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

Device Description

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 4F allows advancement to the target site through a 6F (0.070" I.D.) guiding catheter. A radiopaque marker is located about 2 mm from the distal tip. FETCH is provided with an extension line, 30 cc syringe, one-way stopcock and a 40 micron collection basket. This basket can be used to filter aspirated blood for laboratory analysis of collected thrombus.

AI/ML Overview

The provided text is related to an FDA 510(k) premarket notification for the "FETCH Aspiration Catheter." It details the regulatory approval process and includes a brief device description and indications for use. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or detailed performance studies.

The document states: "Preclinical animal testing supported the substantial equivalency of the FETCH Aspiration Catheter to the predicate device for the indicated use." This indicates that animal testing was performed, but no details of the study design, acceptance criteria, or results are provided. The FDA 510(k) clearance process often relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive new clinical efficacy studies for many Class II devices.

Therefore, I cannot fulfill your request for the following information based on the provided text:

A table of acceptance criteria and the reported device performance: Not available.
Sample size used for the test set and the data provenance: Not available.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
Adjudication method for the test set: Not available.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not available.
If a standalone performance study was done: "Preclinical animal testing" was mentioned, but no study details are provided to assess if it was a standalone performance study in the context of your request (e.g., in a human clinical setting or with detailed metrics).
The type of ground truth used: Not available beyond the mention of "preclinical animal testing."
The sample size for the training set: Not applicable/available, as this appears to be a medical device clearance, not an AI/algorithm-based device in the context of your question about training sets.
How the ground truth for the training set was established: Not applicable/available.

Summary

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September 15, 2021

Possis Medical, Inc. Frank Freedman Sr. RA Associate 9055 Evergreen Blvd., NW Minneapolis, Minnesota 55433-8003

Re: K070363

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 Mav 11, 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,

Gregory W. Digitally signed by
Gregory W. Gregory W. O'connell -S O'connell -S Date: 2021.09.15
O'connell -S 09:25:19 -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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY I 1 2007

Possis Medical, Inc. c/o Dr. Frank Freedman, Ph.D. Sr. Regulatory Affairs Associate 9055 Evergreen Boulevard NW Minneapolis, MN 55433

Re: K070363 Fetch Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: II (two) Product Code: DXE Dated: April 12, 2007 Received: April 16, 2007

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, Or v 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, EDA max publish further announcements concerning your device in the Federal Register.

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

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 not 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Duna R. bohner.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Enclosure

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Indications for Use

510(k) Number (if known): Ko 70363

Device Name: FETCH Aspiration Catheter

Indications For Use: The FETCH™ Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.

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)

Donna P. Holmes

(Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K070363

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K070363

MAY 1 1 2007

Device Common Name:	Embolectomy Catheter
Device Trade Name:	FETCH™ Aspiration Catheter
Device Classification/Name:	Class II	21 CFR
	870.5150Embolectomy Catheter	Product code: DXE
Manufacturer:	Possis Medical, Inc.9055 Evergreen Boulevard, N.W.Minneapolis, MN 55433Phone: 763.717.1013	Fax: 763.780.2227
Contact Person:	SubmitterFrank B. FreedmanPossis Medical, Inc.	Secondary ContactMark D. StenoienPossis Medical, Inc.
Performance Standards:	None have been developed for this device, per Section 514
Predicate Devices:	Pronto Extraction Catheter (K042937), Pronto V3 ExtractionCatheter (K063371) and FETCH Aspiration Catheter (K062172)

Device Description

510(k) Summary

Indications for Use

The FETCH Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.

Comparison to Predicate Devices

The FETCH Aspiration Catheter is substantially equivalent to the Pronto Extraction Catheter, Pronto V3 Extraction Catheter, and FETCH Aspiration Catheter.

Supporting Information

Preclinical animal testing supported the substantial equivalency of the FETCH Aspiration Catheter to the predicate device for the indicated use.

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).