(137 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts, and the device description is purely mechanical.
Yes
The device is indicated for the removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system, which is a therapeutic intervention. It can also be used to infuse therapeutic agents.
No
The device is described as an aspiration catheter used for removing embolic material and for infusing diagnostic or therapeutic agents. It does not perform diagnostic functions itself.
No
The device description clearly states it is a "dual lumen catheter," which is a physical hardware component. The performance studies also focus on bench testing, pre-clinical in vivo studies, and biocompatibility testing, all related to a physical device.
Based on the provided information, the Export Advance™ Aspiration Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body (in vivo) for removing material from blood vessels and delivering agents. IVDs are used to examine specimens outside the body (in vitro), such as blood, urine, or tissue samples, to diagnose conditions.
- Device Description: The description reinforces its use as a catheter for accessing and manipulating structures within the vascular system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostic testing.
Therefore, the Export Advance™ Aspiration Catheter is a medical device used for interventional procedures within the arterial system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Export Advance™ Aspiration Catheter is indicated for:
- -Removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system, and
- To sub selectively infuse/deliver diagnostics or therapeutics agents with or without vessel occlusion.
Product codes (comma separated list FDA assigned to the subject device)
QEZ, KRA, DXE
Device Description
The Export Advance™ Aspiration Catheter is a dual lumen catheter used for the aspiration of thrombus and/or debris from a vascular site. The Export Advance™ may also be used for the infusion of diagnostic or therapeutic agents to a desired vascular site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels of the arterial system
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)
Design verification (bench) testing qualification and biocompatibility testing was conducted in accordance with the recommendations presented from the relevant FDA guidance to demonstrate that the subject device Export Advance™ Aspiration Catheter has met the acceptance criteria and performance similar to the predicate device.
Design Verification Testing: The design verification (bench) testing was performed based upon the subject device performance specifications. The tests performed for bench testing included:
- Profile Dimensions (Major & Minor Profile)
- Guide Wire Lumen ID
- Working Length
- Proximal Shaft Tensile
- Microlumen Tear
- Tip Tensile
- Marker Band Tensile
- Hub Tensile
- Stylet Hub Tensile
- Vacuum Integrity
- Pressure Integrity
- Air Aspiration
- Proximal Shaft Crush
- Proximal Shaft Buckle
- Evacuation Flow Rate
- Particle Retrieval
- 2D Track and Lesion Cross
- Lubricity & Durability
- Proximal Shaft Stiffness Room Temp
- Proximal Shaft Stiffness Body Temp
- Torque Strength
- Distal Kink
- Particulate Generation
Pre-clinical Study (Non-GLP): Medtronic Vascular conducted pre-clinical in vivo (non-GLP) studies for design evaluation on Export Advance. These in vivo studies results provided confirmatory evidence that the Export Advance design is suitable to meet the incremental performance attributes as compared with its predicate device. Export AP Catheter, and related comparative evaluations to support the substantial equivalence.
Biocompatibility Testing (GLP): Pursuant to the ISO 10993-1:2009/AC: 2010- Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process; and 21 CFR 58 -Good Laboratory Practice for Nonclinical Laboratory Studies; Medtronic Vascular has concluded full biocompatibility testing on the subject device.
-
- Cytotoxicity
-
- In vitro Hemolysis
-
- Systemic Toxicity
-
- Sensitization
-
- C3a Complement Activation
-
- Sc5b9 Complement Activation
-
- ISO Intracutaneous Reactivity
-
- USP Material Mediated Pyrogen Study
-
- In vivo Thromboresistance
No new safety or effectiveness issues were raised during the testing. The bench testing qualification and biocompatibility testing demonstrated that the subject device Export Advance™ Aspiration Catheter is safe, effective, and substantially equivalent to the predicate device.
No clinical investigation has been performed on the subject device Export Advance™ catheter.
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.
K120808 - Medtronic Vascular Export® AP Catheter.
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 contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 27, 2020
Medtronic Inc. Colleen Mullins Principle Regulatory Affairs Specialist 37a Cherry Hill Drive Danvers, Massachusetts 01923
Re: K130536
Trade/Device Name: Export Advance Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ, KRA
Dear Colleen Mullins:
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 July 16, 2013. 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,
Gregory W. O'connell -S
Digitally signed by Gregory W. )'connell -S Date: 2020.07.27 08:04:14
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
Image /page/1/Picture/1 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, composed of three overlapping silhouettes. The figure is positioned to the right of the department's name, which is arranged in a circular fashion around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 16, 2013
Medtronic Inc. C/O Colleen Mullins 37a Cherry Hill Drive Danvers, MA 01923 US
Re: K130536
Trade/Device Name: Export Advance™ Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: June 5, 2013 Received: June 6, 2013
Dear Ms. Mullins:
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 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. Iisting 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 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
2
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
M.A. Hillebrand
for
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
510(k) Number:
Device Name: Medtronic Export Advance™ Aspiration Catheter
Indications for Use:
The Export Advance™ Aspiration Catheter is indicated for:
- -Removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system, and
- To sub selectively infuse/deliver diagnostics or therapeutics agents with or without vessel occlusion.
