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 and enteroscopy except as follows: Patients with a critical active implantable device such as a pacemaker and an implantable cardioverter defibrillator Pregnant women
< MAJ-1878 > This instrument has been designed to be used with an Olympus endoscope and the endoscope position detecting unit for detection and display of the location and/or shape of the inserted endoscope.

Device Description

The Endoscope Position Detecting Unit (UPD-3) has been designed to be used with Olympus endoscope systems and Endoscope Position Marking Probe (MAJ-1878) for the detection and display of the shape of an endoscope once inserted into the patient. The UPD-3 detects the magnetic field generated by magnetic coils built directly into the endoscope or the MAJ-1878 inserted into the endoscope's instrument channel. The position coordinate of each coil is computed by carrying out arithmetic processing and is displayed on the UPD-3 monitor.

AI/ML Overview

The provided document describes a Traditional 510(k) Notification for the ENDOSCOPE POSITION MARKING PROBE (MAJ-1878) and the ENDOSCOPE POSITION DETECTING UNIT (UPD-3) by Olympus Medical Systems, Corp. The submission concludes that the devices are substantially equivalent to their predicate devices and do not incorporate significant changes that would affect safety or effectiveness.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific performance-based acceptance criteria in numerical terms (e.g., accuracy percentages, precision metrics) for the device's function of detecting and displaying endoscope shape/position.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through various non-clinical tests and adherence to standards, implying that meeting these standards and showing no degradation from the predicate constitutes meeting acceptance criteria.

The "reported device performance" is implicitly that the device performs as intended for "detection and display of the shape of an endoscope once inserted into the patient" and maintains the safety and effectiveness of the predicate devices.

Acceptance Criteria Category	Detail (from document)	Reported Device Performance
Technological Equivalence (UPD-3)	No technological difference between the subject and predicate devices, except for minor software features that do not affect safety and effectiveness.	The UPD-3 detects the magnetic field generated by magnetic coils and computes/displays the position coordinate of each coil, maintaining the performance and specifications of the predicate device (K103312).
Technological Equivalence (MAJ-1878)	Addition of use in the small intestine, and modifications to materials, dimensions, and applicable reprocessing methods, which do not affect safety and effectiveness.	The MAJ-1878, when used with an Olympus endoscope and the UPD-3, facilitates the detection and display of the location and/or shape of the inserted endoscope, performing as intended without compromising safety or effectiveness due to modifications.
Bench Testing	Bench test of small intestine model performed.	Implied confirmation that the device functions correctly and safely within the small intestine model.
Risk Analysis	Carried out in accordance with ISO 14971:2007, identifying design verification tests and acceptance criteria.	Implied that all identified risks were mitigated to acceptable levels through design and testing.
Software Validation	Performed in accordance with FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (Minor Level of Concern).	Implied that the software functions reliably and safely as intended, with no identified safety or effectiveness issues.
Biocompatibility	Performed in accordance with FDA Guidance, "Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, Blue Book Memo, G95-1".	Implied that the device materials are biocompatible and safe for patient contact.
Reprocessing Validation	Performed in accordance with FDA guidance "Labelling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance - April 1996" and "Draft Guidance for Industry and FDA Staff - Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling – May 2011".	Implied that the device can be safely and effectively reprocessed according to manufacturer instructions, maintaining sterility and functionality.
Adherence to Standards	Applied various IEC and ISO standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-2-18, IEC 60601-1-2, ISO 14971, IEEE Std C95.1 for UPD-3).	Implied that the device meets general safety and performance requirements for medical electrical equipment and risk management.

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

The document does not specify a sample size for a test set that would typically involve patient data or human subjects. The described "tests" are primarily bench tests and validation activities against established standards and internal acceptance criteria.

The data provenance is from non-clinical testing in a controlled environment, including a "bench test of small intestine model." The country of origin of the data is not specified beyond being generated by Olympus Medical Systems Corp. and its manufacturing affiliates (Japan). The data is retrospective in the sense that it evaluates the device against pre-defined specifications and standards.

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

This information is not provided in the document. The nature of the non-clinical tests (bench tests, risk analysis, software validation, biocompatibility, reprocessing validation, adherence to standards) did not involve establishing ground truth through human experts in the way clinical studies or expert review for diagnostic AI would. Decisions were based on engineering specifications, regulatory guidelines, and scientific standards.

4. Adjudication Method for the Test Set

Since the tests described are non-clinical (bench tests, validation against standards), an adjudication method like "2+1" or "3+1" (which typically applies to expert consensus in clinical data review) is not applicable and not mentioned in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document describes non-clinical testing for substantial equivalence, not a clinical trial involving human readers or comparative effectiveness with or without AI assistance. The device itself is an endoscopy position detecting unit, not an AI-powered diagnostic tool requiring human interpretation comparison.

