(84 days)
The AngioJet Xpeedior 120 Catheter is intended for use with the AngioJet System
- in breaking apart and removing thrombus from infrainguinal peripheral arteries >3.0 mm in diameter; and/or
- with the AngioJet Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.
The AngioJet Xpeedior 120 Catheter is a single-use component of the AngioJet Rheolytic Thrombectomy System. The AngioJet System is intended for mechanical throbectomy removal. The Power Pulse Spray Ancillary Kit enables the AngioJet Xpeedior 120 Catheter to deliver a pulsed infusion of a physician-specified fluid to a local treatment area during a peripheral intervention.
The provided text is a 510(k) premarket notification for the AngioJet Xpeedior 120 Catheter. This document is for a medical device that physically removes thrombus (blood clots), not an AI/Software as a Medical Device (SaMD). Therefore, the concepts of "acceptance criteria," "device performance," "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "sample size for training set" in the context of AI/SaMD do not apply to this submission.
The document focuses on demonstrating substantial equivalence to a predicate device, as typically required for 510(k) submissions.
Here's an analysis based on the information provided, reinterpreting some questions for a physical medical device context where possible:
1. A table of acceptance criteria and the reported device performance
Since this is a physical medical device and not an AI/SaMD, the concept of "acceptance criteria" and "reported device performance" typically refers to engineering specifications, safety, and functional performance, rather than diagnostic accuracy metrics. The document states:
- Device Description: "The AngioJet Xpeedior 120 Catheter is a single-use component of the AngioJet Rheolytic Thrombectomy System. The AngioJet System is intended for mechanical thrombectomy removal."
- Intended Use: "The AngioJet Xpeedior 120 Catheter is intended for use with the AngioJet System... in breaking apart and removing thrombus from infrainguinal peripheral arteries ≥3.0 mm in diameter; and/or... with the AngioJet Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system."
- Functional and Safety Testing: "The Xpeedior 120 Catheter is nearly the same device as identified K040013. Therefore, the testing listed in K040013 is sufficient to determine that the subject device is suitable for its intended use."
The document implicitly indicates that the device meets the functional and safety requirements by asserting substantial equivalence to the predicate device K040013, which would have undergone its own testing. Explicit "acceptance criteria" and "reported performance" metrics for this device are not detailed in the provided text, as this is a summary of the 510(k) rather than the full submission with detailed test reports.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not an AI/SaMD and does not use a "test set" in the context of evaluating an algorithm's performance on data. The evaluation relies on the device itself being "nearly the same" as a previously cleared device. Any clinical data or bench testing related to the predicate device (K040013) would have been used for its clearance, but details are not provided here for this specific submission (K052256).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No "ground truth for a test set" is established as this is not an AI/SaMD.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No "adjudication method for a test set" is mentioned as this is not an AI/SaMD.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/SaMD.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/SaMD.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No "ground truth" is used as this is not an AI/SaMD. The evaluation is based on engineering principles and substantial equivalence to a predicate device.
8. The sample size for the training set
Not applicable. This is not an AI/SaMD and does not use a "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/SaMD and does not use a "training set" or "ground truth" in that context.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized graphic. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
September 15, 2021
Possis Medical, Inc. Mark Stenoien Manager, Clinical & Regulatory Affairs 9055 Evergreen Blvd., N.w. Minneapolis, Minnesota 55433-8003
Re: K052256
Trade/Device Name: Angiojet Xpeedior 120 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 November 10, 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. O'connell -S O'connell -S Date: 2021.09.15
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}------------------------------------------------
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 0 2005
Possis Medical, Inc. c/o Mr. Mark Stenoien Manager, Clinical & Regulatory Affairs 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003
Re: K052256
AngioJet® Xpeedior® 120 Catheter Regulation Number: 21 CFR 870.5150 and 870.1210 Regulation Name: Embolectomy Catheter and Continuous Flush Catheter Regulatory Class: Class II (Two) Product Code: DXE and KRA Dated: August 16, 2005 Received: August 18, 2005
Dear Mr. Stenoien:
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.
{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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
una R. vichner
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use Page
510(k) Number (if known): Kos 2256
Device Name: AngioJet Xpeedior 120 Catheter
Indications For Use:
The AngioJet Xpeedior 120 Catheter is intended for use with the AngioJet System
- . in breaking apart and removing thrombus from infrainguinal peripheral arteries >3.0 mm in diameter; and/or
- with the AngioJet Power Pulse Kit for the control and selective infusion of physician . specified fluids, including thrombolytic agents, into the peripheral vascular system.
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)
Dana R. Vochner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K052266
Page 1 of 1
ﮯ
{4}------------------------------------------------
NOV 1 0 2005
SECTION 2. SUMMARY AND CERTIFICATION
| A. 510(k) Summary | |
|---|---|
| Submitter: | Possis Medical, Inc. |
| 9055 Evergreen Boulevard NW | |
| Minneapolis, MN 55433-8003 USA | |
| Contact Person: | Mr. Mark Stenoien, Manager, Clinical & Regulatory Affairs |
| 9055 Evergreen Boulevard NW | |
| Minneapolis, MN 55433-8003 USA | |
| Phone: (763) 780-4555Fax: (763) 780-2227 | |
| Email: mark.stenoien@possis.com | |
| Date Prepared: | 16-August-2005 |
| Trade Name: - | The AngioJet Xpeedior 120 Catheter |
| Classification Nameand Number: | AngioJet Xpeedior 120 Catheter is a class II device per 21 CFR870.5150 for peripheral thrombectomy and the Power Pulse SprayAncillary Kit is a class II devices as defined by 21 CFR 870.1210 forinfusion of Physician-specified fluids into the peripheral vasculature. |
| Product Code: | AngioJet Xpeedior 120 Catheter product code is DXE and 74 KRA. |
| Predicate Device(s): | The AngioJet 120 Catheter is substantially equivalent to the deviceslisted below: |
| • The AngioJet Pulse Spray Kit and Xpeedior 120 Catheter(K040013.) | |
| Device Description: | The AngioJet Xpeedior 120 Catheter is a single-use component ofthe AngioJet Rheolytic Thrombectomy System. The AngioJetSystem is intended for mechanical throbectomy removal. ThePower Pulse Spray Ancillary Kit enables the AngioJet Xpeedior 120Catheter to deliver a pulsed infusion of a physician-specified fluid toa local treatment area during a peripheral intervention. |
| Intended Use: | The AngioJet Xpeedior 120 Catheter is intended for use with theAngioJet System |
| • in breaking apart and removing thrombus from infrainguinalperipheral arteries ≥3.0 mm in diameter; and/or | |
| • with the AngioJet Power Pulse Kit for the control and selectiveinfusion of physician specified fluids, including thrombolyticagents, into the peripheral vascular system. | |
| Functional andSafety Testing: | The Xpeedior 120 Catheter is nearly the same device as identifiedK040013. Therefore, the testing listed in K040013 is sufficient todetermine that the subject device is suitable for its intended use. |
| Conclusion: | Possis Medical, Inc. considers the Xpeedior 120 Catheter to besubstantially equivalent to the predicate devices listed above. Thisconclusion is based upon the devices' similarities in functionaldesign, materials, indications for use, and principles 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).