The proposed Symphony™ Nitinol Stent Transhepatic Biliary System is a two-part system consisting of a self-expanding stent and a flexible delivery catheter. The delivery catheter is designed to facilitate transhepatic access to the biliary tree and the stent is designed to maintain luminal patency of biliary strictures produced by malignant neoplasms.

The proposed Symphony™ Nitinol Stent will be provided bre-loaded by Boston Scientific Corporation onto the delivery catheter. The stent is mounted on the catheter shaft and an outer sheath is positioned over the stent/catheter subassembly. The delivery catheter is compatible with 7F introducer systems and the multi-lumen design provides a priming lumen and accomodates a .035" guidewire.

AI/ML Overview

This document is a 510(k) premarket notification for the Symphony™ Nitinol Stent Transhepatic Biliary System. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain a detailed study proving the device meets specific acceptance criteria in the clinical sense.

Therefore, many of the requested sections (2-9) cannot be answered from the provided text, as they pertain to clinical or performance studies that are not detailed here.

However, based on the provided text, the following information can be extracted regarding acceptance criteria and the "study" that supports it:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (from "Safety and Performance" section)
Functional Bench Testing	Performed, data supported substantial equivalence
Integrity Bench Testing	Performed, data supported substantial equivalence
Biocompatibility Testing	Performed (according to FDA guidance ODE Blue Book Memorandum #G95-1, May 1, 1995, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"), data supported substantial equivalence

Note: The acceptance criteria here are broad categories of testing intended to support "substantial equivalence" to a predicate device, as required for a 510(k) submission. Specific numerical or pass/fail thresholds for these tests are not provided in this summary. The "device performance" is stated as having met the requirements to demonstrate substantial equivalence to the predicate device.

2. Sample size used for the test set and the data provenance:

Not explicitly stated. The document mentions "functional and integrity bench testing" and "Biocompatibility testing," but does not provide details on the sample sizes used for these tests or the data provenance (e.g., country of origin, retrospective/prospective). These are typically internal verification and validation tests rather than clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This document describes bench and biocompatibility testing, not studies requiring expert-established ground truth.

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

Not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical endpoints, which are not detailed here.

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 document does not describe an MRMC study or any AI component.

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

Not applicable. This device is a physical medical device (stent), not a software algorithm.

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

For the bench and biocompatibility testing, the "ground truth" would be established by validated test methods and specifications for material properties, mechanical performance, and biological response, as per recognized standards (e.g., ISO-10993 for biocompatibility).

8. The sample size for the training set:

Not applicable. There is no mention of a training set as this is a physical medical device, not a machine learning model.

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

Not applicable. There is no mention of a training set.

In summary, the provided document is a 510(k) summary demonstrating substantial equivalence for a physical medical device. It details bench and biocompatibility testing performed to support this claim, but does not provide the kind of detailed clinical study information often associated with AI/software devices or more extensive clinical trials.

Summary

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Boston
Scientific
Corporation

One Boston Scientific Place Natick, MA 01760-1537 508-650-8000

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Pursuant to §513(1)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification" ... adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation chooses to submit a summary of information respecting safety and effectiveness. According to §513(0)(3)(B), " Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data conceming adverse health effects..."

The summary regarding the adverse heath effects of the proposed Symphony™ Nitinol Stent Transhepatic Biliary System is as follows:

Trade Name:	SymphonyTM Nitinol Stent Transhepatic Biliary System
Manufacturer:	Boston Scientific Corporation480 Pleasant StreetWatertown, MA 02172
Device Generic Name:	Biliary Stent
Classification:	According to Section 513 of the Federal Food, Drug and CosmeticAct, the device classification is Class II, Performance Standards(CFR 876.5010).
Predicate Device:	Wallstent® Transhepatic Biliary Endoprosthesis withUnistepTM Delivery System

Device Description:

Indications For Use:

For use in the treatment of biliary strictures produced by malignant neoplasms.

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Image /page/1/Picture/0 description: The image shows the logo for Boston Scientific Corporation. The logo is composed of three lines of text, with each line containing one or two words. The words are stacked vertically, with "Boston" on the top line, "Scientific" on the second line, and "Corporation" on the third line. The font is a serif typeface, and the text is black.

Safety and Performance:

Functional and integrity bench testing and Biocompatibility testing(according to the FDA guidance document, ODE Blue Book Memorandum #G95-1, May 1, 1995, Use of International Standard ISO-10993, "Biological Evelyation of Medical Devices Part 1: Evaluation and Testing" ) were performed, and the data supported the substantial equivalence of the Symphony™ Nitinol Stent Transhepatic Biliary System to the Wallstent® Transhepatic Biliary Endoprosthesis with Unistep™ Delivery System.

Conclusion:

Based on the indications for use, technological characteristics, and safety and performance testing, the Symphony™ Nitinol Stent Transhepatic Biliary System has been shown to be safe and effective for its intended use.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 1 1997

Ms. Laura Mondano Project Manager, Regulatory Affairs Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760-1537

Re: K963254

Symphony™ Nitinol Stent Transhepatic Biliary System Dated: February 19, 1997 Received: February 20, 1997 Regulatory Class: II 21 CFR 876.5010/Procode: 78 FGE

Dear Ms. Mondano:

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 (Act). 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 (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 Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Willian Yi, Ph.D.

Lillian Yin, Ph.D Director, Division of Reproduc Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K963254

Page 1 of . 1

INDICATION FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Symphony™ Nitinol Stent Transhepatic Biliary System Device Name: _____

Indications for Use:

. . .

For Use in the treatment of biliary strictures produced by malignant neoplasms.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Weber R. Nothing

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K963254

Prescription Use

Over-The-Counter Use_

(Per 21 CFR 801.109)

(Option Format 1-2-96)

iia

Regulation Number and Section

§ 876.5010 Biliary catheter and accessories.

(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.