CROSSER RECANALIZATION SYSTEM

K112308 · C.R. Bard, Inc. · PDU · Aug 17, 2011 · Cardiovascular

Device Facts

• Record ID: K112308
• Device Name: CROSSER RECANALIZATION SYSTEM
• Applicant: C.R. Bard, Inc.
• Product Code: PDU · Cardiovascular
• Decision Date: Aug 17, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

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

Device Story

System uses high-frequency mechanical vibration to recanalize peripheral artery chronic total occlusions (CTO). Components: electronic generator, foot switch, transducer, single-use catheter, sterile drape. Generator/transducer convert AC power to high-frequency mechanical vibrations; energy propagates through Nitinol core wire to titanium or stainless steel catheter tip. Vibrational energy ablates plaque via mechanical impact and cavitation. Used in clinical settings by physicians. Requires power injector for saline delivery. Output is mechanical vibration at catheter tip; enables guidewire passage through occlusions. Benefits patient by facilitating recanalization of otherwise difficult-to-cross arterial blockages.

Clinical Evidence

Bench testing only. No clinical data presented. Substantial equivalence supported by prior bench testing and risk assessment confirming the device meets design requirements for the clarified indications.

Technological Characteristics

System consists of electronic generator, foot switch, transducer, and single-use catheter. Catheter materials: Nitinol core wire, titanium or stainless steel tip, Pebax shaft with hydrophilic coating. Energy source: AC power converted to high-frequency mechanical vibration. Catheter configurations vary by diameter (0.6mm to 1.5mm) and length (125cm to 154cm). Sterilization: Not specified. Connectivity: Standalone system requiring manual operation via foot switch.

Indications for Use

Indicated for patients with peripheral artery chronic total occlusions to facilitate intra-luminal guidewire placement via atherectomy. 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™ System (K072776, K091119, K092175)
• Diamondback 360 Orbital Atherectomy System (K090521)
• Jetstream System (K110626)

Submission Summary (Full Text)

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K112308 page 1 of 4

AUG 17 2011

### CROSSER™ Recanalization System

#### 510(k) Summary 21 CFR 807.92

As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is based is as follows:

#### Submitter Information:

| Applicant: | FlowCardia, Inc<br>745 N. Pastoria Ave.<br>Sunnyvale, CA 94085 |
|------------|----------------------------------------------------------------|
| Phone: | 480-638-2939 |
| Fax: | 480-449-2546 |
| Contact: | Timothy Wade, Regulatory Affairs Associate |
| Date | July 28, 2011 |

| Device Trade Name: | CROSSER TM Recanalization System |
|-----------------------|------------------------------------------------------------------------|
| Common or Usual Name: | Peripheral Atherectomy Catheter (21 CFR<br>870.4875, Product Code MCW) |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |

#### Predicate Devices:

- CROSSER™ System .
- Models: GEN200, CRU14S, CRU14P, CRU18 (K072776; cleared o December 7, 2007)
- Models: GEN200, CRUO14S, CRUO14P (K091119; cleared May o 15, 2009)
- Models: GEN200, CRUS6 (K092175; cleared February 17, 2010) O
- Diamondback 360 Orbital Atherectomy System (K090521; cleared March ● 20, 2009)
- . Jetstream System (K110626; cleared April 20, 2011)

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#### Device Description:

The CROSSER™ Recanalization System is a high frequency mechanical vibration device designed for placement of guidewires through obstructed peripheral arteries by the removal or reduction of occlusive material. The system consists of an electronic CROSSER™ Generator, Foot Switch, high frequency Transducer, single-use CROSSER™ Catheter and sterile drape. The catheters are offered in a variety of configurations as shown in the table below. The system is required to be used with a power injector system for the delivery of saline. The CROSSER™ Catheter, which is intended for one procedure only, is connected to the CROSSER™ Generator through the high frequency The Foot Switch is used to activate the CROSSER™ System. The Transducer. CROSSER™ Generator and Transducer convert AC power into high frequency mechanical vibrations, which are propagated through a Nitinol core wire to the titanium or stainless steel tip of the CROSSER™ Catheter. The main body of the catheter is constructed from Pebax and a hydrophilic coating which covers the distal end of the catheter. The vibrational energy ablates intravascular plaque by mechanical impact and cavitational effects.

