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 XT & Export AP Catheters are dual lumen catheters used for the aspiration of thrombus and/or debris from a vascular site. The Export XT & Export AP Catheters may also be used for the infusion of diagnostic or therapeutic agents to a desired vascular site.

AI/ML Overview

The provided text is a 510(k) summary for the Medtronic Vascular Export XT and Export AP Catheters, which are embolectomy catheters. This type of submission to the FDA focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria for a new, novel device. Therefore, the document does not contain the detailed acceptance criteria and a study proving the device meets those criteria in the way one might expect for a new device requiring de novo authorization or a PMA.

However, based on the information provided, I can infer the "acceptance criteria" were related to demonstrating that a material change (PFOA-Free emulsifier for PTFE resin in microlumen tubing) did not negatively impact the device's performance compared to its predicate. The "study" was a series of non-clinical (bench and biocompatibility) tests.

Here's an attempt to structure the information based on your request, even though some points cannot be directly answered as the document is a 510(k) summary, not a detailed study report:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The device in question, the Medtronic Vascular Export XT and Export AP Catheters, underwent a 510(k) submission (K120808) due to a material change: replacing a PFOA emulsifier with a PFOA-Free emulsifier for the PTFE resin in the microlumen tubing. The "acceptance criteria" and "study" described below are focused on demonstrating that this material change did not alter the fundamental safety and effectiveness of the device compared to its legally marketed predicate devices, thereby establishing substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test	Acceptance Standard (Inferred)	Reported Device Performance
Material Performance	Shaft Stiffness Test	Performance similar to predicate devices (K061958, K081573)	Met acceptance criteria and performed similarly.
	Microlumen Wire Pull Through Test	Performance similar to predicate devices (K061958, K081573)	Met acceptance criteria and performed similarly.
Biocompatibility	Cytotoxicity	Compliant with ISO 10993-1:2009 and 21 CFR 58	Full biocompatibility testing performed; no new safety issues.
	In vitro Hemolysis	Compliant with ISO 10993-1:2009 and 21 CFR 58	Full biocompatibility testing performed; no new safety issues.
	Systemic Toxicity	Compliant with ISO 10993-1:2009 and 21 CFR 58	Full biocompatibility testing performed; no new safety issues.
	Sensitization	Compliant with ISO 10993-1:2009 and 21 CFR 58	Full biocompatibility testing performed; no new safety issues.
	C3a Complement Activation	Compliant with ISO 10993-1:2009 and 21 CFR 58	Full biocompatibility testing performed; no new safety issues.
	Sc5b9 Complement Activation	Compliant with ISO 10993-1:2009 and 21 CFR 58	Full biocompatibility testing performed; no new safety issues.
	ISO Intracutaneous Reactivity	Compliant with ISO 10993-1:2009 and 21 CFR 58	Full biocompatibility testing performed; no new safety issues.
	USP Material Mediated Pyrogen Study	Compliant with ISO 10993-1:2009 and 21 CFR 58	Full biocompatibility testing performed; no new safety issues.
	In vivo Thromboresistance	Compliant with ISO 10993-1:2009 and 21 CFR 58	Full biocompatibility testing performed; no new safety issues.

Summary Conclusion from Data: The bench testing qualification and biocompatibility testing demonstrated that the proposed Export XT & Export AP Catheters devices are substantially equivalent to the predicate devices. No new safety or effectiveness issues were raised during the testing.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify exact sample sizes for the bench or biocompatibility tests. It only states that testing was "performed specific to the material change" and "full biocompatibility testing on the proposed device."
Data Provenance: Not specified in the document. Given it's a submission to the US FDA, the testing was likely conducted in compliance with US regulatory requirements, but the physical location of the labs is not noted. The nature of the tests (bench/biocompatibility) implies prospective testing for the current device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided in a 510(k) summary for a device like an embolectomy catheter, especially when demonstrating substantial equivalence for a material change through non-clinical testing. "Ground truth" in this context would be defined by validated test methods and established standards (e.g., ISO 10993-1, 21 CFR 58), rather than expert consensus on cases.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable to bench and biocompatibility testing of a medical device's physical properties and material safety. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of images or patient outcomes, often in the context of diagnostic AI.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. The document explicitly states: "No clinical investigation has been performed for these devices." This being a material change within an already cleared device, such a study would not typically be required. Furthermore, this device is a physical catheter, not an AI-powered diagnostic tool, so the concept of "human readers improve with AI" is not relevant here.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done

Not applicable. The device is a physical catheter and does not involve an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests conducted (bench and biocompatibility), the "ground truth" is established by adherence to recognized international standards and regulatory guidelines.
- Bench Testing: Engineering specifications and performance metrics derived from the predicate devices.
- Biocompatibility Testing: Standards such as ISO 10993-1:2009 (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).

8. The sample size for the training set

Not applicable. As this is not an AI/machine learning device, there is no concept of a "training set."

