(165 days)
No
The description focuses on mechanical components and fluid delivery control via clamps, with no mention of AI/ML terms or functionalities.
Yes
The device is intended for the "control and selective infusion of physician-specified fluids, including thrombolytic agents, into the peripheral vascular system using the AngioJet Ultra System," which directly participates in the treatment of a medical condition.
No
Explanation: The device is intended for the control and selective infusion of fluids into the peripheral vascular system for treatment, not for diagnosing a condition.
No
The device description explicitly details physical components like a Y-set, vented bag spikes, tubing, and clamps, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "control and selective infusion of physician-specified fluids, including thrombolytic agents, into the peripheral vascular system". This describes a therapeutic or procedural use within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a kit for delivering fluids into the vascular system. It involves tubing, clamps, and connections to IV bags. This aligns with a system for administering substances to a patient, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to deliver fluids into the body.
N/A
Intended Use / Indications for Use
The AngioJet® Ultra Power Pulse Kit is intended for use only with the AngioJet Ultra Thrombectomy Sets indicated for the control and selective infusion of physician-specified fluids, including thrombolytic agents, into the peripheral vascular system using the AngioJet Ultra System.
Product codes
QEW, KRA
Device Description
AngioJet Ultra Power Pulse Kit enables the AngioJet Ultra Thrombecomy Set to deliver a pulsed infusion of physician-specified fluid to a local treatment area. The AngioJet Ultra Power Pulse Kit includes a Y-set with vented bag spikes that are bonded to tubing. Each upper arm of the Y-tubing contains a tubing clamp, one white and one red.
The vented bag-spikes are used to access the standard intravenous saline solution bag used with the AngioJet Ultra System and a second intravenous bag, containing physician-specified fluid. The tube clamps are used to control the flow of the two fluids.
The physician-specified fluid is delivered using the AngioJet Ultra System, which includes the AngioJet Ultra Console and Thrombectomy Set.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician-specified fluids, physician-specified fluid
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
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), Physiochemical (ISO 10993-18), Pyrogenicity (ISO 10993-11), Hemolysis (ISO 10993-4)
Mechanical integrity: Clamp open/close, Leak, Component separation
Key Metrics
Not Found
Predicate Device(s)
K052256 AngioJet® Xpeedior® 120 Catheter
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 logos of the Department of Health & Human Services USA and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 27, 2020
Medrad, Inc. Amra Racic Senior Regulatory Affairs Specialist 9055 Evergreen Blvd Nw Minneapolis, Minnesota 55433-8003
Re: K130381
Trade/Device Name: Angiojet Ultra Power Pulse Kit Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEW
Dear Amra Racic:
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 July 29, 2013. Specifically, FDA is updating this SE Letter 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.
O'connell -S
Digitally signed by Gregory
W. O'connell -S
Date: 2020.07.27 08:02:16
-04'00'
Gregory O'Connell Assistant Director Plaque Modification Devices Team 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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 29, 2013
MEDRAD, INC. c/o Amra Racic Senior Regulatory Affairs Specialist 9055 Evergreen Boulevard NW Minneapolis, MN 55433
Re: K130381
Trade/Device Name: AngioJet® Ultra Power Pulse® Kit Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: May 30, 2013 Received: May 31, 2013
Dear Ms. Racic:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
2
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 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" (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
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.
of Surveillance and Biometrics/Division of Postmarket Surveillance.
Sincerely yours,
Bram D. Zuckerman -S
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): ____________________________________________________________________________________________________________________________________________________
Device Name: AngioJet® Ultra Power Pulse® Kit
Indications for Use:
The AngioJet® Ultra Power Pulse Kit is intended for use only with the AngioJet Ultra Thrombectomy Sets indicated for the control and selective infusion of physician-specified fluids, including thrombolytic agents, into the peripheral vascular system using the AngioJet Ultra System.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
Bram D. Zuckerman -S 2013.07.29 18:16:15 -04'00
4
Section 5 – 510(k) Summary
| Submitter: | MEDRAD, INC.
9055 Evergreen Boulevard NW
Minneapolis, MN 55433-8003 USA |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Amra Racic
Senior Regulatory Affairs Specialist
Phone: (763) 450-8500
Fax: (763) 780-2227
Email: amra.racic@bayer.com |
| Date Prepared: | February 13, 2013 |
| Trade Name: | AngioJet® Ultra Power Pulse® Kit |
| Classification: | 870.1210 |
| Product Code: | KRA |
| Predicate Device(s): | The subject device is equivalent to the following device:
• K052256 AngioJet® Xpeedior® 120 Catheter |
| Device Description: | AngioJet Ultra Power Pulse Kit enables the AngioJet Ultra Thrombecomy Set to deliver a pulsed infusion of physician-specified fluid to a local treatment area. The AngioJet Ultra Power Pulse Kit includes a Y-set with vented bag spikes that are bonded to tubing. Each upper arm of the Y-tubing contains a tubing clamp, one white and one red.
The vented bag-spikes are used to access the standard intravenous saline solution bag used with the AngioJet Ultra System and a second intravenous bag, containing physician-specified fluid. The tube clamps are used to control the flow of the two fluids.
The physician-specified fluid is delivered using the AngioJet Ultra System, which includes the AngioJet Ultra Console and Thrombectomy Set. |
| Intended Use: | The AngioJet Ultra Power Pulse Kit is intended for use only with AngioJet Ultra Thrombectomy Sets indicated for the control and selective infusion of physician-specified fluids, including thrombolytic agents, into the peripheral vascular system using the AngioJet Ultra System. |
| Comparison to predicate: | A comparison of the modified device and the currently marketed AngioJet Power Pulse Kit show the following similarities:
• Same intended use.
• Same operating principle.
• Same technological characteristics.
• Same performance claims. |
| Performance Data: | This submission is a result of material modification to use DEHP free tubing.
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 |
| MEDRAD, INC. | Page 1 of 2 |
5
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
- Physiochemical (ISO 10993-18) O
- Pyrogenicity (ISO 10993-11) O
- Hemolysis (ISO 10993-4) O
- Mechanical integrity ●
- Clamp open/close O
- Leak o
- Component separation O