(260 days)
Not Found
No
The device description and performance studies focus on mechanical properties and physical testing, with no mention of AI/ML algorithms or data processing.
Yes
The device is described as a "Mechanical Retrieval Device" intended for the removal of "embolic / thrombotic material," which directly treats a medical condition (clots/obstructions) in the body.
No
The device is described as a "Mechanical Retrieval Device" intended for "removal of embolic / thrombotic material," which clearly indicates a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly outlines a physical, catheter-based device with mechanical components (stainless steel coil) intended for insertion into the body. It is not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Function: The NexGen Mechanical Retrieval Device (MRD) is a mechanical device used inside the body (in vivo) to physically remove blockages from blood vessels. It does not analyze or test biological samples.
- Intended Use: The intended use clearly states the device is for the "removal of embolic / thrombotic material... from peripheral arteries and veins, etc." This is a therapeutic intervention, not a diagnostic test.
- Device Description: The description details a catheter-based device with a coil designed to physically enmesh and remove material from blood vessels. This is a mechanical action within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory testing.
Therefore, based on the provided information, the NexGen Mechanical Retrieval Device (MRD) is a therapeutic medical device used for mechanical thrombectomy/embolectomy, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OEW, DXE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral arteries and veins, peripheral bypass grafts, clotted syntheric dialysis grafts and arterio-venous fistulas.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing:
- 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.
No clinical evaluations of this product have been conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K090932, 510(k) Unknown, K892410, K070403
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).
Not Found
§ 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).
0
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
1
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.
1
2
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
3
INDICATIONS FOR USE STATEMENT
510(k) Number: K110315
Device Name: NexGen Peripheral Mechanical Retrieval Device
INDICATIONS:
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 syntheric dialysis grafts and arterio-venous fistulas.
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
4
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 Mechanical
Retrieval Device (MRD) |
|----------------|---------------------------------------------------------------------------------|
| 510(k) Unknown | Edwards Lifesciences - Fogarty Venous Thrombectomy
Catheter |
| K892410 | Edwards Lifesciences - Fogarty Thru Lumen Embolectomy
Catheter |
| K070403 | Vascular Solutions - Pronto .035" extraction catheter |
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.
5
K110315
P. 20f3
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.
Intended Use/Indications for Use
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.
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
6
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.
7
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
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 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.
8
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,
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
9
INDICATIONS FOR USE STATEMENT
510(k) Number: K110315
Device Name: NexGen Peripheral Mechanical Retrieval Device
INDICATIONS:
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.
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