Use The ReFLOW Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary, carotid and peripheral vasculature.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

OR

Over the Counter Use _______

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Matthew G Nillebrenner

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### 510(K) SUMMARY

| SPONSOR: | Volcano Corporation<br>3661 Valley Centre Drive Suite 200<br>San Diego, CA 92130 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Brian Park<br>Senior Regulatory Affairs Specialist<br>Volcano Corporation<br>3661 Valley Centre Dr. Suite 200<br>San Diego, CA 92130<br>Tel: [phone] |
| DATE OF SUBMISSION: | April 5, 2013 |
| DEVICE: | Volcano ReFLOW® Aspiration Catheter |
| Trade Name: | ReFLOW Aspiration Catheter |
| Common Name: | Catheter, Embolectomy |
| Classification: | 21 CFR Part 870. 5150<br>Class II Device |
| PREDICATE DEVICE: | Lumen Medical Xtract Aspiration Catheter |
| DEVICE DESCRIPTION: | The ReFLOW Aspiration Catheter is an embolectomy<br>catheter comprised of a catheter shaft and hub. It is 150cm<br>long and is available in 6F and 7F diameters. |
| INDICATIONS FOR USE: | The ReFLOW Aspiration Catheter is indicated for the<br>removal of fresh, soft emboli and thrombi from vessels in<br>the coronary, carotid and peripheral vasculature. |
| COMPARISON OF<br>CHARACTERISTICS: | The proposed device is substantially equivalent to<br>the predicate device. Both devices are aspiration catheters<br>consisting of a catheter shaft and hub. The proposed<br>ReFLOW Aspiration Catheter is offered in two sizes,<br>identical to the predicate device. The outer and inner shaft<br>diameters are identical for both the predicate and proposed<br>devices. |
| PERFORMANCE DATA: | Non-clinical device testing was conducted to confirm the<br>performance of the device. Bench testing was conducted<br>against known standards or product specifications and<br>evaluated the following: |

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- Dimensional Verification ●
- Visual Inspection
- Particulate Evaluation ●
- Tube to Stopcock Tensile Strength
- Tube to Luer Tensile Strength
- RX Notch Tensile Strength
- Hub to Shaft Tensile Strength
- Loading Tool Tensile Strength ●
- Liquid Leak Pressure Test
- Wall Integrity Test
- Guidewire Loading Test
- Torque Strength ●
- Coating Adhesion Test ●
- Kink Resistance
- Liquid Aspiration Leak Test ●
- Aspiration Flow Rate
- Thromboemboli Aspiration Simulated Use Testing ●

Biocompatibility testing was conducted on the device and the following tests were successfully completed:

- Cytotoxicity .
- . Intracutaneous
- Systemic Toxicity ●
- Maximum Sensitization ●
- Material Mediated Pyrogen ●
- ASTM Hemolysis ●
- . In Vitro Hemolysis
- C3a Complement Activation .
- SC5-b Complement Activation ●
- Partial Thromboplastin Time ●
- In vivo Thromboresistence ●
- Limulus Amebocyte Lysate .

Completion of these tests concluded the ReFLOW catheter is substantially equivalent to the predicate device.