The Valet™ Micro Catheter is indicated for use as a conduit for the exchange/support of guidewires in the peripheral and coronary vasculatures. The Valet™ Micro Catheter is also indicated to infuse and deliver saline and contrast agents. The Valet™ Micro Catheter is not intended for use in the neurovasculature.

Device Description

The Valet™ Micro Catheter is a support catheter comprised of a catheter shaft and hub. It is available in lengths 100, 123, 135, and 150 cm. The outer diameter is available in 2 sizes and is tapered from 2.3F to 1.8F and 4.0F to 3.5F. The device offers 45° and 60° angled tips as well as a straight tip.

AI/ML Overview

The provided document describes the safety and effectiveness summary for the Volcano Valet™ Micro Catheter, which is a Class II device. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing. No clinical study or AI/Machine Learning component is mentioned.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Non-Clinical Performance Testing
Dimensional Verification	Confirmed against known standards, product specifications, or predicate device.
Leak Testing	Successfully completed.
Leak Testing of Air into the Hub During Aspiration	Successfully completed.
Catheter Bond Strength	Confirmed against known standards, product specifications, or predicate device.
Flexibility and Kink Test	Confirmed against known standards, product specifications, or predicate device.
Torque Strength Test	Confirmed against known standards, product specifications, or predicate device.
Radiopacity	Confirmed against known standards, product specifications, or predicate device.
Coating Adhesion	Confirmed against known standards, product specifications, or predicate device.
Coating Integrity	Confirmed against known standards, product specifications, or predicate device.
Particulate Evaluation	Confirmed against known standards, product specifications, or predicate device.
Catheter Body Burst Pressure	Confirmed against known standards, product specifications, or predicate device.
Contrast Media Flow Rate	Confirmed against known standards, product specifications, or predicate device.
Biocompatibility Testing
Cytotoxicity	Successfully completed.
Sensitization	Successfully completed.
Intracutaneous (irritation)	Successfully completed.
Systemic Toxicity	Successfully completed.
ASTM Hemolysis	Successfully completed.
In Vitro Hemolysis	Successfully completed.
C3a Complement Activation	Successfully completed.
SC5-b Complement Activation	Successfully completed.
Pyrogens	Successfully completed.
Hemocompatibility	Successfully completed.
In vivo Thromboresistence	Successfully completed.

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

The document does not specify sample sizes for any of the non-clinical or biocompatibility tests. The provenance of the data is also not specified, but it is implied to be internal testing conducted by Volcano Corporation, given the context of a 510(k) submission. These are non-clinical studies (bench and lab testing), not human or imaging data.

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)

Not applicable. This submission is for a medical device (catheter) and relies on non-clinical performance and biocompatibility testing. There is no mention of an "expert" panel establishing "ground truth" as would be the case for an AI/ML diagnostic device interpreting medical images.

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

Not applicable. As there is no human interpretation or diagnostic decision involved in the described testing, no adjudication method is relevant.

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 study was not done. This device is a catheter, and the submission focuses on its physical and biological performance, not on AI-assisted human reading.

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

No. There is no algorithm or AI component to this device. The testing described is for the physical and biological characteristics of the catheter itself.

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

For the non-clinical performance tests, the "ground truth" would be defined by known engineering standards, product specifications, or direct comparison to the predicate device's measured performance. For biocompatibility, the "ground truth" is established by validated biological test methods and their predetermined acceptance criteria (e.g., cell viability in cytotoxicity tests).

8. The sample size for the training set

Not applicable. There is no training set mentioned or implied as this is not an AI/ML device.

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

Not applicable. As there is no training set.

