The Atlantis SR Pro² catheter is 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 included in the Atlantis™ family of intravascular ultrasound coronary imaging catheters (i.e., SR, SR Plus, SR Pro, and SR Pro') are designed to be used with the Clearview® Ultra with High Frequency (HF) option, Galaxy™ or Galaxy™ 2 intravascular ultrasound imaging instruments. These catheters are comprised of two main assemblies: Imaging core and Catheter body. The catheter body is comprised of three sections: Distal lumen, Proximal lumen, and Telescoping section. The imaging core is composed of a hi-torque, flexible, rotating drive shaft with a radially-looking 40 MHz ultrasonic transducer at the distal tip. An electromechanical connector interface at the proximal end makes the connection to the Motor Drive Unit (MDU) which is in turn connected to the imaging system (e.g., Galaxy™ system). The MDU-Catheter interface consists of an integrated mechanical drive hub and an electrical connection. The catheter body has a distal guidewire lumen with proximal exit port at approximately 1.5 cm from the distal end. The catheter body is attached to the telescope section via a male/female luer connection. A radiopaque (RO) marker is embedded in the catheter body at 0.5 cm from the distal tip. In addition, an insertion depth indicator is located on the catheter body at 105 cm, corresponding to femoral insertions. Within the catheter body, the distal lumen and proximal lumen sections comprise the "working length" of the catheter, and the telescoping section remains outside of the quiding catheter. The telescoping section allows the imaging core to be advanced and retracted for 15 cm of linear movement. The corresponding movement of the transducer occurs from the proximal end of the wire exit port, to the proximal end of the distal lumen. 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 oneway valve helps retain saline in the catheter during use. The Atlantis SR Pro2 catheter modifications are being implemented to improve performance and functionality of the catheter. The Atlantis™ SR Pro2 catheter is the same as the Atlantis™ SR Plus catheter, except for the following changes: Inclusion of a hydrophilic coating (Bioslide™) to the distal 230mm portion of the catheter sheath. The purpose of the hydrophilic-coating is to improve catheter lubricity, thus reducing catheter frictional resistance during introduction into the coronary vessel. A change is made to switch from Dymax adhesive 1-20271-G to Dymax adhesive 191 M-T in the Female Telescope assembly.

AI/ML Overview

The provided text describes specific modifications to an existing device (BSS Atlantis™ SR Plus Coronary Imaging Catheter) to create the BSS Atlantis™ SR Pro2 Coronary Imaging Catheter. The submission primarily focuses on demonstrating substantial equivalence to its predicate device rather than presenting a de novo study with new acceptance criteria and performance data for a novel device.

Therefore, the information regarding acceptance criteria and a study to prove performance is framed within the context of verification testing for modifications to an already cleared device, aiming to show that the changes do not adversely affect safety or effectiveness and that the modified device meets the established performance requirements of the predicate device.

Here's the breakdown based on the provided text:

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

The document does not provide a formal table of specific acceptance criteria with numerical targets and corresponding performance values for the Atlantis™ SR Pro2 Coronary Imaging Catheter. Instead, it states that:

Acceptance Criteria Category	Reported Device Performance
Physical Integrity and Functionality	"The results demonstrated that the device satisfies all performance, physical, and functional requirements." This included dimensional testing, sheath bond tensile testing, and various functional and performance testing of the sheath assembly, the telescope assembly, and the final sterile device. Specifically for the Dymax adhesive change: "The bond strength met the acceptance criteria" during verification testing.
Biocompatibility	"The results of the biocompatibility testing demonstrate that the catheter is acceptable for its intended use." This was assessed against ISO 10993 standards and included bioburden, endotoxin, sterility assurance, and latex testing.
Acoustic Output	"Acoustic Output testing was not required... as the addition of hydrophilic coating to the distal sheath of the catheter will not change the Acoustic Output measurement of the transducer, thus undetectable to the performance of the catheter." The device was deemed "unchanged from its predicate device." A "rationale for not conducting Acoustic Output testing" and an "Acoustic Output equivalency comparison" were provided (though not detailed in the summary).
Material/Manufacturing Variability (Adhesive)	"The bond strength met the acceptance criteria" for the new Dymax adhesive (191 M-T) in the female telescope assembly.
Improved Lubricity	The hydrophilic coating was added "to improve catheter lubricity, thus reducing catheter frictional resistance during introduction into the coronary vessel." While the benefit is stated, a specific quantitative acceptance criterion or performance measure for this improvement is not detailed in the summary.

