This instrument has been designed to be used with Olympus endoscope systems for the detection and display of the shape of an endoscope once inserted into the patient.

Patients who require colonoscopy except as follows: -Patients with a pacemaker -Pregnant women

Device Description

This instrument has been designed to be used with Olympus endoscope systems for the detection and display of the shape of an endoscope once inserted into the patient.

The device detects the magnetic field generated by magnetic coils built directly into the endoscope or the probe inserted into the endoscope's instrument channel.

This device consists of the ENDOSCOPE POSITION DETECTING UNIT (UPD-Y0003) and a RECEIVER DISH (MAJ-1868). The RECEIVER DISH is connected to the UPD-Y0003 via a RECEIVER DISH CABLE (MAJ-1875 or MAJ-1927).

The ENDOSCOPE POSITION DETECTING UNIT (UPD-Y0003) supplies "driving" signals to the source coils in 1) the endoscope or probe, 2) the Hand Coil and 3) the Reference Plate. The endoscope and probe have plural source coils. The Hand Coil has one source coil. The Reference Plate has plural source coils. The driving signals are sent to each source coil. The driving signal is delivered to the endoscope or probe through a UPD CABLE (MAJ-1881). The driving signal is delivered to the Hand Coil through an integrated cable and the Reference Plate through an integrated cable.

When the source coils receive the driving signal, a magnetic field is generated. The magnetic field is then detected by the sense coils built into the RECEIVER DISH. The signals detected by each sense coil are processed in the UPD-Y0003. The UPD-Y0003 calculates the spatial coordinates for the specific source coil. This calculation is repeated for every source coil built into the endoscope or probe. The UPD-Y0003 then creates the visual image of the endoscope on the monitor, by then putting the spatial coordinates of the multiple source coils in order (distal to proximal) and connects them.

Akin to the methodology described above, the same process takes place for the reference plate and hand coil. The spatial coordinates data obtained from the source coils in the reference plate are used to create the standard plane of endoscope's position. The source coil in the "hand coil" is used to create an independent reference point in the field of view, as displayed on the video monitor.

AI/ML Overview

The provided text is a 510(k) summary for the ENDOSCOPE POSITION DETECTING UNIT UPD-Y0003. This document focuses on demonstrating substantial equivalence to a predicate device and outlines technical specifications and compliance with standards. It does not contain information about specific clinical trials, acceptance criteria with reported performance values, or detailed study methodologies that would typically be found in direct performance studies.

Therefore, many of the requested details cannot be extracted from this particular document.

Here's a breakdown of what can and cannot be found:

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

Not Found: The document states that "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." However, it does not provide the specific acceptance criteria or the reported performance values against these criteria for the device itself. The "Comparison of Specifications" table (Table 12-2) lists technical specifications, not performance acceptance criteria.

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

Not Found: This document does not describe any specific test set or clinical study involving human patients. The testing primarily refers to "design verification tests" and "software validation activities" without specifying sample sizes or data provenance.

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 Found: As no specific test set involving medical image interpretation or diagnosis is described, there's no mention of experts or their qualifications for establishing ground truth.

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

Not Found: No information on adjudication methods for a test set 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 Found: The device is an "ENDOSCOPE POSITION DETECTING UNIT," which detects and displays the shape of an endoscope. It is not an AI-assisted diagnostic tool that would typically involve human readers or comparative effectiveness studies of the kind described.

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

Partially Applicable/Contextual: The device calculates and displays the endoscope's position. Its "performance" would likely be assessed by the accuracy of this display. The document mentions "Calculation method of the spatial coordinate of each source coil" as a modification. The "design verification tests" would assess this standalone performance, but the details (like specific metrics or results) are not provided.

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

Not Found: Given the device's function (endoscope position detection), ground truth would likely refer to highly accurate physical measurements of endoscope position in controlled environments. However, the document does not specify how ground truth was established for its internal design verification tests.

8. The sample size for the training set

Not Found: This device does not appear to be an AI/machine learning model that would require a "training set" in the conventional sense. The "modifications" were to the "mechanism to drive the source coils" and the "calculation method."

