(51 days)
No
The device description and performance studies focus on the mechanical aspects of the catheter and its ability to aspirate emboli/thrombi, with no mention of AI or ML.
Yes
The device is described as an aspiration catheter designed for the removal of fresh, soft emboli and thrombi from arterial vessels, which is a therapeutic intervention.
No
Explanation: The device is indicated for the removal of emboli and thrombi, which is a therapeutic rather than a diagnostic function. While it collects material for laboratory analysis, its primary purpose is not diagnosis.
No
The device description clearly outlines a physical catheter, syringe, stopcock, and collection basket, which are hardware components.
Based on the provided information, the FETCH™ Aspiration Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- FETCH Catheter Function: The FETCH Aspiration Catheter is a medical device used within the body (in vivo) to physically remove emboli and thrombi from blood vessels. It is a therapeutic device, not a diagnostic test performed on a sample outside the body.
- Lack of Diagnostic Testing: The description mentions a collection basket that can be used to filter aspirated blood for laboratory analysis, but the device itself is not performing the diagnostic analysis. The analysis would be a separate IVD process performed on the collected sample.
Therefore, the primary function and intended use of the FETCH Aspiration Catheter clearly place it outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
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 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arterial system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Bench, biocompatibility, animal, packaging and sterilization testing supported the substantial equivalency of the FETCH Aspiration Catheter.
Key Metrics
Not Found
Predicate Device(s)
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 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
1
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
2
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
2
Enclosure
3
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)
3
(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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4
Deficiency Response (K062172) FETCH Aspiration Catheter
9/7/2006
Appendix 3
| 5.
| 510(k) Summary | SEP 20 200 | |||||
|---|---|---|---|---|---|---|
| Device Common Name: | Embolectomy Catheter | |||||
| Device Trade Name: | FETCH™ Aspiration Catheter | |||||
| Device Classification/Name: | Class II | |||||
| 21CFR 870.5150 | ||||||
| Embolectomy Catheter | ||||||
| Product Code, DXE | ||||||
| Manufacturer: | Possis Medical, Inc. | |||||
| 9055 Evergreen Boulevard, N.W. | ||||||
| Coon Rapids, MN 55433 | ||||||
| Phone: 763.717.1013 | Fax: 763.780.2227 | |||||
| Establishment Registration: | 2183460 | |||||
| Submitter: | Frank B. Freedman | |||||
| Contact Person: | Primary Contact | |||||
| Frank B. Freedman | ||||||
| Possis Medical, Inc. | Secondary Contact | |||||
| Mark D. Stenoien | ||||||
| Possis Medical, Inc. | ||||||
| Performance Standards: | No performance standards have been developed under | |||||
| Section 514 for this device. | ||||||
| Predicate Devices: | Pronto Extraction Catheter (K042937) and other | |||||
| embolectomy catheters |
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 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
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.
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