This instrument has been designed to be used with Olympus Endoscopes for endoscopic retrograde biliary drainage (ERBD). The stent is not intended to be permanently implanted in the patient. The stent is intended only for short-term implantation.

Device Description

The subject Single Use Billary Drainage Stent V PBD-1030/ 1031/ 1032/ 1033 Stent Series, MAJ-1818/ 1819/ 1820/ 1821/ 1822 Insertion Kit Series and PBD-V630P/ V631P/ V632P Preloaded Stent Series are designed to be used with Olympus endoscopes for Endoscopic Biliary Drainage(ERBD) procedure. The subject Biliary Stent is placed into the duodenal papilla by using a Guidewire and Pusher Catheter to maintain the flow of bile by indwelling in the duodenal papilla.

AI/ML Overview

This is a medical device application for a single-use biliary drainage stent. The provided document focuses primarily on establishing substantial equivalence to a predicate device through non-clinical testing, rather than reporting on a study that proves the device meets specific performance acceptance criteria in a clinical setting with human subjects. Therefore, many of the requested categories are not applicable or cannot be extracted from this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "established in-house acceptance criteria based on ISO 14971:2007" for risk analysis and "design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment." However, the specific quantitative or qualitative acceptance criteria for these tests (e.g., maximum cytotoxicity levels, minimum tensile strength, specific flexibility range) and the detailed results demonstrating the device met these specific criteria are not explicitly provided in the summary.

Instead, the document broadly states that the non-clinical tests were "performed" and that results demonstrated "stability for the stated shelf-life" and that test devices "continued to meet their specifications." This is a general statement of compliance, not a detailed reporting of criteria and performance.

Test Category	Acceptance Criteria (Not explicitly stated in detail)	Reported Device Performance (Summary statement)
Biocompatibility	Established in-house criteria based on ISO 10993 series	Cytotoxicity, sensitization, intracutaneous reaction, implantation, subacute toxicity, systemic toxicity, chemistry special test, and bile solution pH tests were performed. (Specific criteria and results not provided, but implicitly met for submission.)
Stability	Established in-house criteria (e.g., flexibility, tensile strength, patency, compatibility with endoscope over time)	"Representative samples of devices were subjected to accelerated and real time ageing. The results of the accelerated age testing demonstrates that the device will be stable for the stated shelf-life. In addition, real time age testing will confirm the results of the accelerated age testing. The test devices were evaluated to ensure they continued to meet their specifications, including flexibility, tensile strength, tensile strength after stent placement, patency and compatibility with the endoscope."
Bench Testing	Established in-house criteria (e.g., flexibility characteristics)	"Bench testing was performed to compare the flexibility of the stent." (No specific criteria or comparison results are provided in the summary.)
Risk Analysis	Established in-house acceptance criteria based on ISO 14971:2007	"The risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment." (Results not detailed.)

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

Sample Size for Test Set: The document mentions "Representative samples of devices" were used for stability testing and "test devices" for other non-clinical tests. However, the exact sample sizes are not specified for any of the non-clinical tests.
Data Provenance: The tests are non-clinical (bench and lab-based testing) performed by the manufacturer, Aomori Olympus Co., Ltd. in Aomori, Japan. There is no patient data involved in the reported studies, so provenance like "country of origin of data" in terms of patient population or "retrospective/prospective" is not applicable.

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

This information is not applicable as the studies described are non-clinical, benchtop and laboratory tests. There is no "ground truth" established by human experts in the context of clinical outcomes or image interpretations. The "ground truth" for these tests would be objective measurements against defined specifications.

4. Adjudication Method for the Test Set

This information is not applicable as the studies described are non-clinical, benchtop and laboratory tests. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving expert consensus on patient data.

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

This information is not applicable. This document describes a traditional 510(k) submission for a physical medical device (biliary stent) prior to the widespread integration of AI in such devices. There is no AI component mentioned, and therefore, no MRMC study involving AI assistance for human readers.

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

This information is not applicable. There is no algorithm or software component described that would operate in a standalone manner.

7. The Type of Ground Truth Used

For the non-clinical tests described:

Biocompatibility: The ground truth is established by adherence to specified biological safety standards (e.g., ISO 10993 series) and laboratory measurements of biological responses.
Stability: The ground truth is the device meeting its predefined engineering specifications (flexibility, tensile strength, patency, compatibility) after various aging conditions.
Bench Testing (Flexibility): The ground truth would be objective measurements of flexibility against internal specifications or a comparison to the predicate device's flexibility.

In essence, the "ground truth" for these engineering and materials tests is the objective technical specification and standard.

8. The Sample Size for the Training Set

This information is not applicable. This is a submission for a physical medical device. There is no software algorithm that would require a "training set" in the context of AI/ML.

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

This information is not applicable, as there is no training set mentioned or implied.

