THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200

K092175 · Flowcardia, Inc. · PDU · Feb 17, 2010 · Cardiovascular

Device Facts

• Record ID: K092175
• Device Name: THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200
• Applicant: Flowcardia, Inc.
• Product Code: PDU · Cardiovascular
• Decision Date: Feb 17, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CROSSER S6 System is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions. The device is contraindicated for use in carotid arteries. The CROSSER S6 Catheter is only intended for use with the CROSSER Electronics System. Refer to the CROSSER Electronics System Manual of Operations for proper use.

Device Story

System consists of reusable electronic generator, foot switch, high-frequency transducer, and single-use CROSSER S6 catheter. Generator and transducer convert AC power into high-frequency mechanical vibrations; vibrations propagate through internal Nitinol core wire to stainless steel catheter tip. Used in clinical settings to facilitate guidewire placement across peripheral artery chronic total occlusions. Physician operates foot switch to activate system; mechanical energy at tip assists in navigating occlusions. Benefits include improved ability to cross difficult lesions, facilitating subsequent interventional procedures.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, including dimensional verification, tensile strength, torque strength, torqueability, tip flexibility, coating adherence/integrity, biocompatibility, simulated efficiency, catheter fatigue, and shelf life testing. Animal studies were previously conducted with the predicate CROSSER LP device to establish initial safety and performance.

Technological Characteristics

System components: reusable electronic generator, transducer, foot switch, and single-use catheter. Catheter materials: Nitinol core wire, stainless steel tip, Pebax body, hydrophilic coating. Energy source: AC power converted to high-frequency mechanical vibrations. Connectivity: proprietary connection between catheter and electronics system. Sterilization: not specified.

Indications for Use

Indicated for patients with peripheral artery chronic total occlusions to facilitate intra-luminal placement of conventional guidewires. Contraindicated for use in carotid arteries.

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

• CROSSER LP System (K080765)
• CROSSER System (K072776)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for FLOWCARDIA, INC. The logo features the company name in bold, uppercase letters, with a horizontal line underneath. To the right of the name, there is a stylized image of a heart connected to a sine wave, possibly representing blood flow or cardiac activity.

# 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.

| <b>510(k) Number</b> | K092175 |
|------------------------------|-----------------------------------------------------------------------------------------------|
| <b>Applicant Information</b> | FEB 1 7 2010 |
| Date Prepared: | July 16, 2009 |
| 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] |
| <b>Device Information</b> | |
| Classification: | DQY |

| Classification: | DQY |
|----------------------|-------------------------------------------------|
| Trade Name: | The CROSSER S6 System |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter, 74 DQY / 21 CFR 870.1250 |

## Predicate Devices

The CROSSER LP System manufactured by FlowCardia, Inc. (K080765) The CROSSER System manufactured by FlowCardia, Inc. (K072776)

## Device Description

The CROSSER S6 System consists of a re-usable electronic Generator, Foot Switch, high-frequency Transducer, and single-use CROSSER S6 Catheter.

Each 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 Catheter. The main body of the catheter

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is constructed from Pebax and a hydrophilic coating which covers the distal end of the catheter.

## Indications For Use

The CROSSER S6 System is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions. The device is contraindicated for use in carotid arteries.

The CROSSER S6 Catheter is only intended for use with the CROSSER Electronics System. Refer to the CROSSER Electronics System Manual of Operations for proper use.

## Technological Characteristics

The FlowCardia CROSSER S6 System is substantially equivalent to the predicate devices. The predicate CROSSER LP Catheter (K080765) and CROSSER S6 Catheter are substantially equivalent with respect to materials, design, construction, and performance. The CROSSER S6 System has the same indication as the predicate CROSSER System (K072776). All CROSSER Systems utilize the same CROSSER Electronics (Generator, transducer, foot switch) for operation.

# Physical Test Data

Design analysis, bench, and biocompatibility testing were conducted according to the relevant guidance documents to demonstrate that the FlowCardia CROSSER S6 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, and Shelf Life Testing. Animal studies were conducted with the CROSSER LP predicate device to establish initial safety and performance.

## Conclusion

Based upon device physical comparisons, the CROSSER S6 System is substantially equivalent to the predicate devices.

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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 eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

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

FlowCardia, Inc. Mr. Dustin Michaels Vice President, Clinical, Quality & Regulatory Affairs 745 N. Pastoria Ave. Sunnyvale, CA 94085

Re: K092175

Trade/Device Name: Crosser S6 Catheter System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: December 4, 2009 Received: December 7, 2009

SEP 1 8 2013

Dear Mr. Michaels:

This letter corrects our substantially equivalent letter of February 17, 2010.

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 Amendmonts 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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

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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Z.M.Z.

Image /page/3/Picture/8 description: The image shows the word "for" written in cursive. The letters are connected and slightly slanted to the right. The word is written in a dark color, possibly black or dark blue, against a white background.

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):

K092195

Device Name:

The CROSSER S6 System

Indications for Use:

The CROSSER S6 System is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions. The device is contraindicated for use in carotid arteries.

The CROSSER S6 Catheter is only intended for use with the CROSSER Electronics System. Refer to the CROSSER Electronics System Manual of Operations for proper use.

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)

-

unar R. Vadner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K 09217 5