(30 days)
The AngioJet DVX Rheolytic Thrombectomy Catheter is intended for use with the AngioJet System in breaking apart and removing thrombus from infra-inguinal peripheral arteries ≥ 3mm in diameter.
The AngioJet DVX Catheter is a 90 cm, 6 French, sterile, single-use catheter designed for removing thrombus from vascular conduits. High velocity saline jets directed back into the Catheter create a localized low-pressure zone at the distal tip (Bernoulli effect) that results in suction, break-up, and removal of thrombus through the exhaust lumen. The Catheter is designed to track over a 0.035" guide wire and through an 8 French high flow guide catheter (0.086 inch minimum internal diameter), which allows sufficient passage of the Catheter with adequate clearance for injection of standard contrast media, if desired.
This is a 510(k) summary for a medical device and typically does not contain detailed studies with acceptance criteria and performance data as it's primarily focused on demonstrating substantial equivalence to a predicate device. Therefore, much of the requested information cannot be extracted from this document.
However, I can extract information available and indicate what is not present.
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a table of acceptance criteria or specific quantitative performance metrics for the AngioJet DVX Rheolytic Thrombectomy Catheter. The submission aims to prove substantial equivalence to a predicate device rather than presenting detailed performance against specific criteria.
2. Sample Size Used for the Test Set and Data Provenance
Not available in this document. The 510(k) summary does not describe a test set or clinical study with sample sizes.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. No test set or ground truth establishment process is described.
4. Adjudication Method for the Test Set
Not applicable. No test set or adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This document is a 510(k) submission focused on substantial equivalence to a predicate device. It does not describe a comparative effectiveness study involving human readers with and without AI assistance. The device itself is a mechanical thrombectomy catheter, not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The device is a physical medical instrument, not an AI algorithm.
7. Type of Ground Truth Used
Not applicable. No ground truth is described in this document as it's not a clinical trial report.
8. Sample Size for the Training Set
Not applicable. This document is for a medical device, not an AI model, so there is no training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Information that is available:
- Device Name: AngioJet® DVX™ Rheolytic™ Thrombectomy Catheter
- Intended Use: The AngioJet DVX Rheolytic Thrombectomy Catheter is indicated for use with the AngioJet System in breaking apart and removing thrombus from infra-inguinal peripheral arteries ≥ 3mm in diameter.
- Predicate Device: AngioJet XPEEDIOR® 120 Catheter (K040013, cleared 5/18/2004)
- Basis for Substantial Equivalence: Similarities in:
- Indications for use
- Operating principle
- Basic design
- Manufacturing environment
- Sterilization process
- Packaging configurations
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Image /page/0/Picture/0 description: The image shows 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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 8, 2021
Possis Medical, Inc. Mark Stenoien Manager, Clinical & RA 9055 Evergreen Blvd., N.w. Minneapolis, Minnesota 55433-8003
Re: K050794
Trade/Device Name: Angiojet DVX Rheolytic Thrombectomy Catheter 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 administrative change related to your previous substantial equivalence (SE) determination letter dated April 28, 2005. 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 Pate: 2021.10.08
10:36:15 -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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Image /page/1/Picture/2 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
APR 2 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Possis Medical, Inc. c/o Mr. Mark Stenoien Manager, Clinical & Regulatory Affairs 9055 Evergreen Blvd. N.W. Minneapolis, MN 55433
Re: K050794
AngioJet® DVX™ Rheolytic™ Thrombectomy Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II (Two) Product Code: DXE Dated: March 28, 2005 Received: March 29, 2005
Dear Mr. Stenoien:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regars) to regars and the Medical Device American Device of Days commerce prior to May 20, 1978, the 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 r ou may, merciole, market the act include requirements for annual registration, listing of general controls provisions or vice, 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 If your device is classified (500 a00 virols. Existing major regulations affecting your device can may be subject to such additions, 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 not 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 I veally marketed predicate device results in a classification for your device and thus, permitts 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 (301) 594-4648. 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 (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Dma R. Vochner
A 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 Page
510(k) Number (if known):
AngioJet® DVX™ Rheolytic™ Thrombectomy Catheter Device Name:
Indications for Use:
The AngioJet DVX Rheolytic Thrombectorny Catheter is intended for use with the AngioJet System in breaking apart and removing thromby Cameror 15 included to "die Will interies 2 3 mm in diameter.
ﯿﮯ
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109)
Or
Over-the-Counter Use
Dma R. VcLunes
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K050794
2 23 of 69
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KOSO794 10f1
APR 2 8 2005
510(k) Summary
| Submitter: | Possis Medical, Inc.9055 Evergreen Blvd. N.W.Minneapolis, MN 55433USA |
|---|---|
| Contact Person: | Mr. James GustafsonVice President, Research, Development & EngineeringPossis Medical, Inc.9055 Evergreen Blvd. N.W.Minneapolis, MN 55433USAPhone: (763) 780-4555Fax: (763) 780-2227Email: jgustafson@Possis.com |
| Date Prepared: | March 28, 2005 |
| Trade Name: | AngioJet® DVXT™ Rheolytic™ Thrombectomy Catheter |
| ClassificationName and No. | 21 CFR 870.5150Embolectomy Catheter -Class II |
| Product Code: | DXE |
| Predicate Device | AngioJet XPEEDIOR® 120 Catheter under K040013 on 5/18/2004. |
| Device Description: | The AngioJet DVX Catheter is a 90 cm, 6 French, sterile, single-usecatheter designed for removing thrombus from vascular conduits. Highvelocity saline jets directed back into the Catheter create a localizedlow-pressure zone at the distal tip (Bernoulli effect) that results insuction, break-up, and removal of thrombus through the exhaust lumen.The Catheter is designed to track over a 0.035" guide wire and throughan 8 French high flow guide catheter (0.086 inch minimum internaldiameter), which allows sufficient passage of the Catheter with adequateclearance for injection of standard contrast media, if desired. |
| Intended Use: | The AngioJet DVX Rheolytic Thrombectomy Catheter is indicated foruse with the AngioJet System in breaking apart and removing thrombusfrom infra-inguinal peripheral arteries ≥ 3mm in diameter. |
| Statement ofTechnologicalComparison | The subject device have the following similarities:• The same indication for use;• The same operating principle;• The same basic design;• The same manufacturing environment;• The same sterilization process; and• The same packaging configurations.In summary, the AngioJet DVX Catheter, as described in thissubmission is, in the opinion of Possis Medical Inc., substantiallyequivalent to the predicate device. |
| Conclusion: | The AngioJet DVX Catheter, as described in this submission, issubstantially equivalent to the predicate device, the XPEEDIOR 120Catheter K040013. This conclusion is based upon the similarities of thedevices in terms of functional design, indication for use, principles ofoperation, materials, and performance characteristics. |
.
§ 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).