F.A.S.T. SYSTEM SED AND CXD

K092623 · Genesis Medical Interventional, Inc. · QEW · Oct 30, 2009 · Cardiovascular

Device Facts

• Record ID: K092623
• Device Name: F.A.S.T. SYSTEM SED AND CXD
• Applicant: Genesis Medical Interventional, Inc.
• Product Code: QEW · Cardiovascular
• Decision Date: Oct 30, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The F.A.S.T.™ System SED and CXD are indicated for: - The non-surgical removal of emboli and thrombi from blood vessels. - The non-surgical removal of thrombi from synthetic grafts. - Temporary use in vessel/graft occlusions. - Injection, infusion, and/or aspiration of contrast media and other fluids into or from a vessel/graft. - Catheter placement over a guidewire.

Device Story

F.A.S.T. System SED and CXD are sterile, disposable thrombectomy catheters for non-surgical removal of emboli/thrombi from vessels or synthetic grafts. SED features self-expanding nitinol basket on core wire; deployed by withdrawing microcatheter. CXD features expandable nitinol basket with operator-controlled expansion/contraction via proximal handle. Both devices compatible with 0.021-in ID microcatheters; include radiopaque markers for fluoroscopic visualization. Used by physicians in clinical settings for minimally invasive vascular procedures. Devices facilitate clot removal and fluid management; aid in restoring vessel patency. Benefit includes non-surgical intervention for occlusions.

Clinical Evidence

Bench testing and in-vivo testing performed. Verification activities demonstrated adequate device performance and safety equivalent to the predicate device, raising no new questions of safety or effectiveness.

Technological Characteristics

Nitinol basket; core wire/hollow tube construction; radiopaque markers for fluoroscopy; compatible with 0.021-in ID microcatheters; sterile, disposable; manual mechanical operation.

Indications for Use

Indicated for non-surgical removal of emboli and thrombi from blood vessels and synthetic grafts, temporary use in vessel/graft occlusions, fluid injection/aspiration, and catheter placement over a guidewire.

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

• Genesis Medical Interventional™ F.A.S.T.™ (Facilitated Aspiration/Suction Thrombectomy) System (K040010)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, the FDA logo is displayed in blue, with the words "U.S. FOOD & DRUG" stacked above the word "ADMINISTRATION".

May 20, 2021

Genesis Medical Interventional, Inc. Anne Worden VP, Regulatory & Quality Assurance 2801 Bering Drive, Suite X San Jose, CA 95131

Re: K092623

Trade/Device Name: F.A.S.T. System SED AND CXD Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEW, KRA

Dear Anne Worden:

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 30. 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 09:43:16-04'00'

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

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The circular seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. The symbol on the right resembles a stylized caduceus or a representation of human figures, with three abstract shapes that could be interpreted as people or wings.

#### Public Health Service

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

OCT 3 0 2009

Genesis Medical Interventional, Inc. c/o Ms. Anne Worden Vice President of Regulatory & Quality Assurance 2081 Bering Drive San Jose. CA 95131

Re: K092623

> Trade/Device Name: F.A.S.T.TM System SED and CXD Common Name: Catheter, Thrombectomy Regulation Number: 21 CFR 870.5150 Regulatory Class: II Product Code: DXE Dated: September 29, 2009 Received: September 30, 2009

Dear Ms. Worden:

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

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Page 2 - Ms. Anne Worden

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 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

M.A. Hellemann

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

Enclosure

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# Statement of Indications for Use

510(k) Number (if known): K 092623

Device Name: F.A.S.T.TM System SED and CXD

Indications for Use: The F.A.S.T.™ System SED and CXD are indicated for:

AND/OR

- The non-surgical removal of emboli and thrombi from blood vessels. �
- The non-surgical removal of thrombi from synthetic grafts.
- Temporary use in vessel/graft occlusions.
- Injection, infusion, and/or aspiration of contrast media and other fluids into or from a vessel/graft.
- Catheter placement over a guidewire.

Prescription Use × (Per 21 C.F.R. 801 Subpart D) Over-the-Counter Use. (21 C.F.R. 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. Y. Wilhelmi

ardiovascular Devices

5 10/k) Nim

Page 1 of 1

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K092623

# OCT 3 0 2009

## 510(k) Summary for the F.A.S.T.TM SED and CXD System

#### L. General Information

Submitter:

Genesis Medical Interventional, Inc. 2801 Bering Drive Suite X San Jose, CA 95131

| Contact Person: | Anne C. Worden<br>VP, Regulatory & Quality Assurance |
|-----------------|------------------------------------------------------|
|-----------------|------------------------------------------------------|

August 23, 2009 Summary Preparation Date:

- II. Names
Device Names: F.A.S.T.™ SED and CXD System

Embolectomy Catheter Primary Classification Name:

## III. Predicate Device

- Genesis Medical Interventional™ F.A.S.T.M (Facilitated Aspiration/Suction Thrombectomy) System (K040010)
## IV. Product Description

The F.A.S.T.TM System - SED (Self-Expanding Device) and F.A.S.T.™ System - CXD (Controlled Expansion Device) are sterile, disposable, thrombectomy systems for the non-surgical removal of emboli and thrombi from blood vessels or grafts.

The F.A.S.T.™ System -- SED consists of a self-expanding nitinol basket mounted on a core wire. The device is compressed and sheathed in an introducer designed to facilitate loading and advancement of the device into the proximal hub of an 0.021-in (0.533-mm) microcatheter. When advanced to the distal end of a microcatheter, the compressed basket is deployed by withdrawing the microcatheter over the basket may be reconstrained back into the microcatheter.

The F.A.S.T.™ System - CXD Device consists of an expandable nitinol basket mounted on a hollow tube and core wire. Basket expansion and contraction to the desired diameter is controlled by the operator at the proximal end of the device. Using the handle control, the basket is contracted prior to withdrawing the device back into the microcatheter.

Both the F.A.S.T.™ System - SED and the F.A.S.T.TM System - CXD have markers at the proximal and distal ends of the basket to facilitate visualization under fluoroscopy and are compatible with 0.021 inch (0.533-mm) inner diameter (ID) microcatheters.

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### V. Indications for Use

The F.A.S.T.TM System SED and CXD are indicated for:

- . The non-surgical removal of emboli and thrombi from blood vessels.
- . The non-surgical removal of thrombi from synthetic grafts.
- . Temporary use in vessel/graft occlusions.
- Injection, infusion, and/or aspiration of contrast media and other fluids into or . from a vessel/graft.
- . Catheter placement over a guidewire.

### VI. Rationale for Substantial Equivalence

The F.A.S.T.TM System SED and CXD share the same or similar: indications for use, fundamental scientific technology, general device operation, materials, sterilization process, and packaging requirements, and, therefore, are substantially equivalent for use in minimally invasive vascular applications to the Genesis Medical Interventional™ F.A.S.T.TM (Facilitated Aspiration/Suction Thrombectomy) System (K040010). In addition, verification activities demonstrated adequate device performance.

#### VII. Safety and Effectiveness Information

Verification testing conducted on the F.A.S.T.7M System SED and CXD demonstrates the devices are substantially equivalent to the predicate device and do not raise new questions regarding safety and effectiveness with respect to embolectomy catheters when used in accordance with the Instructions for Use.

#### VIII. Conclusion

As described in this 510(k) Summary, the F.A.S.T.™ System SED and CXD are substantially equivalent to the Genesis Medical Interventional™ F.A.S.T.™ (Facilitated Aspiration/Suction Thrombectomy) System based on a comparison of intended uses and the results of in-vitro and in-vivo testing.