The FETCH Aspiration Catheter is a rapid exchange, low-profile tip, dual lumen catheter that uses a 0.014" (0.36 mm) guide wire to track to the target site. It is used for aspiration of fresh, soft emboli and thrombi. Its outer diameter 0.052" (1.33 mm) or 45 allows advancement to the target site through a 6F (0.070" I.D.) guiding catherer. A radiopaque marker is located about 2 mm from the distal tip. FETCH is provided with an exterpsion line, 30 cc syringe, one-way stopcock and a 40 micron collection basket. This backet can be used to filter aspirated blood for laboratory analysis of collected three " the

AI/ML Overview

The provided text is a 510(k) premarket notification for the FETCH Aspiration Catheter, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing robust clinical trial data with acceptance criteria and performance metrics described in medical AI/device studies. Therefore, much of the requested information cannot be directly extracted from this document.

However, I can extract information related to the device description and the type of testing performed to support substantial equivalence.

Based on the provided document:

1. A table of acceptance criteria and the reported device performance:

The document does not specify quantitative acceptance criteria or detailed performance metrics in the way a clinical study for a new AI/diagnostic device would. The approval is based on "substantial equivalence" to a predicate device.

2. Sample size used for the test set and the data provenance:

The document mentions "Bench, biocompatibility, animal, packaging and sterilization testing."
It does not specify specific sample sizes for these tests, nor does it detail data provenance (e.g., country of origin, retrospective/prospective).
Given the nature of the device (catheter for aspiration), the test set would likely refer to the number of devices or animal subjects used in the non-clinical tests mentioned. These are not typically human clinical data in the context of substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as the document describes an embolectomy catheter, not a diagnostic or AI device that requires expert-established ground truth for a test set. The validation relies on engineering and biological testing rather than interpretation of data by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This is not applicable for the same reason as point 3.

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:

This is not applicable. The device is an aspiration catheter, not an AI or imaging diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This is not applicable. The device is a physical medical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the non-clinical tests (bench, biocompatibility, animal), the "ground truth" would be established by standard engineering measurements, material science evaluations, and observed biological responses (e.g., tissue reaction, effectiveness of clot removal in animal models). This is not expert consensus, pathology, or outcomes data in the typical sense for a diagnostic device.

8. The sample size for the training set:

This is not applicable as the device is a physical catheter, not an AI model that requires a training set.

9. How the ground truth for the training set was established:

This is not applicable for the same reason as point 8.

Summary of available information from the document regarding the device and its testing:

Device Name: FETCH Aspiration Catheter
Indications For Use: Removal of fresh, soft emboli and thrombi from 2 mm or larger vessels in the arterial system.
Regulatory Basis: Substantial equivalence (510(k)) to predicate devices, specifically the Pronto Extraction Catheter (K042937) and other embolectomy catheters.
Supporting Information (Testing): Bench, biocompatibility, animal, packaging, and sterilization testing. No specific details on sample sizes or detailed results are provided in this summary document, as the focus is on the regulatory determination of substantial equivalence.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency's name in a lighter shade of blue.

September 15, 2021

Possis Medical, Inc. Frank Freedman Senior Regulatory Affairs Associate 9055 Evergreen Blvd., N.w. Coon Rapids, Minnesota 55433-8003

Re: K062172

Trade/Device Name: Fetch Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ

Dear Frank Freedman:

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 September 20, 2006. 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 ○'connell -S Date: 2021.09.15
09:20:47 -04:00:20:47 -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/2 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted as a series of curved lines forming a bird-like shape. The text "- IN SERVICE - USA" is arranged in a circular pattern around the top of the logo.

SEP 2 0 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Possis Medical, Inc. c/o Frank B. Freedman, Ph.D. Senior Regulatory Affairs Associate 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003

K062172 Re:

Trade/Device Name: FETCH Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: II Product Code: DXE Dated: September 7, 2006 Received: September 8, 2006

Dear Dr. Freedman:

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. You must

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Page 2 - Frank B. Freedman, Ph.D.

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 Of A rate 677) havemes (QS) regulation (21 CFR Part 820); and if applicable, the electronic rorduct radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product ladiation control to begin marketing your device as described in your Section 510(k) rms lotter notification. The FDA finding of substantial equivalence of your device to a legally premaince noticated with 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Dmna R. Wulner

A 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

510(k) Number (if known): |0(c Z 17 2

Device Name: FETCH Aspiration Catheter

Indications For Use: The FETCH™ Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from 2 mm or larger vessels in the arterial system.

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 NEEDED)

Duna R. Vodmer

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_k062172

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Deficiency Response (K062172) FETCH Aspiration Catheter

9/7/2006

Appendix 3

5.510(k) Summary
Device Common Name:	Embolectomy Catheter
Device Trade Name:	FETCH™ Aspiration Catheter
Device Classification/Name:	Class II21CFR 870.5150Embolectomy CatheterProduct Code, DXE
Manufacturer:	Possis Medical, Inc.9055 Evergreen Boulevard, N.W.Coon Rapids, MN 55433Phone: 763.717.1013	Fax: 763.780.2227
Establishment Registration:	2183460
Submitter:	Frank B. Freedman
Contact Person:	Primary ContactFrank B. FreedmanPossis Medical, Inc.	Secondary ContactMark D. StenoienPossis Medical, Inc.
Performance Standards:	No performance standards have been developed underSection 514 for this device.
Predicate Devices:	Pronto Extraction Catheter (K042937) and otherembolectomy catheters

Device Description

Indications for Use

The FETCH™ Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

Supporting Information

Bench, biocompatibility, animal, packaging and sterilization testing supported the substantial equivalency of the FETCH Aspiration Catheter.

Conclusion

FETCH is substantially equivalent to the Pronto Extraction Catheter and other embolectomy catheters.

Regulation Number and Section

§ 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).