The subject ALT-Y0003 is used to detect leaks from Olympus flexible endoscopes. It utilizes two testing modes; one is automated leak test mode (ALT mode) and the other is manual leak test mode (MLT mode). In ALT mode, it is not required to soak the tested endoscope in water. The ALT-Y0003 detects leak from the difference of air pressure. The ALT-Y0003 can also be used for conventional manual leak test by soaking an endoscope in water. The ALT-Y0003 has an RFID function to recognize endoscope and operator identification. It can store test results in its internal memory and this stored record can be printed out with the designated printer and/or transferred to deginated USB memory.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance

Criterion	Acceptance Criteria	Reported Device Performance
Leak Detecting Rate (ALT vs. MLT)	The leak detecting rate of the Automated Leak Test (ALT) mode should be equivalent to that of the conventional Manual Leak Test (MLT) mode.	"It has been demonstrated that there is no significant difference in leak detection rates between ALT and conventional MLT." (The document states equivalency was confirmed in nonclinical testing).
Detection Threshold	The ALT-Y0003 should be able to detect a leak that actually causes a water leak.	"it has been confirmed that the detection threshold of the ALT-Y0003 can detect a leak which actually causes a water leak."
Software Validation	Compliance with FDA Guidance: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (Device software considered "Minor Level of Concern").	"The software validation activities were performed in accordance with the FDA Guidance, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'"
Electrical Safety	Compliance with IEC 61010-1.	"Basic safety and performance testing was performed in accordance with IEC 61010-1..."
EMC Standard	Compliance with IEC 61326-1.	"...and IEC 61326-1."
FCC Part 15 Standard (Intentional Radiator)	Compliance with Federal Communications Commission (FCC) 47 CFR Part 15 - Radio Frequency Devices, Subject C - Intentional Radiators.	"As the ALT-Y0003 is considered to be an intentional radiator prescribed under Federal Communications Commission (FCC) 47 CFR Part 15 – Radio Frequency Devices, Subject C – Intentional Radiators, it has been evaluated to verify compliance with this regulation."
Mechanical and Functional Performance	Verification of mechanical and functional performance (specific criteria not detailed, but likely involve proper operation of all device features).	"In addition, verification was conducted to evaluate the mechanical and functional performance."
Risk Analysis	Risk analysis carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. Design verification tests and their acceptance criteria identified and performed as a result of this risk analysis assessment.	"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." (This implies the internal acceptance criteria were met, though specifics are not provided for each risk identified).

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

The document does not explicitly state the specific sample size used for the test set of endoscopes in the performance testing. It refers to "nonclinical testing" without detailing the number of endoscopes or the specific characteristics of the leaks tested.

The data provenance is not explicitly stated in terms of country of origin, but the manufacturer is Japanese (Olympus Medical Systems Corp. and Shirakawa Olympus Co., Ltd.). The mention of "nonclinical testing" implies these were controlled laboratory tests rather than retrospective or prospective clinical data from patients.

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

This information is not provided in the document. The study described is a performance validation of a leak detection device, not a diagnostic imaging device where expert interpretation of images would typically establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. The study compares the device's diagnostic capability (leak detection) to a conventional method, not to expert consensus on interpretation.

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

No, an MRMC comparative effectiveness study was not done. This device is an automated endoscope leak tester, not an AI-assisted diagnostic tool for human readers. The study compares the device's automated leak detection mode to a manual leak testing mode, not to human readers interpreting data.

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

Yes, a standalone performance assessment of the automated leak test (ALT) mode was done. The study specifically compared the ALT mode (which operates without human intervention beyond setting up the test) to the conventional manual leak test (MLT) mode. The core of the performance testing revolved around demonstrating the standalone capability of the ALT mode to detect leaks effectively.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for "leak detection" in this context would likely be the actual presence or absence of a leak in the tested endoscopes, confirmed by a reference method. The document mentions "it has been confirmed that the detection threshold of the ALT-Y0003 can detect a leak which actually causes a water leak," suggesting a direct physical assessment of leakage (e.g., observing water expulsion/bubbles when pressurized or actual damage causing water ingress) served as the ultimate ground truth for the detection threshold. For the comparison of detection rates, the "ground truth" would be which endoscopes actually had a leak, as determined by a highly sensitive method (possibly the conventional manual leak test itself, if it was deemed the gold standard, or a more rigorous laboratory-controlled method).

8. The Sample Size for the Training Set

This information is not provided. The document describes a performance validation study for a medical device that uses software, but it doesn't specify if the leak detection algorithm itself underwent a machine learning training phase. The context is more about validating a programmed automated test than a learned AI model.

