(252 days)
No
The document describes a mechanical aspiration catheter and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for the "removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature," which is a direct treatment aimed at alleviating a medical condition.
No
The device is described as an "Aspiration Catheter" for "removal of fresh, soft emboli and thrombi". While it can collect samples for "laboratory analysis", its primary function is therapeutic removal, not diagnosis.
No
The device description clearly outlines physical components such as a catheter, guide wire, extension line, syringes, and collection baskets, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Fetch 2 Aspiration Catheter Function: The Fetch 2 Aspiration Catheter is a device used within the body (in vivo) to physically remove emboli and thrombi from blood vessels. Its primary function is a therapeutic intervention, not the analysis of a specimen outside the body to diagnose or monitor a condition.
- Collection Baskets: While the description mentions collection baskets that can be used to filter aspirated blood for laboratory analysis, this is a secondary function and the device itself is not primarily intended for this diagnostic purpose. The core function is the aspiration of the clot.
Therefore, based on the intended use and device description, the Fetch 2 Aspiration Catheter is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi: from vessels in the peripheral and coronary vasculature.
Product codes
OEZ, DXE
Device Description
The Fetch 2 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 (0.056" or 4F) allows advancement to the target site through a 6F (0.070" I.D.) guiding catheter. A radiopaque marker is located near the distal tip. Fetch 2 is provided with an extension line (connected to a one-way stopcock), 2 - 30 cc syringes, and 2 - 40 micron collection baskets. The baskets 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 peripheral and coronary 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
Bench and laboratory testing was performed to support a determination of substantial equivalence to the predicate device. Results from the testing provide assurance that the proposed device conforms to the requirements for its intended use. This included the following tests: Biocompatibility, Cytotoxicity (ISO 10993-5), Intracutaneous Reactivity (ISO 10993-10), Sensitization (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), Material Mediated Pyrogen (ISO 10993-11), Physiochemical (ISO 10993-18), Hemocompatibility, ASTM Hemolysis (ISO 10993-4), Partial Thromboplastin Time Assay (ASTM F2382-04), C3a Complement Activation (ISO 10993-4), SC5b-9 Complement Activation (ISO 10993-4), Thromboresistance (ISO 10993-4), Package integrity, Sterilization testing, Dimensional testing, Operational characteristics, Aspiration testing, Tracking, Mechanical integrity, Kink resistance.
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).
0
Image /page/0/Picture/0 description: The image shows 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 ADMINISTRATION" in blue text.
February 8, 2021
MEDRAD Interventional/Possis Doug Atkins Sr. Regulatory Affairs Associate 9055 Evergreen Blvd NW Minneapolis, Minnesota 55433
Re: K101354
Trade/Device Name: Fetch 2 Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: OEZ
Dear Doug Atkins:
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 January 21, 2011. 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 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 ○'connell -S Date: 2021.02.08
07:58:33-05'00'
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 seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three figures intertwined. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Public Health Service
JAN 2 1 201
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
MEDRAD Interventional / Possis c/o Mr. Doug Atkins Sr. Regulatory Affairs Associate 9055 Evergreen Blvd Minneapolis, MN 55433-8003
Re: K101354
Trade/Device Name: Fetch 2 Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: DXE Dated: December 28, 2010 Received: December 29, 2010
Dear Mr. Atkins:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 that I Drederal statutes and regulations administered by other Federal agencies. You must or any I outer clarees and requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
2
Page 2 - Mr. Doug Atkins
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFB, Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
R. bohner
SBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Fetch® 2 Aspiration Catheter
Indications for Use:
The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi: from vessels in the peripheral and coronary 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 IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
(Division Sign-Off)
Division of Cardiovascular Devices
| 510(k) Number | K101354 |
|---|---|
| --------------- | --------- |
4
KID1354
| Section 5-510(k) Summary | JAN 2 1 2011 |
|---|---|
| Submitter: | MEDRAD Interventional / Possis |
| 9055 Evergreen Boulevard NW | |
| Minneapolis, MN 55433-8003 USA | |
| Contact Person: | Doug Atkins |
| Sr. Regulatory Affairs Associate | |
| Phone: (763) 450-8060 | |
| Fax: (763) 780-2227 | |
| Email: doug.atkins@possis.com | |
| Date Submitted: | May 13, 2010 |
| Trade Name: | Fetch® 2 Aspiration Catheter |
| Classification: | 870.5150 |
| Product Code: | DXE |
| Predicate Device(s): | Fetch Aspiration catheter: K081989 |
| MEDRAD Interventional / Possis | |
| 9055 Evergreen Boulevard N.W. | |
| Minneapolis, MN 55433-8003 | |
| Device Description: | The Fetch 2 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 (0.056" or 4F) allows advancement to the | |
| target site through a 6F (0.070" I.D.) guiding catheter. A radiopaque | |
| marker is located near the distal tip. Fetch 2 is provided with an | |
| extension line (connected to a one-way stopcock), 2 - 30 cc syringes, | |
| and 2 - 40 micron collection baskets. The baskets can be used to filter | |
| aspirated blood for laboratory analysis of collected thrombus. | |
| Intended Use: | The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, |
| soft emboli and thrombi from vessels in the peripheral and coronary | |
| vasculature. | |
| Performance Data: | Bench and laboratory testing was performed to support a |
| determination of substantial equivalence to the predicate device. | |
| Results from the testing provide assurance that the proposed device | |
| conforms to the requirements for its intended use. This included the | |
| following tests: | |
| • Biocompatibility | |
| • Cytotoxicity (ISO 10993-5) | |
| • Intracutaneous Reactivity (ISO 10993-10) | |
| • Sensitization (ISO 10993-10) | |
| • Acute Systemic Toxicity (ISO 10993-11) | |
| • Material Mediated Pyrogen (ISO 10993-11) | |
| • Physiochemical (ISO 10993-18) | |
| • Hemocompatibility | |
| • ASTM Hemolysis (ISO 10993-4) | |
| • Partial Thromboplastin Time Assay (ASTM F2382-04) |
5
- C3a Complement Activation (ISO 10993-4) ﻴﺔ
- SC5b-9 Complement Activation (ISO 10993-4) -
- ﮯ Thromboresistance (ISO 10993-4)
- Package integrity .
- . Sterilization testing
- . Dimensional testing
- Operational characteristics .
- Aspiration testing .
- Tracking .
- Mechanical integrity 0
- . Kink resistance
Conclusion:
MEDRAD Interventional / Possis considers the Fetch 2 Aspiration Catheter to be substantially equivalent to the predicate device listed above. This conclusion is based upon the devices' similarities in functional design, materials, indications for use, and principles of operation.