The Gandras catheter is designed to be used for delivering embolic materials and radiopaque media to selected sites in the vascular system. Diagnostic, embolic, or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer.

Device Description

The Gandras catheter is an angiographic intravascular catheter that has a working length of approximately 80cm, not including the tip length. The Gandras catheter is offered in three tip lengths-2cm (model 5580), 4cm (model 5581), or 6cm (model 5582). Each catheter assembly has a single lumen that is formed by a segment of nylon that extends distally from the hub, a segment of 40 durometer Pebax that extends distally from the nylon, and pellethane that forms the distal tip. Each catheter also has a Texin outer layer that overlays the nylon and pebax tubing in the mid-shaft. The distal 10-15cm of the catheter is hydrophilically coated to provide a lubricious outer surface. The catheter's radiopacity is provided by 40% bismuth subcarbonate loading in the nylon, 60% tungsten loading in the Pebax, and 65% tungsten loading in the pellethane tubing components. Each catheter has a press-fit luer hub and strain relief on the proximal end, and a peelable tip straightener. Each Gandras catheter is compatible with ≥5F introducer sheaths and <0.035" guidewires. The Gandras catheter is provided sterile and intended for a single use.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The 510(k) summary for the Gandras Intravascular Catheter (K073200) lists several bench tests conducted, but it does not explicitly define specific quantitative acceptance criteria or report detailed performance metrics against those criteria. The summary generally states that "The results of the tests confirmed the suitability of the device for its intended use."

Here's a table based on the provided information, noting the lack of specific criteria and data:

Acceptance Criteria (Implied)	Reported Device Performance (Summary Statement)
Hydrophilic coating lubricity	Confirmed suitability for intended use
Visual inspection	Confirmed suitability for intended use
Packaging stylet removal force	Confirmed suitability for intended use
Corrosion resistance	Confirmed suitability for intended use
Catheter Radiopacity	Confirmed suitability for intended use
Curve retention	Confirmed suitability for intended use
Guidewire passage	Confirmed suitability for intended use
Introducer sheath passage	Confirmed suitability for intended use
Tortuosity	Confirmed suitability for intended use
Embolic material passage	Confirmed suitability for intended use
Flow rate with contrast	Confirmed suitability for intended use
Dynamic pressure	Confirmed suitability for intended use
Liquid leak under pressure	Confirmed suitability for intended use
Static pressure	Confirmed suitability for intended use
Leak During Aspiration	Confirmed suitability for intended use
Kink resistance	Confirmed suitability for intended use
Hub bond strength	Confirmed suitability for intended use
Proximal to mid shaft strength	Confirmed suitability for intended use
Mid to distal shaft strength	Confirmed suitability for intended use
Tip straightener peel test	Confirmed suitability for intended use
Packaging-Product Visual Appearance	Confirmed suitability for intended use
Packaging-Label Legibility	Confirmed suitability for intended use

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: The document does not specify the sample size for any of the bench tests mentioned. It only lists the tests performed.
Data Provenance: The data provenance is bench testing, meaning it was conducted in a laboratory setting. There is no information regarding the country of origin, but as the submitter is based in Minneapolis, MN, USA, it's highly probable the testing was conducted within the United States. The testing is retrospective in the sense that it was completed before the 510(k) submission, confirming the device's design.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable to this submission. The "test set" for this device consisted of physical bench tests on the catheter itself, not interpretation of data by experts. The "ground truth" was established by engineering specifications and objective measurements against those specifications.

4. Adjudication Method for the Test Set:

This information is not applicable to this submission. Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation (e.g., image reading) where disagreement needs to be resolved. For bench tests, the outcome is generally determined by objective measurements and passing/failing predefined engineering criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, a MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical evaluations were not required for this device." This type of study would involve human readers and clinical cases, which were not part of this clearance process.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done:

No, an algorithm-only standalone study was not done. This device is a physical intravascular catheter, not an AI or software algorithm. Therefore, "standalone performance" in the context of AI is not relevant here.

