(80 days)
Not Found
No
The summary describes a mechanical thrombectomy device and its components. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on bench and laboratory testing, not algorithmic performance metrics.
Yes
The device is intended to break apart and remove thrombus (blood clots), which is a direct treatment for a medical condition.
No
This device is designed for breaking apart and removing thrombus, which is a therapeutic function, not for diagnosing a condition.
No
The device description explicitly states it is a "sterile, single use, disposable set that includes a Thrombectomy Catheter and Pump in one combined unit," indicating it is a physical medical device with hardware components, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "break apart and remove thrombus from A-V access conduits." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a "Thrombectomy Catheter and Pump" used with a console. This describes a medical device used for intervention within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
Therefore, the AngioJet Ultra AVX Thrombectomy Set is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AngioJet Ultra AVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits >= 3 mm in diameter.
Product codes
DXE
Device Description
AngioJet Ultra AVX Thrombectomy Set is a sterile, single use, disposable set that includes a Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra AVX Thrombectomy Set is used with the AngioJet Ultra Console.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
A-V access conduits
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 and laboratory testing was performed to support a determination of substantial equivalence to the predicate device. Results from the testing provide assurance that the proposed device conforms to the requirements for its intended use. This included the following testing:
Biocompatibility Testing:
- Cytotoxicity (ISO 10993-5)
- Sensitization (ISO 10993-10)
- Intracutaneous Reactivity (ISO 10993-10)
- Acute Systemic Toxicity (ISO 10993-11)
- ASTM Hemolysis (ISO 10993-4)
- Material Mediated Pyrogen (ISO 10993-11)
- Physiochemical (ISO 10993-18)
Design Verification Testing at zero time and at 2 years of accelerated aging: - Operation Pressure
- Net Evacuation
- Infusion rate
- Extended Use
- Dimensional testing
- System leak testing
- Contrast Injection
- Guide Wire Passage
- Mechanical Integrity testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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K133629 p. 1 of 2
.
Section 5 – 510(k) Summary
| Submitter: | MEDRAD, INC.
9055 Evergreen Boulevard NW
Minneapolis, MN 55433-8003 USA | FEB 14 2014 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | George Lucas
Sr. Regulatory Affairs Associate
Phone: (763) 450-8060
Fax: (763) 780-2227
Email: george.lucas@bayer.com | |
| Date Prepared: | November 25, 2013 | |
| Trade Name: | AngioJet® Ultra AVX® Thrombectomy Set | |
| Classification: | 870.5150 | |
| Product Code: | DXE | |
| Predicate Device(s): | The subject device is equivalent to the following device:
• K082382 AngioJet Ultra AVX Thrombectomy Set | |
| Device Description: | AngioJet Ultra AVX Thrombectomy Set is a sterile, single use,
disposable set that includes a Thrombectomy Catheter and Pump in
one combined unit. The AngioJet Ultra AVX Thrombectomy Set is
used with the AngioJet Ultra Console. | |
| Intended Use: | AngioJet Ultra AVX Thrombectomy Set is intended for use with the
AngioJet Ultra System in breaking apart and removing thrombus from
A-V Access conduits ≥ 3 mm in diameter. | |
| Comparison to predicate: | Change to the color of the manifold from yellow to smoke grey. In
addition, design changes were made to the predicate device that
included: change in waste bag tubing, change in bubble trap, change
in glue for manifold bonds, change in manifold strain relief, and
change in waste bag to tube connection. | |
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K133629 p. 2 of 2
Performance Data Bench and laboratory testing was performed to support a determination of substantial equivalence to the predicate device. Results from the testing provide assurance that the proposed device conforms to the requirements for its intended use. This included the following testing:
- Biocompatibility Testing .
- o Cytotoxicity (ISO 10993-5)
- O Sensitization (ISO 10993-10)
- Intracutaneous Reactivity (ISO 10993-10) o
- Acute Systemic Toxicity (ISO 10993-11) o
- o ASTM Hemolysis (ISO 10993-4)
- Material Mediated Pyrogen (ISO 10993-11) o
- o Physiochemical (ISO 10993-18)
- . Design Verification Testing at zero time and at 2 years of accelerated aging.
- O Operation Pressure
- O Net Evacuation
- O Infusion rate
- Extended Use o
- Dimensional testing o
- System leak testing o
- o Contrast Injection
- Guide Wire Passage o
- O Mechanical Integrity testing
- Conclusion: MEDRAD considers the AngioJet Ultra AVX Thrombectomy Set to be substantially equivalent to the predicate device listed above. This conclusion is based upon the devices' similarities in functional design, materials, indications for use, and principles of operation.
2
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 14, 2014
MEDRAD, Inc. Mr. George Lucas Senior Regulatory Affairs Associate 9055 Evergreen Blvd., N.W. Minneapolis, MN 55433-8003
K133629 Re:
Trade/Device Name: AngioJet Ultra AVX Thrombectomy Set Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: January 14, 2014 Received: January 15, 2014
Dear Mr. Lucas,
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
3
Page 2 - Mr. George Lucas
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Kenneth J. Cavanaugh -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: AngioJet® Ultra AVX® Thrombectomy Set
Indications for Use:
The AngioJet Ultra AVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits ≥ 3 mm in diameter.
Prescription Use X (Part 21 CFR 801 Subpart D)
·
AND/OR
Over-The-Counter Use __ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kenneth J. Cavanaugh -S