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

Since no training set is explicitly mentioned or defined in the context of machine learning, the question of how its ground truth was established is not applicable based on the provided document. If there was an internal development process involving data, that information is not detailed in this 510(k) summary.

Summary

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K123704
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510(k) SUMMARY

AUTOMATED ENDOSCOPE LEAK TESTER ALT-Y0003

FEB 4 2013

November 30, 2012

1 General Information

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

Official Correspondent: Daphney Germain-Kolawole Regulatory Affairs Project Manager Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-5691 FAX: 484-896-7128 Email: daphney.germain-kolawole @olympus.com
트 Manufacturer:

■

SHIRAKAWA OLYMPUS CO., LTD. 3-1, Aza-Ookamiyama, Ooaza-Odakura, Nishigo-mura, Nishishirakawa-gun, Fukushima, Japan 961-8061 Establishment Registration No: 3002808148

2 Device Identification

Device Trade Name: AUTOMATED ENDOSCOPE LEAK TESTER ALT-Y0003
I Common Name: Leak Tester
. Regulation Number: 876.1500
B Regulation Name: Endoscope and accessories

. Regulatory Class:
트 Classification Panel:
마 Product Code: PCV

Gastroenterology and urology

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K123704
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3 Predicate Device Information

	PD1	PD2
Device Name:	Endoscope Leak TesterZUTR-10003	Maintenance Unit MU-1
510(k) No.	K093718	K051886
Manufacturer	Zutron Medical	SHIRAKAWA OLYMPUS CO.,LTD.

4 Device Description

5 Indications for Use

This equipment is intended to be used to perform and record leakage testing on Olympus flexible endoscopes.

Comparison of Technological Characteristics റ്

The subject ALT-Y0003 is substantially equivalent to the predicate devices. Both the subject device and predicate devices are used for leak testing of endoscopes in combination with connecting tube by feeding air into endoscopes.

Compared to the predicate devices, the main differences of ALT-Y0003 are as follows:

Automated leak test mode -
. RFID
Internal memory to store test results -

It has been confirmed that the ALT mode has equivalent detecting rate to conventional MLT in nonclinical testing. The subject device was also tested in compliance with electrical safety standard, EMC standard, and FCC Part 15 standard and confirmed there is no problem with safety and effectiveness.

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K123704
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7 Summary of Nonclinical Testing

Performance testing was conducted to confirm that the leak detecting rate of ALT is equivalent to that of conventional MLT. It has been demonstrated that there is no significant difference in leak detection rates between ALT and conventional MLT. Also, it has been confirmed that the detection threshold of the ALT-Y0003 can detect a leak which actually causes a water leak.

The software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The device software is considered a "Minor Level of Concern."

As the ALT-Y0003 is considered to be an intentional radiator prescribed under Federal Communications Commission (FCC) 47 CFR Part 15 - Radio Frequency Devices, Subject C - Intentional Radiators, it has been evaluated to verify compliance with this regulation.

Basic safety and performance testing was performed in accordance with IEC 61010-1 and IEC 61326-1. In addition, verification was conducted to evaluate the mechanical and functional performance.

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.

The following standards have been applied to ALT-Y0003

IEC 61010-1: 2001 .
IEC 61326-1: 2005
ISO 14971: 2007

Conclusion 8

When compared to the predicate devices, the AUTOMATED ENDOSCOPE LEAK TESTER ALT-Y0003 does not incorporate any significant changes in intended use, method of operation 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 logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure with three stylized wing or feather shapes.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

February 4, 2013

OLYMPUS MEDICAL SYSTEMS CORP. % Ms. Daphney Germain-Kolawole Regulatory Affairs Project Manager Olympus America, Inc. 3500 Corporate Parkway CENTER VALLEY PA 18034-0610

Re: K123704

Trade/Device Name: AUTOMATED ENDOSCOPE LEAK TESTER ALT-Y0003 Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: PCV Dated: November 30, 2012 Received: December 3, 2012

Dear Ms. Germain-Kolawole:

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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Page 2 - Ms. Daphney Germain-Kolawole

You must comply with all the Act's requirements, including, but not limited to: registration and I vu must compy with and 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific ad rios court DA/Centers Offices/CDRH/CDRHOffices/ucm115809.htm for go to map. WWW. adiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 1000 and 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 yours,

Benjamin/R._Fisher -S

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): 123704 Device Name: AUTOMATED ENDOSCOPE LEAK TESTER ALT-Y0003 Indications For Use:

This equipment is intended to be used to perform and record leakage testing on Olympus flexible endoscopes.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Benjamin R. Fisher -S 2013.02.05 13:00:05 -05'00'

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(Division Sign-Off) Bivision of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.