GENESIS MEDICAL INTERVENTIONAL F.A.S.T. (FACILITATED ASPIRATION/SUCTION THROMBECTOMY) SYSTEMS

K040010 · Genesis Medical Interventional, Inc. · QEW · Jul 19, 2004 · Cardiovascular

Device Facts

• Record ID: K040010
• Device Name: GENESIS MEDICAL INTERVENTIONAL F.A.S.T. (FACILITATED ASPIRATION/SUCTION THROMBECTOMY) SYSTEMS
• Applicant: Genesis Medical Interventional, Inc.
• Product Code: QEW · Cardiovascular
• Decision Date: Jul 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Genesis Medical Interventional™ F.A.S.T.™ (Facilitated Aspiration/ Suction Thrombectomy) System is indicated for: - The non-surgical removal of emboli and thrombi from blood vessels. - The non-surgical removal of thrombi from synthetic grafts. - Use in temporary blood vessel/graft occlusion. - Injection, infusion, and/or aspiration of contrast media and other fluids into or from a vessel/graft. - Catheter placement over a guidewire.

Device Story

The F.A.S.T. System is a minimally invasive catheter-based device used for thrombectomy and fluid management. It consists of an expanding basket thrombectomy guidewire, funnel sheath catheter, dilator, tip cover, and accessories including an 18-gauge needle and vacuum syringe. The device is operated by a physician in a clinical setting. The system functions by inserting the catheter over a guidewire to the target site; the expanding basket facilitates the mechanical removal of thrombi or emboli, while the funnel sheath and syringe allow for aspiration of fluids or contrast media. The device provides a non-surgical alternative for clearing vascular obstructions and grafts, potentially reducing patient morbidity associated with open surgical interventions.

Clinical Evidence

Bench testing only. Performance data provided to demonstrate that all system components perform in accordance with their specifications.

Technological Characteristics

System components include an expanding basket thrombectomy guidewire, funnel sheath catheter, dilator, and vacuum syringe. The device utilizes mechanical aspiration and basket-based retrieval. It is a class II device (Product Code: DXE).

Indications for Use

Indicated for patients requiring non-surgical removal of emboli and thrombi from blood vessels or synthetic grafts, temporary vessel/graft occlusion, fluid/contrast media infusion or 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

• Embolectomy Irrigation-Occlusion Balloon Catheter (EIOBC) (K974335)
• Over the Wire Embolectomy Catheter (K022145)
• Dual Lumen Graft Cleaning Catheter (K973465)
• MSD Embolectomy Basket (K991093)
• Versa-Cath Arterial Catheter (K961883)
• Biosensors Embolectomy Catheter (K973477)
• Core and Coil Assembly (CCA) Guidewires (K971322)
• Mandrel Guidewire Assembly (K011084)

Submission Summary (Full Text)

{0}------------------------------------------------

# JUL 1 9 2004

## Attachment 19 510(k) Summary for the Genesis Medical Interventional™ F.A.S.T.™ (Facilitated Aspiration/Suction Thrombectomy) System

### General Information I.

| Submitter: | Genesis Medical Interventional, Inc.<br>#1 Uccelli Blvd., PO Box 246<br>Redwood City, CA 94063 |
|---------------------------|------------------------------------------------------------------------------------------------|
| Contact Person: | Anne C Worden<br>VP, Regulatory & Quality Assurance |
| Summary Preparation Date: | December 31, 2003 |

- II. Names

| Device Names: | Genesis Medical InterventionalTM F.A.S.T.TM<br>(Facilitated Aspiration/Suction Thrombectomy) System |
|------------------------------|-----------------------------------------------------------------------------------------------------|
| Primary Classification Name: | Embolectomy Catheter |

#### III. Predicate Devices

- Embolectomy Irrigation-Occlusion Balloon Catheter (EIOBC) manufactured by J-● Lloyd Medical (K974335);
- Over the Wire Embolectomy Catheter manufactured by LeMaitre Vascular . (K022145);
- Dual Lumen Graft Cleaning Catheter manufactured by Applied Medical Resources . (K973465);
- MSD Embolectomy Basket manufactured by Metamorphic Surgical Devices ● (K991093);
- Versa-Cath Arterial Catheter manufactured by Ideas for Medicine (K961883); .
- Biosensors Embolectomy Catheter manufactured by Sunscope International ● (K973477):
- Core and Coil Assembly (CCA) Guidewires manufactured by Lake Region . Manufacturing (K971322);
- Mandrel Guidewire Assembly manufactured by Lake Region Manufacturing . (K011084).

