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

Device Description

The Atlantis™ PV Imaging Catheter consists of two main assemblies: an over-the-wire (OTW) exchange style sheath assembly and an imaging core assembly. The sheath is comprised of the following three sections: Radiopaque soft tip, Proximal dual lumen, and Telescoping section. The imaging core is composed of a hi-torque flexible, rotating drive cable with a radially looking 15 MHz ultrasonic transducer at the distal tip. An electromechanical connector interface at the proximal end makes the connection to the MotorDrive Unit (MDU) / Instrument. A flush port with a one-way valve is used to displace air near the transducer. The catheter is for use with the BSS ClearView Ultra™ and Galaxy™ IVUS Imaging Systems.

AI/ML Overview

The Boston Scientific Scimed (BSS) Atlantis™ PV Imaging Catheter is an intravascular ultrasound imaging catheter. The provided submission describes non-clinical testing performed to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating specific performance metrics against pre-defined acceptance criteria with human subjects or expert readers.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in the form of specific performance metrics (e.g., sensitivity, specificity, accuracy) found in a clinical study for a new diagnostic or AI device. Instead, it details various non-clinical tests performed to demonstrate the device's safety and efficacy for its intended use and its substantial equivalence to predicate devices. The "performance" reported is that the device met the requirements of these tests.

| Test Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Bench Testing | Ensure physical integrity, functionality, and performance of the catheter components (sheath, telescoping assembly, imaging core assembly) and the final sterile device, consistent with its design and intended use. | Testing included dimensional testing, sheath bond tensile testing, and various functional performance tests. This testing demonstrated the physical integrity and functionality of the catheter. |
| Acoustic Output Testing | Acoustic output levels must be below the FDA Track 1 limits as described in the FDA Guidance, "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (Sept. 30, 1997)." | Acoustic output test results for the Atlantis™ PV imaging catheter are below the FDA Track 1 limits. |
| Animal Testing | In-vivo functional and imaging characteristics must be assessed and found consistent with the intended clinical use of the device. | The performance of the Atlantis™ PV imaging Catheter was consistent with the intended clinical use of the device. |
| Biological Safety Testing | Satisfy biocompatibility requirements per ISO 10993, and meet bioburden, endotoxin, and sterility assurance testing standards. | The Atlantis™ PV Imaging Catheter was subjected to and passed a series of biocompatibility tests per ISO 10993, bioburden, endotoxin, and sterility assurance testing. |

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

Sample Size for Test Set: Not applicable in the context of this 510(k) submission, as it describes non-clinical testing rather than a patient-based test set with specific data samples.
Data Provenance: The document does not specify the country of origin for the animal study. The other tests are bench tests performed within the manufacturer's testing environment. All testing appears to be "retrospective" in the sense that it's performed on manufactured devices/components for regulatory submission, rather than prospective clinical trials.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. The ground truth for these non-clinical tests is established by engineering specifications, regulatory standards (like FDA guidance for acoustic output, ISO 10993 for biocompatibility), and observed physical/biological responses in animal models. No human experts are explicitly mentioned as establishing a "ground truth" for interpretation in the same way they would for reading images.
Qualifications of Experts: N/A as per the above.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The testing described does not involve human interpretation or subjective assessment that would require an adjudication method. The outcome of these tests is determined by objective measurements against predefined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. This submission focuses on hardware safety and performance in a non-clinical setting, not on the diagnostic accuracy with human readers.
Effect Size of Human Readers Improve with AI vs without AI: Not applicable, as no MRMC study or AI component is described.

6. If a Standalone Study (i.e. algorithm only without human-in-the-loop performance) was Done

Standalone Study: Not applicable. This device is an imaging catheter; it does not contain an AI algorithm that would have a standalone performance. The "performance" described is the functionality of the physical device.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the verifiable correctness or compliance with established standards for device performance and safety:

Bench Testing: Engineering specifications, design tolerances, and functional requirements.
Acoustic Output Testing: FDA Guidance values (FDA Track 1 limits).
Animal Testing: Physiological and imaging observations in an animal model, judged against expected normal and pathological states to determine the device's functional and imaging characteristics, consistent with its intended use.
Biological Safety Testing: ISO 10993 standards and recognized methods for bioburden, endotoxin, and sterility assurance.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This document describes a medical device (catheter) and its non-clinical testing, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Ground Truth for Training Set: Not applicable, as there is no training set for an AI algorithm described in this submission.

Summary

{0}------------------------------------------------

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Boston Scientific Scimed (BSS) Atlantis™ PV Imaging Catheter

Boston Scientific Scimed Submitted by: IVUS Technology Center 47900 Bayside Parkway Fremont, CA 94538
Contact Person: Irene Jaworski Manager, Regulatory Affairs Tel: (510) 624-1580 Fax: (510) 624-1449 jaworski@bsci.com
July 19, 2002 Date prepared:

Atlantis™ PV Imaging Catheter Proprietary Name:

Ultrasound Diagnostic Imaging Catheter Common Name(s): Diagnostic Ultrasound Transducer (901TX) Diagnostic Intravascular Catheter (74DQQ)

Classification Name(s): Diagnostic Ultrasound Transducer, 21 CFR Part 892.1570 (90ITX); Diagnostic Intravascular Catheter, 21 CFR Part 870.1200 (74DQQ)

