(24 days)
The AngioJet Ultra DVX Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from upper and lower extremity 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.
Each AngioJet Ultra DVX Thrombectomy Set is a sterile, single use, disposable set that includes the Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra DVX Thrombectomy Set is used with the AngioJet Ultra Console.
This document is a 510(k) summary for the AngioJet Ultra DVX Thrombectomy Set, which is a medical device intended to remove thrombus from peripheral arteries and veins. However, it does not contain the specific information required to complete the table and answer all questions related to acceptance criteria and study details.
Here's a breakdown of what can and cannot be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. | "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." (No specific performance metrics are reported) |
2. Sample size used for the test set and data provenance:
- Sample size: Not specified. The document mentions "representative samples" for bench testing.
- Data provenance: Not specified. These are likely internal lab tests (bench testing) and not human clinical data.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- Not applicable. The document describes bench testing, not a study involving ground truth established by experts.
4. Adjudication method for the test set:
- Not applicable. As above, this was bench testing, not a study requiring adjudication.
5. Multi-reader multi-case (MRMC) comparative effectiveness study:
- No. The document does not mention an MRMC comparative effectiveness study. It states "comparative testing to demonstrate appropriate functional and performance characteristics" but this refers to comparison with predicate devices, not human readers with and without AI assistance.
- Effect size: Not applicable, as no such study was performed.
6. Standalone (algorithm only without human-in-the-loop performance) study:
- The device is a physical thrombectomy set used in a medical procedure, not an AI algorithm. Therefore, a standalone (algorithm only) study is not applicable. The bench testing performed could be considered a form of standalone performance evaluation for the physical device.
7. Type of ground truth used:
- For the described bench testing, the "ground truth" would be established by the physical and chemical properties measured during mechanical, biocompatibility, and sterility tests. This is not "expert consensus, pathology, or outcomes data" in the typical sense for a diagnostic device.
8. Sample size for the training set:
- Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is a physical medical device, not an AI model.
In summary:
This 510(k) notification focuses on demonstrating substantial equivalence of the AngioJet Ultra DVX Thrombectomy Set to predicate devices based on functional design, materials, indications for use, and principles of operation, supported by bench testing. It does not provide the detailed information about acceptance criteria or a study with expert-adjudicated ground truth and clinical performance metrics that would be typically found for diagnostic AI devices.
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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 & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out below.
September 15, 2021
Possis Medical, Inc. Mike Burnside Sr. Regulatory Affairs Associate 9055 Evergreen Blvd., N.w. Minneapolis, Minnesota 55433-8003
Re: K072269
Trade/Device Name: Angiojet Ultra DVX Thrombectomy Set Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ, KRA
Dear Mike Burnside:
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 September 28, 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,
Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2021.09.15
10:22:47-04'00'
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a semi-circle around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 8 2007
Mr. Mike Burnside Sr. Regulatory Affairs Associate Possis Medical, Inc. 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003
Re: K072269
Trade/Device Name: AngioJet Ultra DVX Thrombectomy Set, Model 106552 Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE, KRA Dated: August 10, 2007 Received: August 15, 2007
Dear Mr. Burnside:
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.
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. Yourse va comply with all the Act's requirements, including, but not limited to: registration and listing (21
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Page 2 - Mr. Michael Burnside
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 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-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
una R. Vo Ames
$\xi$
Bram D. Zuckerman, M.D. Director Division of Cardiovaslar Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K072269
Device Name: AngioJet® Ultra DVX® Thrombectomy Set
Indications for Use:
The AngioJet Ultra DVX Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from upper and lower extremity peripheral arteries ≥3 mm in diameter; break apart and remove thrombus from upper extremity and infra-inguise lower extremity peripheral veins ≥3 mm in diameter, and for use with the AngioJet Uura Power Puble, Kit for the control and selective infusion of physician specified fluids, including throm business 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)
3
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
sung R. Jo a
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number Ko722G
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2007
Section 5 – 510(k) Summary
20
| Submitter: | Possis Medical, Inc.9055 Evergreen Boulevard NWMinneapolis, MN 55433-8003 USA | SEP 28 |
|---|---|---|
| Contact Person: | Mike BurnsideSr. Regulatory Affairs AssociatePhone: (763) 780-4555Fax: (763) 780-2227Email: mike.burnside@possis.com | |
| Date Prepared: | August 10, 2007 | |
| Trade Name: | AngioJet® Ultra DVX® Thrombectomy Set | |
| Classification: | 870.5150 and 870.1210 | |
| Product Code: | DXE and KRA | |
| Predicate Device(s): | The subject devices are equivalent to the following devices:K071342 AngioJet Ultra XPEEDIOR Thrombectomy Set K071514 AngioJet XPEEDIOR® 120 Catheter K052256 and K061951- AngioJet XPEEDIOR® 120 Catheter K050794 - AngioJet DVX Rheolytic Thrombectomy Catheter | |
| Device Description: | Each AngioJet Ultra DVX Thrombectomy Set is a sterile, single use,disposable set that includes the Thrombectomy Catheter and Pump inone combined unit. The AngioJet Ultra DVX Thrombectomy Set isused with the AngioJet Ultra Console. | |
| Intended Use: | The AngioJet Ultra DVX Thrombectomy Set is intended for use withthe AngioJet Ultra Console to break apart and remove thrombus fromupper and lower extremity 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, including thrombolyticagents, 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 DVXThrombectomy Set to be substantially equivalent to the predicatedevices 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).