NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000

K090932 · Nexgen Medical Systems, Inc. · QEW · Sep 24, 2009 · Cardiovascular

Device Facts

• Record ID: K090932
• Device Name: NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000
• Applicant: Nexgen Medical Systems, Inc.
• Product Code: QEW · Cardiovascular
• Decision Date: Sep 24, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

NexGen Peripheral Mechanical Retrieval Device (MRD) is a catheter-based system designed for mechanical removal of thrombus and embolic debris. Operated by physicians in clinical settings, the device is inserted into peripheral arterial vessels, bypass grafts, or dialysis access sites to retrieve clotted material. It functions as a mechanical embolectomy catheter. The device provides a minimally invasive method to clear obstructions, potentially restoring blood flow and improving patient outcomes in peripheral vascular disease. It is not intended for use in coronary, neurovascular, or venous systems, nor for dilating vessels or removing calcified/fibrous plaque.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on administrative review of device characteristics and intended use.

Technological Characteristics

Embolectomy catheter; mechanical retrieval mechanism; peripheral vascular application; Class II device; 21 CFR 870.5150.

Indications for Use

Indicated for removal of embolic/thrombotic material and debris from peripheral arterial vessels, peripheral bypass grafts, clotted synthetic dialysis grafts, and arterio-venous fistulas. Contraindicated for peripheral vasculature dilatation, coronary/neurovascular use, venous use, and removal of fibrous or calcified material.

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.

Submission Summary (Full Text)

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May 20, 2021

Nexgen Medical Systems, Inc. John Kucharczyk CEO 10471 Double R Blvd. Suite C Reno. Nevada 89521

Re: K090932

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

Dear John Kucharczyk:

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 November 22, 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. [e-mail].

Sincerely,

Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2021.05.20

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

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

NexGen Medical Systems, Inc. c/o Mr. John Kucharczyk President and CEO 10471 Double R. Blvd., Suite C Reno, NV 89521

Re: K090932

Trade/Device Name: NexGen Medical Systems Peripheral Mechanical Retrieval Device (MRD) Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectoniy Catheter Regulatory Class: Class II Product Code: DXE

NOV 22 2009

Received: August 12, 2009

Dear Mr. Kucharczyk:

This letter corrects our substantially equivalent letter of September 24, 2009.

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 (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 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

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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/CDRHQffices/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/McdicalDevices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

uma R.V. Auner

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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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# SECTION 4 - INDICATIONS FOR USE STATEMENT

510(k) Number: K090932

#### Device Name: NexGen Peripheral Mechanical Retrieval Device

### INDICATIONS:

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

## CONTRAINDICATIONS:

- Not intended for peripheral vasculature dilatation. .
- Not for coronary or neurovascular use. ●
- Not intended for venous 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)

uma R. V. Lunes

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(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K690932