The Atlantis™ PV Imaging catheter is Predicate Device(s): substantially equivalent to the following devices:

Product	510(k)	ClearanceDate
BSS Sonicath Ultra™ 6(6F / 20 MHz)	K890772	May 10, 1989
BSS Sonicath Ultra™3.2 (3.2F / 20 MHz)	K970049	June 20, 1997

{1}------------------------------------------------

Description of the Device:

The Atlantis™ PV Imaging Catheter consists of two main assemblies:

an over-the-wire (OTW) exchange style sheath assembly .
. an imaging core assembly

The sheath is comprised of the following three sections:

. Radiopaque soft tip
Proximal dual lumen .
Telescoping section ●

The radiopaque soft tip and proximal dual lumen sections comprise the "working length" of the catheter, and the telescoping section remains outside of the introducer sheath. The telescoping section allows the imaging core to be advanced and retracted within 25 cm of linear movement.

The imaging core is composed of a hi-torque flexible, rotating drive cable with a radially looking 15 MHz ultrasonic transducer at the distal tip. An electromechanical connector interface at the proximal end makes the connection to the MotorDrive Unit (MDU) / Instrument. The MDU-Catheter interface consists of an integrated mechanical drive hub and electrical connection.

A flush port with a one-way valve is used to displace air near the transducer. The catheter must be flushed with heparinized saline prior to use, as this provides the acoustic coupling media required for ultrasonic imaging. The one-way valve helps retain saline in the catheter during use.

The catheter sheath is attached to the telescope shaft via a male/female luer connection. The catheter is for use with the BSS ClearView Ultra™ and Galaxy™ IVUS Imaging Systems.

Intended Use/Indications:

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

Device Technology Characteristics an Comparison to Predicate Device:

The Atlantis™ PV Imaging Catheter utilizes the same basic catheter design as the predicate devices, the BSS Sonicath Ultra™ 6 and Sonicath Ultra™ 3.2 Imaging Catheters. These devices have the same intended use, use the same operating principal, and incorporate that same basic catheter design. In addition, the BSS Sonicath Ultra™ 6 has the same shelf life, and is packaged

{2}------------------------------------------------

Boston Scientific Atlantis™ PV Peripheral Imaging Catheter Special 510(K) Notification

using the same materials and processes as the predicate device. The modifications to Atlantis™ PV Imaging Catheter include a telescoping section, a dual lumen sheath, a radiopaque catheter tip, a proximal flush port with a one-way valve and vent hole, and gold plated distal housing. The Atlantis™ PV Imaging Catheter will be sterilized by E-Beam irradiation, rather than by gamma irradiation, as are the BSS Sonicath Ultra™ 6 and Sonicath Ultra™3.2 Catheters.

Non-clinical Test Results:

Bench, acoustic output, animal and biological safety testing demonstrate that the Atlantis™ PV Imaging Catheter is safe and effective for its intended use.

Bench Testing:

Bench testing was performed to evaluate the physical integrity and functionality of the catheter. This testing included dimensional testing, sheath bond tensile testing, and a variety of functional performance testing of the sheath and telescoping assembly, the imaging core assembly, and of the final sterile device.

Acoustic Output Testing:

The Atlantis PV imaging catheter was tested for acoustic output as described in the FDA Guidance, Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (Sept. 30, 1997). Acoustic output test results for the Atlantis™ PV imaging catheter are below the FDA Track 1 limits.

Animal:

Animal testing was performed to assess the in-vivo functional and imaging characteristics of the Atlantis™ PV imaging catheter. The performance of the Atlantis™ PV imaging Catheter was consistent with the intended clinical use of the device.

Biological Safety Testing:

The Atlantis™ PV Imaging Catheter was subjected to a series of biocompatibility tests per ISO 10993, bioburden, endotoxin and sterility assurance testing.

Conclusion:

The Atlantis™ PV Imaging Catheter utilizes design features and has the same intended use as the predicate devices, the BSS Sonicath Ultra™ 6 and

{3}------------------------------------------------

Boston Scientific Atlantis™ PV Peripheral Imaging Catheter Special 510(K) Notification

Sonicath Ultra™ 3.2 imaging catheters. The tests support a determination of substantial equivalence of the modified device, the Atlantis™ PV imaging Catheter to the predicate devices.

{4}------------------------------------------------

Image /page/4/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

NOV 2 1 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Boston Scientific Scimed c/o Ms. Irene Jaworski Manager, Regulatory Affairs IVUS Technology Center 47900 Bayside Parkway Fremont, CA 94538

Re: K022860

Trade Name: Atlantis™ PV Imaging Catheter Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic Transducer Regulatory Class: Class II (two) Product Code: ITX Dated: October 23, 2002 Received: October 24, 2002

Dear Ms. Jaworski:

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 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.

{5}------------------------------------------------

Page 2 - Ms. Irene Jaworski

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Indications for Use Statement

510(k) Number:
Device Name:	Atlantis TM PV Imaging Catheter
Indications for Use:	The Atlantis TM PV Imaging Catheter is intended for ultrasound examination of peripheral pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K022860

Prescription Use
Per 21 CFR 801.109.

Over the counter Use

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.