(252 days)
The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
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.
The provided document is a 510(k) premarket notification for the Fetch 2 Aspiration Catheter. This document does not describe a study involving an AI-powered device or an algorithm's performance. Instead, it focuses on demonstrating the substantial equivalence of the Fetch 2 Aspiration Catheter to a predicate device through bench and laboratory testing.
Therefore, most of the requested information (acceptance criteria for AI, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone AI performance, type of ground truth for AI, etc.) is not applicable to this submission.
However, I can extract information related to the performance data and the conclusion regarding substantial equivalence for the medical device itself.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" for each performance test in the same way an AI algorithm might have specific sensitivity/specificity targets. Instead, the submission relies on demonstrating that the device "conforms to the requirements for its intended use" and that its performance is "substantially equivalent" to the predicate device. The "reported device performance" is summarized by the successful completion of the listed tests.
| Performance Test Category | Device Performance (Conclusion) |
|---|---|
| Bench and Laboratory Testing | Results provide assurance that the proposed device conforms to the requirements for its intended use and supports a determination of substantial equivalence to the predicate device. Specific tests performed include: Biocompatibility (Cytotoxicity, Intracutaneous Reactivity, Sensitization, Acute Systemic Toxicity, Material Mediated Pyrogen, Physiochemical), Hemocompatibility (ASTM Hemolysis, Partial Thromboplastin Time Assay, C3a Complement Activation, SC5b-9 Complement Activation, Thromboresistance), Package integrity, Sterilization testing, Dimensional testing, Operational characteristics, Aspiration testing, Tracking, Mechanical integrity, Kink resistance. |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each bench or laboratory test. It generally references industry standards (e.g., ISO, ASTM) which would dictate appropriate sample sizes for such tests.
Data Provenance: The testing appears to be conducted in a laboratory setting, likely in the US, as the submitter and contact person are based in Minneapolis, MN, USA. The data is prospective for this device's submission, meaning the tests were performed to support this specific 510(k).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI-powered device using expert-labeled image data. The "ground truth" for the device's performance would be established by the physical and chemical properties and functional outputs measured during the bench and laboratory tests, compared against established engineering and medical device standards.
4. Adjudication method for the test set
Not applicable. There is no human interpretation or labeling of data that would require an adjudication method in this type of submission.
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
Not applicable. This is a medical device (aspiration catheter), not an AI algorithm intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
For the device performance tests listed, the "ground truth" is based on:
- Physical and Chemical Standards: Adherence to established material properties, dimensions, and manufacturing standards.
- Biological Standards: Compliance with biocompatibility and hemocompatibility standards (e.g., ISO 10993).
- Operational Standards: Measured functional performance parameters like aspiration efficiency, trackability, and mechanical integrity, likely compared against the predicate device's known performance or established functional requirements.
8. The sample size for the training set
Not applicable. This is a medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a medical device, not an AI model.
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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
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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
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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
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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 |
|---|---|
| --------------- | --------- |
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KID1354
| Section 5-510(k) Summary | JAN 2 1 2011 |
|---|---|
| Submitter: | MEDRAD Interventional / Possis9055 Evergreen Boulevard NWMinneapolis, MN 55433-8003 USA |
| Contact Person: | Doug AtkinsSr. Regulatory Affairs AssociatePhone: (763) 450-8060Fax: (763) 780-2227Email: 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: K081989MEDRAD Interventional / Possis9055 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 trackto the target site. It is used for aspiration of fresh, soft emboli andthrombi. Its outer diameter (0.056" or 4F) allows advancement to thetarget site through a 6F (0.070" I.D.) guiding catheter. A radiopaquemarker is located near the distal tip. Fetch 2 is provided with anextension line (connected to a one-way stopcock), 2 - 30 cc syringes,and 2 - 40 micron collection baskets. The baskets can be used to filteraspirated 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 coronaryvasculature. |
| Performance Data: | Bench and laboratory testing was performed to support adetermination of substantial equivalence to the predicate device.Results from the testing provide assurance that the proposed deviceconforms to the requirements for its intended use. This included thefollowing 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) |
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- 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.
§ 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).