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 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. .

AI/ML Overview

The provided document is a 510(k) summary for the Genesis Medical Interventional™ F.A.S.T.™ System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than performing a de novo study with acceptance criteria and performance metrics in the way a new, high-risk device might.

Therefore, the specific information requested about acceptance criteria, detailed performance studies, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance, is not present in this type of regulatory submission for this device.

Here's an explanation based on the provided text:

Type of Device and Approval Process: The F.A.S.T.™ System is an "Embolectomy Catheter" (Product Code: DXE), a Class II device. Its approval is via the 510(k) pathway, which means it seeks substantial equivalence to already legally marketed predicate devices. This process primarily involves demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or that any differences do not raise new questions of safety and effectiveness.
"Study" Described: The study mentioned is a comparison to predicate devices to demonstrate substantial equivalence. The document states: "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." This usually refers to internal verification and validation testing to ensure the device meets its own design specifications, and that these specifications are comparable to or better than those of the predicate devices. It does not typically involve clinical trials or studies with specific performance metrics like sensitivity, specificity, or reader improvement, as would be seen for AI/ML devices or novel high-risk devices.

Here's a breakdown of the requested information, indicating why it's not available in this document:

1. A table of acceptance criteria and the reported device performance

Not present. The document states "Performance data was provided to demonstrate that the ... System components perform in accordance with their specifications." However, it does not enumerate these specifications or present formal acceptance criteria with corresponding performance results in a table. For a 510(k) substantial equivalence submission, the primary "acceptance criterion" is often that the device performs equivalently to the predicate devices across relevant functional parameters.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not present. There is no mention of a "test set" in the context of clinical data or patient outcomes. The "performance data" likely refers to bench testing, engineering validation, and possibly animal studies, not human clinical trials with a defined sample size.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not present. This type of information is pertinent to studies involving human interpretation or clinical outcomes, which are not detailed here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not present. As there's no described "test set" for expert review, adjudication methods are not applicable nor mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not present. This document is for a mechanical medical device (a catheter for thrombectomy), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and "human reader improvement with AI" are entirely irrelevant and not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not present. This applies to algorithms, not mechanical devices.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not present. The "ground truth" for a device like this would typically be its ability to physically remove thrombi in controlled (often in vitro or in vivo animal) environments, or its mechanical integrity and functional performance against engineering specifications. No specific type of ground truth data (like pathology or outcomes) is detailed from a clinical study.

8. The sample size for the training set

Not present. This concept is for AI/ML models.

9. How the ground truth for the training set was established

Not present. This concept is for AI/ML models.

In summary: The provided 510(k) summary is a regulatory document focused on demonstrating "substantial equivalence" of a medical device to existing predicate devices. It does not contain the kind of detailed performance study data, acceptance criteria, or clinical trial information that would be found for a novel device undergoing a de novo classification or a more extensive clinical validation. The "performance data" referred to is almost certainly verification and validation testing against engineering specifications, not clinical outcomes from human subjects.

Summary

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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.#1 Uccelli Blvd., PO Box 246Redwood City, CA 94063
Contact Person:	Anne C WordenVP, Regulatory & Quality Assurance
Summary Preparation Date:	December 31, 2003

II. Names

Device Names:	Genesis Medical InterventionalTM F.A.S.T.TM(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. .

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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.

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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

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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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

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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

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
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.(b)
Classification. Class II (performance standards).