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

AI/ML Overview

The provided text is a 510(k) summary for the iCross™ and Atlantis™ SR Pro2 Coronary Imaging Catheters. It describes a change in sterilization method (from Gamma irradiation to Ebeam irradiation) for an already cleared device. As such, the study conducted is primarily for demonstrating substantial equivalence after this change, rather than proving performance against specific clinical acceptance criteria for a novel device.

Therefore, many of the requested categories for a new device's performance study may not be directly applicable or fully detailed in this type of submission.

Here's an analysis based on the provided document:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

Summary: The device in question, the iCross™ and Atlantis™ SR Pro2 Coronary Imaging Catheters, did not undergo a study to demonstrate novel performance against clinical acceptance criteria. Instead, the submission describes a modification to an already cleared device (changing the sterilization method) and the studies conducted were to demonstrate that this modification does not adversely affect the device's original performance, safety, and effectiveness, thereby maintaining substantial equivalence to the predicate. The "acceptance criteria" in this context refer to maintaining the product specifications and safety profiles established for the original device.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Modified Device Post-Ebeam Sterilization)	Reported Device Performance
Performance Requirements: Continue to meet product specifications.	"the results demonstrated the devices satisfy all functional and physical requirements."
Visual Inspections: No adverse changes.	Part of the bench testing, implicitly met by "satisfy all functional and physical requirements."
Electrical Tests: No adverse changes.	Part of the bench testing, implicitly met by "satisfy all functional and physical requirements."
Mechanical Tests: No adverse changes.	Part of the bench testing, implicitly met by "satisfy all functional and physical requirements."
Acoustic Output: Remain below Track 1 acoustic output exposure levels (per FDA Guidance Sep 9, 2008).	"the results continue to be below the Track 1 acoustic output exposure levels."
Biocompatibility: Considered biocompatible for intended use.	"the results demonstrate the devices are considered biocompatible for their intended use."
Sterility Assurance Level (SAL): Maintain an SAL of 10⁻⁶.	"The sterilization validation confirmed Ebeam irradiated iCross and Atlantis SR Pro2 Coronary Imaging Catheters continue to meet a Sterility Assurance Level (SAL) of 10⁻⁶."
Substantial Equivalence: Maintain same design, materials, intended use, and method of manufacture (except sterilization).	"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..." "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 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."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes for the bench testing, biocompatibility testing, or sterilization validation. It only states that these tests were "conducted." The data provenance is not mentioned, as these are technical bench and lab tests, not clinical studies. The tests are prospective in nature, as they are conducted specifically for the submission to demonstrate the impact of the Ebeam sterilization.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable to this submission. The "ground truth" for these tests consisted of established product specifications, industry standards (e.g., for acoustic output), and regulatory requirements (e.g., for biocompatibility and SAL). These are objective measurements and validations, not subjective interpretations requiring medical experts to establish ground truth in the way a diagnostic AI might.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of medical images or data. The tests conducted here are objective engineering, biological, and sterilization validations, not requiring human adjudication of subjective interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. This submission is for a physical medical device (imaging catheter) with a changed sterilization method, not an AI or diagnostic software. Therefore, no MRMC study or AI-related comparative effectiveness study was performed or is relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This is a hardware device, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the tests performed can be characterized as:

Engineering Specifications: For functional, physical, electrical, and mechanical requirements.
Regulatory Standards/Guidance: For acoustic output (FDA Guidance), biocompatibility (standardized tests for medical devices), and sterility (SAL 10⁻⁶ standard).
Predicate Device Performance: The underlying "ground truth" for the overall device performance is that it should perform equivalently to the predicate device, which was already cleared.

8. The sample size for the training set

This is not applicable. There is no training set mentioned or implied, as this is not a machine learning or AI device.

9. How the ground truth for the training set was established

This is not applicable, as there is no training set.

Summary

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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 (510) 624-2546 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)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:

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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:

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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Image /page/3/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & H.S." is arranged vertically along the left side of the logo.

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 (800) 638-2041 or (301) 796-7100 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:

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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Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
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.(b)
Classification. Class II (performance standards).