INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900 THROUGH 7905
Device Facts
| Record ID | K062627 |
|---|---|
| Device Name | INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900 THROUGH 7905 |
| Applicant | Vascular Solutions, Inc. |
| Product Code | DQO · Cardiovascular |
| Decision Date | Jan 5, 2007 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1200 |
| Device Class | Class 2 |
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.
Device Story
The InnerChange Micro-Introducer Catheter facilitates vascular access and contrast media delivery. It consists of a stainless steel percutaneous entry needle, a nitinol guidewire with a stainless steel tip, a dilator, and a catheter with a high-pressure stopcock. The dilator straightens the catheter tip for insertion; upon removal, the tip returns to its preformed shape. Available in 4F and 5F sizes with various lengths (45-125cm) and tip curves. Used by clinicians during diagnostic procedures to access the vascular system and deliver radiopaque media. The device provides a combined micro-introducer and angiographic catheter function, simplifying the procedure by reducing the number of components required for vascular access and contrast injection.
Clinical Evidence
No clinical evaluations were conducted. Substantial equivalence is supported by bench testing, including mechanical, functional, shelf-life, and packaging verification (e.g., curve retention, dynamic fluid testing, static pressure testing, flow rate, and bond strength). Biocompatibility testing was performed in accordance with ISO 10993.
Technological Characteristics
Materials: Stainless steel (needle, guidewire tip), Nitinol (guidewire). Dimensions: 4F and 5F sizes, 45-125cm lengths. Features: Preformed tip configurations, high-pressure stopcock, dilator for tip straightening. Biocompatibility: ISO 10993 compliant. Sterilization: Not specified.
Indications for Use
Indicated for patients requiring vascular access via small gauge needle stick and delivery of radiopaque media during routine diagnostic procedures.
Regulatory Classification
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.
Predicate Devices
- Merit Medical Angiographic Catheter (K000659)
- Galt Micro-Introducer Kits (K000737)
- Vascular Solutions Langston Dual Lumen Pressure Monitoring Catheter (K061565)
Submission Summary (Full Text)
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JAN - 5 2007
# 510(k) SUMMARY
# 510(k) Number: KO62627
## Date Prepared
September 1, 2006
## Submitter Information
Submitter's Name/ Address:
Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369
Establishment Registration 2134812
Contact Person:
Patrice Stromberg Sr. Regulatory Affairs Associate (763) 656-4243 telephone (763) 656-4200 fax pstromberg@vascularsolutions.com
## Device Information
Trade Name: Common Name: Classification Name: Product Code: Regulation:
InnerChange™ Micro-Introducer Catheter Diagnostic Intravascular Catheter Diagnostic Intravascular Catheter DQO Class II, 21 CFR 870.1200
# Predicate Device(s)
- Merit Medical Angiographic Catheter (K000659) .
- Galt Micro-Introducer Kits (K000737) .
- Vascular Solutions Langston Dual Lumen Pressure Monitoring Catheter . (K061565)
# Device Description
The InnerChange Micro-Introducer Catheter combines the function of a micro introducer and angiographic catheter. Each InnerChange Micro-Introducer
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Catheter consists of the following components: Stainless Steel percutaneous entry needle, Nitinol Guidewire with Stainless Steel tip, dilator, and catheter with selected tip shape and high pressure stopcock. The dilator functions to straighten the catheter tip during vascular access. When the dilator is removed, the catheter tip returns to the preformed configuration. The Inner-Change Micro-Introducer Catheter will be available in 4F and 5F sizes with various tip curve configurations and lengths ranging from 45 to 125cm.
#### 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
Performance Testing: Device Verification Testing was performed to support the equivalency of the InnerChange Micro-Introducer Catheter to the predicate devices. Testing included mechanical, functional, shelf life and packaging testing. DVT testing included Catheter Curve Retention, Catheter - Dilator Passage, Taper & Length, Catheter Tortuosity, Catheter Air Leakage into Hub Assembly during Aspiration, Catheter Dynamic Fluid Testing, Catheter Static Pressure Testing, Catheter Flow Rate, Bond Strength: Catheter, Dilator and Guidewire. The InnerChange Micro-Introducer Catheter met all specified design and performance requirements.
Biocompatibility. Biocompatibility testing in accordance with ISO 10993. "Biological Evaluation of Medical Devices" was provided. The material used in the InnerChange Micro-Introducer Catheter has been demonstrated to be biocompatible.
### Summary of Clinical Testing
No clinical evaluations of this product have been conducted.
#### Statement of Equivalence
The InnerChange Micro-Introducer Catheter is similar in intended use and function to the Merit Medical Angiographic Catheters, Galt Micro-Introducer Kits, and the Vascular Solutions Langston Dual Lumen Pressure Monitoring Catheter.
#### Conclusion
Through the data and information presented. Vascular Solutions considers the InnerChange Micro-Introducer Catheter to be substantially equivalent to the Merit Medical Angiographic Catheters, Galt Micro-Introducer Kits, and the Vascular Solutions Langston Dual Lumen Pressure Monitoring Catheter. The testing performed confirms that the InnerChange Micro-Introducer Catheter will perform as intended.
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Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its wing, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 5 2007
Vascular Solutions, Inc. c/o Ms. Patrice Stromberg Sr. Regulatory Affairs Associate 6464 Sycamore Court North Minneapolis, MN 55369
Re: K062627/S1
> Trade/Device Name: InnerChange™ Micro-Introducer Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: catheter, intravascular, diagnostic Regulatory Class: II Product Code: DQO Dated: November 22, 2006 Received: November 24, 206
Dear Ms. Stromberg:
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.
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Page 2 - Ms. Patrice Stromberg
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.
Blumman for
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): K062627
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)
Bhummon
(Division, State, O/C)
ivision Sign-Off Division of Cardiovascular Devices 510(k) Number