6. If a Standalone Performance Study Was Done

Yes, in essence, standalone performance demonstrations were done through the described non-clinical testing. The "bench test of small intestine model" and other validation activities (software, biocompatibility, reprocessing) assess the device's inherent functionality and safety characteristics in isolation, without necessarily involving a human operator in a performance-critical decision-making loop beyond operating the device. However, this is not a "standalone performance" in the context of an AI algorithm making a diagnosis without human intervention, but rather the device itself performing its designated function.

7. The Type of Ground Truth Used

The "ground truth" used for these non-clinical tests corresponds to various engineering, regulatory, and scientific standards:

Bench Test: Ground truth would be defined by the known physical properties and expected outputs of the small intestine model, and the accuracy of the device's position detection against those known parameters.
Risk Analysis: Ground truth is against ISO 14971:2007 and in-house acceptance criteria that define acceptable risk levels.
Software Validation: Ground truth is against the defined software requirements specifications and FDA guidance for software in medical devices, ensuring it functions as intended without critical errors.
Biocompatibility: Ground truth is against toxicological profiles and FDA guidance (G95-1) identifying safe materials.
Reprocessing Validation: Ground truth is against FDA guidance documents for reprocessing, ensuring sterilization and cleaning efficacy.
Adherence to Standards: Ground truth is the requirements outlined in standards like IEC 60601 series, ISO 14971, and IEEE Std C95.1 for electrical safety, electromagnetic compatibility, and risk management.

8. The Sample Size for the Training Set

The document does not refer to a "training set" as would be applicable for machine learning or AI models. This device (UPD-3 and MAJ-1878) is described as using magnetic field detection and arithmetic processing for position computation, not an AI or machine learning algorithm that requires a training set.

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

As there is no mention of a training set for an AI/machine learning model, this question is not applicable based on the provided document. The device's functionality is based on established physics and engineering principles, not statistical learning from data.

Summary

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ENDOSCOPE POSITION MARKING PROBE ENDOSCOPE POSITION DETECTING UNIT Olympus Medical Systems, Corp.

Traditional 510(k) Notification December 27, 2013

MAR - 7 2014

K134026 Page 1 of 5

510(k) SUMMARY UPD-3 ENDOSCOPE POSITION DETECTING UNIT MAJ-1878 ENDOSCOPE POSITION MARKING PROBE

1. General Information

OLYMPUS MEDICAL SYSTEMS CORP. . Applicant: 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047
B Official Daphney Germain-Kolawole Regulatory Affairs Project Manager Correspondent: Olympus Corporation of the Americas 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
Manufacturer: SHIRAKAWA OLYMPUS CO., LTD. 1 3-1.Aza Ookamivama Ooaza Odakura, Nishigo-Mura Nishirakawa-Gun Fukushima, JAPAN 961-8061 Registration Number: 3002808148

AIZU OLYMPUS CO., LTD. 500 Aza Muranishi Ooaza-lidera Monden-cho Aizuwakamatsu-Shi Fukushima,JAPAN 965-8520 Registration Number: 9610595

II. Device Identification
1 Device Trade Name: MAJ-1878
. ENDOSCOPE POSITION MARKING PROBE Common Name:
미 Regulation Number: 876.1500

Section 5 510(k) Summary Page 1 of 5

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Traditional 510(k) Notification

December 27, 2013

ENDOSCOPE POSITION MARKING PROBE ENDOSCOPE POSITION DETECTING UNIT Olympus Medical Systems, Corp.

■ Regulation Name: Endoscope and Accessories

이트 Regulatory Class: ll
Classification Panel: Gastroenterology and urology
트 Product Code: PGU FDA FDF
II. Device Identification
파 UPD-3 Device Trade Name:
트 Common Name: ENDOSCOPE POSITION DETECTING UNIT
E Regulation Number: 876.1500
해 Regulation Name: Endoscope and Accessories
8 Regulatory Class: ll
를 Classification Panel: Gastroenterology and urology
를 Product Code: PGU FDA FDF

Predicate Device Information III.

MAJ-1878
Model name	Applicant	510(k) No.
Probe XB01-657-6	Olympus Optical Co., Ltd.	K002749
UPD-3
Model name	Applicant	510(k) No.
ENDOSCOPE POSITIONDETECTING UNITUPD-Y0003	OLYMPUS MEDICALSYSTEMS CORP.	K103312

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Device Description s

< MAJ-1878&UPD-3 >

The system is used in patients who require colonoscopy and enteroscopy except patients with a critical active implantable device such as a pacemaker and an implantable cardioverter defibrillator or pregnant women.

