(18 days)
No
The device description focuses on mechanical principles (Bernoulli effect, high velocity saline jets) for thrombus removal and does not mention any AI/ML components or functions. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is described as "breaking apart and removing thrombus" from arteries, which is a direct therapeutic action to address a medical condition.
No
The device is described as a catheter used for breaking apart and removing thrombus, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly describes a physical catheter with mechanical components (saline jets, lumens, guidewire tracking) designed for a physical procedure (removing thrombus from arteries). This is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Function: The AngioJet XMI Catheter is a medical device used inside the body (in vivo) to physically break apart and remove thrombus (blood clots) from arteries. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly describes a procedure performed within the vascular system, not a laboratory test on a sample.
- Device Description: The description details the physical components and mechanism of action for removing thrombus from within a blood vessel.
Therefore, the AngioJet XMI Catheter is an in vivo therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AngioJet XMI Catheter - Rapid Exchange is indicated for use with the AngioJet System in breaking apart and removing thrombus from infra-inguinal peripheral arteries ≥2mm in diameter.
Product codes
QEZ, KRA, DXE
Device Description
The AngioJet XMI Catheter – Rapid Exchange is a 135 cm, 4.0 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 0.014" guidewire and through a 6 French high flow guide wire catheter (0.068 inch minimum internal diameter), which allows sufficient passage of the Catheter with adequate clearance for injection of standard contrast medical, if desired.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
infra-inguinal peripheral arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA acronym is in a blue square, and the full name is in blue text. The seal features an eagle with outstretched wings.
October 8, 2021
Possis Medical, Inc. Mark Stenoien Manager, Clinical & Regulatory Affairs 9055 Evergreen Blvd., N.w. Minneapolis, Minnesota 55433-8003
Re: K042874
Trade/Device Name: Angiojet XMI Catheter - Rapid Exchange (XMI-RX) 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 November 5, 2004. 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 O'connell -S Date: 2021.10.08
10:28:57 -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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 5 2004
Possis Medical, Inc. c/o Mr. Mark Stenoien Manager, Clinical and Regulatory Affairs 9055 Evergreen Blvd. N.W. Minneapolis, MN 55433
Re: K042874
Trade Name: AngioJet XMI Catheter and Rapid Exchange (XMI - RX) Regulation Number: 21 CFR 870.5150 and 21 CFR 870.1210 Regulation Name: Embolectomy Catheter and Continuous Flush Catheter Regulatory Class: II (two) Product Code: DXE and KRA Dated: October 15, 2004 Received: October 18, 2004
Dear Mr. Stenoien:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave revious your betermined 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.
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 or any I 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) I mis letter will and n your 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 (301) 594-4646. 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 yours,
Diana R. Kirchner
Image /page/2/Picture/5 description: The image contains a handwritten signature or symbol on the left, which appears to be a combination of curved lines and possibly a letter 'A'. To the right of the signature, there are two lines of text, with the first line being 'B' and the second line being 'I'. The text is in a simple, sans-serif font and is aligned vertically.
(A Bram D. Zuckerman, MD 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): K042874
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The AngioJet XMI Catheter - Rapid Exchange is indicated for use with the AngioJet System in breaking apart and removing thrombus from infra-inguinal peripheral arteries ≥2mm 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)
Duana P. Vorlanis
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K0428 7 4
Page 1 of _
4
510(k) Summary
| Submitter: | Possis Medical, Inc.
9055 Evergreen Blvd. N.W.
Minneapolis, MN 55433 USA |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. James Gustafson
Vice President, Research, Development & Engineering
Possis Medical, Inc.
9055 Evergreen Blvd. N.W.
Minneapolis, MN 55433 USA
Phone: (763) 780-4555
Fax: (763) 780-2227
Email: jgustafson@possis.com |
| Date Prepared: | August 24, 2004 |
| Trade Name: | AngioJet® XMI® Catheter – Rapid Exchange (XMI® - RX) |
| Classification | 21 CFR 870.5150 |
| Name and No. | Embolectomy Catheter –Class II |
| Product Code: | DXE |
| Predicate Device | AngioJet LF140 Catheter under K972610 on 4/11/2000. |
| Device Description: | The AngioJet XMI Catheter – Rapid Exchange is a 135 cm, 4.0 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 0.014" guidewire and through a 6 French high flow guide wire catheter (0.068 inch minimum internal diameter), which allows sufficient passage of the Catheter with adequate clearance for injection of standard contrast medical, if desired. |
| Intended Use: | The AngioJet XMI Catheter – Rapid Exchange is indicated for use with the AngioJet System in breaking apart and removing thrombus from infra-inguinal peripheral arteries ≥2mm in diameter. |
| Statement of
Technological
Comparison | 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 XMI Catheter – Rapid Exchange, as described in this submission is, in the opinion of Possis Medical Inc., substantially equivalent to the predicate device. |
| Conclusion: | The AngioJet XMI Catheter – Rapid Exchange as modified in this submission, is substantially equivalent to the predicate device, the LF140 Catheter K972610. This conclusion is based upon the similarities of the devices in terms of functional design, indication for use, principles of operation, materials, and performance characteristics. |
.