The Sonicath Ultra Imaging Catheter is intended for the ultrasound examination of peripheral and coronary intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

Device Description

The BSC Sonicath Ultra Imaging Catheter is a sterile, single-use disposable device used for the ultrasound examination of intravascular pathology in both the coronary and peripheral vasculatures. The Sonicath Ultra 2.9 F and 3.2 F Imaging Catheters and predicate devices consist of two main components: (1) the catheter body and (2) the imaging core. The imaging core of both the Sonicath Ultra and the predicate device imaging catheters is comprised of a hitorque, flexible, rotating drive cable with an outward looking ultrasonic transducer at the distal tip.

AI/ML Overview

The Boston Scientific Corporation's Sonicath Ultra™ Imaging Catheter (K970049) was subjected to various non-clinical tests to demonstrate its safety and effectiveness. The device's acceptance criteria and performance are detailed below based on the provided 510(k) summary.

1. Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Bench Testing
Catheter Shaft Tensile Strength	Determined to be acceptable and consistent with intended use.
Catheter Joint Tensile Strength	Determined to be acceptable and consistent with intended use.
Imaging Core Weld Joint Tensile Strength	Determined to be acceptable and consistent with intended use.
Acoustic Output Testing
Acoustic Output Limits (FDA Track 1 limits)	Test results are below the FDA Track 1 limits.
Animal Testing
In-vivo functional and imaging characteristics	Performance was consistent with the intended clinical use of the device.
Biocompatibility
Compliance with ISO 10993-1 Part 1	Meets the requirements for biocompatibility testing outlined in ISO 10993-1 Part 1.

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

The provided 510(k) summary does not specify the exact sample sizes for the test sets used in the bench, acoustic output, and animal testing.

Bench Testing: The summary indicates "bench testing was included" without detailing the number of catheters or components tested.
Acoustic Output Testing: "The Sonicath Ultra Imaging Catheter was tested for acoustic output" again without specific numbers.
Animal Testing: "Animal testing was performed" without specifying the number of animals or the type of animal model.

The data provenance is from non-clinical studies (bench and animal testing) conducted by Boston Scientific Corporation, Sunnyvale. The report does not specify countries of origin for test data, but it is implied to be internal testing for regulatory submission in the U.S. It is prospective for the purposes of device evaluation.

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

The 510(k) summary focuses on non-clinical performance and substantial equivalence to predicate devices, not on diagnostic accuracy based on expert interpretation of images. Therefore, it does not mention a number of experts used to establish ground truth for a test set, nor their qualifications, as this type of study was not conducted or reported for this submission.

4. Adjudication Method for the Test Set

As there was no specific test set involving human interpretation requiring ground truth establishment or expert consensus on diagnostic findings, no adjudication method (like 2+1 or 3+1) was reported.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not reported in this 510(k) submission. Therefore, there is no information on the effect size of how much human readers improve with AI vs. without AI assistance, as AI is not a component of, nor is it mentioned in relation to, this device.

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

No, a standalone performance study (algorithm only) was not done, as this device is an imaging catheter and not an AI or algorithm-based diagnostic tool. The performance evaluated was of the physical device itself.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the non-clinical tests was established as follows:

Bench Testing: Engineering specifications and physical integrity standards (e.g., tensile strength values) for catheter components.
Acoustic Output Testing: Governed by FDA Guidance (Revised 510(k) Diagnostic Ultrasound Guidance for 1993, and 510(k) Guide for Measuring and Reporting Acoustic Output of Diagnostic Ultrasound Medical Devices, December, 1985). The "ground truth" here is compliance with defined safety limits.
Animal Testing: In-vivo functional and imaging characteristics were assessed against the "intended clinical use" of the device, likely by direct observation of imaging quality and catheter performance by the researchers conducting the animal studies.

8. The Sample Size for the Training Set

This submission is for a physical medical device (an imaging catheter), not a machine learning or AI algorithm. Therefore, the concept of a "training set" in the context of AI is not applicable here, and no training set sample size is provided.

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

Since there was no "training set" in the context of an AI/ML algorithm, this question is not applicable. The device's design and manufacturing are based on established engineering principles and prior predicate device designs for which safety and effectiveness were already accepted.

Summary

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K970049

510(k) Notification

JUN 2 0 1997 510(k) Summary of Safety and Effectiveness Appendix A.

510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: __

Applicant Information:

January 2, 1997 Date Prepared: Boston Scientific Corporation, BSC Name: Sunnyvale Address: 1327 Orleans Drive Sunnyvale, CA 94089 Contact Person: Steve Jwanouskos Phone Number: (408) 328-7542

Device Information:
Classification:	Class II
Trade Name:	Sonicath Ultra™ Imaging Catheter
Common Names:	Ultrasound Diagnostic Imaging Catheter
	Diagnostic Ultrasonic Transducer (90ITX)
	Diagnostic Intravascular Catheter (74DQQ)
Classification:	21 CFR 892.1570, Diagnostic Ultrasonic Transducer
	(90ITX) and 21 CFR 870.1200, Diagnostic Intravascular
	Catheter (74DQQ)

Equivalent Devices:

The BSC Sonicath Ultra Imaging Catheter is substantially equivalent in intended use, design and / or method of operation to a combination of the following predicate devices:

BSC, Sunnyvale MicroView 2.9 F Coronary Imaging Catheter 1.
BSC, Sunnyvale MicroRail 3.2F Coronary Imaging Catheter 2.
BSC, Natick (Medi-tech) Sonicath 3.5 F Interventional 3. Ultrasound Imaging Catheter

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510(k) Summary of Safety and Effectiveness (continued)

Intended Use:

Comparison To Predicate Devices:

The Sonicath Ultra Imaging Catheter is equivalent in intended use, design and operational characteristics to the following devices: (1) BSC, Sunnyvale -MicroView 2.9 F Coronary Imaging Catheter, (2) BSC, Sunnyvale - MicroRail 3.2 F Coronary Imaging Catheter, and (3) BSC, Natick (Medi-tech)- Sonicath 3.5 F Interventional Ultrasound Imaging Catheter. All predicate devices are used for the ultrasound imaging of intravascular pathology in either the coronary or peripheral vasculature. The Sonicath Ultra Imaging combines various features of the predicate devices to allow for imaging in both the peripheral and coronary vasculature.