Summary

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K103478
pg 1 of 3

FEB 2 4 2011

510(k) SUMMARY

PBD-1030/1031/1032/1033 Series, MAJ-1818/1819/1820/1821/1822 Series, PBD-V630P/V631P/V632P Series Single Use Biliary Drainage Stent V

February 23, 2011

1 General Information

Applicant:	OLYMPUS MEDICAL SYSTEMS CORP.2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507Establishment Registration No: 8010047
Official Correspondent:	Stacy Abbatiello Kluesner, M.S., RACRegulatory Affairs & Quality AssuranceOlympus America Inc.3500 Corporate ParkwayPO Box 610Center Valley, PA 18034-0610, USAPhone: 484-896-5405FAX: 484-896-7128Email: stacy.kluesner@olympus.com
Manufacturer:	Aomori Olympus Co., Ltd.248-1 Okkonoki 2-chome Kuroishi-shi,Aomori, Japan 036-0367Establishment Registration No.: 9614641

2 Device Identification

Device Trade Name:	PBD-1030/1031/1032/1033 Stent Series,MAJ-1818/1819/1820/1821/1822 Insertion Kit Series,PBD-V630P/V631P/V632P Preloaded Stent SeriesSingle Use Biliary Drainage Stent V
Common Name:	Biliary catheter
Regulation Number:	876.5010
Regulation Name:	Biliary catheter and accessories
Regulatory Class:	II
Classification Panel:	Gastroenterology/Urology
Product Code:	FGE

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K103478
pg 2 of 3

3 Predicate Device Information

Device Name: PBD-3Z through 7Z
배 OLYMPUS PBD STENTS Common Name:
I Aomori Olympus Co., Ltd. Manufacturer: 248-1 Okkonoki 2-chome Kuroishi-shi. Aomori, Japan 036-0367 Establishment Registration No .: 9614641
510(k) No. #K933200

ব Device Description

The subject Biliary Stent is placed into the duodenal papilla by using a Guidewire and Pusher Catheter to maintain the flow of bile by indwelling in the duodenal papilla. It is introduced to the biliary duct as follows:

The user pushes the distal end of the guidewire into the papilla of Vater and 1) advance the guidewire to the target area.
The user inserts the guide catheter, stent and pusher catheter over the guidewire. 2) The distal portion of the stent is inserted first.
The user advances the stent until the side flap at its proximal end contacts the 3) papilla of Vater.
The user withdraw the guide catheter from the pusher catheter to release the 4) stent.
The user withdraw the pusher catheter from the endoscope. 5)

Indications for Use റ

Comparison of Technological Characteristics 6

The subject Single Use Biliary Drainage Stent V PBD-1030/1031/1032/1033 Stent Series, MAJ-18181819/1820/1821/1822 Insertion Kit Series and PBD-V630P/V631P/V632P Preloaded Stent Series are basically identical to the predicate biliary stent PBD-62, included in MD-274 except as follows:

The stent material and a pigment have been changed.

1. The dimention and shape have been changed.
1. An accessory device, the Protection Sleeve and straightener have been added.

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K103478
pg 3 of 3

Summary of Non-Clinical Testing 7

The following non-clinical tests were performed:

1. Biocompatibility
a) Cytotoxicity Test
b) Sensitization Test
c) Intracutaneous Reaction Test
d) Implantation Test
e) Subacute toxicity Test
Systemic toxicity Test f)
g) Chemistry special Test (60 day)
h) Bile solution PH

2) Stability

Representative samples of devices were subjected to accelerated and real time ageing. The results of the accelerated age testing demonstrates that the device will be stable for the stated shelf-life. In addition, real time age testing will confirm the results of the accelerated age testing. The test devices were evaluated to ensure they continued to meet their specifications, including flexibility, tensile strength, tensile strength after stent placement, patency and compatibility with the endoscope.

Bench Testing

Bench testing was performed to compare the flexibility of the stent

4) Use of Standards

The following standards were used during the design and validation of the subject devices:

a) ISO 14971, 2007
b) ISO 11135-1, 2007
C) ISO 10993-1, 2003
d) ISO 10993-5, 1999
ISO 10993-6, 1994 e)
f) ISO 10993-10, 2002
ISO 10993-11, 2006 g)
h) ASTM F1980-07

The risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.

Conclusion 8

When compared to the predicate device, the PBD-1030/1031/1032/1033 Stent Series MAJ-1818/1819/1820/1821/1822 Insertion Kit Series and PBD-V630P/V631P/V632P Preloaded Stent Series do not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Olympus Medical Systems Corp. c/o Stacy Abbatiello Kluesner, M.S., RAC Regulatory Affairs Project Manager · Regulatory Affairs & Ouality Assurance Olympus America. Inc. 3500 Corporate Parkway, P.O. Box 610 CENTER VALLEY PA 18034-0610

FFR 2 4 2011

Re: K103478

Trade/Device Name: PBD-1030/1031/1032/1033 Stent Series, MAJ-1818/1819/1820/1821/1822 Insertion Kit Series, and PBD-V630P/V631P/V632P Preloaded Stent Series Single Use Biliary Drainage Stent V

Regulation Number: 21 CFR $876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: November 23, 2010 Received: November 26, 2010

Dear Ms. Kluesner:

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 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 device reporting of medical device-related

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Page 2

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Hubert H. Humphrey

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

K103478

Device Name:

PBD-1030/1031/1032/1033 Series, MAJ-1818/1819/1820/1821/1822 Series PBD-V630P/V631P/V632P Series

Indications For Use:

Prescription Use_ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use_ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices

510(k) Number	K103478
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Page 1 of 1

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.