(47 days)
No
The summary describes a mechanical thrombectomy device and console, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as breaking apart and removing thrombus (blood clots), which is a direct treatment for a medical condition in infra-inguinal peripheral arteries.
No
The device is described as a thrombectomy set intended to "break apart and remove thrombus," indicating a therapeutic rather than diagnostic function.
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 states that the device is used to "break apart and remove thrombus from infra-inguinal peripheral arteries." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a "Thrombectomy Catheter and Pump" used with a "Console." This is consistent with a medical device used for intervention within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
The AngioJet Ultra XMI Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries ≥ 2 mm in diameter.
The AngioJet Ultra XVG 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.
The AngioJet Ultra Spiroflex Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries ≥ 2 mm in diameter.
Product codes (comma separated list FDA assigned to the subject device)
QEZ, DXE
Device Description
Each AngioJet Ultra Thrombectomy Set is a sterile, single use, disposable set that includes the Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra 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
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 (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.
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 20, 2021
Possis Medical, Inc. Mike Burnside Sr. Regulatory Affairs Associate 9055 Evergreen Blvd., N.w. Minneapolis, Minnesota 55433-8003
Re: K072769
Trade/Device Name: Angiojet Ultra XMI, XVG, And Spiroflex Thrombectomy Set Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ
Dear Mike Burnside:
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 14, 2007. Specifically, FDA is updating this SE Letter as an administrative correction 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: 2021.05.20
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
Image /page/1/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of four abstract human figures, represented by flowing lines, symbolizing the department's focus on health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 4 2007
Possis Medical, Inc. c/o Mr. Mike Burnside Sr. Regulatory Affairs Associate 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003
Re: K072769
AngioJet Ultra XMI, XVG, and SpiroFlex Thrombectomy Sets Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II (Two) Product Code: DXE Dated: September 27, 2007 Received: September 28, 2007
Dear Mr. Burnside:
We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 devices, 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
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 (OS) 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 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-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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
ﮨﮯ
3
Indications for Use
510(k) Number (if known): KOZ2769 ____________________________________________________________________________________________________________________________________________
Device Name: AngioJet® Ultra XMI® Thrombectomy Set
Indications for Use:
The AngioJet Ultra XMI Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries ≥ 2 mm in diameter.
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
| 510(k) Number | K072769 |
|---|---|
| --------------- | --------- |
4
Indications for Use
510(k) Number (if known): _KOZZZZ69 ______________________________________________________________________________________________________________________________________________________________________________
Device Name: AngioJet® Ultra XVG® Thrombectomy Set
Indications for Use:
The AngioJet Ultra XVG 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.
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)
5
Indications for Use
510(k) Number (if known): K072769
Device Name: AngioJet® Ultra Spiroflex® Thrombectomy Set
Indications for Use:
The AngioJet Ultra Spiroflex Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries ≥ 2 mm in diameter.
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)
6
Section 5 - 510(k) Summary
| Submitter: | Possis Medical, Inc.
9055 Evergreen Boulevard NW
Minneapolis, MN 55433-8003 USA |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mike Burnside
Sr. Regulatory Affairs Associate
Phone: (763) 780-4555
Fax: (763) 780-2227
Email: mike.burnside@possis.com
NOV 1 4 2002 |
| Date Prepared: | September 27, 2007 |
| Trade Name: | AngioJet® Ultra XMI®, XVG®, and Spiroflex® Thrombectomy Set |
| Classification: | 870.5150 |
| Product Code: | DXE |
| Predicate Device(s): | The subject devices are equivalent to the following devices:
• K960970 AngioJet Rapid Thrombectomy System -- Pump Set
• K972610 AngioJet LF140 Catheter
• K042874 AngioJet XMI® Rheolytic Thrombectomy Catheter
• K071342 AngioJet XPEEDIOR® Thrombectomy Set (reference device-design only)
• K072269 (under FDA review) AngioJet DVX® Thrombectomy Set (reference device-design only) |
| Device Description: | Each AngioJet Ultra Thrombectomy Set is a sterile, single use, disposable set that includes the Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra Thrombectomy Set is used with the AngioJet Ultra Console. |
| Intended Use: | • The AngioJet Ultra XMI Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries ≥ 2mm in diameter.
• The AngioJet Ultra XVG Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries > 3mm in diameter.
• The AngioJet Ultra Spiroflex Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries > 2mm in diameter. |
| 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 XMI, XVG, and Spiroflex Thrombectomy Sets to be substantially equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in functional design, materials, indications for use, and principles of operation. |