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510(k) Summary of Safety and Effectiveness (continued)

Non-Clinical Test Results:

Bench, acoustic output, animal and biocompatibility testing demonstrate that the BSC, Sonicath Ultra Imaging Catheter is safe and effective, while meeting the anticipated clinical requirements for its intended use.

Bench Testing:

Bench testing was included to evaluate the physical integrity of the catheter shaft by testing the tensile strength of the catheter joints and shaft tubing. The catheter joint and shaft tubing strengths were determined to be acceptable and consistent with the intended use of the device. In addition, the physical integrity of the imaging core was examined by evaluating the tensile strengths of the weld joints. The imaging core weld joint strengths were also determined to be acceptable and consistent with the intended use of the device.

Acoustic Output Testing:

The Sonicath Ultra Imaging Catheter was tested for acoustic output as described in the FDA Guidance, The Revised 510(k) Diagnostic Ultrasound Guidance for 1993, Food and Drug Administration, and the 510(k) Guide for Measuring and Reporting Acoustic Output of Diagnostic Ultrasound Medical Devices, December, 1985, Food and Drug Administration. Acoustic output test results for the Sonicath Ultra 2.9 F and 3.2 F Imaging Catheters are below the FDA Track 1 limits.

Animal Testing:

Animal testing was performed to assess the in-vivo functional and imaging characteristics of the catheter. In conclusion, the performance of the Sonicath Ultra Imaging Catheters was consistent with the intended clinical use of the device.

Biocompatibility

The materials used to fabricate the BSC, Sonicath Ultra Imaging Catheter are similar to the predicate devices. The Sonicath Ultra Imaging Catheter was subjected to biocompatibility testing and meets the requirements for biocompatibility testing outlined in ISO 10993-1 Part 1 "Biological Evaluation of Medical Devices".

Summary:

Based on the intended use, design, performance and biocompatibility data provided in this Notification, BSC, Sonicath Ultra Imaging Catheters have been shown to be substantially equivalent to currently marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The seal is black and white.

JUN 20 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dennis L. Wong Manager, Regulatory Affairs Boston Scientific Corporation 2710 Orchard Parkway San Jose, CA 95134-2012

Re: K970049 BSC Sonicath Ultra™ Imaging Catheters Dated: April 25, 1997 Received: April 28, 1997 Regulatory Class: II .. .................................................. 21 CFR 892.1570/Procode: 90 ITX 21 CFR 870.1200/Procode: 74 DQO

Dear Mr. Wong:

We have reviewed your section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. You may, therefore, market the device, subject to the general controls provisions Act (Act). The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the BSC Sonicath Ultra™ Imaging Catheters, as described in your premarket notification:

Transducer Model Number

2.9F and 3.2F/20 MHZ

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This determination of substantial equivalence is granted on the prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's February 17, 1993 "Revised 510(k) Diagnostic Ultrasound Guidance for 1993." If the special report is incomplete or contains unacceptable values (e.g., acoustic ourput greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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Page 2 - Mr. Dennis Wong

This letter will allow you to begin marketing your device as described in your 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 market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10............. for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. · 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html."

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

Radiological Health

for

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and

Enclosure(s)

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Ultrasound Device Indications Statement Page

970047 (if known) : 510 (); ) Number Devire Name: B

Pill out one form for each ultrasound system and each transducer

Diagnostic ultrasound imaging or fluid flow analysis of the m Inter;ded Use : human body as follows :

Mode of Operation

Clin.calAppl.cation	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify)
Neonatal Cephalic
Adult: Cephalic
Cardiac
Trans-esophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal		✓
PeripheralVascular
Laparoscopic
Musculo-Skeletal
Other (Specify)

Additional Comments:

ANQUART PAGE IF NEEDED! CELEASE 80 AD ARTE 38.09 1912 1912 1912 21122 of cons. Office

David A. Seaman

(Division Sign-Off) (Division Sign-Ott)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Prescription Use (Per 21 CFR 801.109)

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P.04/04

Ultrasound Device Indications Statement Page

510(k) Number (if known): K970049
Device Name: BSC Soniview Ultra Imaging Catheter 2.9F/20MHZ

Pill out one form for each ultrasound system and each transducer.

Inter:ded Use: Diagnostic.ultrasound_imaging or flyid_flov_analysis of the l
every of the books been follows: human body as follows:

de of operation

Clin.calApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Feta.
Abdominal
Intr-operative(Specify)
Intr-operativeNeurological
Pediatric
Small Organ(Specify)
Neonatal Cephalic
Adult: Cephalic
Cardiac
Trans-esophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal		✓
PeripheralVascular
Laparoscopic
Musculo-Skeletal
Other (Specify)

PAGE IF MERDED (PLEASE TO MIT ERITY FRIEN THIS WINE-COM 2. 240.255

SPECIE

Edmund A. Segner

(Division Sign-Off) 6 Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Prescription Use (Per 21 CFR 801.109)

TOTAL P.04

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.