No modifications were made to the technology, performance, and specifications for the subject UPD-3 in comparison to the predicate device (K103312).

V. Indications for Use

< MAJ-1878 >

This instrument has been designed to be used with an Olympus endoscope and the endoscope position detecting unit for detection and display of the location and/or shape of the inserted endoscope.

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 and enteroscopy except as follows: Patients with a critical active implantable device such as a pacemaker and an implantable cardioverter defibrillator Pregnant women

VI. Comparison of Technological Characteristics

< MAJ-1878 >

The addition of the device to be used in the small intestine does not affect the safety and effectiveness.

The following design specifications have been modified and do not affect the safety and effectiveness of the device.

-Materials

-Dimensions

-Applicable method of reprocessing

Section 5 510(k) Summary Page 3 of 5

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ENDOSCOPE POSITION MARKING PROBE ENDOSCOPE POSITION DETECTING UNIT Olympus Medical Systems, Corp.

Traditional 510(k) Notification December 27, 2013

There is no technological difference between the subject device and the predicate device: however, the modification on the subject device's software has been made to include additional minor software features, and it does not affect the safety and effectiveness.

VII. Summary of non-clinical testing

The differences of technological characteristics between the predicate device and the subject device are confirmed that they are substantially equivalent through the following tests and standards.

· Bench test of small intestine model.

· 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.

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.

Biocompatibility testing is performed in accordance with the FDA Guidance," Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, Blue Book Memo, G95-1".

The validation test on the reprocessing has been perfomed in accordance with the FDA quidance "Labelling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance - April 1996". The FDA quidance "Draft Guidance for Industry and FDA Staff -Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling – May 2011" was also taken into consideration.

The following standards have been applied to the MAJ-1878&UPD-3:

· IEC 60601-1
· IEC 60601-1-1
· IEC 60601-2-18
· IEC 60601-1-2
· ISO 14971
· IEEE Std C95.1(only UPD-3)

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ENDOSCOPE POSITION MARKING PROBE ENDOSCOPE POSITION DETECTING UNIT Olympus Medical Systems, Corp.

Traditional 510(k) Notification December 27, 2013

VIII. Conclusion

When compared to the predicate device, the MAJ-1878 & UPD-3 do not incorporate any significant changes in intended use, method of operation, or design that could affect the safety or effectiveness of the device.

Section 5 510(k) Summary Page 5 of 5

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wings, representing health, services, and people. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

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

March 7, 2014

OLYMPUS MEDICAL SYSTEMS CORP. % Daphney Germain-Kolawole Regulatory Affairs Project Manager Olympus Corporation of the Americas, Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610

Re: K134026

Trade/Device Name: ENDOSCOPE POSITION MARKING PROBE and ENDOSCOPE POSITION DETECTING UNIT Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: PGU, FDA, FDF Dated: December 27, 2013 Received: December 30, 2013

Dear Daphney 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.

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/6/Picture/6 description: The image shows the name "Benjamin Fisher-S" in a bold, sans-serif font. The letters "FDA" are stacked on top of each other in the middle of the name. The letters "FDA" are outlined in black and white.

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K134026

Device Name

ENDOSCOPE POSITION DETECTING UNIT

Indications for Use (Describe)

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 and enteroscopy except as follows: Patients with a critical active implantable device such as a pacemaker and an implantable cardioverter defibrillator Pregnant women

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

Prescription Use (Part 21 CFR 801 Subpart D)

43 1 20 11 12

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

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

3 THE FOR FOR FOR FOR FOR FOR THE CONTRACT CART CONTRACTOR PRODUCTION لقارير الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموق . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . * Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (9/13)

PSC Publishing Services (JQ) | 443-6740

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

K134026

Device Name

ENDOSCOPE POSITION MARKING PROBE

Indications for Use (Describe)

This instrument has been designed to be used with an Olympus endoscope and the endoscope position detecting unit for detection and display of the location and/or shape of the inserted endoscope.

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

Prescription Use (Part 21 CFR 801 Subpart D) ,

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

Please do not write below this line - continue on a separate page if needed.

Comments of the States of Children Comments of Top FDA JISE ONLY - Portugues of Program Comments 1992 15 17

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

Image /page/8/Picture/15 description: The image contains the name "Benjamin" in bold font on the top left. Below the name is the date "2014.03.07". The right side of the image contains some illegible text that appears to be a signature. The text ends with "05'00'".

FORM FDA 3881 (9/13)

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.