(122 days)
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.
The InnerChange Micro-Introducer Catheter combines the function of a micro introducer and angiographic catheter. Each InnerChange Micro-Introducer 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.
This 510(k) summary describes a medical device called the InnerChange™ Micro-Introducer Catheter. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing, as no clinical evaluations were conducted. Therefore, the device meets acceptance criteria primarily through engineering and laboratory performance.
Here's an analysis of the provided information based on your requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test Description | Reported Device Performance |
|---|---|---|
| Mechanical Testing | Catheter Curve Retention | Met specified design and performance requirements. |
| Catheter - Dilator Passage | Met specified design and performance requirements. | |
| Taper & Length | Met specified design and performance requirements. | |
| Catheter Tortuosity | Met specified design and performance requirements. | |
| Bond Strength: Catheter, Dilator, and Guidewire | Met specified design and performance requirements. | |
| Functional Testing | Catheter Air Leakage into Hub Assembly during Aspiration | Met specified design and performance requirements. |
| Catheter Dynamic Fluid Testing | Met specified design and performance requirements. | |
| Catheter Static Pressure Testing | Met specified design and performance requirements. | |
| Catheter Flow Rate | Met specified design and performance requirements. | |
| Shelf Life Testing | Not explicitly detailed, but implied as part of "Device Verification Testing" | Met specified design and performance requirements. |
| Packaging Testing | Not explicitly detailed, but implied as part of "Device Verification Testing" | Met specified design and performance requirements. |
| Biocompatibility | ISO 10993 "Biological Evaluation of Medical Devices" | Material demonstrated to be biocompatible. |
| Intended Use Equivalence | Intended use similar to predicate devices | Stated as similar in intended use and function to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific non-clinical test (e.g., number of catheters tested for curve retention). The testing is generally referred to as "Device Verification Testing."
The data provenance is retrospective, as it refers to testing performed on the device before seeking 510(k) clearance, for the purpose of demonstrating substantial equivalence. The document does not specify the country of origin of the data, but it can be inferred that the testing was conducted by or for Vascular Solutions, Inc. in Minneapolis, MN, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device's acceptance criteria were met through non-clinical, engineering, and laboratory testing rather than clinical studies requiring expert ground truth for interpretation of human data.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring human adjudication. The "ground truth" for non-clinical tests is established by objective measurements against predefined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device, not an AI-powered diagnostic tool, and no MRMC study was conducted. No clinical studies were conducted at all.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm. Device performance was evaluated in isolation through engineering tests.
7. The type of ground truth used
The "ground truth" for this device's acceptance was:
- Predefined Design Specifications and Performance Requirements: This refers to the engineering and functional parameters the device was designed to meet.
- Industry Standards: Specifically, ISO 10993 for biocompatibility.
- Comparison to Predicate Devices: Performance was evaluated in the context of demonstrating equivalency to existing, legally marketed devices.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of this device's non-clinical evaluation. This is a physical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there was no training set.
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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
§ 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).