| | CROSSER Catheters<br>14P and 14S | CROSSER Catheter<br>18 | CROSSER Catheter<br>S6 |
|----------------------------------|----------------------------------------|--------------------------------|--------------------------------|
| Working Length | 146cm | 125cm | 154cm |
| Tip Outer Diameter | 1.1mm (0.044") | 1.5mm (0.061") | 0.6mm (0.025") |
| Catheter Shaft Outer<br>Diameter | Rapid<br>Exchange<br>1.3mm<br>(0.052") | 1.5mm (0.058") | 1.3mm (0.051") |
| | Over The<br>Wire<br>1.6mm<br>(0.063") | | |
| Guidewire Lumen<br>Length | Rapid<br>Exchange<br>20cm | Rapid Exchange<br>20cm | n/a* |
| | Over The<br>Wire<br>152 cm | | |
| Guidewire Compatibility | 0.014" (0.36mm) | 0.018" (0.46mm) | n/a* |
| Guide Catheter<br>Compatibility | 6Fr<br>(min ID 0.067" [1.7mm]) | 7Fr<br>(min ID 0.080" [2.0mm]) | 5Fr<br>(min ID 0.053") [1.3mm] |
| Sheath Compatibility | 5Fr<br>(min ID 0.067" [1.7mm]) | 6Fr<br>(min ID 0.080" [2.0mm]) | 5Fr<br>(min ID 0.053") [1.3mm] |

* CROSSER™ Catheter S6 does not contain a guidewire lumen but creates a channel large enough to accommodate a guidewire up to 0.018".

#### Indications for Use of Device:

The CROSSER™ Recanalization System is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions

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via atherectomy. The device is contraindicated for use in the carotid arteries. The CROSSER™ Catheter is only intended for use with the CROSSER™ Generator. Refer to the CROSSER™ Generator Manual of Operations for proper use.

### Review of the Modified Indications for Use:

The modified indication for use statement for the CROSSER™ Recanalization System does not raise any new issues of safety and effectiveness as demonstrated through the risk analysis process based on the proposed indications for use statement as compared to the predicate devices, the CROSSER™ System, the Diamondback System, and the Jetstream System. The modified indication clarifies the mechanism of action by which the CROSSER™ Recanalization System recanalizes a Chronic Total Occlusion (CTO) as the removal or reduction of occlusive material from the artery (atherectomy). The Diamondback System and Jetstream Systems are also indicated for the atherectory of occlusive material in the peripheral arteries. Therefore, the subject device, the CROSSER™ Recanalization System, is substantially equivalent to the predicate devices.

### Technological Comparison to Predicate Devices:

The CROSSER™ Recanalization System has the following similarities to the predicate devices:

- Similar intended use (all predicates) .
- Similar indications for use (all predicates) .
- Same target population (all predicates) .
- Same fundamental scientific technology (all predicates) .
- Same operating principle (Crosser predicates) .
- Similar operating principle (Diamondback and Jetstream predicates) .
- Same mechanism of action (all predicates) .
- Same materials (Crosser predicates) .
- Same packaging materials and configuration (Crosser predicates) .
- Same sterility assurance level and method of sterilization (Crosser ● predicates)

#### Performance Data:

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To demonstrate substantial equivalence of the subject device, the CROSSER™ Recanalization System to the predicate devices, the technological characteristics and performance criterion were evaluated through bench testing. Using FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Assessment procedures, no additional in vitro tests or in vivo studies were required as the Crosser System previously met all requirements. As this 510(k) is clarifying the system mechanism of action, prior bench testing is presented.

#### Conclusions:

The subject device, the Crosser™ Recanalization System, satisfied the design requirements associated with the modified indications for use statement, as specified by applicable standards, guidance, test protocols and/or customer inputs. Therefore, the Crosser™ Recanalization System is substantially equivalent to the legally marketed predicate devices, the Crosser™ System, the Diamondback System, and the Jetstream System.

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

C.R. Bard, Inc. c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th St. NW Buffalo, MN 55313

SEP 1 8 2013

Re: K112308

Trade/Device Name: Crosser Recanalization System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: August 10, 2011 Received: August 11, 2011

Dear Mr. Job:

This letter corrects our substantially equivalent letter of August 17, 2011.

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. Isting 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

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comply with all the Act's requirements, including, but not limited to: registration and listing (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 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,

ZZn.Z

for

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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## Indications for Use

# 510(k) Number (if known): K112308

..

Device Name: CROSSER™ Recanalization System

Indications for Use: The CROSSER™ Recanalization System is indicated · to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions via atherectomy. The device is contraindicated for use in carotid arteries.

The CROSSER™ Catheter is only intended for use with the CROSSER™ Generator. Refer to the CROSSER™ Generator Manual of Operations for proper use.

Prescription Use_X (Part21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Oit) Division of Cardiovascular Devices

510(k) Number K112309

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