The Atlantis™ 018 Peripheral Imaging Catheter is intended for intravascular ultrasound examination of peripheral vessels only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

Device Description

The Atlantis™ 018 Peripheral Imaging Catheter is a sterile, single patient use 40MHz transducer imaging catheter, intended for intravascular ultrasound examination of peripheral vessels. This imaging catheter is designed to be operated with Boston Scientific Corporation (BSC) Intravascular Ultrasound (IVUS) Systems: iLab™ (K072517), Galaxy2/Galaxy (K980851), and Clearview™M Ultra (K921750). The Atlantis™ 018 Peripheral Imaging Catheter consists of two main assemblies: Imaging core and Catheter body. The catheter body comprises three sections: Distal lumen, Proximal single lumen, and Telescoping section. The imaging core is composed of a hi-torque, flexible, rotating drive cable with a radial looking 40 MHz ultrasonic transducer at the distal tip. An electro-mechanical connector interface at the proximal end makes the connection to the BSC IVUS System Motor Drive Unit (MDU).

AI/ML Overview

The Atlantis™ 018 Peripheral Imaging Catheter is an intravascular ultrasound catheter intended for examination of peripheral vessels. The submission does not detail specific quantitative acceptance criteria with numerical targets. Instead, it relies on demonstrating that the device "meets or exceeds" performance requirements through various tests.

Here's a breakdown of the requested information based on the provided text:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from text)	Reported Device Performance
Bench Testing	Physical integrity and functionality (dimensional and functional verification)	"Met or exceeded all required specifications."
Acoustic Output	Acoustic output within FDA guidance document limits (FDA Track 1 specified limits)	"Test results are below the FDA Track 1 specified limits."
Animal Testing	In-vivo deliverability and imaging characteristics demonstrating clinical acceptability for intended use	"Demonstrated clinical acceptability for the intended use."
Biocompatibility	Acceptable for intended use per ISO-10993 and G95-1	"Test results demonstrate the device is acceptable for its intended use."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for the bench, acoustic output, or animal testing.

Bench Testing: "Bench testing was conducted to evaluate the physical integrity and functionality of the catheter sheath and imaging core." No specific sample size provided.
Acoustic Output: "Acoustic output testing was conducted..." No specific sample size provided.
Animal Testing: "The Atlantis™ 018 Peripheral Imaging Catheter was evaluated through animal testing..." No specific sample size provided.
Data Provenance: The document does not specify the country of origin for any test data or whether it was retrospective or prospective. It implies these were studies specifically conducted for this submission (prospective, in-house testing).

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish a "ground truth" in the context of human interpretation for diagnostic performance. The evaluation is focused on the physical device's performance through bench, acoustic, animal, and biocompatibility tests.

4. Adjudication Method

Not applicable, as this is a device performance evaluation, not a study involving human interpretation with a need for adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission is for an imaging catheter, not an AI software or a device that directly aids human readers in interpretation.

6. Standalone Performance Study

Yes, the studies described are essentially standalone performance evaluations of the device itself (bench, acoustic, animal, and biocompatibility testing). The "algorithm" here is the physical catheter's ability to produce images and operate safely and effectively.

7. Type of Ground Truth Used

The ground truth for the performance evaluations was based on:

Bench Testing: Engineering specifications and design requirements (e.g., dimensional accuracy, functional performance).
Acoustic Output: FDA guidance document limits for diagnostic ultrasound systems and transducers.
Animal Testing: Clinical acceptability for deliverability and imaging characteristics, as assessed by the animal study.
Biocompatibility: International Standard ISO-10993 and Blue Book Memo, G95-1.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that would require a "training set." The device is a physical imaging catheter.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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510(k) Summary of Safety and Effectiveness

Boston Scientific Corporation

Atlantis™ 018 Peripheral Imaging Catheter

Submitted By	Boston Scientific Corporation
	47900 Bayside Parkway
	Fremont, CA 94538

Contact Person	Emilly TojimaRegulatory Affairs Specialist IITel: (510) 624-2546Fax: (510) 624-2569emilly.tojima@bsci.com
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Date Prepared	December 21, 2007
Proprietary Name	Atlantis™ 018 Peripheral Imaging Catheter
Common Name(s)	Ultrasonic Diagnostic Imaging CatheterUltrasonic Diagnostic Transducers (ITX)Intravascular Ultrasound Catheter (OBJ)
Classification Name(s)	21 CFR Part 892. 1570 (ITX, OBJ)Diagnostic Ultrasonic Transducer

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Image /page/1/Picture/1 description: The image shows a fraction with "52736.23" as the numerator and "13,265" as the denominator. The numerator is written above a horizontal line, and the denominator is written below the line. The numbers appear to be handwritten. The image is in black and white.

