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 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 .

AI/ML Overview

The provided document is a 510(k) summary for the InnerChange Micro-Introducer Catheter. It describes the device, its intended use, a summary of non-clinical testing, and concludes with a statement of equivalence to a predicate device.

Crucially, this document does not describe the acceptance criteria or a study that proves the device meets specific performance criteria in the way typically associated with AI/ML-driven devices (e.g., sensitivity, specificity, AUC). Instead, it describes a medical device that undergoes engineering and biocompatibility testing.

Therefore, many of the requested fields are not applicable to the information contained in this submission. I will answer based on the information provided, explicitly stating when information is not present or not applicable.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Bench Test)	Reported Device Performance
Radiopacity	Confirmed suitability
Visual inspection (lubricious coating)	Confirmed suitability
Visual inspection of catheter/dilator	Confirmed suitability
Catheter Curve retention	Confirmed suitability
Dilator passage	Confirmed suitability
Dilator/catheter tapered tip assembly	Confirmed suitability
Guidewire passage	Confirmed suitability
Catheter Tortuosity test	Confirmed suitability
Hydrophilic coating inspection after tortuosity	Confirmed suitability
Flow rate with contrast	Confirmed suitability
Dynamic pressure test (catheter only)	Confirmed suitability
Kink radius	Confirmed suitability
Liquid leak test (catheter only)	Confirmed suitability
Proximal to distal shaft strength	Confirmed suitability
Biocompatibility assessments	Confirmed suitability
Shelf life testing	Confirmed suitability

Note: The document states "The results of this testing confirmed the suitability of the InnerChange Micro-Introducer Catheter for its intended use." It does not provide specific quantitative acceptance criteria or raw performance data for each test, only that the device "confirmed suitability."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "testing conducted" but does not detail sample sizes for each bench test or data provenance. There is no mention of a "test set" in the context of clinical data, as no clinical testing was performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/not provided. The device is a physical medical instrument, not an AI/ML diagnostic tool requiring expert-established ground truth for a test set. The evaluation was based on engineering bench tests and biocompatibility, not interpretations by human experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided. As no clinical or expert-reviewed "test set" was used, no adjudication method was necessary or mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader, multi-case comparative effectiveness study was not done. This document is for a physical medical catheter, not an AI/ML system, so this type of study is irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable. The device is a physical catheter, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This is not applicable. For this type of medical device, the "ground truth" for the bench tests would be defined specifications, engineering standards, and biological compatibility requirements rather than clinical ground truth like pathology or outcomes data. The document states "The results of this testing confirmed the suitability of the InnerChange Micro-Introducer Catheter for its intended use," implying compliance with predefined engineering and safety standards.

8. The sample size for the training set

This information is not applicable/not provided. The device is a physical product. There is no concept of a "training set" as understood in machine learning. Design verification involved bench testing, not machine learning model training.

9. How the ground truth for the training set was established

This information is not applicable/not provided. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.

Summary

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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

. 21G percutaneous entry needle
0.018" guidewire .
Dilator .
Catheter with selected tip shape and attached stopcock .

Intended Use/Indications for Use

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

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:

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

Regulation Number and Section

§ 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).