The Ultraflex™ Diamond Biliary Stent System is a biliary stent system. It is a self-expanding stent made of Nitinol, constructed using a monofilament, twisted method. It has an overall OD of 10 mm and overall lengths of 40-80 mm. The delivery system has a sliding sheath design, a usable length of 194 cm, a shaft OD of 2.7 mm - 3.02 mm, and is compatible with a 0.035" guidewire.

AI/ML Overview

The provided text describes a 510(k) summary for the Ultraflex™ Diamond Biliary Stent System, focusing on its substantial equivalence to a predicate device. This type of submission relies on comparing the new device to a legally marketed predicate device rather than conducting extensive clinical studies with specific acceptance criteria as you might see for novel technologies or higher-risk devices.

Therefore, the information you're requesting regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for performance evaluation is not present in this document. The submission focuses on performance characteristics verified through laboratory testing and biocompatibility assessments, and equivalence based on design and materials.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present a formal table of acceptance criteria for specific performance metrics (like sensitivity, specificity, or reader agreement) and corresponding reported device performance values as would be typical for an AI/CADe device. Instead, the "acceptance criteria" are implied by the substantial equivalence determination, meaning the device must be as safe and effective as the predicate device.

The document states: "Laboratory testing regarding characteristics was performed on Ultraflex™ Diamond Biliary Stem System to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluid-contact materials of the Ultraflex™ Diamond Biliary Stent System with satisfactory results."

The "performance" described is about the physical characteristics of the stent and delivery system compared to the predicate, as shown in Table 10-1.

Characteristic	Ultraflex™ Diamond Biliary Stent System (This 510(k))	Schneider Wallstent® Endoscopic Biliary Endoprosthesis (Predicate)	Result/Comparison
Indications for Use	Malignant Biliary Strictures	Malignant Biliary Strictures	Same
Route of Administration	Endoscopic	Endoscopic	Same
Stent Overall OD	10 mm	8 - 12 mm	Within predicate range
Stent Overall Length	40 - 80 mm	40 - 80 mm	Same
Stent Material	Nitinol	Stainless Steel	Difference (justified by lab testing)
Stent Construction Method	Monofilament, Twisted	Monofilament, Braided	Difference (justified by lab testing)
Stent Expansion Mode	Self-Expanding	Self-Expanding	Same
RO Marker Location	Stent and Delivery System	Delivery System	Difference (design variation)
Delivery System Design	Sliding Sheath	Sliding Sheath	Same
Delivery System Usable Length	194 cm	195 cm	Very similar
Delivery System Shaft OD	2.7 mm - 3.02 mm	2.5 mm	Similar/Slight variation
Delivery System Compatible Guidewire	0.035"	0.035" - 0.038"	Similar/Within predicate range

The "acceptance criteria" here are that the Ultraflex™ Diamond Biliary Stent System's characteristics and performance verified through in-vitro laboratory testing and biocompatibility assessment demonstrate that it is as safe and effective as the predicate device. The slight differences in material, construction, RO marker location, usable length, and shaft OD were deemed acceptable based on the provided laboratory testing and the overall conclusion of substantial equivalence.

The following information is NOT available in the provided text, as it describes a 510(k) submission for a medical device (stent), not an AI/CADe product. Therefore, no studies of the type you describe were conducted or reported.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No clinical test set data is provided. Performance verification was based on in-vitro lab testing and biocompatibility.

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)

Not applicable. No clinical test set data requiring expert ground truth is provided.

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

Not applicable. No clinical test set data requiring adjudication is provided.

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 not an AI/CADe device.

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

Not applicable. This is not an AI/CADe device.

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

Not applicable. The "ground truth" for this medical device submission relies on established engineering principles, material science testing standards, and biocompatibility guidelines.

8. The sample size for the training set

Not applicable. This is not an AI/CADe device, and no training set is mentioned.

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

Not applicable. No training set is mentioned.

Summary

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MAY 20 K

ATTACHMENT 10 510(K) SUMMARY

FOI RELEASABLE

Pursuant to §513(i)(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.

Biliary Stent, Biliary Stent System > Common/Usual Names:
Trade/PropRietary Name: Ultraflex™ Diamond

> Classification Name &DEVICE CLASSIFICATION:	Class II
	Name	Number	21 CFR Ref.
	Biliary Catheter and Accessories 78 FGE		876.5010
> Device Panel/Branch:	Gastroenterology-Urology (GU)
	Gastro-Renal (GRDB)
> Owner/Operator:	Boston Scientific Corporation
	One Boston Scientific Place
	Natick, MA 01760
	Owner/Operator No. 9912058
> Contact Person:	Daniel J. Dillon, Senior Regulatory Affairs Specialist

INDICATIONS FOR USE

The Ultraflex™ Diamond Biliary Stent System is indicated for palliative treatment of patients with malignant biliary strictures.

