The Modified Olbert@ Balloon Catheter products are recommended for biliary tract stenosis/sphincter stenosis and gastrointestinal tract dilatation through a flexible endoscope. The recommended application is printed on the label. *

The recommended application on the label may refer to any combination of transpapillary, pyloric, colonic, anastomotic, and/or esophageal dilatation.

Device Description

Boston Scientific Corporation believes that the Modified Olbert® Balloon Catheter is substantially equivalent to the currently-marketed predicate devices. Table 9-1 compares the descriptive characteristics of these products.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Modified Olbert® Balloon Catheter. This document is a regulatory submission for a medical device and thus focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a detailed clinical study with acceptance criteria and performance metrics in the way one might expect for a novel AI/software-as-a-medical-device (SaMD) product.

Therefore, many of the requested elements (e.g., sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or available in this type of submission.

The document primarily focuses on performance characteristics in terms of verifying safety through laboratory testing and biocompatibility assessments, and demonstrating substantial equivalence to predicate devices based on design, materials, and intended use.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly defined by the safety and performance standards expected of a medical device and the demonstration of substantial equivalence to predicate devices, rather than explicit numerical thresholds. The "performance" is the device's ability to meet these general safety and equivalence requirements.

Acceptance Criteria (Implicit)	Reported Device Performance (as stated in the document)
Safety: Biocompatibility	"A biocompatibility assessment was performed on the patient- and fluid-contact materials of the Modified Olbert® Balloon Catheter with satisfactory results."
Safety: Sterilization Efficacy	"The Modified Olbert® Balloon Catheter will be sterilized using... ethylene oxide sterilization." (Implied efficacy through standard sterilization methods.)
Safety: Pyrogenicity (endotoxin levels)	"Pyrogenicity testing will be performed on a periodic basis to monitor bacterial endotoxin levels." (Implied meeting pyrogenicity standards.)
Performance: Functionality (e.g., inflation, deflation)	"Laboratory testing regarding characteristics was performed on Modified Olbert® Balloon Catheter to verify its safety and performance." (Specific characteristics not detailed but implied to meet functional requirements.)
Equivalence: Indication for Use	"The Modified Olbert® Balloon Catherer is equivalent in its indications for use... The Modified Olbert® Balloon Catheter products are recommended for biliary tract stenosis/sphincter stenosis and gastrointestinal tract dilatation through a flexible endoscope." (Matches or is similar to predicate devices, as shown in Table 9-1).
Equivalence: Design/Materials	"The Modified Olbert® Balloon Catherer is equivalent in its indications for use, while being very similar in design and materials." (Table 9-1 comparing design features like diameter, length, pressure, material, catheter shaft length/diameter, shows substantial similarity or justifiable differences to predicates). Example: Balloon material is Polyurethane, same as many predicates; Catheter shaft length 180cm, same as one predicate and within range of others; Diameter 4-14mm, same as one predicate and overlapping with others.
Overall Conclusion (Substantial Equivalence to Predicates)	"Boston Scientific Corporation believes that Modified Olbert® Balloon Catherer is substantially equivalent to the currently-marketed predicate devices... The information presented provides assurance that the Modified Olbert® Balloon Catheter will meet the minimum requirements that are considered acceptable for its intended use."

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

Sample size: Not applicable/not specified. The "testing" referred to is laboratory testing of the physical device, not a human reader or clinical trial involving a "test set" of cases or data.
Data provenance: Not applicable.

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

Not applicable. Ground truth in this context would refer to clinical outcomes or diagnoses, which are not part of this type of premarket submission for a physical device.

4. Adjudication method for the test set

Not applicable.

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 physical medical device (balloon catheter), not an AI-based diagnostic tool.

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

Not applicable.

7. The type of ground truth used

For the laboratory testing and biocompatibility assessment, the "ground truth" implicitly would be established industry standards and test methodologies for material safety, sterility, and mechanical performance. For substantial equivalence, the "ground truth" is the established safety and effectiveness profile of the predicate devices.

8. The sample size for the training set

Not applicable. No training set as this is not an AI/ML device.

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

Not applicable.

Summary

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SECTION 9 510(K) SUMMARY

NOV 1 0 1997

FOI RELEASABLE

Pursuant to § 13(1)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required Pursualit to your results of the result, Dreg, and secures.
to submit with this Premarket Notification " ...dequate summary of any information respecting setty and to submit with this frometion will be made available upon request of any person." Boston encentific Corporation chooses to submit a summary of information respecting safety and effectiveness.

