This product consists of the operation portion (Handle) and insertion portion. The insertion portion consists of distal end portion and sheath portion. The distal end portion contains a basket. The Basket is connected to the Control grip of the operating portion through the insertion portion. Activating the Control grip allows the basket to open or close.

The insertion portion and the distal end portion of the subject device are inserted into the biliary tract through the endoscope. The Basket opens to retrieve the stones from the biliary tract.

AI/ML Overview

This document, K170811 for the Olympus Single Use Retrieval Nitinol Basket V, is a 510(k) summary provided to the FDA for market clearance. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel device performance.

Therefore, many of the typical elements of an acceptance criteria and study report for an AI/ML medical device will not be present in this document. This device is a mechanical basket for retrieving stones, not an AI-powered diagnostic tool.

Based on the provided document, here's what can be extracted regarding acceptance criteria and performance, with explanations for what is not present:

1. A table of acceptance criteria and the reported device performance:

The document outlines performance testing categories but does not provide a quantitative table of specific acceptance criteria values and the corresponding measured device performance for each metric. Instead, it states that tests were conducted "to demonstrate the basic performance of the subject device and confirmed that the subject device performs as intended." This general statement serves as the "reported device performance" in this context.

Acceptance Criteria Category	Reported Device Performance (Summary)
Biocompatibility	Performed in accordance with ISO 10993-1, including cytotoxicity, sensitization, and irritation testing. Confirmed to meet standards.
Sterilization Validation	Carried out with Half-cycle approach in accordance with ISO 11135:2014. Confirmed.
Shelf Life Testing	Conducted based on accelerated aging per ASTM F1980-16. Results support intended shelf life; real-time aging ongoing.
Mechanical Performance	Tested for: Insertion/withdrawal, Open/Close basket, Dimensions of the basket, Attachment/Detachment of hook, Injecting fluid, Visual inspection of package, Peel strength of package, Endurance to splitting of package, Integrity of package, Maximum diameter of catheter, Working length of catheter, Position of V marking, Strength of junction. Confirmed that the subject device performs as intended for all tested items.
Risk Analysis	Carried out in accordance with ISO 14971:2007. Addressed and resulted in design verification tests.

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

Sample Size: The document does not specify the exact number of devices or test repetitions used for each mechanical performance test. This information is typically detailed in the test reports themselves, which are part of the full 510(k) submission but not included in this public summary.
Data Provenance: Not applicable in the context of mechanical bench testing. The testing was conducted internally by Olympus's manufacturing and R&D facilities (e.g., Aomori Olympus Co., Ltd. in Japan). This is not data from human patients or a clinical setting.
Retrospective/Prospective: Not applicable. These were bench tests, not clinical studies.

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. For a mechanical device like this, "ground truth" is established by engineering specifications, validated test methods, and compliance with recognized industry standards (e.g., ISO, ASTM). There are no human experts "establishing ground truth" in the way radiologists establish ground truth for image analysis. Performance is measured against predefined engineering and material specifications.

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

Not Applicable. This refers to methods for reconciling discordant expert interpretations in clinical data, which is not relevant for bench testing of a mechanical device.

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 mechanical device, not an AI/ML algorithm or a device that assists human readers.

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

Not Applicable. This is a mechanical device, not an algorithm.

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

The "ground truth" for this device's performance relies on pre-defined engineering specifications, international standards (ISO, ASTM), and internal quality control criteria. For example, a basket dimension might have a specified range (e.g., "within +/- 0.5 mm"), and the "truth" is whether the measured dimension falls within that range. Similarly, "integrity of the package" is generally verified against a standard visually or through specific tests to ensure no punctures or seals breaches.

8. The sample size for the training set:

Not Applicable. This is a mechanical device, not a machine learning model, so there is no training set.

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

Not Applicable. As there is no training set or ML model, this question is not relevant.

In summary, this 510(k) submission for a mechanical medical device (a retrieval basket) relies on demonstrating substantial equivalence through a combination of:

Comparison of technological characteristics to existing predicate devices.
Verification that the device meets established engineering and quality control specifications through various bench-top performance tests (e.g., mechanical, sterilization, shelf-life, biocompatibility). These tests are designed to ensure the device functions as intended and is safe for its indicated use.
Compliance with recognized international standards (e.g., ISO 10993, ISO 11135, ISO 14971, ASTM F1980) for medical device development and manufacturing.

The "acceptance criteria" are implied by these standards and the "performance as intended" statement for each test category, indicating successful demonstration of functional and safety attributes.

Summary

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November 27, 2017

Olympus Medical Systems Corp. % Sheri L. Musgnung Regulatory Affairs Manager Olympus Corporation of the Americas 3500 Corporate Parkway P.O. Box 610 Center Valley, PA 18034-0610

Re: K170811

Trade/Device Name: Single Use Retrieval Nitinol Basket V Regulation Number: 21 CFR& 876.5010 Regulation Name: Biliary catheter and Accessories Regulatory Class: II Product Code: LQR, OCZ Dated: October 16, 2017 Received: October 17, 2017

Dear Sheri L. Musgnung:

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.

