(78 days)
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.
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.
The provided text is a 510(k) summary for the AngioJet Ultra XPEEDIOR Thrombectomy Set, indicating that Possis Medical, Inc. considers the device to be substantially equivalent to previously cleared predicate devices.
However, the document does not contain information regarding detailed acceptance criteria, specific study designs, sample sizes for testing, ground truth establishment methods, expert qualifications, or comparative effectiveness studies (MRMC) with specific effect sizes.
The "Functional and Safety Testing" section (page 4) broadly states: "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." This is a general statement about the types of tests performed but lacks any specific results or details that would allow for filling out the requested table and information.
Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them based on the text provided.
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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
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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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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 |
3
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Section 5 - 510(k) Summary
JUL 3 1 2007
| Submitter: | Possis Medical, Inc.9055 Evergreen Boulevard NWMinneapolis, MN 55433-8003 USA |
|---|---|
| Contact Person: | Mr. Mark Stenoien,Director of Worldwide Regulatory AffairsPhone: (763) 780-4555Fax: (763) 780-2227Email: 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 |
| PredicateDevice(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, singleuse, disposable set that includes the Thrombectomy Catheter andPump in one combined unit. The AngioJet Ultra XPEEDIORThrombectomy Set is used with the AngioJet Ultra Console. |
| Intended Use: | The AngioJet Ultra XPEEDIOR Thrombectomy Set is intended foruse with the AngioJet Ultra Console to break apart and removethrombus 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 foruse with the AngioJet Ultra Power Pulse Kit for the control andselective infusion of physician specified fluids,includingthrombolytic agents, into the peripheral vascular system. |
| Functional andSafety Testing: | Representative samples of the devices underwent bench testing,including but not limited to mechanical testing, biocompatibility,sterility, comparative testing to demonstrate appropriate functionaland performance characteristics. |
| Conclusion: | Possis Medical, Inc. considers the AngioJet Ultra XPEEDIORThrombectomy Set to be substantially equivalent to the predicatedevice listed above. This conclusion is based upon the devices'similarities in functional design, materials, indications for use, andprinciples of operation. |
§ 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).