> Common/Usual Names:	Balloon Catheter
> TRADE/PROPRIETARY NAME:	Olbert Balloon Catheter System®, NoProfile® Olbert BalloonCatheter System®
> Classification Name &DEVICE CLASSIFICATION:	Class II
	Name	Number	21 CFR Ref.
	Esophageal DilatorEndoscope & Accessories	78 KNQ78 KOG	876.5365878.1500
> DEVICE PANEL/BRANCH:	Gastroenterology-Urology (GU)Gastro-Renal (GRDB)
> Owner/Operator:	Boston Scientific CorporationOne Boston Scientific PlaceNatick, MA 01760Owner/Operator No. 9912058
> Contact Person:	Daniel J. Dillon, Senior Regulatory Affairs Specialist

INDICATIONS FOR USE

The Modified Olbert@ Balloon Catheter products are recommended for biliary tract stenosis/sphincter Inc Mounted Cloud Collection through a flexible endoscope. The recommended application is printed on the label.

CONTRAINDICATIONS

Not recommended for cascs in which the bile duct has been surgically intervened, a stricture which is totally impassable, or for dilatation of strictures due to external mechanical obstruction, i.e., suure and metallic clips.

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POTENTIAL COMPLICATIONS

Potential complications with biliary tract dilation include incre-hepatic damage, transient bleeding, post-operative cholangitis, and stricture of a primary hepatic duct. Potential complication from GI tract dilation include, but may not be limited to perforation , hemorthage, hematoma, septicemia./infection, allergic reaction to contrast medium.

DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES

PERFORMANCE CHARACTERISTICS

Laboratory testing regarding characteristics was performed on Modified Olbert@ Balloon Catheter to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluidcontact materials of the Modified Olbert® Balloon Catherer with satisfactory results.

PACKAGING, STERILIZATION, AND PYROGENICITY

The Modified Olbert® Balloon Catheter will be packaged a styrene/butadiene copolymer (SBS) tray with a Tyvek lid and a Tyvek outer pouch. The Modified Olbert® Balloon Catheter will be sterilized using ryvek no and a 1 your of your procol for ethylene oxide sterilization. Pyrogenicity testing will be performed on a periodic basis to monitor bacterial endotoxin levels.

CONCLUSION

Boston Scientific Corporation believes that Modified Olbert® Balloon Catherer is substantially equivalent Doston Belonal o Ocedicate devices. Table 9-1 compares the descriptive characteristics of these to the carrently manologies in Table 9-1, the Modified Olbert® Balloon Catherer is equivalent in its indications for use, while being very similar in design and materials. In addition, Boston Scientific metemons for are, and biocompatibility information. The information. The information presented provides assurance that the Modified Obert® Balloon Catheter will meet the minimum requirements that are considered acceptable for its intended use.

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T ABLE 9-1: COMPARISON OF MODIFIED OLBERT® BALLOON CATHETER TO PREDICATE DEVICES

Modified Olbert®Balloon Catheter(This 510(k))	NoProfile® withModified End Connector(510(k) No. K934411)	Modified NoProfile®(510(k) No. K945576)	NoProfile® withVectran Fibers(510(k) No. K952887)	Olbert Balloon Catheterfor Biliary Dilatation(510(k) No. K851647)	Vector TTS™ BalloonDilatation Catheter(510(k) No. K961438)
-------------------------------------------------------	-------------------------------------------------------------------	---------------------------------------------	-----------------------------------------------------------	---------------------------------------------------------------------------	--------------------------------------------------------------------

USE
Indication	Dilatation of Biliary andOther Non-GI Strictures	«- Same	«- Same	«- Same	«- Same	Dilatation of GIStrictures

BALLOON
Diameter	4-14 mm	3-10 mm	3-10 mm	3-12 mm	4-14 mm	6-25 mm
Length	2.5-4.0 cm	2.0-4.0 cm	2-10 cm	2-10 cm	2.5-4.0 cm	5.5-8.0 cm
MaximumRecommendedPressure	9-12 atm	10-12 atm	10-12 atm	12 atm	9-12 atm	2-6 atm
Material	Polyurethane	«- Same	«- Same	«- Same	«- Same	Ethylene VinylAcetate
CATHETER SHAFT
Length	180 cm	180	40-180 cm	40-180 cm	40-180 cm	180-240 cm
Diameter	5.8-7.8 Fr	4.8-7.8 Fr	4.8-7.8 Fr	4.8-7.8 Fr	6-7.5 Fr	7 Fr., tapers to 5 Fr

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The text is in all capital letters.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 25, 2015

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

Re: K973113 Trade/Device Name: Olbert Balloon Catheter System® Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE, KNO Dated (Date on orig SE Itr): August 18, 1997 Received (Date on orig SE Itr): August 20, 1997

Dear Daniel J. Dillon,

This letter corrects our substantially equivalent letter of November 10, 1997.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be

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Page 2 -

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.

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); medical dovice reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joyce M. Whang -S

for Benjamin R. Fisher, Ph.D.

Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 1 INDICATIONS FOR USE

510(k) Number: K973113

Device Name: Modified Olbert® Balloon Catheter

Indication for Use:

The recommended application on the label may refer to any combination of transpapillary, pyloric, colonic, anastomotic, and/or esophageal dilatation.

Robert Ratliff/
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number 73117

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.