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 sample sizes for any of the bench or biological testing. The provenance of the data is not mentioned (e.g., country of origin, retrospective/prospective), but it is implied to be internal testing conducted by Boston Scientific/Scimed.

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 type of information is not relevant or provided in the context of this 510(k) submission. The testing described (bench and biological) does not involve human interpretation or expert ground truth in the way a diagnostic imaging study would.

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

Not applicable. Adjudication methods are typically used in clinical studies or studies involving human judgment (e.g., image interpretation), which is not the nature of the testing described for this device modification.

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

Not applicable. This is a premarket notification for a medical device (intravascular imaging catheter). It is not an AI-assisted diagnostic device, and no MRMC study was conducted or is relevant to the type of testing described in this submission.

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

Not applicable. This device is an imaging catheter, not an AI algorithm. Its performance is related to its physical and functional capabilities, and its ability to generate images for human interpretation.

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

The testing described uses engineering specifications and laboratory standards as "ground truth." For example:

Bench Testing: Engineering specifications and performance requirements for physical integrity (e.g., bond strength, dimensions, functional operation).
Biocompatibility Testing: ISO 10993 standards.
Acoustic Output: Established measurements from the predicate device and FDA guidance.

8. The sample size for the training set

Not applicable. This involves physical device testing, not training of an algorithm or AI model.

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

Not applicable. This involves physical device testing, not training of an algorithm or AI model.

Summary

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

MAR 3 0 2005

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Boston Scientific/Scimed (BSS) Atlantis™ SR Pro2 Coronary Imaging Catheter

Submitted by:	Boston Scientific/ScimedIVUS Technology Center47900 Bayside ParkwayFremont, CA 94538
Contact Person:	Veronica M. KockenRegulatory Affairs Specialist IITel: (510) 624-1431Fax: (510) 624-1449kockenv@bsci.com
Date prepared:	March 4, 2005
Proprietary Name:	BSS Atlantis™ SR Pro² Coronary ImagingCatheter
Common Name(s):	Ultrasound Diagnostic Imaging CatheterDiagnostic Intravascular Catheter (74DQO)Diagnostic Ultrasonic Transducers (90ITX)
Classification Name(s):	Diagnostic Intravascular Catheter, 21 CFR Part870.1200 (74DQO)Diagnostic Ultrasonic Transducer, 21 CFR Part892.1570 (90ITX)
Predicate Device(s):	The BSS Atlantis™ SR Pro² Coronary ImagingCatheter is substantially equivalent to thefollowing device:Product 510(k) ClearanceDate Atlantis™ SR PlusCoronary Imaging K010707 March 29,2001

Coronary Imaging Catheter

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

Description of the Device:

. Imaging core
. Catheter body

The catheter body is comprised of three sections:

Distal lumen .
Proximal lumen .
. Telescoping section

The imaging core is composed of a hi-torque, flexible, rotating drive shaft with a radially-looking 40 MHz ultrasonic transducer at the distal tip. An electromechanical connector interface at the proximal end makes the connection to the Motor Drive Unit (MDU) which is in turn connected to the imaging system (e.g., Galaxy™ system). The MDU-Catheter interface consists of an integrated mechanical drive hub and an electrical connection.

The catheter body has a distal guidewire lumen with proximal exit port at approximately 1.5 cm from the distal end. The catheter body is attached to the telescope section via a male/female luer connection. A radiopaque (RO) marker is embedded in the catheter body at 0.5 cm from the distal tip. In addition, an insertion depth indicator is located on the catheter body at 105 cm, corresponding to femoral insertions.

Within the catheter body, the distal lumen and proximal lumen sections comprise the "working length" of the catheter, and the telescoping section remains outside

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

of the quiding catheter. The telescoping section allows the imaging core to be advanced and retracted for 15 cm of linear movement. The corresponding movement of the transducer occurs from the proximal end of the wire exit port, to the proximal end of the distal lumen.

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 oneway valve helps retain saline in the catheter during use.

