THE CROSSER CATHETER, MODEL CR1100 AND SYSTEM ELECTRONICS, MODEL FG1002-02

K062868 · Flowcardia, Inc. · DQY · Jan 19, 2007 · Cardiovascular

Device Facts

• Record ID: K062868
• Device Name: THE CROSSER CATHETER, MODEL CR1100 AND SYSTEM ELECTRONICS, MODEL FG1002-02
• Applicant: Flowcardia, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Jan 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CROSSER System is indicated in coronary arteries to facilitate the intra-luminal placement of conventional guidewires beyond chronic total occlusions.

Device Story

The CROSSER System is a percutaneous catheter system used to facilitate the crossing of chronic total occlusions in coronary arteries. The system comprises a reusable electronic generator, a foot switch, a high-frequency transducer, and a single-use CROSSER 14 catheter. The generator and transducer convert AC power into high-frequency mechanical vibrations, which are transmitted through a Nitinol core wire to the stainless steel tip of the catheter. The device is operated by a physician in a clinical setting. By applying high-frequency mechanical energy at the occlusion site, the device facilitates the advancement of conventional guidewires beyond the obstruction. This process assists in recanalization, potentially benefiting patients by enabling successful intervention in complex vascular occlusions.

Clinical Evidence

Clinical study demonstrated safety and effectiveness substantially equivalent to the predicate device. Bench testing included dimensional verification, tensile strength, torque strength, torqueability, tip flexibility, coating adherence/integrity, biocompatibility, simulated efficiency, catheter fatigue, shelf life, and package integrity testing.

Technological Characteristics

System includes electronic generator, foot switch, transducer, and CROSSER 14 catheter. Catheter constructed from Pebax with hydrophilic coating on distal 90cm; features Nitinol core wire and stainless steel tip. Energy source: high-frequency mechanical vibration. Radiopaque tip for visualization. Compatible with standard coronary guide catheters and percutaneous techniques.

Indications for Use

Indicated for patients with chronic total occlusions in coronary arteries to facilitate intra-luminal placement of conventional guidewires.

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

• Safe Cross Radio Frequency Total Occlusion Crossing System (K032031)

Submission Summary (Full Text)

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# FLOWCARDIA, INC.

# 5) 510(k) Summary

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

| 510(k) Number | K062868 |
|---------------|---------|
|---------------|---------|

# Applicant Information Date Prepared: September 22, 2006 Name and Address: FlowCardia, Inc. 745 N. Pastoria Avenue Sunnyvale, CA 94085 Ph: [phone] Contact Person: Dustin Michaels, Director of RA/CR Ph: [phone] x302 Fax: [phone]

#### Device Information

| Classification: | DQY |
|----------------------|-------------------------------------------------|
| Trade Name: | The CROSSER System |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter, 74 DQY / 21 CFR 870.1250 |

#### Predicate Device

Safe Cross Radio Frequency Total Occlusion Crossing System manufactured by Intraluminal Therapeutics, Inc. (K032031)

#### Device Description

The CROSSER System consists of a re-usable electronic Generator, Foot Switch, high frequency Transducer, and single-use CROSSER 14 Catheter. The CROSSER 14 Catheter is connected to the electronic Generator through the Transducer. The Foot Switch is used to activate the system. The Generator and Transducer convert AC power into high frequency mechanical vibrations which are propagated through a Nitinol core wire to the stainless steel tip of the CROSSER 14 Catheter. The main

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body of the catheter is constructed from Pebax and a hydrophilic coating which covers the distal 90cm of the catheter.

### Technological Characteristics

The FlowCardia CROSSER System is substantially equivalent to the Intraluminal Therapeutics (ILT) Safe-Cross System in intended use. The design (or mode of operation) of the Safe-Cross Wire is similar to the CROSSER 14 Catheter in that it is intended to be delivered through standard coronary guide catheters to a vascular occlusion and then used to facilitate recanalization of the obstruction. Both have roughly the same working length (146cm vs. 175cm) and are designed to be compatible with standard percutaneous techniques and equipment. The devices are constructed from commonly used catheter materials and coated with a hydrophilic material for increased lubricity. Their radiopaque tips are used to visualize their location within the body.

The Safe-Cross and the CROSSER System both use an energy source to facilitate placement of devices beyond total occlusions. The Safe-Cross System uses RF energy for this purpose versus the CROSSER System which utilizes high frequency vibration. Despite the differences in both energy source and construction materials the intended and method of use are substantially equivalent.

#### Physical Test Data

Design analysis, bench, and biocompatibility testing were conducted according to the relevant guidance documents to demonstrate that the FlowCardia CROSSER System met the acceptance criteria and performed similarly to the predicate device. In addition to dimensional verification, the following functional tests were performed: Tensile Strength, Torque Strength, Torqueability, Tip Flexibility, Coating Adherence/Integrity, Biocompatibility, Bench top Simulated Efficiency, Catheter Fatigue Testing. Shelf Life and Package Integrity Testing.

#### Clinical Test Data

In addition to the physical test data above, clinical study of the FlowCardia CROSSER System demonstrated substantially equivalent safety and effectiveness.

#### Conclusion

Based upon device physical and clinical comparisons the CROSSER System is substantially equivalent to the predicate device.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 9 2007

FlowCardia, Inc. c/o Mr. Dustin Michaels Director of Regulatory Affairs and Clinical Research 745 N. Pastoria Avenue Sunnyvale, CA 94085

Re: K062868 The CROSSER System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutancous Catheter Regulatory Class: II (two) Product Code: DQY Dated: January 11, 2007 Received: January 12, 2007

Dear Mr. Michaels:

We have reviewed your Scction 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 adultcration.

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 devire can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, TDA move publish further announcements concerning your device in the Federal Register.

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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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

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):

K062868

Device Name: .

The CROSSER System

Indications for Use:

The CROSSER System is indicated in coronary arteries to facilitate the intra-luminal placement of conventional guidewires beyond chronic total occlusions.

Prescription Use X (Part 21 CFR 801 Subpart

AND/OR

Over-The-Counter Use

D)

(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)

| (Division Sign-Off) | |
|----------------------------|---------|
| Division of Cardiovascular | |
| 510(k) Number | K062868 |