(119 days)
Not Found
No
The 510(k) summary describes a mechanical device for vascular access and contrast delivery. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies are focused on physical and functional characteristics of the catheter and related components.
No
The device is described as being for "accessing the vascular system" and "delivering radiopaque media" as part of "routine diagnostic procedures", indicating a diagnostic rather than therapeutic purpose.
No
Explanation: The device is described as a catheter for delivering radiopaque media in conjunction with diagnostic procedures, not as a device that performs the diagnostic analysis itself. It facilitates the diagnostic procedure but is not the diagnostic device.
No
The device description explicitly lists physical components such as a needle, guidewire, dilator, and catheter, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The INNERCHANGE micro-introducer catheter is used to access the vascular system and deliver radiopaque media within the body for imaging purposes. It is a tool used in a diagnostic procedure, but it does not analyze a sample in vitro.
- Intended Use: The intended use clearly states it's for "accessing the vascular system" and "delivering radiopaque media to selected sites in the vascular system." This is an in vivo (within the living body) procedure.
- Device Description: The components and description align with a device used for accessing and navigating within the vascular system, not for analyzing samples outside the body.
The device is used in conjunction with diagnostic procedures (like angiography), but it is not an IVD itself.
N/A
Intended Use / Indications for Use
The INNERCHANGE micro-introducer catheter is intended for use in accessing the vascular system through a small gauge needle stick and for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.
Product codes
DQO
Device Description
The INNERCHANGE micro-introducer catheter combines a micro-introducer kit for obtaining vascular access with a hydrophilically coated diagnostic catheter. The INNERCHANGE catheter is designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures. The INNERCHANGE micro-introducer catheter is compatible with
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for Vascular Solutions. The logo consists of the words "Vascular" on the top line and "Solutions" on the second line. Above the words is a graphic of a square made up of smaller squares that fade out as they go up.
510(k) Summary
510(k) Number: K073585
Date Prepared
December 19, 2007
Submitter Information
Submitter's Name/ Address:
Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369
Establishment Registration 2134812
Contact Person:
Alternative contact:
Alyssa Malinski 763-656-4300 amalinski@vascularsolutions.com Doralie Poganski 763-656-4300 dpoganski(@)vascularsolutions.com
Device Information
Trade Name: InnerChange™ Micro-Introducer Catheter Common Name: Diagnostic Intravascular Catheter Classification Name: Diagnostic Intravascular Catheter Product Code: DQO Regulation: Class II, 21 CFR 870.1200
Predicate Device(s)
- Vascular Solutions, Inc. InnerChange Micro-Introducer Catheter (K062627) .
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Device Description
The INNERCHANGE micro-introducer catheter combines a micro-introducer kit for obtaining vascular access with a hydrophilically coated diagnostic catheter. The INNERCHANGE catheter is designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures. The INNERCHANGE micro-introducer catheter is compatible with ≤0.038" / 965mm guidewires. Each INNERCHANGE micro-introducer catheter consists of the following components:
- . 21G percutaneous entry needle
- 0.018" guidewire .
- Dilator .
- Catheter with selected tip shape and attached stopcock .
Intended Use/Indications for Use
The INNERCHANGE micro-introducer catheter is intended for use in accessing the vascular system through a small gauge needle stick and for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.
Summary of Non-Clinical Testing
Testing conducted included assessments of the design verification of the InnerChange Micro-Introducer Catheter along with biocompatibility assessments and shelf life testing. The results of this testing confirmed the suitability of the InnerChange Micro-Introducer Catheter for its intended use. Each bench test that was conducted is listed:
- Radiopacity .
- . Visual inspection (lubricious coating)
- . Visual inspection of catheter/dilator
- Catheter Curve retention .
- Dilator passage .
- � Dilator/catheter tapered tip assembly
- Guidewire passage .
- 4 Catheter Tortuosity test
- Hydrophilic coating inspection after tortuosity .
- . Flow rate with contrast
- Dynamic pressure test (catheter only)
- . Kink radius
- Liquid leak test (catheter only) .
- Proximal to distal shaft strength .
Summary of Clinical Testing
No clinical evaluations of this product have been conducted.
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Statement of Equivalence
The InnerChange Micro-Introducer Catheter has the exact intended use and function as the Vascular Solutions InnerChange Catheters (K062627).
Conclusion
Through the data and information presented, Vascular Solutions considers the InnerChange Micro-Introducer Catheter to be substantially equivalent to the Vascular Solutions InnerChange Catheters (K062627). The testing performed confirms that the InnerChange Micro-Introducer Catheter will perform as intended.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an eagle or bird in flight, with three curved lines representing the wings and a wavy line representing the body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 7 2008
Vascular Solutions c/o Ms. Alyssa Malinski 6464 Sycamore Court Minneapolis, MN 55369
Re: K073585
Trade Name: InnerChange Micro-Introducer Catheter (Models 7900, 7901, 7902, 7903, 7904, 7905) Regulation Number 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: DQO Dated: April 11, 2008 Received: April 14, 2008
Dear Ms. Malinski:
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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality
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Page 2 -- Ms. Alyssa Malinski
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 Biometric's (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 mav 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,
buma R. bohner
S
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 Statement
510(k) Number (if known): K07 35 85
Device Name: InnerChange™ Micro-Introducer Catheter
Indications for Use:
The INNERCHANGE micro-introducer catheter is intended for use in accessing the vascular system through a small gauge needle stick and for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.
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)
sumna D. de Aunes
510(k) Number K023585
(Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular Devices