(27 days)
Not Found
No
The summary describes a mechanical thrombectomy device and its intended use, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is intended to break apart and remove thrombus, which is a therapeutic intervention to treat a medical condition (thrombosis).
No
The device is a thrombectomy set designed to remove blood clots, which is a therapeutic function rather than a diagnostic one.
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 hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The AngioJet Solent Omni Thrombectomy Set is used inside the body (in vivo) to physically break apart and remove thrombus (blood clots) from blood vessels. It's a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly describes a procedure performed within the vascular system, not the analysis of bodily fluids or tissues in a lab setting.
Therefore, this device falls under the category of an in vivo therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The AngioJet Solent Omni Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from:
- . upper and lower extremity peripheral arteries > 3.0mm in diameter,
- . upper extremity peripheral veins > 3.0mm in diameter,
- . ileofemoral and lower extremity veins > 3.0mm in diameter,
- A-V access conduits > 3.0mm in diameter and .
- for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of . physician specified fluids, including thrombolytic agents, into the peripheral vascular system.
Product codes (comma separated list FDA assigned to the subject device)
QEZ, KRA
Device Description
AngioJet Solent Omni Thrombectomy Set is a sterile, single use, disposable set that includes a Thrombectomy Catheter and Pump in one combined unit. The AngioJet Solent Omni 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
upper and lower extremity peripheral arteries, upper extremity peripheral veins, ileofemoral and lower extremity veins, 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
- Cytotoxicity (ISO 10993-5)
- Intracutaneous Reactivity (ISO 10993-10)
- Sensitization (ISO 10993-10)
- Acute Systemic Toxicity (ISO 10993-11)
- Material Mediated Pyrogen (ISO 10993-11)
- Physiochemical (ISO 10993-18)
Hemocompatibility - ASTM Hemolysis (ISO 10993-4)
- Partial Thromboplastin Time Assay (ASTM F2382-04)
- C3a Complement Activation (ISO 10993-4)
- SC5b-9 Complement Activation (ISO 10993-4)
- Thromboresistance (ISO 10993-4)
Catheter operational characteristics - Leak testing
- Guide wire compatibility tests
- Particulate generation
- Tracking
- Extended use
- Kink resistance
- Clot removal
- Hemolysis
- Catheter tip temperature
- Mechanical integrity (tensile strengths, compression / buckling, torque testing)
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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 8, 2021
MEDRAD, Inc. Doug Atkins Sr. Regulatory Affairs Specialist 9055 Evergreen Blvd NW Minneapolis, Minnesota 55433-8003
Re: K111182
Trade/Device Name: AngioJet Solent Omni Thrombectomy Set Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ, KRA
Dear Doug Atkins:
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 May 24, 2011. 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 regarding 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 O'connell -S 0ate: 2021.02.08
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
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with outstretched wings. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MEDRAD, INC. c/o Mr. Doug Atkins 9055 Evergreen Blvd. Minneapolis, MN 55433-8003
MAY 2 4 201
Re: K111182
Trade/Device Name: AngioJet Solent Omni Thrombectomy Set Regulation Number: 21 CFR 870.5150 Regulatory Class: Class II (two) Product Code: DXE, KRA Dated: April 25, 2011 Received: April 27, 2011
Dear Mr. Atkins:
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
2
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.
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/CDRH/CDRHOffices/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 (if known): K111182
Device Name: AngioJet® Solent™ Omni Thrombectomy Set
Indications for Use:
The AngioJet Solent Omni Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from:
- . upper and lower extremity peripheral arteries > 3.0mm in diameter,
- . upper extremity peripheral veins > 3.0mm in diameter,
- . ileofemoral and lower extremity veins > 3.0mm in diameter,
- A-V access conduits > 3.0mm in diameter and .
- for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of . physician specified fluids, including thrombolytic agents, into the peripheral vascular system.
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, Off valuation (ODE)
(Division Sign-off)
Division of Cardiovascular Devices
510(k) Number K111/82
4
KHIL82 page 1 of 2
Section 5 - 510(k) Summary
MAY 2 4 2011 Submitter: MEDRAD, INC. 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003 USA Contact Person: Doug Atkins Sr. Regulatory Affairs Associate Phone: (763) 450-8060 Fax: (763) 780-2227 Email: doug.atkins@possis.com Date Prepared: April 25, 2011 AngioJet® Solent™ Omni Thrombectomy Set Trade Name: Classification: 870.5150 and 870.1210 Product Code: DXE and KRA Predicate Device(s): The subject device is equivalent to the following devices: K101406 AngioJet Ultra Solent Proxi Thrombectomy Set ● K091593 AngioJet Ultra Xpeedior Thrombectomy Set o Device Description: AngioJet Solent Omni Thrombectomy Set is a sterile, single use, disposable set that includes a Thrombectomy Catheter and Pump in one combined unit. The AngioJet Solent Omni Thrombectomy Set is used with the AngioJet Ultra Console. Intended Use: The AngioJet Solent Omni Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from: upper and lower extremity peripheral arteries > 3.0mm in ● diameter, . upper extremity peripheral veins > 3.0mm in diameter, ileofemoral and lower extremity veins > 3.0mm in diameter. ● A-V access conduits ≥ 3.0mm in diameter and . for use with the AngioJet Ultra Power Pulse Kit for the control . and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system. Comparison to Design changes were made to the predicate device which included: predicate: change in length of device, changes to the jet body, changes to catheter shaft, changes to distal section of catheter, changes to bar code operational parameters, changes to catheter manifold, and changes to the packaging tray. 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 . o Cytotoxicity (ISO 10993-5)
5
- Intracutaneous Reactivity (ISO 10993-10) o
- Sensitization (ISO 10993-10) o
- o Acute Systemic Toxicity (ISO 10993-11)
- Material Mediated Pyrogen (ISO 10993-11) o
- Physiochemical (ISO 10993-18) o
- Hemocompatibility o
- · ASTM Hemolysis (ISO 10993-4)
- · Partial Thromboplastin Time Assay (ASTM F2382-04)
- · C3a Complement Activation (ISO 10993-4)
- · SC5b-9 Complement Activation (ISO 10993-4)
- · Thromboresistance (ISO 10993-4)
- Catheter operational characteristics .
- Leak testing ●
- Guide wire compatibility tests ◆
- . Particulate generation
- Tracking
- . Extended use
- . Kink resistance
- . Clot removal
- Hemolysis
- Catheter tip temperature .
- Mechanical integrity (tensile strengths, compression / ● buckling, torque testing)
Conclusion:
MEDRAD considers the AngioJet Solent Omni Thrombectomy Set to be substantially equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in functional design, materials, indications for use, and principles of operation.