(68 days)
Not Found
No
The device description and performance studies focus on mechanical properties and functionality for guidewire placement and exchange, with no mention of AI or ML.
No
The device facilitates the placement and exchange of guidewires, which are diagnostic and interventional tools, but it does not directly treat a disease or medical condition itself.
No
The device is described as a catheter used to facilitate the placement and exchange of guidewires for interventional procedures, not to diagnose a condition.
No
The device description clearly details physical components (catheter, push wire, shaft, marker band) and performance studies involve physical testing (kink, tensile, torque), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for facilitating the placement and exchange of guidewires within the coronary and peripheral vasculature. This is an in vivo procedure, meaning it is performed within a living organism.
- Device Description: The description details a catheter designed to be inserted into blood vessels. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not to directly interact with the body's internal structures in the way this catheter does.
N/A
Intended Use / Indications for Use
The Switch-It catheter is intended to be used in conjunction with guide catheters to facilitate placement and exchange of guidewires in the discrete coronary and peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Switch-It catheter (Switch-It) is an addition to the VSI guide extension catheter product family. Switch-It is a rapid-exchange catheter intended for use with a standard 6F guide catheter to place and exchange standard length 0.014" guidewires. The working length of Switch-It is 145 cm, consisting of a 117 cm proximal stainless steel push wire attached to a 28 cm microcatheter-type shaft. The push wire and shaft are joined by a short funnel section that directs a proximally inserted guidewire into the shaft. The inner diameter of the shaft is sized to accommodate an 0.014" guidewire. The distal 20 cm of the shaft has a hydrophilic coating and a platinum-iridium marker band located 2 mm or less from the distal tip, which is visible using standard fluoroscopic methods. The push wire has two positioning marks located at 95 cm (single mark) and 105 cm (double mark) from the distal tip, respectively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Switch-It design was qualified through the following tests:
- . Simulated anatomy/concomitant device use
- . Kink
- . Tensile
- . Torque
- . Dimensional verification
Results of the verification testing did not raise new safety or performance questions.
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
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
MAY 1 5 2012
Vascular Solutions, Inc.
Traditional 510(k) Premarket Not Switch-It™ Catheter
2 510(k) Summary
[As required by 21 CFR 807.92]
510(k) Number: K120707
Submitter's Information / Contact Person
Manufacturer Contact Person Vascular Solutions, Inc. Ellie Gillespie Senior Regulatory Product Specialist 6464 Sycamore Court Minneapolis, MN 55369 USA Tel: 763-656-4230 (direct) Establishment Registration Number: 2134812 Fax: 763-656-4253
Date Prepared: March 7, 2012
Email: egillespie@vasc.com
General Information
| Trade Name | Switch-It tm catheter |
|---|---|
| Common / Usual Name | Catheter |
| Classification Name | 21 CFR 870.1250, Percutaneous catheter |
| Predicate Devices | GuideLiner tm V2 catheter (K112082 - Vascular Solutions, Inc.) |
| SuperCross tm microcatheter (K101659 - Vascular Solutions, Inc.) |
Device Description
The Switch-It catheter (Switch-It) is an addition to the VSI guide extension catheter product family. Switch-It is a rapid-exchange catheter intended for use with a standard 6F guide catheter to place and exchange standard length 0.014" guidewires. The working length of Switch-It is 145 cm, consisting of a 117 cm proximal stainless steel push wire attached to a 28 cm microcatheter-type shaft. The push wire and shaft are joined by a short funnel section that directs a proximally inserted guidewire into the shaft. The inner diameter of the shaft is sized to accommodate an 0.014" guidewire. The distal 20 cm of the shaft has a hydrophilic coating and a platinum-iridium marker band located 2 mm or less from the distal tip, which is visible using standard fluoroscopic methods. The push wire has two positioning marks located at 95 cm (single mark) and 105 cm (double mark) from the distal tip, respectively.
Intended Use / Indications
The Switch-It catheter is intended to be used in conjunction with guide catheters to facilitate placement and exchange of guidewires in the discrete coronary and peripheral vasculature.
1
Vascular Solutions, Inc.
Traditional 510(k) Premarket Notification Switch-It™ Catheter
Substantial Equivalence and Summary of Studies
Switch-It is substantially equivalent to the GuideLiner V2 catheter (GuideLiner V2) based on comparisons of intended use, device functionality, and technological characteristics. In addition, the intended use. microcatheter-like design, and materials of Switch-It are similar to the SuperCross microcatheter (SuperCross).
Switch-It and the predicate devices are intended to be used in the coronary and peripheral vasculature to facilitate placement and exchange guidewires. The predicate devices are intended to facilitate placement and exchange of guidewires and other interventional devices; however, the smaller ID of Switch-It allows only the passage of guidewires, not interventional devices. The Switch-It intended use is a subset of the GuideLiner V2 and SuperCross indications, as Switch-It is only indicated to facilitate placement and exchange of guidewires and not other interventional devices.
The Switch-It design was qualified through the following tests:
- . Simulated anatomy/concomitant device use
- . Kink
- . Tensile
- . Torque
- . Dimensional verification
Results of the verification testing did not raise new safety or performance questions.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a staff with two snakes entwined around it, representing medicine and health.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 5 2012
Vascular Solutions, Inc. c/o Ms. Ellie Gillespie Senior Regulatory Product Specialist 6464 Sycamore Court Minneapolis. MN 55369
Re: K120707
Switch-It™ Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: March 7, 2012 Received: March 8, 2012
Dear Ms. Gillespie:
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
3
Page 2 - Ms. Ellie Gillespie
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 11 you dobilio povefice as v/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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" (21CFR 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.
Sincerelv yours.
CM of Killebrew
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K1207 510(k) Number (if known):
Device Name: Switch-It" catheter
Indications for Use:
The Switch-It catheter is intended to be used in conjunction with guide catheters to facilitate placement and exchange of guidewires in the discrete 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)
M.F. Kilburn
on Sign-Off on of Cardiovascular Devices
1120707 510(k) Number