MICROSHEATH XL CATHETERS

K073289 · Flowcardia, Inc. · DQY · Jan 11, 2008 · Cardiovascular

Device Facts

• Record ID: K073289
• Device Name: MICROSHEATH XL CATHETERS
• Applicant: Flowcardia, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Jan 11, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The MicroSheath XL is a single lumen catheter intended to create a pathway for other devices in the peripheral vasculature.

Device Story

MicroSheath XL is a single lumen percutaneous catheter; available in 53cm, 73cm, 93cm, or 123cm lengths; features vertebral, internal mammary artery, or multipurpose tip configurations. Device includes standard luer fitting at proximal end; radiopaque distal tip for fluoroscopic visualization; atraumatic distal tip for vessel navigation. Compatible with 7F sheaths. Used by clinicians in peripheral vasculature procedures to provide access pathway for other interventional devices. Bench testing confirms performance characteristics including tensile strength, tip flexibility, torque strength, and navigation capabilities.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included dimensional verification, tensile strength, tip flexibility, access and navigation bench modeling, critical bend testing, leak and pressure testing, and torque strength.

Technological Characteristics

Single lumen percutaneous catheter; radiopaque distal tip; standard luer fitting. Materials, manufacturing, and sterilization methods equivalent to VP Sheath. Dimensions vary by length (53-123cm) and tip configuration. No software or energy source.

Indications for Use

Indicated for use as a single lumen catheter to create a pathway for other devices in the peripheral vasculature.

Regulatory Classification

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.

Predicate Devices

• VP Sheath (K051580)
• Viking 6Fr Guiding Catheters (K972484)
• Zuma 6Fr Guiding Catheters (K981198)

Submission Summary (Full Text)

{0}------------------------------------------------

ﺰ ﺗ

# FLOWCARDIA, INC.

## 5) 510(k) Summary

This summary of 510(k) information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21CFR807.92.

510(k) Number

## Applicant Information

Date Prepared: November 20, 2007

| Name and Address: | FlowCardia, Inc. |
|-------------------|-------------------------------------------|
| | 745 N. Pastoria Avenue |
| | Sunnyvale, CA 94085 |
| | Ph: [phone] |
| Contact Person: | Dustin Michaels, Sr. Director of RA/QA/CR |
| | Ph: [phone] x302 |
| | Fax: [phone] |

#### Device Information

| Classification: | DQY |
|----------------------|-------------------------------------------------|
| Trade Name: | MicroSheath XL Catheters |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter, 74 DQY / 21 CFR 870.1250 |

#### Predicate Devices

The VP Shcath manufactured by FlowCardia, Inc. (K051580) Viking 6Fr Guiding Catheters manufactured by Guidant (K972484) Zuma 6Fr Guiding Catheters manufactured by Mcdtronic (K981198)

#### Device Description

The FlowCardia MicroSheath™ XL is a single lumen catheter that is available in four lengths: 53cm, 73cm, 93cm or 123cm, and three different tip configurations: vertebral, internal mammary artery, and multipurpose. All MicroSheath XL catheters have a standard lucr fitting at the proximal end. A radiopaque distal tip aids in fluoroscopic visualization. The distal tip is atraumatic to help facilitate vessel navigation. The MicroSheath XL is also 7F Sheath compatible.

{1}------------------------------------------------

# Intended Use:

The MicroSheath XL is a single lumcn catheter intended to create a pathway for other devices in the peripheral vasculature.

# Technological Characteristics

The MicroSheath XL is equivalent to the VP Sheath with respect to materials, manufacturing methods and sterilization. It is also substantially equivalent to the Viking and Zuma guiding catheters in terms of catheter stiffness, tensile strength, torque strength, and tip shapes. The MicroSheath XL is substantially cquivalent to all three predicate devices when comparing intended use.

# Physical Test Data

Design analysis, bench, and biocompatibility testing were conducted according to the relevant guidance documents to demonstrate that the FlowCardia MicroSheath XL Catheters met the acceptance criteria and performed similarly to the predicate devices. In addition to dimensional verification, the following functional tests were performed and compared to the predicates: Tensile Strength, Tip Flexibility, Access and Navigation Bench Modeling, Critical Bend Testing, Leak and Pressure Testing, Tensile Testing, and Torque Strength.

# Conclusion

Based upon these comparisons the MicroSheath XL is substantially equivalent to the predicate devices.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a bird in flight. The symbol is composed of three curved lines that converge to form the body and wings of the bird.

Public Health Service

JAN 11 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FlowCardia, Inc. c/o Mr. Dustin Michaels Sr. Director 745 N. Pastoria Avenue Sunnyvale, CA 94085

Re: K073289 MicroSheath XL Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: November 20, 2007 Received: November 21, 2007

Dear Mr. Michaels:

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.

{3}------------------------------------------------

Page 2 - Mr. Dustin Michaels

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Dona R. Vochmel

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Statement of Indications for Use

510(k) Number (if known):

KO 73289

Device Name:

#### MicroSheath XL Catheters

Indications for Use:

The MicroSheath XL is a single lumen catheter intended to create a pathway for other devices in the peripheral vasculature.

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)

Duna R. Jame

Division of Carakorasoular Devices

510(k) Number K073289