(78 days)
Not Found
No
The document does not mention AI, ML, or any related concepts like deep learning, neural networks, or image processing that would typically indicate the presence of AI/ML in a medical device. The description focuses on mechanical and functional aspects of the device.
Yes
The device is intended to "break apart and remove thrombus," which is a direct treatment of a medical condition.
No
The device is intended to break apart and remove thrombus and for selective infusion of fluids, which are therapeutic actions, not diagnostic.
No
The device description explicitly states it is a "sterile, single use, disposable set that includes the Thrombectomy Catheter and Pump in one combined unit," indicating it is a physical medical device with hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a procedure performed within the body (in vivo) to break apart and remove thrombus from blood vessels. IVDs are used to examine specimens from the body (in vitro), such as blood, urine, or tissue samples, to provide information about a person's health.
- Device Description: The device is a catheter and pump designed for direct interaction with the patient's vascular system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory testing.
Therefore, the AngioJet Ultra XPEEDIOR Thrombectomy Set is a therapeutic medical device used for a procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AngioJet® Ultra XPEEDIOR® Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries ≥ 3 mm in diameter; break apart and remove thrombus from upper extremity and infra-inguinal lower extremity peripheral veins ≥ 3 mm 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 (updated September 15, 2021)
DXE, KRA (original July 31, 2007)
Device Description
The AngioJet Ultra XPEEDIOR Thrombectomy Set is a sterile, single use, disposable set that includes the Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra XPEEDIOR 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
infra-inguinal peripheral arteries ≥ 3 mm in diameter; upper extremity and infra-inguinal lower extremity peripheral veins ≥ 3 mm in diameter.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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)
Representative samples of the devices underwent bench testing, including but not limited to mechanical testing, biocompatibility, sterility, comparative testing to demonstrate appropriate functional and performance characteristics.
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 text logo on the right. The FDA text logo is in blue and includes the letters "FDA" stacked on top of the words "U.S. FOOD & DRUG ADMINISTRATION".
September 15, 2021
Possis Medical, Inc. Mark Stenoien Director Of Regulatory Affairs 9055 Evergreen Blvd., N.w. Minneapolis, Minnesota 55433-8003
Re: K071342
Trade/Device Name: Angiojet Ultra XPEEDIOR Thrombectomy Set Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ, KRA
Dear Mark Stenoien:
The Food and Drug Administration (FDA) is sending this letter to notify you of an adminis trative change related to your previous substantial equivalence (SE) determination letter dated July 31, 2007. 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. Digitally signed by
Gregory W. Gregory W. O'connell -S O'connell -S Date: 2021.09.15
10:16:48-04'00'
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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 1 2007
Possis Medical, Inc. c/o Mr. Mark Stenoien Director of Worldwide Regulatory Affairs 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003
Re: K071342
AngioJet Ultra XPEEDIOR Thrombectomy Set Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE, KRA Dated: June 29, 2007 Received: July 2, 2007
Dear Mr. Stenoien:
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 iddications 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 Amendopotite 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, ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration,
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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2
Page 2 - Mr. Mark Stenoien
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 list in the Party of CFR Patts 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 rine DNY.000 ULD. In and (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Bram D/Zuckerman, M.D. . Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): 4071342
Device Name: AngioJet® Ultra XPEEDIOR® Thrombectomy Set
Indications for Use:
The AngioJet Ultra Xpeedior Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries ≥ 3 mm in diameter; break apart and remove thrombus from upper extremity and infra-inguinal lower extremity peripheral veins ≥ 3 mm 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, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 610(k) Number | K071347 |
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4
Section 5 - 510(k) Summary
JUL 3 1 2007
| Submitter: | Possis Medical, Inc.
9055 Evergreen Boulevard NW
Minneapolis, MN 55433-8003 USA |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Mark Stenoien,
Director of Worldwide Regulatory Affairs
Phone: (763) 780-4555
Fax: (763) 780-2227
Email: mark.stenoien@possis.com |
| Date Prepared: | 07/25/2007 |
| Trade Name: | AngioJet® Ultra XPEEDIOR® Thrombectomy Set |
| Classification: | 80.5150 and 870.1210 |
| Product Code: | DXE and KRA |
| Predicate
Device(s): | The subject device is equivalent to the following device:
• K052256 AngioJet XPEEDIOR 120 Catheter
• K061951 AngioJet XPEEDIOR 120 Catheter |
| Device Description: | The AngioJet Ultra XPEEDIOR Thrombectomy Set is a sterile, single
use, disposable set that includes the Thrombectomy Catheter and
Pump in one combined unit. The AngioJet Ultra XPEEDIOR
Thrombectomy Set is used with the AngioJet Ultra Console. |
| Intended Use: | The AngioJet Ultra XPEEDIOR Thrombectomy Set is intended for
use with the AngioJet Ultra Console to break apart and remove
thrombus from infra-inguinal peripheral arteries ≥3 mm in diameter;
break apart and remove thrombus from upper extremity and infra-
inguinal lower extremity peripheral veins ≥3 mm 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. |
| Functional and
Safety Testing: | Representative samples of the devices underwent bench testing,
including but not limited to mechanical testing, biocompatibility,
sterility, comparative testing to demonstrate appropriate functional
and performance characteristics. |
| Conclusion: | Possis Medical, Inc. considers the AngioJet Ultra XPEEDIOR
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. |