#### IV. Product Description

The Genesis Medical Interventional™ F.A.S.T.TM (Facilitated Aspiration/Suction Thrombectomy) System is comprised of the following main components:

- Expanding Basket Thrombectomy Guidewire; .
- Funnel Sheath Catheter; .
- Dilator:
- . Funnel Sheath Catheter/Dilator assembly Tip Cover
- Accessories 18 gauge needle and vacuum syringe. .

{1}------------------------------------------------

#### V. Indications for Use

The Genesis Medical Interventional™ F.A.S.T. TM (Facilitated Aspiration/Suction Thrombectorny) System is indicated for the non-surgical removal of emboli and thrombi from blood vessels, the non-surgical removal of thrombi from synthetic grafts, use in temporary blood vessel/graft occlusion, infusion, and/or aspiration of contrast media and other fluids into or from a vessel/graft, and catheter placement over a guidewire.

#### VI. Rationale for Substantial Equivalence

The Genesis Medical Interventional™ F.A.S.T.TM (Facilitated Aspiration/Suction Thrombectomy) System shares the same or similar indications for use, device operation, overall dimensions, materials, sterilization process, and packaging, and therefore are substantially equivalent for use in minimally invasive vascular applications to the predicate Embolectomy Irrigation-Occlusion Balloon Catheter (EIOBC) manufactured by J-Lloyd Medical (K974335), the currently marketed predicate Over the Wire Embolectomy Catheter manufactured by LeMaitre Vascular (K022145), the predicate Dual Lumen Graft Cleaning Catheter manufactured by Applied Medical Resources (K973465), the predicate MSD Embolectomy Basket manufactured by Metamorphic Surgical Devices (K991093), the predicate Versa-Cath Arterial Catheter manufactured by Ideas for Medicine (K961883), the predicate Biosensors Embolectomy Catheter manufactured by Sunscope International (K973477), the predicate Core and Coil Assembly (CCA) Guidewires manufactured by Lake Region Manufacturing (K971322), and the Mandrel Guidewire Assembly manufactured by Lake Region Manufacturing (K011084). In addition, validation data demonstrated adequate device performance.

#### VII. Safety and Effectiveness Information

Performance data was provided to demonstrate that the Genesis Medical Interventional™ F.A.S.T. ™ (Facilitated Aspiration/Suction Thrombectomy) System components perform in accordance with their specifications.

## VIII. Conclusion

The Genesis Medical Interventional™ F.A.S.T.™ (Facilitated Aspiration/Suction Thrombectorny) System was found to be substantially equivalent to the predicate Embolectomy Irrigation-Occlusion Balloon Catheter (EIOBC) manufactured by J-Lloyd Medical (K974335), the currently marketed predicate Over the Wire Embolectomy Catheter manufactured by LeMaitre Vascular (K022145), the predicate Dual Lumen Graft Cleaning Catheter manufactured by Applied Medical Resources (K973465), the predicate MSD Embolectomy Basket manufactured by Metamorphic Surgical Devices (K991093), the predicate Versa-Cath Arterial Catheter manufactured by Ideas for Medicine (K961883), the predicate Biosensors Embolectorny Catheter manufactured by Sunscope International (K973477), the predicate Core and Coil Assembly (CCA) Guidewires manufactured by Lake Region Manufacturing (K971322), and the Mandrel Guidewire Assembly manufactured by Lake Region Manufacturing (K011084). The Genesis Medical Interventional™ F.A.S.T. ™ (Facilitated Aspiration/Suction Thrombectomy) System shares similar indications for use, design features, and similar functional features, and thus is substantially equivalent to the predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.

JUL 1 9 2004

Genesis Medical Interventional, Inc. c/o Ms. Anne Worden V.P. Regulatory & Quality Assurance 652 Bair Island Road, Suite 103 Redwood City, CA 94063

K040010 Re:

Genesis Medical Interventional™ F.A.S.T.™ System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: II Product Code: DXE Dated: June 3, 2004 Received: June 7, 2004

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 such 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.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

{3}------------------------------------------------

Page 2 - Ms. Anne Worden

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Omna R. Vechner

Image /page/3/Picture/5 description: The image contains what appears to be a signature. The signature is composed of a series of connected strokes, forming a unique and stylized design. The strokes are bold and fluid, suggesting a confident and practiced hand. The overall impression is that of a personal mark or endorsement.

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

Enclosure

{4}------------------------------------------------

### Attachment 2 Indications for Use Statement as Requested By FDA

510(k) Number (if Known): K040010

Device Name: Genesis Medical Interventional™ F.A.S.T.™ System

Indications for Use:

The Genesis Medical Interventional™ F.A.S.T.™ (Facilitated Aspiration/ Suction Thrombectomy) System is indicated for:

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

Prescription Use . . . (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)

Duna R. Vuchner

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K040010

Page 1 of 1