(93 days)
No
The device description and summary of performance studies focus on the mechanical function of the catheter for aspiration and do not mention any AI/ML components or capabilities.
Yes
The device is indicated for the "removal of fresh, soft emboli and thrombi," which is a treatment intended to restore health.
No
The device is described as an aspiration catheter for removing emboli and thrombi, which is a therapeutic function, not a diagnostic one. While it can collect material for laboratory analysis, its primary function is not to diagnose.
No
The device description clearly describes a physical catheter, syringe, stopcock, and collection basket, which are hardware components.
Based on the provided information, the FETCH™ Aspiration Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The primary intended use is the removal of emboli and thrombi from vessels. This is a therapeutic procedure performed in vivo (within the body).
- Device Description: The description details a catheter designed for physical aspiration and collection of material from within blood vessels.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. While the collected thrombus can be sent for laboratory analysis, the device itself is not performing the diagnostic test. The collection basket is a tool for sample preparation, not the diagnostic test itself.
Therefore, the FETCH™ Aspiration Catheter is a medical device used for a therapeutic procedure, not an IVD device.
N/A
Intended Use / 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.
Product codes
QEZ, DXE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels in the coronary and peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Preclinical animal testing supported the substantial equivalency of the FETCH Aspiration Catheter to the predicate device for the indicated use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Pronto Extraction Catheter (K042937), Pronto V3 Extraction Catheter (K063371) and FETCH Aspiration Catheter (K062172)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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 logo on the right. The FDA logo features 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. 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
1
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with outstretched arms, composed of three curved lines.
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)
3
(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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MAY 1 1 2007
| Device Common Name: | Embolectomy Catheter | |
|---|---|---|
| Device Trade Name: | FETCH™ Aspiration Catheter | |
| Device Classification/Name: | Class II | 21 CFR |
| 870.5150 | ||
| Embolectomy Catheter | Product code: DXE | |
| Manufacturer: | Possis Medical, Inc. | |
| 9055 Evergreen Boulevard, N.W. | ||
| Minneapolis, MN 55433 | ||
| Phone: 763.717.1013 | Fax: 763.780.2227 | |
| Contact Person: | Submitter | |
| Frank B. Freedman | ||
| Possis Medical, Inc. | Secondary Contact | |
| Mark D. Stenoien | ||
| Possis Medical, Inc. | ||
| Performance Standards: | None have been developed for this device, per Section 514 | |
| Predicate Devices: | Pronto Extraction Catheter (K042937), Pronto V3 Extraction | |
| Catheter (K063371) and FETCH Aspiration Catheter (K062172) |
Device Description
510(k) Summary
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.
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.