(101 days)
Not Found
No
The device description and intended use focus on mechanical extraction and support functions of catheters and related accessories. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The "Intended Use / Indications for Use" section explicitly states that the SKYWAY OTW and TWIN-PASS catheters "may be used to subselectively infuse/deliver therapeutic agents," which is a therapeutic function. Additionally, the PRONTO extraction catheter is indicated for "the removal of fresh, soft emboli and thrombi," which is a direct therapeutic intervention.
No
The device is primarily intended for the removal of emboli and thrombi (therapeutic intervention) and for facilitating the placement and exchange of guidewires and other interventional devices (support). While the TWIN-PASS catheter mentions the subselective infusion/delivery of "diagnostic or therapeutic agents," the core function of the listed devices is not diagnostic; rather, their function is interventional, therapeutic, or supportive to therapeutic procedures. The "laboratory analysis of any thrombosis" facilitated by the filter basket is a secondary analytical step, not the primary function of the device itself.
No
The device description clearly details physical catheters and related accessories, which are hardware components, not software.
Based on the provided information, no, 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 described devices (Pronto extraction catheters, Skyway support catheters, and Twin-Pass dual access catheter) are interventional devices used directly within the patient's vasculature. Their primary function is mechanical: removing thrombi, providing support for guidewires, facilitating device exchange, and delivering therapeutic agents.
- Lack of Specimen Analysis: While the Pronto catheters include a filter basket for potential laboratory analysis of removed thrombus, the device itself is not performing the diagnostic test on the specimen. The analysis would be a separate process performed in a laboratory setting using other IVD devices or methods. The device's primary intended use is the removal of the thrombus, not its analysis for diagnostic purposes.
Therefore, these devices fall under the category of medical devices used for treatment and intervention within the body, not for in vitro diagnostic testing of specimens.
N/A
Intended Use / Indications for Use
Pronto® V3 extraction catheter, Pronto® LP extraction catheter
The PRONTO extraction catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
Skyway® OTW support catheter, Skyway® RX support catheter
The SKYWAY support catheter is intended to be used in conjunction with steerable guidewires in order to access discreet regions of the arterial and or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. The SKYWAY OTW also may be used to subselectively infuse/deliver therapeutic agents.
Twin-Pass® dual access catheter
The TWIN-PASS dual access catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents.
Product codes (comma separated list FDA assigned to the subject device)
OEZ, DXE, DQY
Device Description
The Pronto V3 extraction catheter is a dual lumen, hydrophilically coated, rapid exchange catheter with related accessories. The smaller wire lumen of the catheter is able to accommodate guidewires that are ≤ 0.014"/0.36mm in diameter. The larger extraction lumen allows for the removal of thrombus by use of the included syringe through the extension line and stopcock. The catheter has a rounded distal tip with a protected, sloped opening of the extraction lumen to facilitate advancement of the catheter into the blood vessel and maximize extraction of thrombus through the extraction lumen. The proximal end of the catheter has a standard luer adapter that attaches to the included extension line, stopcock and syringes. The catheter has a working length of 140cm and is compatible with standard 6F guide catheters. A 70um filter basket is included for assistance in filtering the blood removed during the procedure for laboratory analysis of any thrombosis.
The Pronto LP extraction catheter is a dual lumen, hydrophilically coated rapid exchange catheter with related accessories. The smaller wire lumen of the catheter is able to accommodate guidewires 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).
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 seal on the left and the FDA acronym and name on the right. The FDA acronym is in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
May 20, 2021
Vascular Solutions, Inc. Charmaine Sutton Acting VP Of Regulatory 6464 Sycamore Court Minneapolis, Minnesota 55369
Re: K083784
Trade/Device Name: Pronto V3 Extraction Center, Pronto LP Extraction Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: OEZ
Dear Charmaine Sutton:
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 March 30, 2009. 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,
Image /page/0/Picture/9 description: The image shows a digital signature. On the left side, the name "Gregory W. O'connell -S" is written in a large font. On the right side, the text "Digitally signed by Gregory W. O'connell -S Date: 2021.05.20 09:35:42 -04'00'" is written in a smaller font. The signature indicates that the document was signed by Gregory W. O'connell on May 20, 2021, at 09:35:42 with a time zone offset of -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
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Public Health Service
MAR 3 0 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vascular Solutions, Inc. c/o Ms. Charmaine Sutton, RAC 6464 Sycamore Court Minneapolis, MN 55369
Re: K083784
Trade/Device Name: Pronto V3 extraction catheter, Pronto LP extraction catheter, Skyway RX support catheter, Skyway OTW support catheter, and Twin-Pass dual access catheter
Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: DXE, DQY Dated: March 16, 2009 Received: March 17, 2009
Dear Ms. Sutton:
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 comply with all the Act's requirements, including, but not limited to: registration and listing (21
2
Page 2 - Ms. Charmaine Sutton
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 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,
Duna R. Turner
Image /page/2/Picture/5 description: The image shows a handwritten symbol or character. It appears to be a stylized or cursive form, possibly resembling a letter or a unique mark. The symbol is drawn with thick, dark lines, suggesting it was created with a pen or marker. The overall impression is that of a signature, initial, or abstract design.
