ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER

K111043 · Boston Scientific Corp · OBJ · Aug 4, 2011 · Cardiovascular

Device Facts

• Record ID: K111043
• Device Name: ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER
• Applicant: Boston Scientific Corp
• Product Code: OBJ · Cardiovascular
• Decision Date: Aug 4, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The iCross™ and Atlantis™ SR Pro2 Coronary Imaging Catheters are intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

Device Story

The iCross and Atlantis SR Pro2 are sterile, single-use, 40MHz intravascular ultrasound (IVUS) imaging catheters. The device consists of a sheath assembly with a hydrophilic coating and an internal rotating imaging core containing a piezoelectric transducer. The catheter connects to compatible imaging consoles (ClearView Ultra, Galaxy, Galaxy2, or iLab). The transducer converts electrical energy from the console into ultrasonic energy for tissue examination and converts returned echoes back into electrical signals for display. A proximal telescoping section allows the imaging core to advance or retract across an anatomical region of interest without moving the sheath. Used by clinicians during coronary interventional procedures to visualize intravascular pathology; the output provides real-time ultrasonic images to assist in clinical decision-making and procedural guidance.

Clinical Evidence

No clinical data. Evidence consists of bench testing, biocompatibility testing, and sterilization validation. Bench testing confirmed performance, electrical, and mechanical requirements post-Ebeam sterilization. Acoustic output testing verified levels remain below Track 1 exposure limits per FDA guidance.

Technological Characteristics

40MHz intravascular ultrasound catheter; piezoelectric transducer; hydrophilic coating on distal 230mm; short rail (SR) design with proximal telescoping section; Ebeam sterilization; compatible with BSC ClearView Ultra, Galaxy, Galaxy2, and iLab consoles.

Indications for Use

Indicated for patients who are candidates for transluminal coronary interventional procedures requiring ultrasound examination of coronary intravascular pathology.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• iCross™ Coronary Imaging Catheter (K063312)
• Atlantis™ SR Pro2 Coronary Imaging Catheter (K063312)

Submission Summary (Full Text)

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Submitted by: Boston Scientific Corporation 47900 Bayside Parkway Fremont, CA 94538 Emilly Tojima Nurthen Contact: Regulatory Affairs Manager 47900 Bayside Parkway Fremont, CA 94538 [phone] Date Prepared: April 14, 2011 iCross™ Coronary Imaging Catheter Trade Names: Atlantis™ SR Pro2, Coronary Imaging Catheter

#### Common Names/Classification:

| | Diagnostic Intravascular Catheter, 21 CFR 870.1200 (OBJ)<br>Diagnostic Ultrasonic Transducer, 21 CFR 892.1570 (ITX) |
|--------------------|---------------------------------------------------------------------------------------------------------------------|
| Predicate Devices: | iCross™ Coronary Imaging Catheter |
| | Atlantis™ SR Pro2 Coronary Imaging Catheter |
| | K063312, cleared on November 30, 2006 |

#### Device Description:

The Catheters are sterile, single use, short rail (SR) 40MHz imaging catheters. These catheters are intended to operate with the BSC ClearView Ultra, Galaxy, Galaxy2, or iLab intravascular ultrasound imaging consoles. The coronary imaging catheter and console form an imaging system for ultrasonic examination of coronary intravascular pathology.

The Catheters consist of two (2) main assemblies: a sheath assembly and an imaging core assembly. The sheath assembly is the outer part of the catheter that comprises much of the working length of the device, and has a hydrophilic coating to the distal 230mm on the catheter. The imaging core is internal to the sheath assembly and rotates independently of the sheath. The imaging core contains the piezoelectric transducer that converts electrical energy from the imaging console to ultrasonic energy that is in turn transmitted. The transducer converts the returned ultrasonic energy into electrical energy for display on the instrument. The rotating imaging core driveshaft directs the path of the ultrasonic energy (beam) from the transducer. A proximal telescoping section allows the

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Boston Scientific Cornarstini

imaging core to be retracted and advanced, across an anatomical region of interest, without requiring movement of the sheath within the anatomy.

## Intended Use/Indications for Use:

The iCross™ and Atlantis™ SR Pro2 Coronary Imaging Catheters are intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

#### Predicate Device Comparison

The modified Catheter has the same design, materials, intended use and method of manufacture as the predicate device with the exception of product sterilization using Electron Beam (Ebeam) irradiation instead of Gamma irradiation in the currently marketed Catheters.

## Non-Clinical Test Results

Bench and biocompatibility testing, in addition to a sterilization validation were conducted to demonstrate the modified iCross and Atlantis SR Pro- Coronary Imaging Catheters meet performance requirements and are substantially equivalent to the predicate devices.

## Bench Testing

Bench testing was conducted to evaluate if the modified iCross and Atlantis SR Pro2 catheters continue to meet product specifications post Ebeam sterilization. This evaluation consisted of performance, visual inspections, electrical and mechanical tests, of which the results demonstrated the devices satisfy all functional and physical requirements.

Acoustic output testing was conducted in accordance with the FDA Guidance Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (Sept 9, 2008) and the results continue to be below the Track 1 acoustic output exposure levels.

#### Biocompatibility

The modified iCross and Atlantis SR Pro- Coronary Catheters were tested for biocompatibility and the results demonstrate the devices are considered biocompatible for their intended use.

#### Sterilization

The sterilization validation confirmed Ebeam irradiated iCross and Atlantis SR Pro2 Coronary Imaging Catheters continue to meet a Sterility Assurance Level (SAL) of 10°

## Conclusion

The testing conducted on the modified Catheters demonstrates they continue to meet performance requirements and are safe and effective for their intended use. The modified

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and and the states of

## comments Bostom Bolenille our politic or a comments of the service

iCross and Atlantis SR Pro2 Coronary Imaging Catheters have the same intended use as the predicate and the test results support a determination of substantial equivalence to the currently marketed Catheters.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002

Boston Scientific Corporation c/o Emilly Tojima Nurthen . Regulatory Affairs Manager 47900 Bayside Parkway Fremont. CA 94538

AUG - 4 2011

Re: K11043/S001

Trade/Device Name: iCross™ and Atlantis™ SR Pro2 Coronary Imaging Catheters Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheters Regulatory Class: Class II (two) Product Code: OBJ, ITX Dated: July 8, 2011 Received: July 11, 2011

Dear Ms Tojima:

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 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 -- - -

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Page 2 – Ms. Tojima

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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Resourcesfor You/Industry/default.htm.

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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# lications for Us

K-11 1043 510(k) Number:

ーナー 【あるのですが、何分からないと言えます

Device Names: iCross™ Coronary Imaging Catheter, Atlantis™ SR Pro2 Coronary Imaging Catheter

Indications for Use:

The iCross™ and Atlantis™ SR Pro2 Coronary Imaging Catheters are intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Sieyascular Devices

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