Summary

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12112035

JAN - 5 2012

510(K) SUMMARY of SAFETY AND EFFECTIVENESS

SPONSOR:	Volcano Corporation2870 Kilgore Road.Rancho Cordova, CA 95670
CONTACT/SUBMITTER:	Lisa M. QuagliaSenior Director, Regulatory AffairsVolcano Corporation1 Fortune DriveBillerica, MA 01821Tel: (978) 439-3586
DATE OF SUBMISSION:	December 2, 2011
DEVICE:	Volcano Valet™ Micro Catheter
Trade Name:	Valet™ Micro Catheter
Common Name:	Catheter, Percutaneous
Classification:	21 CFR Part 870.1250Class II Device
PREDICATE DEVICE:	Asahi Corsair Microcatheter (K083127)
DEVICE DESCRIPTION:	The Valet™ Micro Catheter is a support cathetercomprised of a catheter shaft and hub. It is available inlengths 100, 123, 135, and 150 cm. The outer diameter isavailable in 2 sizes and is tapered from 2.3F to 1.8F and4.0F to 3.5F. The device offers 45° and 60° angled tips aswell as a straight tip.
INTENDED USE:	The Valet™ Micro Catheter is indicated for use as aconduit for the exchange/support of guidewires in theperipheral and coronary vasculatures. The Valet™ MicroCatheter is also indicated to infuse and deliver saline andcontrast agents. The Valet™ Micro Catheter is notintended for use in the neurovasculature.
COMPARISON OFCHARACTERISTICS:	The proposed device is substantially equivalent tocurrently marketed device. Both devices are supportcatheters consisting of a catheter shaft and hub. Theproposed Valet™ Micro Catheter is offered in four cathetershaft lengths whereas the predicate device is offered intwo lengths. Additionally, the Valet™ Micro Catheter offersmultiple inner lumen diameters while the predicate deviceoffers a single inner lumen diameter. The indications foruse is the same for both devices.

510(k) Premarket Notification for Volcano Corporation Valet™ Micro Catheter

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PERFORMANCE DATA:

Non-clinical device testing was conducted to confirm the performance of the device. Bench testing was conducted against known standards, product specification, or against the predicate device and evaluated the following:

. Dimensional Verification
Leak Testing .
Leak Testing of Air into the Hub During Aspiration .
. Catheter Bond Strength
Flexibility and Kink Test .
Torque Strength Test .
Radiopacity .
. Coating Adhesion
Coating Integrity .
Particulate Evaluation .
. Catheter Body Burst Pressure
. Contrast Media Flow Rate

Biocompatibility testing was conducted on the device and the following tests were successfully completed:

Cytotoxicity .
Sensitization .
. Intracutaneous
Systemic Toxicity .
. ASTM Hemolysis
In Vitro Hemolysis .
C3a Complement Activation .
. SC5-b Complement Activation
Pyrogens .
. Hemocompatibility
In vivo Thromboresistence �

Completion of these tests concluded the Valet 100 Micro Catheter is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JAN - 5 2012

Volcano Corporation c/o Ms. Lisa M. Quaglia Senior Director, Regulatory Affairs 1 Fortune Drive Billerica, MA 01821

Re: K112035

Trade/Device Name: Volcano Valet™ Micro Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: December 2, 2011 Received: December 5, 2011

Dear Ms. Quaglia:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(x) promative is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule for regally manation power and call Device Ameral Food. Drug commerce prior to May 20, 1970, the enactions and on the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval app and Cosment Act (Act) that to not require approval controls provisions of the Act. The Act. The Y ou may, therefore, market the device, basjev to weegent for annual registration, listing of the general Controls provisions of the received ing, and prohibitions against misbranding and_ adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classifica (sec above) into times a considerations affecting your device can be may be subject to additional confrois: "Dalsung in Jords 800 to 898. In addition, FDA may found in the Code of I caeral resguing your device in the Federal Register. publish further announcents concerning your at novemberse determination does not mean Please be advised that FDA s issuales of a sudes with other requirements of the Act
that FDA has made a determination that your device complies. You must that FDA has made a decertimation administered by other Federal agencies. You must of any Federal Statutes and regulations annumbles and limited to: registration and listing

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Page 2 – Ms. Lisa M. Quaglia

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Wm. G. Killebrew

رمان 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)

Page 1 of 1

Valet™ Micro Catheter Device Name

The Valet™ Micro Catheter is indicated for use as a conduit for the Indications for Use exchange/support of guidewires in the peripheral and coronary vasculatures. The Valet™ Micro Catheter is also indicated to infuse and deliver saline and contrast agents. The Valet™ Micro Catheter is not intended for use in the neurovasculature.

Prescription Use X (Per 21 CFR 801.109)

Over the Counter Use

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Cardiovascular Devices

KII 2035 510(k) Number

510(k) Premarket Notification for Volcano Corporation Valet™ Micro Catheter

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).