Prescription Use X (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)
M.A. Hillebrand
Page 1 of __
4
K130536 Traditional 510(k) Summary
JUL 1 6 2013
| Submitter: | Medtronic Vascular
37A Cherry Hill Drive
Danvers, MA 01923-5186 |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Anu Gaur
Senior Regulatory Affairs Specialist
Phone: (978) 739-3080
Fax: (978) 750-8204 |
| Alternate Contact | Fred Boucher
Director of Regulatory Affairs
Phone: (978) 739-3116
Fax: (978) 750-8204 |
| Date Prepared: | May 20, 2013 |
| Trade Name: | Export Advance™ Aspiration Catheter |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Embolectomy Catheter
Class II per 21 CFR 870.5150, Product Code DXE |
| Predicate Devices: | K120808 - Medtronic Vascular
Export® AP Catheter. |
| Device
Description: | The Export Advance™ Aspiration Catheter is a dual
lumen catheter used for the aspiration of thrombus
and/or debris from a vascular site. The Export
Advance™ may also be used for the infusion of
diagnostic or therapeutic agents to a desired vascular
site. |
| Statement of Intended
Use: | The Export Advance™ Aspiration Catheter is indicated
for:
• Removal/aspiration of embolic material
(thrombus/debris) from vessels of the arterial
system, and
• To sub selectively infuse/deliver diagnostics or
therapeutics agents with or without vessel
occlusion. |
| Comparison to the
predicate devices | The Export Advance™ Aspiration Catheter represents a
series of incremental performance improvements over
its predicate device Export® AP Catheter, with primary
attributes including, improved deliverability, improved
kink resistance, and improved aspiration rate; and
including a design feature of a removable preloaded
stylet. |
| Summary of
Technological
Characteristics: | The Export Advance™ includes the following features:
i. Removable Stylet
ii. Luer Hub
iii. Strain Relief
iv. Inner Liner
v. Braid Wire
vi. Proximal Shaft
vii. Distal Shaft (Dual Lumen/Oversleeve)
viii. Soft Tip
ix. Microlumen (wire lumen)
x. Distal Tip
xi. Marker band
xii. Hydrophilic lubricous coating |
| Summary of Non-clinical
Data: | Design verification (bench) testing qualification and
biocompatibility testing was conducted in accordance
with the recommendations presented from the relevant
FDA guidance to demonstrate that the subject device
Export Advance™ Aspiration Catheter has met the
acceptance criteria and performance similar to the
predicate device.
Design Verification Testing: The design verification
(bench) testing was performed based upon the subject
device performance specifications. The tests performed
for bench testing included:
- Profile Dimensions (Major & Minor Profile)
- Guide Wire Lumen ID
- Working Length
- Proximal Shaft Tensile
- Microlumen Tear
- Tip Tensile
- Marker Band Tensile
- Hub Tensile
- Stylet Hub Tensile
- Vacuum Integrity |
.
5
6
-
- Pressure Integrity
-
- Air Aspiration
-
- Proximal Shaft Crush
-
- Proximal Shaft Buckle
-
- Evacuation Flow Rate
-
- Particle Retrieval
-
- 2D Track and Lesion Cross
-
- Lubricity & Durability
-
- Proximal Shaft Stiffness Room Temp
-
- Proximal Shaft Stiffness Body Temp
-
- Torque Strength
-
- Distal Kink
-
- Particulate Generation
Pre-clinical Study (Non-GLP):
Medtronic Vascular conducted pre-clinical in vivo (non-GLP) studies for design evaluation on Export Advance. These in vivo studies results provided confirmatory evidence that the Export Advance design is suitable to meet the incremental performance attributes as compared with its predicate device. Export AP Catheter, and related comparative evaluations to support the substantial equivalence.
Biocompatibility Testing (GLP): Pursuant to the ISO
10993-1:2009/AC: 2010- Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process; and 21 CFR 58 -Good Laboratory Practice for Nonclinical Laboratory Studies; Medtronic Vascular has concluded full biocompatibility testing on the subject device.
-
- Cytotoxicity
-
- In vitro Hemolysis
-
- Systemic Toxicity
-
- Sensitization
-
- C3a Complement Activation
-
- Sc5b9 Complement Activation
-
- ISO Intracutaneous Reactivity
-
- USP Material Mediated Pyrogen Study
-
- In vivo Thromboresistance
No new safety or effectiveness issues were raised during the testing. The bench testing qualification and biocompatibility testing demonstrated that the subject device Export Advance™ Aspiration Catheter is safe, effective, and substantially equivalent to the predicate device.
7
| Summary of Clinical | No clinical investigation has been performed on the |
|---|---|
| Data: | subject device Export Advance™ catheter. |
| Conclusion from Data: | Medtronic Vascular has demonstrated that the subject |
| device Export Advance™ Aspiration Catheter is | |
| substantially equivalent to the predicate device. |
:
.
. .