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

Not Applicable: No training set is mentioned.

Summary

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510(k) SUMMARY

MAY 1 2 2011

ENDOSCOPE POSITION DETECTING UNIT UPD-Y0003

May 11, 2011

1 General Information

l OLYMPUS MEDICAL SYSTEMS CORP. Applicant: 2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, Japan Establishment Registration No.: 8010047
. Stacy Abbatiello Kluesner, M.S., RAC Official Correspondent: Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-5405 FAX: 484-896-7128 Email: stacy kluesner@olympus.com 를
- Shirakawa Olympus Co., Ltd. Manufacturer: 3-1, Aza-Ookamiyama, Ooaza-Odakura, Nishigo-mura, Nishishirakawa-gun, Fukushima, Japan 961-8061 Establishment Registration No .: 3002808148

2 Device Identification

Device Trade Name:	UPD-Y0003
Common Name:	ENDOSCOPE POSITION DETECTING UNIT
Regulation Number:	21 CFR 876.1500
Regulation Name:	Endoscope and accessories
Regulatory Class:	II
Classification Panel:	Gastroenterology/Urology
Product Code:	FDF

. 3 Legally Marketed Device to which Substantial Equivalence is Claimed

The following table shows the primary component (part of this submission) of the ENDOSCOPE POSITION DETECTING UNIT UPD-Y0003 and the device to which we claim substantial equivalence (predicate device).

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Table 12-1 Primary Component & Predicate Device of the ENDOSCOPE POSITION DETECTING UNIT UPD-Y0003

Subject Device(Part of this Submission)	Predicate Device	PD's510(k)No.
ENDOSCOPE POSITION DETECTINGUNIT UPD-Y0003	Endoscope Contour Detection Device3DX45	K002749

ঞ্চ Device Description

This instrument has been designed to be used with Olympus endoscope systems for the detection and display of the shape of an endoscope once inserted into the patient.

The device detects the magnetic field generated by magnetic coils built directly into the endoscope or the probe inserted into the endoscope's instrument channel.

< Operating Principle of the subject device>

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The following two modifications were made to the fundamental technology of the Subject

Device from the Predicate Device's:

The mechanism to drive the source coils
Calculation method of the spatial coordinate of each source coil

5 Indications for Use

This instrument has been designed to be used with Olympus endoscope systems for the detection and display of the shape of an endoscope once inserted into the patient.

Patients who require colonoscopy except as follows: -Patients with a pacemaker -Pregnant women

6 Comparison of Technological Characteristics

ENDOSCOPE POSITION DETECTING UNIT UPD-Y0003 is basically identical to its predicate device in intended use, and similar in specifications. Comparison between the subject and predicate devices is shown in Table 12-2.

Table 12-2 Comparison of Specifications

Subject Device: ENDOSCOPE POSITION DETECTING UNIT UPD-Y0003 Predicate Device: Endoscope Contour Detection Device Olympus 3DX45 (K002749) Main unit