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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 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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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Indications for Use

510(k) Number (if known)

K170811

Device Name Single Use Retrieval Nitinol Basket V

Indications for Use (Describe)

This instrument has been designed to be used with Olympus endoscopes to retrieve stones from the biliary tract.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) SUMMARY Single Use Retrieval Nitinol Basket V

November 27, 2017

K170811 Page 1 of 4

5.1 General Information

Applicant:	OLYMPUS MEDICAL SYSTEMS CORP.
	2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan
	192-8507
	Establishment Registration No: 8010047

Official Correspondent: Sheri L. Musgnung Manager, Regulatory Affairs Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-3147 FAX: 484-896-7128 Email: sheri.musgnung@olympus.com
Manufacturer: Aomori Olympus Co., Ltd. 248-1 Okkonoki 2-chome Kuroishi-shi, Aomori, Japan 036-0357 Establishment Registration No.: 9614641

5.2 Device Identification

■ Device Trade Name:	Single Use Retrieval Nitinol Basket V
■ Common Name:	Retrieval Basket
■ Regulation Number:	876.5010
■ Regulation Name:	Biliary Catheter and Accessories
■ Regulatory Class:	II
■ Classification Panel:	Gastroenterology and urology
■ Product Code:	LQR, OCZ

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Predicate Device Information 5.3

Device Trade Name	Common Name	Applicant	510(k)number
TRAPEZOID RXLITHOTRIPTERCOMPATIBLEBASKET,MODELS 1086,1087, 1088	Retrieval Basket /LithotripsyBasket	BOSTON SCIENTIFICCORP.	K040447
Olympus BasketGraspers	Grasping forceps	OLYMPUS AMERICA INC.	K955063

5.4 Device Description

The subject device is designed to be used with Olympus endoscopes to retrieve stones from the biliary tract.

The insertion portion and the distal end portion of the subject device are inserted into the biliary tract through the endoscope. The Basket opens to retrieve the stones from the biliary tract.

ર્સ્ડ Indications for Use

This instrument has been designed to be used with Olympus endoscopes to retrieve stones from the biliary tract.

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Comparison of Technological Characteristics ર્સ્વ

Compared to the predicate devices, the proposed subject device: Single Use Retrieval Nitinol Basket V, has similar technological characteristics. There is no significant difference that affects the safety or effectiveness of the subject device.

5.7 Summary of non-clinical testing

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

•Biocompatibility testing

Biocompatibility testing is performed in accordance with the FDA Guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process"" including cytotoxicity, sensitization, and irritation testing.

•Performance testing including sterilization validation, shelf life, and mechanical performance/bench testing was conducted to demonstrate the basic performance of the subject device and confirmed that the subject device performs as intended.

Sterilization validation

Sterilization validation was carried out with Methods Half-cycle approach in accordance with ISO 11135:2014.

Shelf life testing

Shelf life testing was conducted based on an accelerated aging test in accordance with ASTM F1980-16, the standard guide for accelerated aging of sterile barrier systems for medical devices. Three years real-time aging test will be performed to demonstrate longer stability and support the results of the accelerated aging test.

Mechanical performance testing

Mechanical performance testing was conducted on the following items to demonstrate the basic performance of the subject device and confirmed that the subject device performs as intended.

1. Insertion / withdrawal
2, Open/Close basket
3, Dimensions of the basket
4, Attachment / Detachment of hook

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5, Injecting fluid
6, Visual inspection of package
7, Peel strength of the package
8, Endurance to splitting of the package
9, Integrity of the package
10, Maximum diameter of catheter
11, Working length of the catheter
12, Position of V marking
13, Strength of junction

·The following standards have been applied to the Single Use Retrieval Nitinol Basket V.

Standard number	Standard Title
ISO 10993-1 FourthEdition:2009-10-15	Biological Evaluation Of Medical Devices - Part1:Evaluation And Testing Within A Risk ManagementProcess [Including: Technical Corrigendum 1(2010)]
AAMI ANSI ISO10993-5:2009/(R)2014	Biological Evaluation Of Medical Devices – Part5:Tests For In Vitro Cytotoxicity
ISO 10993-10 Third Edition:2010-08-01	Biological Evaluation Of Medical Devices - Part10: Tests For Irritation And Skin Sensitization
ISO 11135 Second Edition2014	Sterilization Of Health-Care Products: EthyleneOxide - Requirements For The Development,Validation And Routine Control Of A SterilizationProcess For Medical Devices.
ASTM F1980-16	Standard Guide For Accelerated Aging Of SterileBarrier Systems For Medical Devices
ISO 14971 Second Edition:2007-03-01	Medical Devices - Application Of RiskManagement To Medical Devices

5.8 Conclusion

When compared to the predicate device, the Single Use Retrieval Nitinol Basket V does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device.

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.