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K Number
K152335
Device Name
Export Advance Aspiration Catheter
Manufacturer
Medtronic, Inc.
Date Cleared
2015-09-18

(30 days)

Product Code
DXE
Regulation Number
870.5150
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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.
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.
More Information

K130536

Not Found

No
The summary describes a mechanical aspiration catheter and bench testing for performance and biocompatibility. There is no mention of AI or ML.

Yes
The device is indicated to "sub selectively infuse/deliver diagnostics or therapeutics agents," which includes therapeutic purposes.

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is to be used "To sub selectively infuse/deliver diagnostics or therapeutics agents". This indicates that the device can be used to deliver diagnostic agents, making it part of a diagnostic process.

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 of physical attributes and biocompatibility, further indicating it is a hardware device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is for the "Removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system" and "To sub selectively infuse/deliver diagnostics or therapeutics agents". These are direct interventions within the body, not tests performed on samples taken from the body.
  • Device Description: The description reinforces its function as a catheter for aspiration and infusion within the vascular system.
  • Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.

IVD devices are designed to perform tests on samples taken from the human body to provide information about a person's health. This device is a therapeutic and diagnostic delivery/removal tool used directly within the patient's vascular system.

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)

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 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: Given that the only difference between the modified design for the subject device and the commercially available design of the predicate device is the dual lumen section, only attributes impacted by the design modification were tested. The design verification (bench) testing was performed based upon the subject device performance specifications. The tests performed for bench testing included:

  1. Profile Dimensions (Major & Minor Profile)
  2. Microlumen Tear
  3. 2D Track and Lesion Cross

Biocompatibility Testing (GLP): The materials, packaging and configuration of the subject device is not changing as a result of the dual lumen design change. The microlumen sleeve material is changing from 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 is no requirement for additional biocompatibility testing. Existing biocompatibility data previously performed on the 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 management process; and 21 CFR 58 -Good Laboratory Practice for Nonclinical Laboratory Studies; Medtronic Vascular has concluded full biocompatibility testing on the predicate device.

  1. Cytotoxicity
  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

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 substantially equivalent to the predicate device.

No clinical investigation has been performed on the subject device Export Advance™ Aspiration 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.

K130536 - Medtronic Vascular Export® Advance Aspiration 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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion. The logo is simple and professional, and it is easily recognizable.

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 Vascular
37A Cherry Hill Drive
Danvers, MA 01923-5186 |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Colleen Mullins
Principal Regulatory Affairs Specialist
Phone: (978) 739-3267
Fax: (978) 739-3280 |
| Alternate Contact | Fred Boucher
Director of Regulatory Affairs
Phone: (978) 739-3116
Fax: (978) 750-8204 |
| Date Prepared: | August 17th, 2015 |
| 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: | K130536 - Medtronic Vascular
Export® Advance Aspiration 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
change to the dual lumen section (micro-lumen section) |
| 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
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: Given that the only
difference between the modified design for the subject
device and the commercially available design of the
predicate device is the dual lumen section, only
attributes impacted by the design modification were
tested. The design verification (bench) testing was
performed based upon the subject device performance
specifications. The tests performed for bench testing
included:

  1. Profile Dimensions (Major & Minor Profile)
  2. Microlumen Tear
  3. 2D Track and Lesion Cross |
    | | Biocompatibility Testing (GLP): The materials,
    packaging and configuration of the subject device is
    not changing as a result of the dual lumen design
    change. The microlumen sleeve material is changing
    from 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 is
    no requirement for additional biocompatibility testing.
    Existing biocompatibility data previously performed on
    the 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 management
    process; and 21 CFR 58 -Good Laboratory Practice
    for Nonclinical Laboratory Studies; Medtronic
    Vascular has concluded full biocompatibility testing on
    the predicate device. |
    | | 1. Cytotoxicity
  4. In vitro Hemolysis
  5. Systemic Toxicity
  6. Sensitization
  7. C3a Complement Activation
  8. Sc5b9 Complement Activation
  9. ISO Intracutaneous Reactivity
  10. USP Material Mediated Pyrogen Study
  11. 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
    substantially equivalent to the predicate device. |
    | Summary of Clinical
    Data: | No clinical investigation has been performed on the
    subject device Export Advance™ Aspiration Catheter. |
    | Conclusion from Data: | Medtronic Vascular has demonstrated that the subject
    device Export Advance™ Aspiration Catheter is
    substantially equivalent to the predicate device. |

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within the proximal outer jacket component, distal cuff,