MICROSHEATH LP AND LP-AT

K080849 · Flowcardia, Inc. · DQY · Jul 25, 2008 · Cardiovascular

Device Facts

• Record ID: K080849
• Device Name: MICROSHEATH LP AND LP-AT
• Applicant: Flowcardia, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Jul 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

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

Device Story

MicroSheath LP is a 123 cm single-lumen percutaneous catheter; available in straight or angled tip configurations. Distal tip is atraumatic to facilitate vessel navigation. Radiopaque markers (one on straight, five on angled) enable fluoroscopic visualization. Device is 6F Sheath/7Fr Guide compatible. Used by physicians in clinical settings to create a pathway for other interventional devices within coronary or peripheral vasculature. Operates via manual insertion and navigation under fluoroscopic guidance. Provides mechanical access to target vascular sites; facilitates subsequent device delivery.

Clinical Evidence

Bench testing only. No clinical data provided. Functional 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 catheter, 123 cm length, luer fitting. Available in straight/angled tip shapes. Radiopaque markers for fluoroscopy. 6F Sheath/7Fr Guide compatible. Materials, manufacturing, and sterilization equivalent to predicate.

Indications for Use

Indicated for patients requiring a pathway for other devices in the coronary or 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)

Submission Summary (Full Text)

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# 5) 510(k) Summary

JUL 2 5 2008

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

510(k) Number Ko8 0849

# Applicant Information

Date Prepared: March 25, 2008

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

## Device Information

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

## Predicate Devices

The VP Sheath manufactured by FlowCardia, Inc. (K051580)

## Device Description

The FlowCardia MicroSheath LP a single lumen catheter, 123 cm in length, with a standard luer fitting at the proximal end. The catheter is available in two tip shapes, straight and angled. The distal tip is atraumatic to help facilitate vessel navigation. A single radiopaque marker on the straight version of the MicroSheath LP and five radiopaque markers on the angled version aid in fluoroscopic visualization. The MicroSheath LP is 6F Sheath/7Fr Guide compatible.

## Intended Use:

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

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#### Technological Characteristics

The MicroSheath LP is equivalent to the VP Sheath with respect to materials, manufacturing methods and sterilization. It is also substantially equivalent to the predicate in terms of catheter stiffness, tensile strength, and torque strength. The MicroSheath LP and predicate device have the same 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 LP 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 LP is substantially equivalent to the predicate device.

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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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Flowcardia, Inc. c/o Mr. Dustin Michaels Vice President of CR/QA/RA 745 N. Pastoria Avenue Sunnyvalc, CA 94085

JUL 2 5 2008

K080849 Re: MicroSheath LP Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: Class II Product Code: DQY Dated: July 17, 2008 Received: July 18, 2008

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 ass battle 11 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 rr your de fiel to such additional controls. Existing major regulations affecting your device can be fray of babyer 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 r fouse be advisou and 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.

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Page 2 – Mr. Dustin Michaels

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,

Dina R. Lochner

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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Statement of Indications for Use

510(k) Number (if known):

K080849

Device Name:

#### MicroSheath LP Catheters

Indications for Use:

The MicroSheath LP is a single lumen catheter intended to create a pathway for other devices in the coronary or 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)

Dona R. LaClair

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K 080899