(28 days)
No
The document describes a mechanical thrombectomy device and its intended use. 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 mechanical and operational characteristics.
No.
A therapeutic device is one that treats a disease or condition. The AngioJet Solent Proxi Thrombectomy Set is used to remove thrombus and facilitate drug infusion, which directly treats the vascular condition.
No
The device is described as a thrombectomy set used to break apart and remove thrombus, which is a therapeutic rather than diagnostic function.
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." This indicates a physical, hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The AngioJet Solent Proxi Thrombectomy Set is a medical device used within the body (in vivo) to physically break apart and remove blood clots from blood vessels. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly describes a procedure performed on the patient's vascular system, not a laboratory test on a sample.
Therefore, the AngioJet Solent Proxi Thrombectomy Set falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AngioJet Solent Proxi 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
QEZ, KRA
Device Description
AngioJet Solent Proxi Thrombectomy Set is a sterile, single use, disposable set that includes a Thrombectomy Catheter and Pump in one combined unit. The AngioJet Solent Proxi 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)
- Physicochemical (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
- Corrosion
- Clot removal
- Hemolysis
- Catheter pass wall temperature
- Mechanical integrity (tensile strengths and compression / buckling)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K091593 AngioJet Ultra DVX and Xpeedior Thrombectomy Sets
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 20, 2021
MEDRAD Interventional/Possis Doug Atkins Sr. Regulatory Affairs Associate 9055 Evergreen Blvd NW Minneapolis, Minnesota 55433
Re: K101406
Trade/Device Name: AngioJet Solent Proxi 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 June 16, 2010. 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. O'connell -S O'connell -S Date: 2021.05.20
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/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, to the right. Encircling the caduceus are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
JUN 1 3 2010
MEDRAD Interventional / Possis c/o Mr. Doug Atkins Senior Regulatory Affairs Associate 9055 Evergreen Boulevard Minneapolis, MN 55433-8003
Re: K101406
Angiojet Solent Proxi Thrombectomy Set Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE, KRA Dated: May 18, 2010 Received: May 19, 2010
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. However, we remind you 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
2
Page 2 - Mr. Doug Atkins
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 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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
R. Vihner
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Indications for Use
510(k) Number (if known): K101406
Device Name: AngioJet® Solent™ Proxi Thrombectomy Set
Indications for Use:
The AngioJet Solent Proxi 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)
| (Division Sign-Off) | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|---|
| Division of Cardiovascular Devices |
510(k) Number K101406
4
JUN 1 3 2010
Section 5 – 510(k) Summary
| Submitter: | MEDRAD Interventional / Possis
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: | June 15, 2010 |
| Trade Name: | AngioJet® Solent™ Proxi Thrombectomy Set |
| Classification: | 870.5150 and 870.1210 |
| Product Code: | DXE and KRA |
| Predicate Device(s): | The subject device is equivalent to the following devices:
K091593 AngioJet Ultra DVX and Xpeedior Thrombectomy Sets |
| Device Description: | AngioJet Solent Proxi Thrombectomy Set is a sterile, single use,
disposable set that includes a Thrombectomy Catheter and Pump in
one combined unit. The AngioJet Solent Proxi Thrombectomy Set is
used with the AngioJet Ultra Console. |
| Intended Use: | The AngioJet Solent Proxi 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
predicate: | Design changes were made to the predicate device which included:
changes to the catheter shaft design, changes to the catheter manifold
and tip to facilitate guide wire usage, and a change to the strain relief /
manifold joint. |
5
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
- Cytotoxicity (ISO 10993-5) o
- Intracutaneous Reactivity (ISO 10993-10) o
- Sensitization (ISO 10993-10) O
- Acute Systemic Toxicity (ISO 10993-11) o
- Material Mediated Pyrogen (ISO 10993-11) O
- O Physiochemical (ISO 10993-18)
- 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 .
- . Corrosion
- Clot removal .
- . Hemolysis
- Catheter pass wall temperature .
- . Mechanical integrity (tensile strengths and compression / buckling)
Conclusion:
MEDRAD Interventional / Possis considers the AngioJet Solent Proxi 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.