Specifications	Subject DeviceENDOSCOPE POSITIONDETECTING UNIT UPD-Y0003	Predicate DeviceSystem Controller UnitX301811
Rated voltage	Voltage: 100-240V AC ±10%Frequency: 50/60Hz ±1Hz	Voltage: 120V AC ±10%Frequency: 50/60Hz ±1Hz
Power consumption	110VA	480VA
Unit composition	Monitor and receiver dish areseparated.	Monitor, receiving unit and the mainunit are built in one unit.
Dimensions	370(W) x 482(D) x 81(H)mm	490(W) x 500(D) x 1820(H) mm
Weight	9kg	59kg
Specification for ScopeModel display	-The Display now shows theinsertion portion even where asource coil is not installed, areasoutside the detection area, andareas in which a source coil isbroken,	-Displayed in a shaft shape or in apolygonal line graph.-The part of The insertion portionwhere source coil is not installed isnot displayed.
Display of overlappingintersection area	Available	Not available
Scope/probe/referenceplate/hand markerConnection Indicator	Available	Not available
Viewpoint indicator display	Select from the following:-Operating image model-Figure image model	Select from the following:-Operating table model-Coordinate axis model-Simultaneous display of Operatingtable model and Coordinate axismodel
Patient data display	Patient ID, patient name, age andsex.	Patient ID
Error message display	Available	Not available
Display rotation	-Scope model is rotated by 90degrees to left and right by onepush of the switch.-Depending on the setting on themenu, scope model is rotated byevery 2.5 degrees vertically andhorizontally.	-Scope model is rotated by every2.5 degrees vertically andhorizontally.
Setting for the display startposition of the scope model(Scope position)	-Setting method: Using externalmarker or the position of the distalend of the endoscope.-Display start position: Bottomcenter or top center of display.	-Setting method: Using externalmarker.-Display start position: Center ofdisplay.
Marking	Available	Not available
Background color	The user can choose from threepredefined background colors.	-It is set by adjusting the RGBdensity.
Display of the distal end ofscope model	The distal end of a scope model isdisplayed in yellow.	-The user can choose whether todisplay the distal end of a scopemodel in yellow or not.
Detection of the source coilwire break	Source coil wire break is detectedautomatically and reflected on thescope model display.	Manually input the number of thebroken source coil to reflect it onthe scope model display.
Change of the display mode	Display of the scope model can beset by the user:-Displayed from the bottom(standard setting)-Displayed from the top	Not available
Scope model thicknesssetup	Adjustable.The size of external markerchanges depending on the scopemodel thickness.	Adjustable.The size of external marker doesnot change.
Show/hide information	Show/Hide various informationindividually.	Show/Hide information cannot beset individually. It is either show orhide all information.
Saving and recalling thesetting	Save 20 presets.	Save only one preset.
Patient data	Input via a communicationconnector via video system center.And patient data is displayed.	Input with Ten-key pad. And patientdata is displayed.
Video signal output	-Y/C: 1-SD-SDI: 1-XGA: 1	VGA: 1
Communication terminal	RS232C: 1	Not available
Receiving antenna inputterminal	One.	Not available
Driving signal outputterminal for external marker	Two.	One.
Driving signal outputterminal for reference plate	Two.	One.
Safety standards	IEC 60601-1 Ed.2IEEE Std C95.1, 2005 +Amendment 1:2010	IEC 60601-1IEEE Std C95.1, 1999
EMC compliance	Class B	Class A
Plate cover	REFERENCE PLATE COVERMAJ-1880 is provided	Not provided
Installation on the patient:	Fasten the reference plate with abelt on the patient (body surface).	Attach the reference place on thepatient's body (over the gown) withsurgical tape.

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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 verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.

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."

The following standards have been applied to the ENDOSCOPE POSITION DETECTING UNIT (UPD-Y0003):

-IEC 60601-1: 1988, Amendment 1: 1991, Amendment 2: 1995 -IEC 60601-1-1: 2000 -IEC 60601-2-18: 1996, Amendment 1: 2000 -IEC 60601-1-2: 2007 -ISO 14971: 2007 -IEEE Std C95.1: 2005+ Amendment 1: 2010

8 Conclusion

When compared to the predicate device, the ENDOSCOPE POSITION DETECTING UNIT UPD-Y0003 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.

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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G6 Silver Spring, MD 20993-0002

MAY 1 2 2011

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

Re: K103312

Trade/Device Name: ENDOSCOPE POSITION DETECTION UNIT UPD-Y0003 Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: April 12, 2011 Received: April 14, 2011

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/CDRH/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 yours.

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):

K103312

Device Name: ENDOSCOPE POSITION DETECTING UNIT UPD-Y0003

Indications for Use:

This instrument has been designed to be used with Olympus endoscope systems for the detection and display of the shape of an endoscope once inserted into the patient.

Patients who require colonoscopy except as follows: -Patients with a pacemaker -Pregnant women

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)

(Division Sign-Off)
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Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K1033/2

Page 1 of 1

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.