(137 days)
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.
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.
The provided text describes the Medtronic Export Advance Aspiration Catheter, which is indicated for the removal/aspiration of embolic material from vessels of the arterial system and for subselectively infusing/delivering diagnostic or therapeutic agents. This device is an aspiration catheter, not an AI/ML medical device. Therefore, the information requested in the prompt, such as acceptance criteria and studies related to AI/ML performance, is not applicable.
The document focuses on demonstrating substantial equivalence to a predicate device (Export AP Catheter) through non-clinical bench testing and biocompatibility testing. No clinical investigation was performed on the subject device.
Here's an overview of the non-clinical testing performed:
1. Acceptance Criteria and Reported Device Performance:
The document broadly states that the device "met the acceptance criteria and performance similar to the predicate device" based on design verification (bench) testing. Specific quantitative acceptance criteria or detailed device performance metrics for each test are not provided in this summary. Instead, it lists the types of tests performed.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Design Verification (Bench) Testing: | "met the acceptance criteria and performance similar to the predicate device." Specific quantitative values are not provided in this summary. |
| Profile Dimensions | Passed |
| Guide Wire Lumen ID | Passed |
| Working Length | Passed |
| Proximal Shaft Tensile | Passed |
| Microlumen Tear | Passed |
| Tip Tensile | Passed |
| Marker Band Tensile | Passed |
| Hub Tensile | Passed |
| Stylet Hub Tensile | Passed |
| Vacuum Integrity | Passed |
| Pressure Integrity | Passed |
| Air Aspiration | Passed |
| Proximal Shaft Crush | Passed |
| Proximal Shaft Buckle | Passed |
| Evacuation Flow Rate | Passed |
| Particle Retrieval | Passed |
| 2D Track and Lesion Cross | Passed |
| Lubricity & Durability | Passed |
| Proximal Shaft Stiffness Room Temp | Passed |
| Proximal Shaft Stiffness Body Temp | Passed |
| Torque Strength | Passed |
| Distal Kink | Passed |
| Particulate Generation | Passed |
| Biocompatibility Testing: | "concluded full biocompatibility testing". No new safety or effectiveness issues were raised. |
| Cytotoxicity | Passed |
| In vitro Hemolysis | Passed |
| Systemic Toxicity | Passed |
| Sensitization | Passed |
| C3a Complement Activation | Passed |
| Sc5b9 Complement Activation | Passed |
| ISO Intracutaneous Reactivity | Passed |
| USP Material Mediated Pyrogen Study | Passed |
| In vivo Thromboresistance | Passed |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify sample sizes for each of the design verification (bench) tests. The data provenance is described as "Design verification (bench) testing" and "Pre-clinical in vivo (non-GLP) studies," implying laboratory and animal testing, respectively. This data is retrospective from the perspective of the 510(k) submission, as the tests were completed before submission. The country of origin is not explicitly stated but can be inferred to be the US, given the submission to the FDA.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable, as this is not an AI/ML device requiring expert-established ground truth for a test set. The evaluation is based on engineering specifications and biological safety.
4. Adjudication Method:
Not applicable, as this is not an AI/ML device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable, as this is not an AI/ML device designed to assist human readers.
6. Standalone (Algorithm Only) Performance:
Not applicable, as this is a physical medical device, not a software algorithm.
7. Type of Ground Truth Used:
For design verification testing, the "ground truth" would be established by the engineering specifications and performance standards met by the predicate device and relevant industry standards. For biocompatibility testing, the ground truth is based on established biological safety standards (e.g., ISO 10993-1 and 21 CFR 58).
8. Sample Size for the Training Set:
Not applicable, as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as this is not an AI/ML device.
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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
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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
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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
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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 __
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K130536 Traditional 510(k) Summary
JUL 1 6 2013
| Submitter: | Medtronic Vascular37A Cherry Hill DriveDanvers, MA 01923-5186 |
|---|---|
| Contact Person: | Anu GaurSenior Regulatory Affairs SpecialistPhone: (978) 739-3080Fax: (978) 750-8204 |
| Alternate Contact | Fred BoucherDirector of Regulatory AffairsPhone: (978) 739-3116Fax: (978) 750-8204 |
| Date Prepared: | May 20, 2013 |
| Trade Name: | Export Advance™ Aspiration Catheter |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Embolectomy CatheterClass II per 21 CFR 870.5150, Product Code DXE |
| Predicate Devices: | K120808 - Medtronic VascularExport® AP Catheter. |
| DeviceDescription: | The Export Advance™ Aspiration Catheter is a duallumen catheter used for the aspiration of thrombusand/or debris from a vascular site. The ExportAdvance™ may also be used for the infusion ofdiagnostic or therapeutic agents to a desired vascularsite. |
| Statement of IntendedUse: | The Export Advance™ Aspiration Catheter is indicatedfor:• Removal/aspiration of embolic material(thrombus/debris) from vessels of the arterialsystem, and• To sub selectively infuse/deliver diagnostics ortherapeutics agents with or without vesselocclusion. |
| Comparison to thepredicate devices | The Export Advance™ Aspiration Catheter represents aseries of incremental performance improvements overits predicate device Export® AP Catheter, with primaryattributes including, improved deliverability, improvedkink resistance, and improved aspiration rate; andincluding a design feature of a removable preloadedstylet. |
| Summary ofTechnologicalCharacteristics: | The Export Advance™ includes the following features:i. Removable Styletii. Luer Hubiii. Strain Reliefiv. Inner Linerv. Braid Wirevi. Proximal Shaftvii. Distal Shaft (Dual Lumen/Oversleeve)viii. Soft Tipix. Microlumen (wire lumen)x. Distal Tipxi. Marker bandxii. Hydrophilic lubricous coating |
| Summary of Non-clinicalData: | Design verification (bench) testing qualification andbiocompatibility testing was conducted in accordancewith the recommendations presented from the relevantFDA guidance to demonstrate that the subject deviceExport Advance™ Aspiration Catheter has met theacceptance criteria and performance similar to thepredicate device.Design Verification Testing: The design verification(bench) testing was performed based upon the subjectdevice performance specifications. The tests performedfor bench testing included:1. Profile Dimensions (Major & Minor Profile)2. Guide Wire Lumen ID3. Working Length4. Proximal Shaft Tensile5. Microlumen Tear6. Tip Tensile7. Marker Band Tensile8. Hub Tensile9. Stylet Hub Tensile10. Vacuum Integrity |
.
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-
- 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.
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| 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 subjectdevice Export Advance™ Aspiration Catheter issubstantially equivalent to the predicate device. |
:
.
. .
§ 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).