7. The Type of Ground Truth Used:

The ground truth for the bench tests would have been based on predetermined engineering specifications, industry standards, and material properties relevant to intravascular catheters. For example, "flow rate with contrast" would have a specified minimum flow rate, "kink resistance" would have a minimum force/angle, and "hub bond strength" would have a minimum pull force. These are objective engineering parameters, not expert consensus or outcomes data.

8. The Sample Size for the Training Set:

This information is not applicable. "Training set" refers to data used to train an AI algorithm. As this device is a physical medical device and not an AI system, there is no training set in this context.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable. As per point 8, there is no "training set" for this device.

Summary

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510(k) Summary (As required by 21 CFR 807.92(c))

510(k) Number: K073200

Date Prepared

January 16, 2008

Submitter Information

Submitter's Name:	Vascular Solutions, Inc.
Address:	6464 Sycamore Court
	Minneapolis, MN 55369

Contact Person:	Julie Tapper
	Senior Regulatory Affairs Associate
	Phone 763-656-4300, x228
	Fax 763-656-4250

Device Information

Trade Name:	Gandras™ Intravascular Catheter
Common Name:	Diagnostic intravascular catheter
Class:	II
Classification Name:	Diagnostic intravascular catheter(21 CFR 870.1200, Product Code DQO)

Predicate Devices

Renegade STC™ 18 Microcatheter (K023681, K020012), manufactured by Boston Scientific Corporation.

AngioDynamics Soft-Vu and AngioDynamics Mariner Hydrophilic Coated Catheters (K061733), manufactured by AngioDynamics, Inc.

Device Description

FEB - 1 2003

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Each catheter has a press-fit luer hub and strain relief on the proximal end, and a peelable tip straightener. Each Gandras catheter is compatible with ≥5F introducer sheaths and <0.035" guidewires.

The Gandras catheter is provided sterile and intended for a single use.

Intended Use/Indications for Use

Summary of Non-clinical Testing

Bench testing was conducted on the Gandras catheter, including the packaging, and included an assessment of the physical properties of the device and its ability to achieve its intended use. The results of the tests confirmed the suitability of the device for its intended use. Each bench test that was conducted is listed, below.

Hydrophilic coating lubricity	Dynamic pressure
Visual inspection	Liquid leak under pressure
Packaging stylet removal force	Static pressure
Corrosion resistance	Leak During Aspiration
Catheter Radiopacity	Kink resistance
Curve retention	Hub bond strength
Guidewire passage	Proximal to mid shaft strength
Introducer sheath passage	Mid to distal shaft strength
Tortuosity	Tip straightener peel test
Embolic material passage	Packaging-Product Visual Appearance after Distribution Testing
Flow rate with contrast	Packaging-Label Legibility after Distribution Testing

Summary of Clinical Testing

Clinical evaluations were not required for this device.

Statement of Equivalence

The Gandras catheter is substantially equivalent to the currently marketed Renegade STC. Soft Vu, and Mariner catheters, based on comparisons of the device classifications, indications for use, technological characteristics, and sterilization methods.

Conclusion

The Gandras catheter is substantially equivalent to the currently marketed Renegade STC. Soft Vu. and Mariner catheters, based on comparisons of the device classifications, indications for use, technological characteristics, and sterilization methods. Bench tests confirmed the suitability of the device for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the eagle. The eagle is depicted in a minimalist style, with flowing lines suggesting its feathers and form. The text is in all caps and is evenly spaced around the circle.

FEB - 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vascular Solutions, Inc. c/o Ms. Julie Tapper Senior Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, MN 55369

Re: K073200

Trade Name: Gandras 110 Intravascular Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: January 16, 2008 Received: January 17, 2008

Dear Ms. Tapper:

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. Iisting 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

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Page 2 - Ms. Julie Tapper

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 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 Biometrics' (OSB) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Mcdical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

buna R. V. de Auner

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: K073200

Device Name:

Gandras™ Intravascular 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)

Duma R. Jachner

(Division Sign-Off) Division of Cardrovascular Devices

510(k) Number_K073260

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).