(36 days)
Not Found
No
The device description focuses on the mechanical and material properties of the catheter and its accessories, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature, which is a therapeutic intervention.
No
The device description indicates that the Pronto catheter is used for the "removal of fresh, soft emboli and thrombi," which is a therapeutic action, not a diagnostic one. While it mentions "fluoroscopic visualization," this is for guiding the therapeutic procedure, not for diagnosing a condition.
No
The device description clearly details a physical catheter with various material components, lumens, and accessories, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Pronto catheter is a medical device used within the body (in vivo) to physically remove emboli and thrombi from blood vessels. It is an interventional device, not a diagnostic one.
- Lack of Diagnostic Purpose: The device's intended use is for the removal of material, not for analyzing a specimen to diagnose a condition or provide diagnostic information. While the removed thrombus can be sent for laboratory analysis (as mentioned with the filter basket), the catheter itself is not performing the diagnostic test.
Therefore, the Pronto catheter is a therapeutic medical device used for intervention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Pronto catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
Product codes
OEZ, DXE
Device Description
The Pronto V3 extraction catheter is a dual lumen polymeric catheter that is reinforced with a braided metallic mid-layer. The Pronto V3 includes related accessories. The extraction lumen allows for the aspiration and removal of embolic material (thrombus/debris) by using the included syringe, extension line and stopcock. The catheter has a rounded distal tip with a protected, sloped opening of the extraction lumen that facilitates atraumatic advancement of the catheter into the blood vessel and maximizes the extraction of emboli/thrombi through the extraction lumen. Near the catheter's distal tip is a non-blood contacting radiopaque marker for fluoroscopic visualization. The catheter has a monorail design. It has a flexible distal region and stiffness along the shaft and proximal region. The proximal end of the catheter has a standard luer adapter that attaches to the included extension line, stopcock, and syringe. The distal region of the catheter has a lubricious hydrophilic coating that allows for ease of catheter advancement. The catheter has an approximate outer diameter of 0.065 inches, allowing for delivery through standard 6F guide catheters. The guide wire lumen of the catheter accommodates guide wires that are
§ 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 ADMINISTRATION" in blue text.
September 15, 2021
Vascular Solutions, Inc. Julie Tapper Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, Minnesota 55369
Re: K063371
Trade/Device Name: Pronto V3 Extraction Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: OEZ
Dear Julie Tapper:
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 December 14, 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
O'connell -S Date: 2021.09.15
09:24:12 -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 seal of the U.S. Department of Health and Human Services. The seal features an abstract design of a human figure, with three stylized arms and legs. The figure is positioned to the right of the seal. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 2006
Vascular Solutions, Inc. c/o Ms. Julie Tapper Regulatory Affairs Associate 6464 Sycamore Court North Minneapolis, MN 55369
Re: K063371
ProntoTM V3 Extraction Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Catheter, Embolectomy Regulatory Class: II (two) Product Code: DXE Dated: November 6, 2006 Received: November 8, 2006
Dear Ms. Tapper:
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, isting 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.
2
Page 2 - Ms. Julie Tapper
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 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. Vachner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k) Number: _ 106.3371
Device Name:
Pronto™ V3 Extraction Catheter
Indications for Use:
The Pronto 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)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dvina R. kachner
sion Sign-C Division of Cardiovascular Devices
510(k) Number_K 065
4
510(k) Summary (As required by 21 CFR 807.92(c)) 1653 510(k) Number:
Date Prepared November 29, 2006
Submitter Information
| Submitter's Name: | Vascular Solutions, Inc. |
|---|---|
| Address: | 6464 Sycamore Court |
| Minneapolis, MN 55369 |
Contact Person: Julie Tapper Regulatory Affairs Associate Phone 763-656-4228 Fax 763-656-4253
Device Information
| Trade Name: | Pronto™ V3 Extraction Catheter |
|---|---|
| Common Name: | Embolectomy catheter |
| Class: | II |
| Classification Name: | Embolectomy catheter |
| (21CFR870.5150, Product Code DXE) |
Predicate Devices
Pronto™ V3 Extraction Catheter (K052232), manufactured by Vascular Solutions, Inc.
Device Description
The Pronto V3 extraction catheter is a dual lumen polymeric catheter that is reinforced with a braided metallic mid-layer. The Pronto V3 includes related accessories. The extraction lumen allows for the aspiration and removal of embolic material (thrombus/debris) by using the included syringe, extension line and stopcock. The catheter has a rounded distal tip with a protected, sloped opening of the extraction lumen that facilitates atraumatic advancement of the catheter into the blood vessel and maximizes the extraction of emboli/thrombi through the extraction lumen. Near the catheter's distal tip is a non-blood contacting radiopaque marker for fluoroscopic visualization.
5
The catheter has a monorail design. It has a flexible distal region and stiffness along the shaft and proximal region. The proximal end of the catheter has a standard luer adapter that attaches to the included extension line, stopcock, and syringe. The distal region of the catheter has a lubricious hydrophilic coating that allows for ease of catheter advancement. The catheter has an approximate outer diameter of 0.065 inches, allowing for delivery through standard 6F guide catheters. The guide wire lumen of the catheter accommodates guide wires that are