Atlantis SR Pro2 catheter

The Atlantis SR Pro2 catheter modifications are being implemented to improve performance and functionality of the catheter. The Atlantis™ SR Pro2 catheter is the same as the Atlantis™ SR Plus catheter, except for the following changes:

Inclusion of a hydrophilic coating (Bioslide™) to the distal 230mm portion of . the catheter sheath. The purpose of the hydrophilic-coating is to improve catheter lubricity, thus reducing catheter frictional resistance during introduction into the coronary vessel.
A change is made to switch from Dymax adhesive 1-20271-G to Dymax . adhesive 191 M-T in the Female Telescope assembly. The Dymax adhesive 191 M-T is currently being used within the same product for the Male Telescope assembly. The reason for the change is to reduce material variability in manufacturing of the catheter, and to limit the types of adhesives used in the device. The change is being implemented based on acceptable results from verification testing, in which the bond strength met the acceptance criteria. The female telescope assembly is a section of catheter that remains external to the patient during the application of the device.

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

Intended Use/Indications:

The Atlantis SR Pro2 catheter is 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 Technology Characteristics an Comparison to Predicate Device:

The BSS Atlantis™ SR Pro2 Coronary Imaging Catheter utilizes the same basic catheter design as the predicate device, the BSS Atlantis™ SR Plus Coronary Imaging Catheter, cleared in March 29, 2001, and the current Atlantis™ SR Pro, cleared via internal documentation (letter-to-file dated, February 14, 2003 and January 27, 2004). These devices have the same intended use, use the same operating principal, incorporate that same basic catheter design, have the same shelf life, and are packaged using the same materials and processes. The two modifications from the Atlantis™ SR Pro to the Atlantis™ SR Pro2, is the addition of lubricous hydrophilic coating (Bioslide™) to distal segment (230mm minimum) of the catheter sheath, and the use of Dymax 191 M-T adhesive on the telescope assembly.

Non-clinical Test Results:

Bench and biological safety testing demonstrate that the Atlantis™ SR Pro2 imaging catheter meets or exceeds the performance requirements and 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 and performance testing of the sheath assembly, the telescope assembly, and the final sterile device. The results demonstrated that the device satisfies all performance, physical, and functional requirements.

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

Biological Safety Testing:

The Atlantis™ Pro2 catheter was subjected to a series of biocompatibility tests per ISO 10993, bioburden, endotoxin, sterility assurance, and latex testing. The results of the biocompatibility testing demonstrate that the catheter is acceptable for its intended use.

Acoustic Output Testing:

Acoustic Output testing was not required for the Atlantis™ SR Pro2, as the addition of hydrophilic coating to the distal sheath of the catheter will not change the Acoustic Output measurement of the transducer, thus undetectable to the performance of the catheter.

Per the FDA Guidance, Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (September 30 1997), Acoustic Output measurements for the Atlantis™ SR Pro2 catheter remains unchanged from its predicate device, the Atlantis™ SR Plus catheter and the Atlantis™ SR Pro catheter for which a letter-to-file was documented.

Table 2 of this submission provides the Acoustic Output equivalency comparison, followed by a rationale for not conducting Acoustic Output testing on the Atlantis™ SR Pro2 coronary catheter.

Conclusion:

The BSS Atlantis™ SR Pro2 Coronary Imaging Catheter utilizes the same design features and has the same intended use as the predicate device, the Atlantis™ SR Plus Coronary Imaging Catheter. The tests support a determination of substantial equivalence of the modified device, the Atlantis™ SR Pro2 Coronary Imaging Catheter to its predicate device.

< 050577

」 : /

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping wave-like shapes, often interpreted as representing the human form. The logo is black and white.

MAR 3 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Boston Scientific Corp. IVUS Technology Center c/o Ms. Veronica Kocken Regulatory Affairs Specialist II 47900 Bayside Parkway Freemont, CA 94538-6515

Re: K050577

Trade Name: Atlantis SR Pro2 Coronary Imaging Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: II (two) Product Code: DQO Dated: March 04, 2005 Received: March 07, 2005

Dear Ms. Kocken:

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.

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

Page 2 -- Ms. Veronica Kocken

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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

B/Simimas for

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

Enclosure

{7}------------------------------------------------

Indications for Use Statement

510(k) Number:	K050577
Device Name:	Boston Scientific/Scimed, Atlantis™ SR Pro² CoronaryImaging Catheter
Indications for Use:	The Atlantis SR Pro² catheter is intended for ultrasoundexamination of coronary intravascular pathology ONLY.Intravascular ultrasound imaging is indicated in patientswho are candidates for transluminal coronary interventionalprocedures.
Prescription UseX	AND/OR Over the counter Use

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

Part 21 CFR 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blummore

(Part 21 CFR 801 Subpart D)

ardiovascular Devices

Confidential

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).