(68 days)
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.
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.
The provided text describes the Switch-It™ Catheter and its 510(k) premarket notification. It outlines the device description, intended use, and substantial equivalence to predicate devices, supported by verification testing.
Here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for the performance tests. Instead, it describes the types of tests performed and concludes that the "Results of the verification testing did not raise new safety or performance questions." This implies that the device met whatever internal acceptance criteria were set for these tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Simulated Anatomy/Concomitant Device Use (No new safety/performance issues when used with standard 6F guide catheter and 0.014" guidewires) | Results did not raise new safety or performance questions. |
| Kink Resistance (Device maintains integrity and functionality) | Results did not raise new safety or performance questions. |
| Tensile Strength (Device withstands appropriate tensile forces) | Results did not raise new safety or performance questions. |
| Torque Response (Device maintains steerability/response to torque) | Results did not raise new safety or performance questions. |
| Dimensional Verification (Device dimensions meet specifications) | Results did not raise new safety or performance questions. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes (number of devices or tests) for the verification testing. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective) for these engineering tests. Given the nature of these tests (simulated anatomy, kink, tensile, torque, dimensional), they are typically conducted in a laboratory setting.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable. The study described is a series of engineering verification tests (simulated anatomy, kink, tensile, torque, dimensional verification) for a medical device. These types of tests do not typically involve human experts establishing "ground truth" in the way clinical studies or diagnostic AI algorithms do. The "ground truth" for these tests would be the established engineering standards and specifications.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes engineering verification tests, not a clinical study involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The device described is a physical medical catheter, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the verification tests would be defined by engineering specifications and established test methods for catheter performance. For example, kink resistance would be judged against a defined kinking force threshold, tensile strength against a breaking point, and dimensional verification against manufacturing tolerances. These are objective measures rather than expert consensus, pathology, or outcomes data typically associated with diagnostic studies.
8. The Sample Size for the Training Set
Not applicable. The device is a physical catheter, not an AI or algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this device does not involve a training set.
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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.
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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.
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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
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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
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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
§ 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).