FETCH 2 ASPIRATION CATHETER MODEL 109400-001

K101354 · Medrad Interventional/Possis · QEZ · Jan 21, 2011 · Cardiovascular

Device Facts

• Record ID: K101354
• Device Name: FETCH 2 ASPIRATION CATHETER MODEL 109400-001
• Applicant: Medrad Interventional/Possis
• Product Code: QEZ · Cardiovascular
• Decision Date: Jan 21, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

Device Story

Fetch 2 Aspiration Catheter is a rapid exchange, low-profile, dual-lumen catheter; tracks to target site via 0.014" guidewire; compatible with 6F guiding catheters. Used by physicians in interventional settings for aspiration of fresh, soft emboli and thrombi. Includes extension line, one-way stopcock, syringes, and 40-micron collection baskets for filtering aspirated blood. Radiopaque marker at distal tip aids visualization. Device removes obstructions to restore blood flow, potentially benefiting patients with vascular occlusions.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-5, -10, -11, -18), hemocompatibility (ISO 10993-4, ASTM F2382-04), package integrity, sterilization, dimensional testing, aspiration testing, tracking, mechanical integrity, and kink resistance.

Technological Characteristics

Rapid exchange, dual-lumen catheter; 0.056" (4F) outer diameter; 0.014" guidewire compatible. Features radiopaque distal marker. Includes accessory collection baskets (40 micron). Biocompatibility per ISO 10993 series; hemocompatibility per ISO 10993-4 and ASTM F2382-04.

Indications for Use

Indicated for removal of fresh, soft emboli and thrombi from peripheral and coronary vasculature.

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

• Fetch Aspiration catheter (K081989)

Submission Summary (Full Text)

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February 8, 2021

MEDRAD Interventional/Possis Doug Atkins Sr. Regulatory Affairs Associate 9055 Evergreen Blvd NW Minneapolis, Minnesota 55433

Re: K101354

Trade/Device Name: Fetch 2 Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: OEZ

Dear Doug Atkins:

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 January 21, 2011. 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 this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, [phone], Gregory. Oconnell(@FDA.HHS.gov.

Sincerely,

Gregory W. Digitally signed by
Gregory W. Gregory W. O'connell -S ○'connell -S Date: 2021.02.08
07:58:33-05'00'

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

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three figures intertwined. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

## Public Health Service

JAN 2 1 201

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

MEDRAD Interventional / Possis c/o Mr. Doug Atkins Sr. Regulatory Affairs Associate 9055 Evergreen Blvd Minneapolis, MN 55433-8003

## Re: K101354

Trade/Device Name: Fetch 2 Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: DXE Dated: December 28, 2010 Received: December 29, 2010

Dear Mr. Atkins:

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 that I Drederal statutes and regulations administered by other Federal agencies. You must or any I outer clarees and requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Mr. Doug Atkins

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.html 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" (21CFB, 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

R. bohner

SBram D. 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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Fetch® 2 Aspiration Catheter

Indications for Use:

The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi: from vessels in the peripheral and coronary vasculature.

Prescription Use X (Part 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) |
|--------------------------------------------------------|
|--------------------------------------------------------|

____________________________________

(Division Sign-Off)

Division of Cardiovascular Devices

| 510(k) Number | K101354 |
|---------------|---------|
|---------------|---------|

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KID1354

| Section 5-510(k) Summary | JAN 2 1 2011 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | MEDRAD Interventional / Possis<br>9055 Evergreen Boulevard NW<br>Minneapolis, MN 55433-8003 USA |
| Contact Person: | Doug Atkins<br>Sr. Regulatory Affairs Associate<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Submitted: | May 13, 2010 |
| Trade Name: | Fetch® 2 Aspiration Catheter |
| Classification: | 870.5150 |
| Product Code: | DXE |
| Predicate Device(s): | Fetch Aspiration catheter: K081989<br>MEDRAD Interventional / Possis<br>9055 Evergreen Boulevard N.W.<br>Minneapolis, MN 55433-8003 |
| Device Description: | The Fetch 2 Aspiration Catheter is a rapid exchange, low-profile tip,<br>dual lumen catheter that uses a 0.014" (0.36 mm) guide wire to track<br>to the target site. It is used for aspiration of fresh, soft emboli and<br>thrombi. Its outer diameter (0.056" or 4F) allows advancement to the<br>target site through a 6F (0.070" I.D.) guiding catheter. A radiopaque<br>marker is located near the distal tip. Fetch 2 is provided with an<br>extension line (connected to a one-way stopcock), 2 - 30 cc syringes,<br>and 2 - 40 micron collection baskets. The baskets can be used to filter<br>aspirated blood for laboratory analysis of collected thrombus. |
| Intended Use: | The Fetch 2 Aspiration Catheter is indicated for the removal of fresh,<br>soft emboli and thrombi from vessels in the peripheral and coronary<br>vasculature. |
| Performance Data: | Bench and laboratory testing was performed to support a<br>determination of substantial equivalence to the predicate device.<br>Results from the testing provide assurance that the proposed device<br>conforms to the requirements for its intended use. This included the<br>following tests:<br>• Biocompatibility<br>• Cytotoxicity (ISO 10993-5)<br>• Intracutaneous Reactivity (ISO 10993-10)<br>• Sensitization (ISO 10993-10)<br>• Acute Systemic Toxicity (ISO 10993-11)<br>• Material Mediated Pyrogen (ISO 10993-11)<br>• Physiochemical (ISO 10993-18)<br>• Hemocompatibility<br>• ASTM Hemolysis (ISO 10993-4)<br>• Partial Thromboplastin Time Assay (ASTM F2382-04) |

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- C3a Complement Activation (ISO 10993-4) ﻴﺔ
- SC5b-9 Complement Activation (ISO 10993-4) -
- ﮯ Thromboresistance (ISO 10993-4)
- Package integrity .
- . Sterilization testing
- . Dimensional testing
- Operational characteristics .
- Aspiration testing .
- Tracking .
- Mechanical integrity 0
- . Kink resistance

## Conclusion:

MEDRAD Interventional / Possis considers the Fetch 2 Aspiration Catheter to be substantially equivalent to the predicate device listed above. This conclusion is based upon the devices' similarities in functional design, materials, indications for use, and principles of operation.