9. How the ground truth for the training set was established

Not applicable. There is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 8, 2021

Medtronic Inc. c/o Anupama Gaur, Ph.D. Senior Regulatory Affairs Specialist 35-37a Cherry Hill Drive Danvers, Massachusetts 01923-5186

Re: K120808

Trade/Device Name: Medtronic Vascular Export XT Catheter, Medtronic Vascular Export AP Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ, KRA

Dear Dr. Gaur:

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 June 07, 2012. Specifically, FDA is updating this SE Letter as an administrative correction 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 this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075, Gregory. Oconnell(@FDA.HHS.gov.

Sincerely,

Gregory W. Digitally signed by
Gregory W. Gregory W. O'connell -S ○'connell -S Date: 2021.02.08
08:18:32 -05'00'

Gregory O'Connell Assistant Director 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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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 features the department's emblem, which is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare. The emblem is accompanied by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the emblem.

Public Health Service

JUN - 7 2012

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Medtronic Vascular c/o Anupama Gaur, Ph.D. Senior Regulatory Affairs Specialist 35-37A Cherry Hill Drive Danvers, MA 01923

Re: K120808

Trade/Device Name: Export XT and Export AP Catheters Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: May 10, 2012 Received: May 11, 2012

Dear Dr. Gaur ..

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 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

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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/CDRH0ffices/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

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Indications for Use

510(k) Number:

Device Name: Medtronic Vascular Export XT & Export AP Catheters

Indications for Use:

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)

(Division Sign-Off)
---------------------

Division of Cardiovascular Devices
510(k) Number K120808
Page 1 of 1

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Indications for Use

510(k) Number:

Device Name: Medtronic Vascular Export XT & Export AP Catheters

Indications for Use:

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)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K120808

Page 1 of 1

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K120808
P. 1 of 3

JUN - 7 2012

510(k) Summary

Submitter:	Medtronic Vascular35-37A Cherry Hill DriveDanvers, MA 01923-5186
Contact Person:	Anu GaurSenior Regulatory Affairs SpecialistPhone: (978) 739-3080Fax: (978) 750-8204
Alternate Contact	Fred BoucherDirector of Quality & Regulatory AffairsPhone: (978) 739-3116Fax: (978) 750-8204
Date Prepared:	June 7th, 2012
Trade Name:	Medtronic Vascular Export® XT CatheterMedtronic Vascular Export® AP Catheter
Common Name:	Percutaneous Catheter
ClassificationName:	Embolectomy CatheterClass II per 21 CFR 870.5150, Product Code DXE
Predicate Devices:	K061958 - Medtronic Vascular Export® XT CatheterK081573 - Medtronic Vascular Export® AP Catheter
DeviceDescription:	The Export XT & Export AP Catheters are dual lumen cathetersused for the aspiration of thrombus and/or debris from a vascularsite. The Export XT & Export AP Catheters may also be usedfor the infusion of diagnostic or therapeutic agents to a desiredvascular site.
Statement ofIntended Use:	Export XT & Export AP Catheters indications for use include:- Removal/aspiration of embolic material (thrombus/debris)from vessels of the arterial system, and- To sub selectively infuse/deliver diagnostics or therapeuticsagents with or without vessel occlusion.
Comparison to thepredicate devices	A change in the processing aid (emulsifier) for the PTFE resinused for the microlumen tubing in the distal end of the catheter.The change replaces the PFOA emulsifier with a PFOA-Freeemulsifier.
Summary ofTechnologicalCharacteristics:	The modified Medtronic Export XT & Export AP Cathetersinvolves the following features:i. Luer Hubii. Strain Reliefiii. Inner Lineriv. Braid Wirev. Proximal Shaftvi. Distal Shaft (Dual Lumen/Oversleeve)vii. Soft Tipviii. Microlumen (PTFE PFOA-Free)
Summary of Non-clinical Data:	The bench testing qualification and the biocompatibility testingfor the material modification was conducted in accordance withthe recommendations from the relevant FDA guidance todemonstrate that the proposed Export XT & Export APCatheters have met the acceptance criteria and performedsimilarly to the predicate devices.Bench Testing: The bench testing qualification was performedspecific to the material change. The tests performed for benchtesting included:1. Shaft Stiffness Test.2. Microlumen Wire Pull Through Test.Biocompatibility Testing: Pursuant to the ISO 10993-1:2009 -Biological evaluation of medical devices - Part 1: Evaluationand testing within a risk management process; and 21 CFR 58 -Good Laboratory Practice for Nonclinical Laboratory Studies;Medtronic Vascular has concluded full biocompatibility testingon the proposed device.1. Cytotoxicity2. In vitro Hemolysis3. Systemic Toxicity4. Sensitization5. C3a Complement Activation6. Sc5b9 Compliment Activation7. ISO Intracutaneous Reactivity8. USP Material Mediated Pyrogen Study9. In vivo ThromboresistanceNo new safety or effectiveness issues were raised during the

想

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KI20808
p. 2 of 3

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testing. The bench testing qualification and biocompatibility testing demonstrated that the proposed Export XT & Export AP Catheters devices are substantially equivalent to the predicate devices.

Summary of Clinical Data: No clinical investigation has been performed for these devices.

Conclusion from Data:

Medtronic Vascular has demonstrated that the proposed Export XT & Export AP Catheters are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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).