CONTRAINDICATIONS

The Ultraflex™ Diamond Biliary Stent System is contraindicated for biliary duct strictures of benign etiology; biliary obstruction preventing either endoscopic or perculaneous cholangiography; concurrent perforated bile duct, those patients for whom endoscopic or perculaneous procedures are contraindicated; any use other than those specifically outlined under Indications for Use.

POTENTIAL COMPLICATIONS

The following complications have been reported in the literature for plastic and metal biliary stent placement. Procedural: infection, bleeding, perforation of the duct, pain, aspiration, oxygen desaturation related to sedation, stent misplacement, pancreatitis, Post-Stent Placement: stent migration, stent occlusion due to sludge formation, stent occlusion due to turnor ingrowth, stent occlusion due to tumor overgrowth of stent ends, stent occlusion due to excessive hyperplastic tissue ingrowth, recurrent obstructive jaundice related to stent occlusion, infection, bleeding, bile duct ulceration and/or perforation

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DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES

Boston Scientific Corporation believes that the Ultraflex™ Diamond Biliary Stent System is substantially equivalent to the currently-marketed Schneider Wallstent® Endoscopic Biliary Endoprosthesis. Table 10-1 compares the descriptive characteristics of these products.

PERFORMANCE CHARACTERISTICS

Laboratory testing regarding characteristics was performed on Ultraflex™ Diamond Biliary Stem System to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluid-contact materials of the Ultraflex™ Diamond Biliary Stent System with satisfactory results.

PACKAGING, STERILIZATION, AND PYROGENICITY

The Ultraflex™ Diamond Biliary Stent System will be packaged in a TyvelyPolyester-polyethylene pouch. The Ultraflex™ Diamond Billiary Stent System will be sterilized using ethylene oxide gas using the AAMI protocol for ethylene oxide sterilization. Pyrogenicity testing will be performed on a periodic basis to monitor bacterial endotoxin levels.

CONCLUSION

Boston Scientific Corporation believes that Ultraflex™ Diamond Biliary Stent System is substantially equivalent to the currently-marketed Ultraflex™ Diamond Biliary Stent System. Table 10-1 compares the descriptive characteristics of these products. As demonstrated in Table 10-1, the Ultrallex™ Diamond Biliary Stent System is equivalent in its indications for use, while being very similar in design and materials. In addition, Boston Scientific Corporation has presented laboratory testing and biocompatibility information. The information presented provides assurance that the Ultraflex™ Diamond Biliary Stent System will meet the minimum requirements that are considered acceptable for its intended use.

962899

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Table 10-1:

SIMILARITIES AND DIFFERENCES BETWEEN ULTRAFLEX™ DIAMOND BILIARY STENT SYSTEM AND Schneider Wallstent® Endoscopic Billary Endoprosthesis

Ultraflex Diamond BiliaryStent System(This 510(k))	Schneider Wallstent®Endoscopic BiliaryEndoprosthesis
	(K925406)

USE

Indication	Malignant Billiary Strictures	«- Same
Route of AdministrationCompany of Concession of Children Company of Children Company------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Company of the contribution of a minimal commens and consideration and the collection of the collection of the collection of the collection of the collection of the collectioEndoscopic	- Same

STENT

Overall OD	10 mm	8 - 12 mm
Overall Length	40 -80 mm	«- Same
Material	Nitinol	Stainless Steel
Construction Method	Monofilament, Twisted	Monofilament, Braided
Expansion Mode	Self-Expanding	«-- Same
RO Marker Location	Stent and Delivery System	Delivery System

DELIVERY SYSTEM

Design	Sliding Sheath	<- Same
Usable Length	194 cm	195 cm
Shaft OD	2.7 mm - 3.02 mm	2.5 mm
Compatible Guidewire	0.035"	0.035" - 0.038"

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its wing, symbolizing service to the nation. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 20 1997

Mr. Daniel J. Dillon Senior Regulatory Affairs Specialist Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760-1537

Re: K962899

Ultraflex™ Diamond Biliary Stent System ---Dated: February 25, 1997 Received: February 26, 1997 Regulatory class: II 21 CFR §876.5010/Product code: 78 FGE

Dear Mr. Dillon:

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 enasment 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 regulation may result in 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 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 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,
hillain Yi

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

Enclosure

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14:46

SECTION 1 INDICATIONS FOR USE

510(k) Number:

To Be Determined

Device Name:

Uluaflex™ Diamond Biliary Stent System

Indication for Use:

The Ultraflex™ Diamond Biliary Stent System is indicated for palliative treatment of patients with malignant biliary strictures.

Robert D. Schilling
(Division Sign-Off)

Division of Reproductive, Andominal, ENT, and Radiological Devices

510(k) Number K962849

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use_

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.