(74 days)
Not Found
No
The description focuses on the mechanical aspects and intended use of a physical catheter, with no mention of AI/ML terms or functionalities.
Yes
Justification: The device is indicated for the removal of emboli and thrombi from vessels, which is a therapeutic intervention.
No
The device is used for the physical removal of emboli and thrombi, not for diagnosing a condition or disease. While it mentions a collection basket for laboratory analysis, the device itself is not performing the diagnostic function.
No
The device description clearly details a physical catheter, syringe, stopcock, and collection basket, which are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The 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 device is a catheter designed for physical aspiration of material from blood vessels. While it includes a collection basket for potential laboratory analysis, the primary function of the device itself is the aspiration procedure, not the analysis of the collected material.
- 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. This device does not perform such analysis.
The collection basket is a component that enables the collection of a sample that could be used for laboratory analysis (which would be an IVD process), but the Fetch Aspiration Catheter itself is a medical device used for a therapeutic intervention.
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 arterial system and coronary vasculature.
Product codes (comma separated list FDA assigned to the subject device)
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 arterial system and coronary vasculature.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Representative samples of the device underwent testing including but not limited to mechanical testing, biocompatibility testing, and sterility assessment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health and Human Services logo is a stylized representation of a human figure, while the FDA part includes the acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 20, 2021
Possis Medical, Inc. Mike Burnside 9055 Evergreen Blvd., N.w. Minneapolis, Minnesota 55433-8003
Re: K081989
Trade/Device Name: Fetch Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ
Dear Mike Burnside:
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 26, 2008. Specifically, FDA is updating this SE Letter as an administrative correction 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: 2021.05.20
Gregory O'Connell Assistant Director Plaque Modification Devices Team 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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
SEP 2 6 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Possis Medical Inc. c/o Mr. Mike Burnside Regulatory Affairs Manager 9055 Evergreen Boulevard N.W. Minneapolis, MN 55433-8003
Re: K081989
Trade/Device Name: Fetch® Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Catheter, Embolectomy Regulatory Class: Class II Product Code: DXE Dated: August 29, 2008 Received: September 2, 2008
Dear Mr. Burnside:
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 agencics. 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
2
Page 2 - Mr. Mike Burnside
systems (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
R. Vochner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indication for Use
510(k) Number (if known): K Ø 8 | 989
Device Name: The 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 arterial system and coronary vasculature.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna D. Holmes
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_上08|989
4
SEP 2 6 2008
:
Section 5 - 510k Summary Information
:
| Applicant: | Possis Medical, Inc.
9055 Evergreen Boulevard N.W.
Minneapolis, MN 55433-8003
Tel: (612) 780-4555
Fax: (612) 780-2227 ERN: 2183460 |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mike Burnside
Regulatory Affairs Manager
Phone: (763) 780-4555
Fax:
(763) 780-2227
Email:
mike.burnside@possis.com |
| Date Prepared: | July 11, 2008 |
| Trade Name: | Fetch® Aspiration Catheter |
| Common Name of
Device/ Classification
and Code: | Catheter,Embolectomy
Product Code: DXE
Class II/21 CFR 870.5150 Cardiovascular |
| Predicate Device: | The Fetch Aspiration Catheter - K062172 and K070363
Possis Medical, Inc.
9055 Evergreen Boulevard N.W.
Minneapolis, MN 55433-8003 |
| 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. |
| Intended Use: | The Fetch® Aspiration Catheter is indicated for the removal of fresh,
soft emboli and thrombi from vessels in the arterial system and
coronary vasculature. |
| Summary of
Technological
Characteristics: | Representative samples of the device underwent testing including but
not limited to mechanical testing, biocompatibility testing, and
sterility assessment. |
| Conclusion: | Possis Medical, Inc. considers the Fetch 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. |