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
3
510(k) Number (if known): _ _ _ 003789
Skyway® OTW support catheter Device Name: Skyway® RX support catheter
Indications for Use:
The SKYWAY support catheter is intended to be used in conjunction with steerable guidewires in order to access discreet regions of the arterial and or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. The SKYWAY OTW also may be used to subselectively infuse/deliver therapeutic agents.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Posted November 13, 2003)
3
4
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Twin-Pass® dual access catheter
Indications for Use:
The TWIN-PASS dual access catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infusc/deliver diagnostic or therapeutic agents.
Prescription Use X (Part 21 CFR 801 Subpart D)
ﻴﺔ
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Posted November 13, 2003)
5
510(k) Number (if known): K083784
.
Pronto® V3 extraction catheter Device Name: Pronto® LP extraction catheter
Indications for Use:
The PRONTO extraction 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 OF NEEDED)
. При 1910 года продательно продобродности при полности и моремника по примество полнения по странция по подательности по полнения по полнения по подательные поведника с
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
5
(Posted November 13, 2003)
R.L. Jones
Division Sign-Off) avision of Cardiovascular Devices
510(k) Number_KO83784
6
Vascular Solutions, Inc.
Traditional 510(k) Premarket Notification Hydrophilic Coating Modification for Pronto V3, Pronto LP, Skyway and Twin-Pass Catheters
1683784
3 510(k) Summary
Date Prepared: December 18, 2008
Submitter's Name / Contact Person
Manufacturer
Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369 USA Establishment Registration # 2134812
Contact Person
Charmaine Sutton, RAC Acting VP of Regulatory Tel: 763.656.4349 (direct); Fax: 763.656.4253 Email: csutton@vascularsolutions.com
| Common Name
| (Classification) | Trade Name | Predicate Device |
|---|---|---|
| Embolectomy | ||
| catheter | ||
| (21 CFR 870.5150) | Pronto® V3 extraction catheter | K063371 Pronto V3 extraction catheter |
| Pronto® LP extraction catheter | K072810 Pronto LP extraction catheter | |
| Percutaneous | ||
| catheter | ||
| (21 CFR 870.1250) | Skyway® RX support catheter | K060327 Skyway RX support catheter |
| Skyway® OTW support catheter | K060327 Skyway OTW support catheter | |
| Twin-Pass® dual access catheter | K060327 Twin-Pass dual access catheter |
General Information
Device Description
The Pronto V3 extraction catheter is a dual lumen, hydrophilically coated, rapid exchange catheter with related accessories. The smaller wire lumen of the catheter is able to accommodate guidewires that are ≤ 0.014"/0.36mm in diameter. The larger extraction lumen allows for the removal of thrombus by use of the included syringe through the extension line and stopcock. The catheter has a rounded distal tip with a protected, sloped opening of the extraction lumen to facilitate advancement of the catheter into the blood vessel and maximize extraction of thrombus through the extraction lumen. The proximal end of the catheter has a standard luer adapter that attaches to the included extension line, stopcock and syringes. The catheter has a working length of 140cm and is compatible with standard 6F guide catheters. A 70um filter basket is included for assistance in filtering the blood removed during the procedure for laboratory analysis of any thrombosis.
The Pronto LP extraction catheter is a dual lumen, hydrophilically coated rapid exchange catheter with related accessories. The smaller wire lumen of the catheter is able to accommodate guidewires that are Trade/Device Name: Pronto V3 extraction catheter, Pronto LP extraction catheter, Skyway RX support catheter, Skyway OTW support catheter, and Twin-Pass dual access catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: DXE, DQY Dated: March 16, 2009 Received: March 17, 2009
Dear Ms. Sutton:
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 comply with all the Act's requirements, including, but not limited to: registration and listing (21
9
Page 2 - Ms. Charmaine Sutton
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 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.
Drma. R. Wulner
Image /page/9/Picture/5 description: The image shows a stylized, handwritten letter 'W'. The letter is formed with curved lines, giving it a flowing appearance. The base of the 'W' has a slight slant, and the overall design is simple and elegant.
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
10
510(k) Number (if known): KO83784
Skyway® OTW support catheter Device Name: Skyway® RX support catheter
Indications for Use:
The SKYWAY support catheter is intended to be used in conjunction with steerable guidewires in order to access discreet regions of the arterial and or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. The SK YWA Y OTW also may be used to subselectively infuse/deliver therapeutic agents.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Posted November 13, 2003)
11
510(k) Number (if known):
Device Name: Twin-Pass® dual access catheter
Indications for Use:
The TWIN-PASS dual access catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Posted November 13, 2003).
12
510(k) Number (if known): K083784
Pronto® V3 extraction catheter Device Name: Pronto® LP extraction catheter
Indications for Use:
The PRONTO extraction 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Posted November 13, 2003)
ima R.L. Jones
Division Sign-Off) Ivision of Cardiovascular Devices
510(k) Number_KO83784