(135 days)
The AngioJet Xpeedior 120 Rheolytic Thrombectomy Catheter is intended for use with the AngioJet System in breaking apart and removing thrombus from infra-inquinal peripheral arteries 3.0 mm in diameter and upper extremity and infrainguinal lower extremity peripheral veins > 3.0 mm in diameter.
When used with the AngioJet System, the Xpeedior Rheolytic Thrombectomy Catheter uses high velocity saline jets to percutaneously break-up and remove thrombus. These suline jests are contained within the Catheter and provide the suction that produces this effect.
This document is a 510(k) summary for a medical device called the AngioJet Xpeedior 120 Rheolytic Thrombectomy Catheter. It outlines the device's intended use and claims substantial equivalence to previously cleared devices. It does NOT contain information about acceptance criteria or supporting studies that prove the device meets acceptance criteria.
The provided text from the 510(k) submission (K061951) for the AngioJet XPEEDIOR 120 Rheolytic Thrombectomy Catheter does not include any acceptance criteria, detailed study designs, or performance data tables.
The document primarily focuses on:
- The FDA's administrative change to the product code.
- The original substantial equivalence determination letter.
- The device's indications for use.
- A brief device description.
- A statement that "Applicable preclinical and clinical experience support the expanded indications for use," but without providing any specifics of these studies.
Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and studies from the provided text. To answer your questions, one would need access to the full 510(k) submission, which would typically contain detailed testing protocols, results, and acceptance criteria.
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September 21, 2021
Possis Medical, Inc. Frank Freedman Senior Regulatory Affairs Associate 9055 Evergreen Blvd., N.w. Minneapolis, Minnesota 55433-8003
Re: K061951
Trade/Device Name: XPEEDIOR Rheolytic Thrombectomy Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ, KRA
Dear Frank Freedman:
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 November 22, 2006. 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,
Digitally signed by Gregory W. Gregory W. O'connell -S ○'connell -S Date: 2021.09.21
07:30:27 -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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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2006 2 2 2006
Possis Medical, Inc. c/o Frank B. Freedman. Ph.D. Senior Regulatory Affairs Associate 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003
Re: K061951
AngioJet XPEEDIOR 120 Rheolytic Thrombectomy Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II (Two) Product Code: DXE Dated: November 16, 2006 Received: November 17, 2006
Dear Mr. Freedman:
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.
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 - Frank B. Freedman, Ph.D.
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); 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
:
Sincerely yours,
B Hemmermon for
2
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): K061951
Device Name: AngioJet Xpeedior 120 Rheolytic Thrombectomy Catheter
Indications For Use:
The AngioJet Xpeedior 120 Rheolytic Thrombectomy Catheter is intended for use with the AngioJet System in breaking apart and removing thrombus from infra-inquinal peripheral arteries 3.0 mm in diameter and upper extremity and infrainguinal lower extremity peripheral veins > 3.0 mm in diameter.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Bimmima
(Division Sign-Off) Division of Cardlovascular Devices 510(k) Number
Page 1 of
3
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Attachment 2 Revised 510(k) Summary
| Submitter: | Frank B. Freedman, Ph.D.Possis Medical, Inc.9055 Evergreen Boulevard, N.W.Rapids, MN 55433Phone: 763.780.4555Fax: 763.780.2227 | NOV 22 2000 | |
|---|---|---|---|
| Contact Person: | Primary ContactFrank B. FreedmanPossis Medical, Inc. | Secondary ContactMark D. StenoienPossis Medical, Inc. | |
| Device Common Name: | Thrombectomy Catheter | ||
| Device Trade Name: | XPEEDIOR Rheolytic Thrombectomy Catheter | ||
| Device Classification Name: | Embolectomy Catheter | ||
| Predicate Devices: | AngioJet XPEEDIOR Rheolytic Thrombectomy Catheter(K993564, K040013 and K052256) and other thrombectomycatheters |
Device Description
When used with the AngioJet System, the Xpeedior Rheolytic Thrombectomy Catheter uses high velocity saline jets to percutaneously break-up and remove thrombus. These suline jests are contained within the Catheter and provide the suction that produces this effect.
Indications for Use
The AngioJet Xpeedior 120 Rheolytic Thrombectomy Catheter is intended for use with the AngioJet System in breaking apart and removing thrombus from infra-inguinal pserifier al arteries TM 3.0 mm in diameter and upper extremity and infrainguinal lower extremity peripheral veins ≥ 3.0 mm in diameter.
Comparison to Predicate Devices
No design, packaging, sterilization or other device change was required to expand the AngioJet XPEEDIOR Rheolytic Thrombectomy Catheter indications for use (K993364, K040013 and K052556).
Supporting Information
Applicable preclinical and clinical experience support the expanded indications for use.
§ 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).