(30 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 a 510(k) premarket notification for the Medtronic Export Advance™ Aspiration Catheter, which is a medical device and not an AI/ML product. Therefore, the requested information regarding acceptance criteria and studies for an AI device is not available in the given document.
The document discusses Design Verification (bench) testing and Biocompatibility testing for the catheter, emphasizing that no clinical investigation was performed on this specific device iteration. The goal was to demonstrate substantial equivalence to a predicate device, not to prove the performance of an AI model against specific acceptance criteria.
Below is a summary of the available information regarding the device's assessment, structured to align with your request where applicable, but noting the absence of AI-specific details:
Device: Medtronic Export Advance™ Aspiration Catheter
Type of Device: Embolectomy Catheter (Class II)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance / Conclusion |
|---|---|---|
| Design Verification (Bench Testing) | 1. Profile Dimensions (Major & Minor Profile) | Met acceptance criteria and showed performance similar to the predicate device. Only attributes impacted by the dual lumen section change were tested. |
| 2. Microlumen Tear | ||
| 3. 2D Track and Lesion Cross | (Specific results not detailed, but stated to have met acceptance criteria) | |
| Biocompatibility Testing | 1. Cytotoxicity | Concluded full biocompatibility, based on existing data for the predicate device and the fact that the material change (microlumen sleeve from Pebax 4033 to Aesno MED Nylon 12 (AV100)) is already in use on the Export Advance and cuff extension. No additional testing was required. |
| 2. In vitro Hemolysis | ||
| 3. Systemic Toxicity | ||
| 4. Sensitization | ||
| 5. C3a Complement Activation | ||
| 6. Sc5b9 Complement Activation | ||
| 7. ISO Intracutaneous Reactivity | ||
| 8. USP Material Mediated Pyrogen Study | ||
| 9. In vivo Thromboresistance | ||
| Overall Conclusion | Substantial Equivalence to Predicate Device | No new safety or effectiveness issues were raised during testing. The bench testing qualification and biocompatibility testing demonstrated that the subject device is substantially equivalent to the predicate device. |
Since this document pertains to a physical medical device (catheter) and not an AI/ML product, the subsequent points (2-9) which are specific to AI/ML model evaluations cannot be answered from the provided text.
Specifically:
- 2. Sample size used for the test set and the data provenance: Not applicable; no AI test set.
- 3. Number of experts used to establish the ground truth... and qualifications: Not applicable; no AI ground truth establishment.
- 4. Adjudication method: Not applicable.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done...: Not applicable; no AI assistance involved.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable; no AI algorithm.
- 7. The type of ground truth used: Not applicable; no AI ground truth. The "ground truth" for a physical device is its physical performance and material properties.
- 8. The sample size for the training set: Not applicable; no AI training set.
- 9. How the ground truth for the training set was established: Not applicable; no AI training set.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic Vascular Colleen Mullins Principal Regulatory Affairs Specialist 37A Cherry Hill Drive Danvers, MA 01923-5186
Re: K152335
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: Aug 17, 2015 Received: Aug 19, 2015
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, 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 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 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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. Hillebrenner
for
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: K152335
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)
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Special 510(k) Summary
| Submitter: | Medtronic Vascular37A Cherry Hill DriveDanvers, MA 01923-5186 |
|---|---|
| Contact Person: | Colleen MullinsPrincipal Regulatory Affairs SpecialistPhone: (978) 739-3267Fax: (978) 739-3280 |
| Alternate Contact | Fred BoucherDirector of Regulatory AffairsPhone: (978) 739-3116Fax: (978) 750-8204 |
| Date Prepared: | August 17th, 2015 |
| 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: | K130536 - Medtronic VascularExport® Advance Aspiration 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 achange to the dual lumen section (micro-lumen section) |
| 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 qualificationconducted in accordance with the recommendationspresented from the relevant FDA guidance todemonstrate that the subject device Export Advance™Aspiration Catheter has met the acceptance criteria andperformance similar to the predicate device.Design Verification Testing: Given that the onlydifference between the modified design for the subjectdevice and the commercially available design of thepredicate device is the dual lumen section, onlyattributes impacted by the design modification weretested. The design verification (bench) testing wasperformed based upon the subject device performancespecifications. The tests performed for bench testingincluded:1. Profile Dimensions (Major & Minor Profile)2. Microlumen Tear3. 2D Track and Lesion Cross |
| Biocompatibility Testing (GLP): The materials,packaging and configuration of the subject device isnot changing as a result of the dual lumen designchange. The microlumen sleeve material is changingfrom Pebax 4033 to Aesno MED Nylon 12(AV100)This material is already in use on the Export Advance | |
| and cuff extension. Based on this information there isno requirement for additional biocompatibility testing.Existing biocompatibility data previously performed onthe subject device will apply to the proposed device. | |
| Pursuant to the ISO 10993-1:2009/AC: 2010-Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk managementprocess; and 21 CFR 58 -Good Laboratory Practicefor Nonclinical Laboratory Studies; MedtronicVascular has concluded full biocompatibility testing onthe predicate device. | |
| 1. Cytotoxicity2. In vitro Hemolysis3. Systemic Toxicity4. Sensitization5. C3a Complement Activation6. Sc5b9 Complement Activation7. ISO Intracutaneous Reactivity8. USP Material Mediated Pyrogen Study9. In vivo Thromboresistance | |
| No new safety or effectiveness issues were raisedduring the testing. The bench testing qualification andbiocompatibility testing demonstrated that the subjectdevice Export Advance™ Aspiration Catheter issubstantially equivalent to the predicate device. | |
| Summary of ClinicalData: | No clinical investigation has been performed on thesubject device Export Advance™ Aspiration Catheter. |
| Conclusion from Data: | Medtronic Vascular has demonstrated that the subjectdevice Export Advance™ Aspiration Catheter issubstantially equivalent to the predicate device. |
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within the proximal outer jacket component, distal cuff,
§ 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).