(83 days)
Not Found
No
The summary describes a mechanical aspiration catheter and infusion device with no mention of AI/ML, image processing, or data analysis that would typically indicate AI/ML involvement.
Yes
Explanation: The device is used for "removal/aspiration of embolic material (thrombus/debris)" and "to sub selectively infuse/deliver diagnostics or therapeutics agents." These actions directly address or alleviate a medical condition, namely the presence of thrombus/debris and the delivery of therapeutic agents, which aligns with the definition of a therapeutic device.
No
The device is primarily intended for the removal/aspiration of embolic material and infusion of agents. While it can deliver diagnostic agents, its core function is not to diagnose.
No
The device description clearly states it is a dual lumen catheter, which is a physical hardware device used for aspiration and infusion. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function as removing/aspirating material from blood vessels and infusing agents into vessels. These are procedures performed within the body (in vivo), not on samples of bodily fluids or tissues outside the body (in vitro).
- Device Description: The description reinforces the in vivo nature of the device, describing it as a catheter used for aspiration and infusion within the vascular system.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples of blood, urine, tissue, or other bodily substances to provide diagnostic information.
IVD devices are specifically designed to be used in vitro to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on direct intervention within the patient's vascular system.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DXE, QEZ, KRA
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.
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)
Bench Testing: The bench testing qualification was performed specific to the material change. The tests performed for bench testing included:
- Shaft Stiffness Test.
- Microlumen Wire Pull Through Test.
Biocompatibility Testing: Pursuant to the 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; Medtronic Vascular has concluded full biocompatibility testing on the proposed device.
- Cytotoxicity
- In vitro Hemolysis
- Systemic Toxicity
- Sensitization
- C3a Complement Activation
- Sc5b9 Compliment 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 proposed Export XT & Export AP Catheters devices are substantially equivalent to the predicate devices.
No clinical investigation has been performed for these devices.
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.
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 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
1
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
2
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
3
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
4
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
5
K120808
P. 1 of 3
JUN - 7 2012
510(k) Summary
| Submitter: | Medtronic Vascular
35-37A 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 Quality & Regulatory Affairs
Phone: (978) 739-3116
Fax: (978) 750-8204 |
| Date Prepared: | June 7th, 2012 |
| Trade Name: | Medtronic Vascular Export® XT Catheter
Medtronic Vascular Export® AP Catheter |
| Common Name: | Percutaneous Catheter |
| Classification
Name: | Embolectomy Catheter
Class II per 21 CFR 870.5150, Product Code DXE |
| Predicate Devices: | K061958 - Medtronic Vascular Export® XT Catheter
K081573 - Medtronic Vascular Export® AP Catheter |
| 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. |
| Statement of
Intended 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 therapeutics
agents with or without vessel occlusion. |
| Comparison to the
predicate devices | A change in the processing aid (emulsifier) for the PTFE resin
used for the microlumen tubing in the distal end of the catheter.
The change replaces the PFOA emulsifier with a PFOA-Free
emulsifier. |
| Summary of
Technological
Characteristics: | The modified Medtronic Export XT & Export AP Catheters
involves the following features:
i. Luer Hub
ii. Strain Relief
iii. Inner Liner
iv. Braid Wire
v. Proximal Shaft
vi. Distal Shaft (Dual Lumen/Oversleeve)
vii. Soft Tip
viii. Microlumen (PTFE PFOA-Free) |
| Summary of Non-
clinical Data: | The bench testing qualification and the biocompatibility testing
for the material modification was conducted in accordance with
the recommendations from the relevant FDA guidance to
demonstrate that the proposed Export XT & Export AP
Catheters have met the acceptance criteria and performed
similarly to the predicate devices.
Bench Testing: The bench testing qualification was performed
specific to the material change. The tests performed for bench
testing included:
- Shaft Stiffness Test.
- Microlumen Wire Pull Through Test.
Biocompatibility Testing: Pursuant to the 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;
Medtronic Vascular has concluded full biocompatibility testing
on the proposed device. - Cytotoxicity
- In vitro Hemolysis
- Systemic Toxicity
- Sensitization
- C3a Complement Activation
- Sc5b9 Compliment Activation
- ISO Intracutaneous Reactivity
- USP Material Mediated Pyrogen Study
- In vivo Thromboresistance
No new safety or effectiveness issues were raised during the |
10
想
6
KI20808
p. 2 of 3
7
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.