The Gelbfish Endo-Vac System is intended for the percutaneous aspiration of thrombus from acutely clotted AV grafts as a part of a percutaneous thrombectomy procedure. The device incorporates an anti-clogging/selfcleaning mechanism to maintain its uninterrupted function.

The device is not (by itself) intended to restore function to clotted AV grafts. It is only used in conjunction with standard percutaneous thrombectomy procedures to facilitate the aspiration of clot from the graft. The arterial and venous anastomotic plug/clot and pathology must still be addressed by standard Fogarty and/or balloon catheter procedures. Expertise in traditional pharmoco-mechanical techniques is necessary, and may be used in conjunction with the Endo-Vac System.

The enclosed device is indicated for use to remove thrombus in clotted synthetic ePTFE grafts only. Its short length makes it suitable for aspiration of clot from the "body" of the graft. It is NOT intended to cross arterial or venous anastomoses or to be used on clot contained in native artery or vein.

Device Description

The Gelbfish EndoVac System consists of a set of three main groups of components: (1) an introducer sheath with side-port for suction connection (with three-way stopcock), plus dilator and guidewire (used for initial sheath insertion), (2) a stainless steel anti-clogging/self-cleaning unit with connector for saline injection, dual check valve, tubing and syringe for saline irrigation, and (3) suction components--a fail-safe trumpet suction valve, and suction tubing. All but the stainless part are components that are presently marketed as medical devices or components. Only the stainless steel self-cleaning unit is new, and it is fabricated from medical grade stainless steel components used for blood contact applications.

AI/ML Overview

Here's an analysis of the provided text regarding the GELBFISH ENDOVAC SYSTEM, focusing on the acceptance criteria and the study used to demonstrate it:

Given the limited information in a 510(k) summary, specific details for several requested fields are not available. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It typically focuses on equivalency rather than establishing de novo performance criteria with extensive clinical trials.

Acceptance Criteria and Device Performance for GELBFISH ENDOVAC SYSTEM

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Mechanical Strength: Stainless steel cleaning mechanism withstands pull test.	"Mechanical testing has demonstrated that the stainless steel cleaning mechanism, which is laser welded together, can withstand a pull test of 20 lbs."
Clinical Efficacy (Thrombus Clearance): Device successfully clears thrombus from AV grafts.	"A clinical study of the device showed that in 47/47 thrombectomy procedures, the EndoVac device successfully cleared thrombus from the graft."
Clinical Integration/Non-interference: Device does not interfere with other standard thrombectomy instruments and techniques.	"The study also demonstrated that the EndoVac device does not interfere in any way with the use of the other instruments and techniques which are required to complete the interventional radiology thrombectomy procedure."
Intended Use Equivalence: Device has the same intended use as predicate devices (aspiration of clot).	"The Gelbfish EndoVac System has the same intended use, notably the aspiration of clot, as the predicate devices." (Implied acceptance criterion: substantial equivalence in intended use).
Technological Characteristics Equivalence: Device is similar to predicate devices.	The document extensively describes the "Anti-clogging/self-cleaning mechanism" as an enhancement and its integration into existing procedures, implying its technological characteristics were deemed equivalent or superior without posing new safety/efficacy concerns compared to existing devices. (Implied acceptance criterion: substantial equivalence in technological characteristics).

2. Sample Size Used for the Test Set and the Data Provenance:

Sample Size: 47 (47 thrombectomy procedures)
Data Provenance: The document does not explicitly state the country of origin. It refers to "Dr. Gelbfish's clinical study," implying it was conducted by the sponsor. Given the sponsor's address in New York, NY, and the FDA submission context, it is highly likely to be United States data.
Retrospective or Prospective: Not explicitly stated. Clinical studies conducted for 510(k) submissions can vary, but this sounds like a prospective observational study series where efficacy was tracked during the use of the device in a clinical setting.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

Number of Experts: Not specified.
Qualifications of Experts: Not specified. However, the study involved "thrombectomy procedures" in "interventional radiology," suggesting the cases were assessed by interventional radiologists or vascular surgeons who would typically perform and evaluate these procedures. The success criteria (successful clearance of thrombus, non-interference) would have been judged by the treating clinicians.

4. Adjudication Method for the Test Set:

Not specified. Given it's a small clinical series referenced in a 510(k), it's highly probable that the evaluation of "successful clearance of thrombus" was determined by the treating physician(s). There's no mention of an independent adjudication panel or formal consensus method beyond the direct observation and judgment of the clinicians involved in the 47 procedures.

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:

No, an MRMC comparative effectiveness study was not done. This device is a mechanical medical device (endovascular suction catheter), not an AI/software as a medical device (SaMD). Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

Not applicable. As stated above, this is a mechanical medical device. It does not operate as an "algorithm only" or a standalone AI system. Its performance is directly tied to its use by a human operator during a procedure.

