The NexGen Mechanical Retrieval Device (MRD) is indicated for the removal of embolic / thrombotic material, including thrombus and debris, from peripheral arteries and veins, peripheral bypass grafts, and the removal of thrombus from clotted synthetic dialysis grafts and arterio-venous fistulas.

Device Description

The MRD is a member of a family of sterile, single use, catheter-based devices that are intended to mechanically remove blood clots and other obstructions from blood vessels in the human body. The MRD is designed to be used for peripheral vascular applications.

The Device design is intended to allow easier access into anatomically difficult endovascular locations because it is pushed out of a small profile guide catheter. Other devices such as those delivering laser, ultrasound, or photo-acoustical energy may be too stiff to access tortuous blood vessels, and too large.

The MRD consists of a stainless steel coil that is inserted into a standard 4F guide catheter. The guide catheter is inserted into the vessel and past the occlusion using a standard guide catheter. Coils released from the MRD are then deployed distal to the occlusion. As the guide catheter is withdrawn, additional MRD coils are released proximal to the occlusion, thereby enmeshing the embolic material for removal.

AI/ML Overview

This document describes the premarket notification (510(k)) for the NexGen Peripheral Mechanical Retrieval Device (MRD), a device intended for the removal of embolic/thrombotic material. The submission primarily relies on non-clinical (bench) testing to demonstrate substantial equivalence to predicate devices, rather than clinical studies.

Here's a breakdown of the requested information based on the provided text, with an emphasis on what is not available as well:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantitative acceptance criteria or detailed performance results from the bench tests. It lists the types of tests conducted to "verify the device met design specifications and its intended use." To create a table, we can list the tests performed, but without numerical criteria or outcomes, the "Reported Device Performance" would simply be a confirmation that the tests were passed.

Acceptance Criterion (Implied)	Reported Device Performance
Successfully perform simulated use and efficacy	Test conducted, device met intended use
Demonstrate adequate pushability/trackability	Test conducted, device met design specifications
Effective in-vitro emboli removal	Test conducted, device met intended use
Maintain joint tensile strength	Test conducted, device met design specifications
Exhibit appropriate tip flexibility	Test conducted, device met design specifications
Resist corrosion	Test conducted, device met design specifications
Demonstrate adequate torque properties	Test conducted, device met design specifications
Resist kinking up to a certain diameter	Test conducted, device met design specifications
Exhibit appropriate radial force	Test conducted, device met design specifications
Perform effectively in bypass graft applications	Test conducted, device met intended use
Be biocompatible	Biocompatibility testing performed in accordance with ISO 10993; materials demonstrated to be biocompatible

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

Sample Size for Test Set: Not specified. The document only mentions that "bench testing was conducted." The number of devices or iterations used for each test is not detailed.
Data Provenance: The tests are categorized as "bench testing" and "in-vitro," indicating laboratory, non-clinical studies. There is no information regarding country of origin or whether the data is retrospective or prospective, as it's not a clinical study.

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

Not applicable. This was a non-clinical (bench and in-vitro) study. Ground truth in this context would refer to engineering specifications and performance metrics established during device design and testing, not typically clinical expert consensus.

4. Adjudication Method for the Test Set

Not applicable. Given this was non-clinical bench testing, an adjudication method for a test set (as typically seen in clinical studies with human assessors) is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a mechanical retrieval device, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI assistance.

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

Not applicable. This device is a physical medical instrument, not an algorithm or software-only device.

7. The Type of Ground Truth Used

The "ground truth" for this device, in the context of its 510(k) submission, is based on engineering specifications, design requirements, and a demonstration of mechanical and biological performance through bench and in-vitro testing. It relies on the device meeting predefined criteria for physical characteristics, functional performance in simulated environments (e.g., embolic removal in-vitro), and biocompatibility following ISO standards. There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for this submission, as "No clinical evaluations of this product have been conducted."

8. The Sample Size for the Training Set

Not applicable. As this is a mechanical medical device and not an AI/ML algorithm, there is no "training set" in the conventional sense.

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

Not applicable, as there is no training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.

February 8, 2021

NexGen Medical Systems, Inc. Craig Pagan Regulatory Affairs 1050 W. Nasa Blvd. Suite 136 Melbourne, Florida 32901

Re: K110315

Trade/Device Name: NexGen Peripheral Rechanical Retrieval Device Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: OEW

Dear Craig Pagan:

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 20, 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 regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075, Gregory. Oconnell(@FDA.HHS.gov.

