(18 days)
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.
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.
The provided text is a 510(k) summary for the AngioJet XMI Catheter - Rapid Exchange (XMI-RX). It explains that the device is substantially equivalent to a predicate device and outlines its intended use and a comparison of technological characteristics. However, the document does not contain details about specific acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or detailed performance studies.
The summary focuses on demonstrating substantial equivalence to a predicate device (AngioJet LF140 Catheter under K972610), which is a regulatory pathway that often relies on demonstrating similar safety and effectiveness without necessarily conducting new clinical trials against specific performance metrics.
Therefore, I cannot populate the table or answer most of your questions based only on the provided text, as the information you are requesting is not present.
Here's a breakdown of what can and cannot be inferred from the provided text:
What can be inferred from the document:
- Device Performance: The document states the device is "indicated for use with the AngioJet System in breaking apart and removing thrombus from infra-inguinal peripheral arteries ≥2mm in diameter." This describes its intended function, but not specific quantitative performance metrics or acceptance criteria.
- Sample Size for Test Set and Data Provenance: Not mentioned.
- Number of experts and qualifications for ground truth: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
- Standalone (algorithm only) performance: Not applicable, as this is a physical medical device, not an AI algorithm.
- Type of ground truth used: Not mentioned. The approval is based on substantial equivalence, not a direct clinical outcomes study with defined ground truth.
- Sample size for the training set: Not applicable and not mentioned.
- How ground truth for the training set was established: Not applicable and not mentioned.
However, to address the request as directly as possible based on the spirit of the questions and the limited information:
Given that this is a 510(k) submission and the conclusion states "substantially equivalent to the predicate device," the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are implicitly tied to demonstrating this substantial equivalence. This typically involves:
- Bench testing: To show mechanical and functional equivalence to the predicate.
- Biocompatibility testing: To demonstrate material safety.
- Sterilization validation: To ensure the device is sterile.
These tests are performed to demonstrate that the new device is as safe and effective as the predicate device. The "device performance" reported would be that it functions equivalently to the predicate in these various tests.
No information about specific quantitative acceptance criteria or results of such tests are detailed in the provided documents. The summary merely asserts that such comparisons were made and demonstrated equivalence.
Therefore, I cannot fully complete the table or answer the questions with specific data points as they are not present in the provided 510(k) summary.
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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 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
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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.
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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 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
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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 _
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510(k) Summary
| Submitter: | Possis Medical, Inc.9055 Evergreen Blvd. N.W.Minneapolis, MN 55433 USA |
|---|---|
| Contact Person: | Mr. James GustafsonVice President, Research, Development & EngineeringPossis Medical, Inc.9055 Evergreen Blvd. N.W.Minneapolis, MN 55433 USAPhone: (763) 780-4555Fax: (763) 780-2227Email: 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 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 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. |
.
§ 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).