Predicate Devices

The Atlantis™ 018 Peripheral Imaging Catheter is substantially equivalent to the following devices:

Product	510(k)	Clearance Date
Atlantis™ SR Pro Coronary ImagingCatheter	K063312	November 30, 2006
Sonicath Ultra™ Imaging Catheter(3.2F)	K060947	April 19, 2006

Description of the Device

The Atlantis™ 018 Peripheral Imaging Catheter consists of two main assemblies:

. Imaging core
. Catheter body

The catheter body comprises three sections:

. Distal lumen
. Proximal single lumen
. Telescoping section

The distal lumen and proximal single lumen sections compose the "working length" of the catheter, and the telescoping section remains outside of the guiding catheter and/or introducer sheath. The telescoping shaft section allows the imaging core to be advanced and retracted for 15 cm of linear movement. The corresponding movement

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of the transducer occurs from the proximal end of the wire exit port to the proximal end of the distal lumen.

The imaging core is composed of a hi-torque, flexible, rotating drive cable with a radial looking 40 MHz ultrasonic transducer at the distal tip. An electro-mechanical connector interface at the proximal end makes the connection to the BSC IVUS System Motor Drive Unit (MDU).

Intended Use / Indications for Use

Device Technology Characteristics and Comparison to Predicate Device

The Atlantis™ 018 Peripheral Imaging Catheter and the predicate devices are comprised of a catheter body and an imaging core. The Atlantis™ 018 Peripheral Imaging Catheter is equivalent in terms of design, operational characteristics, and material composition to the Atlantis™ SR Pro Coronary Imaging Catheter.

In terms of intended use and operational characteristics, the Atlantis™ 018 Peripheral Imaging Catheter is equivalent to the Sonicath Ultra™ 3.2F Peripheral Imaging Catheter. The use of the device in intravascular ultrasound imaging is the same among the 2 predicate devices and Atlantis™ 018; however both Atlantis™ 018 and Sonicath Ultra™ 3.2F are indicated for peripheral use, while Atlantis™ SR Pro is indicated for coronary use.

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Non-Clinical Test Results

The performance test results of the Atlantis™ 018 Peripheral Imaging Catheter demonstrate the device meets or exceeds the performance requirements for the specified intended use. Bench, acoustic output, animal, and biocompatibility tests were conducted on the device.

Bench Testing

Bench testing was conducted to evaluate the physical integrity and functionality of the catheter sheath and imaging core. The testing consisted of dimensional and functional verification. The Atlantis™ 018 Peripheral Imaging Catheter met or exceeded all required specifications.

Acoustic Output

Acoustic output testing was conducted as specified in the FDA guidance document Information for Manufacturers Seeking Market Clearance of Diagnostic Ultrasound Systems and Transducers, issued in 1997. The Atlantis™ 018 Peripheral Imaging Catheter test results are below the FDA Track 1 specified limits.

Animal Testing

The Atlantis™ 018 Peripheral Imaging Catheter was evaluated through animal testing to assess the in-vivo deliverability and imaging characteristics of the catheter. The device performance demonstrated clinical acceptability for the intended use.

Biocompatibility Testing

Biocompatibility tests were selected in accordance with Blue Book Memo, G95-1, Use of International Standard ISO-10993, and Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, dated May 1, 1995. The biocompatibility test results demonstrate the device is acceptable for its intended use.

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Conclusion

The Atlantis™ 018 Peripheral Imaging Catheter is substantially equivalent to the Atlantis™ SR Pro Coronary Imaging Catheter and the Sonicath Ultra™ 3.2F Peripheral Imaging Catheter. The Atlantis™ 018 Peripheral Imaging Catheter test results support the determination of substantial equivalence to predicate devices, and confirm the device is safe and effective for its intended use.

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Public Health Service

Image /page/5/Picture/11 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 2008

Boston Scientific Corporation c/o Ms. Emilly Tojima Regulatory Affairs Specialist II 47900 Bayside Parkway Fremont, CA 94538

Re: K073623

Trade Name: Atlantis 018 Peripheral Imaging Catheter Regulation Number: 21 CFR 892.1570 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Codes: ITX, OBJ Date: December 21, 2007 Received: December 26, 2007

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, Trug, 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 such 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. Emilly 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); 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Bfommemasfor

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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510(k) Number: K073623

Device Name: Atlantis™ 018 Peripheral 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)

Blummer

n Sian-Off Vices 510

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.