(175 days)
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Not Found
No
The provided text describes a mechanical retrieval device and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for the removal of embolic/thrombotic material, which is a therapeutic intervention aimed at treating medical conditions.
No.
The device is indicated for the removal of material, which is a therapeutic function, not a diagnostic one.
No
The description clearly indicates a "Peripheral Mechanical Retrieval Device," which is a physical, hardware-based device used for removing material from blood vessels. There is no mention of software as the primary or sole component.
Based on the provided information, the NexGen Peripheral Mechanical Retrieval Device (MRD) is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or states of health by analyzing things like blood, urine, tissue, etc.
- The NexGen Peripheral Mechanical Retrieval Device is a mechanical device used within the body. Its intended use is to physically remove material from blood vessels and grafts.
The description clearly indicates a device that is used invasively within the patient's circulatory system, not a device that analyzes samples taken from the patient.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
QEW, DXE
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
peripheral arterial blood vessels and peripheral bypass grafts; clotted synthetic dialysis grafts and arterio-venous fistulas.
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo has the letters FDA in a blue square.
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, (301) 796-6075, Gregory. Oconnell@FDA.HHS.gov.
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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Image /page/1/Picture/0 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text around the perimeter reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The symbol in the center consists of three curved lines that resemble a stylized human figure.
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
2
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
uma R.V. Auner
Image /page/2/Picture/7 description: The image shows a close-up of text, with the word "Bra" visible at the top right. Below "Bra" is the word "Dir". To the left of these words is a symbol that looks like a signature. The text is in a clear, sans-serif font and appears to be part of a larger document or label.
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