(22 days)
The Medtronic Export® AP Catheter is indicated for:
- Removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system, and
- To subselectively infuse/deliver diagnostics or therapeutic agents with or without vessel occlusion
The Medtronic Export® AP Aspiration Catheter is a dual lumen catheter used for aspiration of thrombus and/or debris from a vascular site. The Medtronic Export® AP may also be used for the infusion of diagnostic or therapeutic agents to a desired vascular site.
The provided text is a 510(k) summary for the Medtronic Export® AP Catheter. This type of submission is for medical devices that are substantially equivalent to a legally marketed predicate device and typically does not include the detailed performance studies or acceptance criteria that a standalone AI/software medical device submission would. The document focuses on demonstrating equivalence to a prior device rather than proving novel performance.
Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance (especially those related to AI/software, ground truth, expert review, sample sizes for training/test sets, and comparative effectiveness studies) are not applicable and cannot be found in this document.
This device is an embolectomy catheter, a physical medical device, not a software or AI product. The "performance" assessment here refers to its physical characteristics and functionality, not diagnostic accuracy or efficacy in an AI context.
Here's a breakdown based on the information available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific numerical acceptance criteria or detailed performance metrics (like sensitivity, specificity, accuracy) are reported in the provided text. The "performance" is implicitly demonstrated through the device passing "all design verification and validation testing" and its substantial equivalence to a predicate device.
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (Explicitly Stated in Document) |
|---|---|
| Not explicitly listed as numerical criteria. The underlying criteria are that the device performs as intended and is substantially equivalent to the predicate device. | "The proposed Medtronic Export® AP Aspiration Catheter has successfully passed all design verification and validation testing." |
| "Medtronic has demonstrated that the Export® AP Aspiration Catheter is substantially equivalent to the predicate device based upon indications for use, design, test results and fundamental scientific technology." |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document refers to "all design verification and validation testing," but does not detail the number of units tested or specific test cases.
- Data Provenance: Not applicable in the context of clinical data for AI. Physical device testing typically involves laboratory settings, mechanical testing, and potentially animal or benchtop models, but the specifics are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is a physical catheter, not an AI or diagnostic imaging device that requires expert ground truth for performance assessment. Its "ground truth" would be objective measurements of its physical and functional properties.
4. Adjudication method for the test set:
Not applicable. This is not a study requiring adjudication of diagnostic outcomes.
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-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device used by a human.
7. The type of ground truth used:
The "ground truth" for a physical device like a catheter would typically be objective physical measurements (e.g., burst pressure, tensile strength, flow rates, flexibility) and functional tests, along with a review of its design and materials. The document states it passed "design verification and validation testing," which implies these types of tests were conducted against established engineering specifications. Specific details are not provided.
8. The sample size for the training set:
Not applicable. This is not a machine learning device.
9. How the ground truth for the training set was established:
Not applicable. This is not a machine learning device.
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May 20, 2021
Medtronic Vascular Tara Turney Regulatory Affairs Specialist 37a Cherry Hill Drive Danvers, Massachusetts 01923
Re: K081573
Trade/Device Name: Medtronic Export AP Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ, KRA
Dear Tara Turney:
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 June 27, 2008. 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. 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
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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 consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 7 2008
Medtronic Vascular c/o Ms. Tara N. Turney Regulatory Affairs Specialist 37A Cherry Hill Drive Danvers, MA 01923-5186
Re: K081573
Trade Name: Medtronic Export® AP Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II (two) Product Code: DXE Dated: June 4, 2008 Received: June 5, 2008
Dear Ms. Turney:
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
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Page 2 - Ms. Tara N. Turney
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 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 Biometrics' (OSB) 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 yours.
R. Vachner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K68573 510(k) Number (if known):
Device Name: Medtronic Export® AP Catheter -
Indications for Use:
The Medtronic Export® AP Catheter is indicated for:
- Removal/aspiration of embolic material (thrombus/debris) from vessels of 0 the arterial system, and
- To subselectively infuse/deliver diagnostics or therapeutic agents with or � without vessel occlusion
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)
Duna R. Sochmer
(Division Sign-Off) Division of Cardiovascular Devices Page 1 of
510(k) Number_K081593
Page 88
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081573
JUN 27 2008 510(k) Summary Submitter: Medtronic Vascular 37A Cherry Hill Drive Danvers, MA 01923-5186 Contact Person: Tara N. Turney Regulatory Affairs Specialist Phone: 978-739-6654 Fax: 978-777-0390 tara.n.turney@medtronic.com June 4th, 2008 Date Prepared: Trade Name: Medtronic Export® AP Aspiration Catheter Common Name: Aspiration Catheter Classification Embolectomy Catheter Name: Predicate Device: Medtronic Export® XT Aspiration Catheter K061958 Device The Medtronic Export® AP Aspiration Catheter is a dual Description: lumen catheter used for aspiration of thrombus and/or debris from a vascular site. The Medtronic Export® AP may also be used for the infusion of diagnostic or therapeutic agents to a desired vascular site. Statement of The Medtronic Export® AP Aspiration Catheter is indicated Intended Use: for: Removal/aspiration of embolic material . (thrombus/debris) from vessels of the arterial system, and . To subselectively infuse/deliver diagnostics or therapeutic agents with or without vessel occlusion. Summary of . Distal Dual Lumen: The smaller of the two lumens Technological provides a conduit for delivery over a 0.014" Characteristics: guidewire, or equivalent, and the larger lumen provides conduit for aspiration of embolic material. . Radiopaque Markerband: Embedded in the distal tip to facilitate placement by fluoroscopy.
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- External Coating: Provides lubricious external surface . for ease of delivery. Wire Braided Shaft: Provides a balance of stiffness . and compliance for delivery of the catheter to the intended therapy site. Luer Hub: Provides a connection fitting to mate the . shaft with the aspiration line. The proposed Medtronic Export® AP Aspiration Catheter has Summary of Nonsuccessfully passed all design verification and validation clinical Data: testing. Conclusion from Medtronic has demonstrated that the Export® AP Aspiration Data: Catheter is substantially equivalent to the predicate device based upon indications for use, design, test results and fundamental scientific technology.
§ 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).