LogoFDA 510(k) Search
K Number
K112035
Device Name
VALET MICRO CATHETER
Manufacturer
VOLCANO CORPORATION
Date Cleared
2012-01-05

(174 days)

Product Code
DQY
Regulation Number
870.1250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

K083127

Not Found

No
The summary describes a physical medical device (a micro catheter) and its performance testing, with no mention of software, algorithms, or AI/ML capabilities.

No
The Intended Use / Indications for Use section states that the device is a "conduit for the exchange/support of guidewires" and is used to "infuse and deliver saline and contrast agents," which are supportive functions and do not directly treat a disease or condition.

No

The device is indicated for use as a conduit for guidewire exchange/support and for infusion/delivery of saline and contrast agents. These are therapeutic or procedural support functions, not diagnostic ones.

No

The device description clearly states it is a physical catheter comprised of a shaft and hub, and the performance studies describe bench testing and biocompatibility testing of a physical device.

Based on the provided information, the Valet™ Micro Catheter is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use: The intended use clearly states the device is used as a conduit for guidewires and to infuse/deliver substances within the peripheral and coronary vasculatures. This is an in vivo application (within a living organism).
  • Device Description: The description details a catheter designed for insertion into blood vessels.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside the body to provide information for diagnosis, monitoring, or screening.

IVD devices are specifically designed for testing samples taken from the body. The Valet™ Micro Catheter is a medical device used for interventional procedures within the body.

N/A

Intended Use / Indications for Use

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.

Product codes

DQY

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral and coronary vasculatures

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Asahi Corsair Microcatheter (K083127)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

0

12112035

JAN - 5 2012

.

510(K) SUMMARY of SAFETY AND EFFECTIVENESS

| SPONSOR: | Volcano Corporation
2870 Kilgore Road.
Rancho Cordova, CA 95670 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Lisa M. Quaglia
Senior Director, Regulatory Affairs
Volcano Corporation
1 Fortune Drive
Billerica, MA 01821
Tel: (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 870.1250
Class II Device |
| PREDICATE DEVICE: | Asahi Corsair Microcatheter (K083127) |
| 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. |
| INTENDED USE: | 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. |
| COMPARISON OF
CHARACTERISTICS: | The proposed device is substantially equivalent to
currently marketed device. Both devices are support
catheters consisting of a catheter shaft and hub. The
proposed Valet™ Micro Catheter is offered in four catheter
shaft lengths whereas the predicate device is offered in
two lengths. Additionally, the Valet™ Micro Catheter offers
multiple inner lumen diameters while the predicate device
offers a single inner lumen diameter. The indications for
use is the same for both devices. |

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

1

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.

2

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

3

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

4

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)

OR

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