7. The Type of Ground Truth Used:

The ground truth for the clinical study was based on clinical observation of successful thrombus clearance during the thrombectomy procedure and the observed non-interference with other instruments/techniques. This would be considered clinical observation/outcomes data as judged by the treating clinicians.

8. The Sample Size for the Training Set:

Not applicable. As a mechanical device, there is no "training set" in the context of machine learning or AI. The device's design and functionality are based on engineering principles and existing medical practice, not data-driven algorithmic training.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. See point 8.

Summary

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KA90233

510(k) Summary

OCT - 8 1997

GELBFISH ENDOVAC SYSTEM

Endovascular Suction Catheter

Gary A. Gelbfish, M.D. Sponsor: 2502 Avenue I New York, NY 10035 Phone: 800-563-1463 Fax: 718-421-0628 Garv A. Gelbfish, M.D. Contact:

October 1, 1997 Prepared:

LEGALLY MARKETED PREDICATE DEVICES A.

The Gelbfish EndoVac System is substantially equivalent to two preamendment devices, both endovascular suction catheters, marketed in the 1960s by the A. S. Aloe Company, St. Louis, MO, and by the Klista Company, Nashville, TN. These devices were used in general vascular surgery applications where it was necessary to remove thrombus. It is also similar to another pre-amendments suction thrombectomy device that is still marketed today by Medi-tech, the Greenfield Pulmonary Embolectomy Catheter which uses a suction mechanism for the extraction of clot from the pulmonary vasculature.

B. DEVICE DESCRIPTION

Common Name:

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INDICATIONS FOR USE C.

The Gelbfish EndoVac System is intended for the percutaneous aspiration of thrombus from acutely clotted AV grafts as a part of a percutaneous thrombectomy procedure. The device incorporates an anticlogging/self-cleaning mechanism to maintain its uninterrupted function.

The enclosed device is indicated for use to remove thrombus in clotted synthetic ePTFE grafts only. Its short length makes it suitable for aspiration of clot from the body of the graft. It is NOT intended to cross arterial or venous anastomoses or to be used on clot contained in native artery or vein.

TECHNOLOGICAL CHARACTERISTICS D.

The percutaneous thrombectomy procedure in which the EndoVac device is used involves a series of steps, almost all of which are already part of both the radiological and surgical procedures. The only enhancement is the aspiration of clot from the graft via the introducer sheath in conjunction with the anti-clogging/self-cleaning mechanism.

The anti-clogging/self-cleaning mechanism consists of a blunt tip of the same diameter as the tip of the sheath, a short half-cylindrical tube of the same diameter as the tip, and a 22-gauge tube to inject saline just behind the tip and to provide the mechanical movement of the tip. When the tip is extended just beyond the end of the sheath, the half-cylindrical tube allows thrombus to be sucked into the sheath through its open half. When thrombus clogs the sheath during suction, the tip is withdrawn into the sheath, cutting off the interior of the sheath from the clotted graft. Saline is introduced inside the tip behind the clog and allows the sheath to be cleared, after which the tip is again extended into the open position and aspiration continues.

Clinical procedure: An introducer sheath is inserted in the venous limb of the graft pointing towards the venous anastomosis. The sideport is connected to wall suction controlled via a hand held valve. The sheath with self-cleaning mechanism is inserted into the graft, suction is

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activated and the sheath is slowly pulled back, reciprocating the selfcleaning mechanism and with active irrigation as necessary.

TESTING E.

Mechanical testing has demonstrated that the stainless steel cleaning mechanism, which is laser welded together, can withstand a pull test of 20 lbs.

A clinical study of the device showed that in 47/47 thrombectorny procedures, the EndoVac device successfully cleared thrombus from the araft. The study also demonstrated that the EndoVac device does not interfere in any way with the use of the other instruments and techniques which are required to complete the interventional radiology thrombectorny procedure.

CONCLUSIONS F.

The Gelbfish EndoVac System has the same intended use, notably the aspiration of clot, as the predicate devices. Dr. Gelbfish has demonstrated through his clinical study on the device and his comparison of the device's characteristics with those of the predicate devices that it is substantially equivalent to the predicate devices.

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Image /page/3/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three stylized profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Gary A. Gelbfish, M.D. c/o Robert L. Sheridan Vice President for Device Evaluation C.L. McIntosh Associates Inc. 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852

Re: K970233 Gelbfish EndoVac System Requlatory Class: II Product Code: MCW Dated: July 8, 1997 Received: July 9, 1997

Dear Dr. Gelbfish:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.q., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal

OCT - 8 1997

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Page 2 - Gary A. Gelbfish, M.D.

Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

This letter will allow you to begin marketing your device as described in your 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 the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97) . . Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Gelbfish Endo-Vac System

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE Ludith fanisher for Concurrence of CDRH, Office of Device Evaluation (C

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

0660^8

Regulation Number and Section

§ 870.4875 Intraluminal artery stripper.

(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).