Sincerely,

Digitally signed by Gregory Gregory W. W. O'connell -S Date: 2021.02.08 07:59:58 O'connell -S -05,00 Gregory O'Connell Assistant Director Plaque Modification Devices Team 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the left side of the logo.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 2 0 2011

NexGen Medical Systems, Inc. c/o Mr. Craig Pagan 1050 W. NASA Blvd., Suite 136 Melbourne, FL 32901

Re: K110315

Trade Name: NexGen Peripheral Mechanical Retrieval Device Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II (two) Product Code: DXE Dated: September 27, 2011 Received: September 28, 2011

Dear Mr. Pagan:

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 intestate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmonts, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Dr w 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 mastering.

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.

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Page 2 -- Mr. Craig Pagan

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); 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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INDICATIONS FOR USE STATEMENT

510(k) Number: K110315

Device Name: NexGen Peripheral Mechanical Retrieval Device

INDICATIONS:

CONTRAINDICATIONS:

· Not intended for peripheral vasculature dilatation.
Not for coronary or neurovascular use.
Not intended for the removal of fibrous or calcified material.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 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

Page_1 of 1

510(k) Number K110315

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p. 1 of 3

510(K) SUMMARY

OCT 2 0 2011

510(k) Number: K110315

Date Prepared

October 20, 2011

Submitter Information

Submitter's Name: Address:

NexGen medical Systems Inc. 10471 Double R Blvd. Suite A Reno, NV 89521

3008106780 Establishment Registration

Contact Person:

John Kucharczyk Phone: (775) 851-7337 (775) 849-4162 Fax: Email: johnkucharczyk(@aol.com

Device Information

Trade Name
Common Name
Classification Name
Product Code:
Regulation:

NexGen Peripheral Mechanical Retrieval Device (MRD) Embolectomy Catheter Embolectomy Catheter DXE Class II, 21 CFR 870.5150

Predicate Devices

K090932	NexGen Medical Systems – NexGen Peripheral MechanicalRetrieval Device (MRD)
510(k) Unknown	Edwards Lifesciences - Fogarty Venous ThrombectomyCatheter
K892410	Edwards Lifesciences - Fogarty Thru Lumen EmbolectomyCatheter
K070403	Vascular Solutions - Pronto .035" extraction catheter

Device Description

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K110315
P. 20f3

Intended Use/Indications for Use

Contraindications:

· Not intended for peripheral vasculature dilatation.
· Not for coronary or neurovascular use.
· Not intended for the removal of fibrous or calcified material.

Summary of Non-Clinical Testing

Performance Testing:

The following bench testing was conducted to verify the device met design specifications and its intended use:

. Simulated Use and Efficacy Test
. Pushability/Trackability Testing
. In-Vitro Emboli Testing
. Joint Tensile Strength Test
Tip Flexibility .
Corrosion Resistance
. Torque Testing
. Kink Diameter Testing
. Radial Force Testing
. Bypass Graft Testing

Biocompatibility:

Biocompatibility testing has been performed in accordance with ISO 10993, "Biological Evaluation of Medical Devices". The materials used in the NexGen Peripheral Mechanical Retrieval Device (MRD) have demonstrated that they are biocompatible.

Summary of Clinical Testing

No clinical evaluations of this product have been conducted

Statement of Equivalence

Based on the information and data presented, NexGen Medical Systems, Inc. considers the NexGen modified Peripheral Mechanical Retrieval Device (MRD) to be substantially equivalent to the NexGen Peripheral Mechanical Retrieval Device (MRD), NexGen

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K110315
p. 3 of 3

Medical Systems; Fogarty Venous Thrombectomy Catheter and Fogarty Thru Lumen Embolectomy Catheter, Edwards Lifesciences; and the Pronto .035" Extraction Catheter, Vascular Solutions, Inc. The testing performed confirms that the NexGen modified Mechanical Retrieval Device (MRD) will perform as intended.

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Image /page/7/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 2 0 2011

NexGen Medical Systems, Inc. c/o Mr. Craig Pagan 1050 W. NASA Blvd., Suite 136 Melbourne, FL 32901

Re: K110315

Dear Mr. Pagan:

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 indictions 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 of class III (I'WA)
found in the Gode of Forley | P 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.

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Page 2 - Mr. Craig Pagan

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

Sincerely yours,

C. Bram D. Zucker, M.D.

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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INDICATIONS FOR USE STATEMENT

510(k) Number: K110315

Device Name: NexGen Peripheral Mechanical Retrieval Device

INDICATIONS:

CONTRAINDICATIONS:

· Not intended for peripheral vasculature dilatation.
· Not for coronary or neurovascular use.
· Not intended for the removal of fibrous or calcified material.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 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 Page 1 of 1

510(k) Number K110315

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).