SYSTEMS INTEGRATION ENDOALPHA (MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-3) Software Version 2
The Systems Integration ENDOALPHA has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, and interlocking operation of the ancillary equipment.
UPGRADE KIT FOR UCES-3 (Version 2) MAJ-1943
This equipment has been designed to install software on the ENDOALPHA UCES-3, MAJ-1831, MAJ-1832, MAJ-1834, and MAJ-1862.

Device Description

The Systems Integration ENDOALPHA has been designed to be used with an Olymous endoscope and ancillary equipment for central operation, central display, automatic initial setting, and interlocking operation of the ancillary equipment.
The ENDOALPHA integrated electrosurgical system has the following system functions.

Centralized control from a non-sterilized area
Centralized control from a sterilized area
Centralized display
Message display
Voice reply
Automatic settings
Scene settings
Display customization
Still image viewing
Automatic smoke evacuation

AI/ML Overview

The Olympus Medical Systems Corp. 510(k) summary for the SYSTEMS INTEGRATION ENDOALPHA (MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-3) Software Version 2 describes design verification and software validation activities rather than a clinical study with human subjects. The device is a system for central operation, display, and control of ancillary endosurgery equipment, performing functions like centralized control, display customization, and automatic settings, with software modifications including additional compatible devices, improved interfacing, increased surgical light capacity, reduced startup time, and an additional language setting.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Tests / Criteria	Reported Device Performance
Risk Analysis	Based on ISO 14971:2007 (established in-house acceptance criteria).	Design verification tests performed as a result of risk analysis assessment.
Design Verification (Hardware & Integration)	Operation/verification testing for improved interfacing between UCES-3 and the Advanced System.	Implied successful, as the summary states the modifications are "minor and substantially equivalent" and have "similar technological characteristics" and "performance." No specific performance metrics or pass/fail rates are provided beyond the statement that tests were performed.
	Operation/verification testing for new compatible ancillary equipment.	Implied successful.
	Operation/verification testing for the increase in the maximum number of connectable surgical lights.	Implied successful.
	Performance testing for the startup time of the UCES-3.	Implied successful, as reduced startup time is listed as a modification.
	Operation testing for additional language setting for text indications.	Implied successful.
Software Validation (FDA Guidance)	Unit level testing (Module verification).	Implied successful. 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."
	Integration level testing (Task verification).	Implied successful.
	System level testing (System verification).	Implied successful.
	Simulated use testing (Validation).	Implied successful.

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

The document describes software validation and design verification tests, not a clinical study involving human patients or a traditional "test set" of patient data. Therefore, information regarding human sample size or data provenance (country of origin, retrospective/prospective) is not applicable or provided. The "test set" in this context refers to the system itself, its components, and its software functions.

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

Not applicable. The "ground truth" for this type of device (an integration system for endosurgery equipment) is based on engineering specifications, functional requirements, and safety standards rather than expert clinical consensus on patient data.

4. Adjudication Method for the Test Set

Not applicable, as this was not a study involving human readers or interpretation of medical images. The acceptance of testing results for design verification and software validation would have been based on engineering and quality assurance protocols.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The device is a control system for endosurgery equipment, not a diagnostic or AI-assisted interpretation tool that would involve human readers or image analysis.

6. Standalone Performance Study

Yes, the testing described appears to be for the standalone system in a simulated environment. The "Operation/verification testing" and "Performance testing" for various aspects like interfacing, new equipment compatibility, surgical light capacity, startup time, and language settings, along with "Unit level testing," "Integration level testing," "System level testing," and "Simulated use testing" for software, all represent standalone performance evaluation of the device's functionality. This is "algorithm only without human-in-the-loop performance" in the sense that the system's functions are verified independently of live clinical use.

7. Type of Ground Truth Used

The ground truth used for this type of device is primarily based on:

Engineering Specifications: Adherence to defined parameters for electrical, mechanical, and communication characteristics, as well as operational principles.
Functional Requirements: Verification that the system performs its designed functions (e.g., centralized control, display, automatic settings, smoke evacuation) as intended.
Safety Standards: Compliance with relevant medical device safety standards like ISO 14971:2007 for risk management.
Software Design Documents: Verification against software requirements specifications and design documents.

8. Sample Size for the Training Set

Not applicable. This device is a control system, not an AI/ML algorithm that requires a "training set" of data in the typical sense (e.g., for image recognition or clinical prediction). The software developed for this system follows conventional software engineering principles rather than machine learning.

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

Not applicable, as there was no training set for an AI/ML algorithm.

Summary

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510(k) SUMMARY

SYSTEMS INTEGRATION ENDOALPHA

December 7, 2010

FEB 1 5 201

102763

1 General Information

Applicant:

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

Official Correspondent: Stacy Abbatiello Kluesner, M.S., RAC 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 Establishment Registration No: 2429304

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 Name:
Manufacturer:

B Common Name:

I Regulation No:
I Regulation Name:
. Regulatory Class:
. Product Code:
. Classification Panel:
. Prescription Status:
1 Performance Standards:

SYSTEMS INTEGRATION ENDOALPHA

(MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-3) Software Version 2 Endosurgery system 21 CFR 876.1500

Endoscope and accessories

ー
ODA, KOG, and GCJ

Gastroenterology/Urology

Prescription device

None established under Section 514.
1/4

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3 Predicate Device Information

Device Name: SYSTEMS INTEGRATION ENDOALPHA
= 510(k) No: K100345 ·
Decision Date: 03/22/2010

Device Description 4

The ENDOALPHA integrated electrosurgical system has the following system functions.

1. Centralized control from a non-sterilized area
  The ancillary equipment connected to the MEDICAL CONTROL UNIT FOR ENDOSURGERY (UCES-3) and EXTENSION UNIT FOR UCES-3 (MAJ-1827) can be controlled in a centralized way using the TOUCH PANEL FOR ENDOALPHA (MAJ-1828).

Centralized control from a sterilized area

Ancillary equipment can be controlled by means of voice from a sterilized area.
Ancillary equipment can be controlled utilizing remote switches of the endoscope connected to the VIDEOSYSTEM CENTER (OLYMPUS CV-180, OLYMPUS OTV-S7Pro) in a sterilized area.

3) Centralized display

The settings of the functions of connected ancillary equipment can be displayed on the screen of the TOUCH PANEL FOR ENDOALPHA (MAJ-1828) and UNIVERSAL DISPLAY FOR ENDOALPHA (MAJ-1176).

4) Message display

Various warning and error messages can be displayed on the screen of the TOUCH PANEL FOR ENDOALPHA (MAJ-1828) and UNIVERSAL DISPLAY FOR ENDOALPHA (MAJ-1176).

1. Voice reply
  The ancillary equipment settings, warning messages, error messages can be fed back in voice.

6) Automatic settings

The default settings of all ancillary equipment can be registered on a per-procedure basis and recalled with a one-touch operation for setting the ancillary equipment to the required settings at once.

7) Scene settings

The operations of the ancillary equipment, performed at the beginning of each scene in the procedure, can be recistered and recalled with a one-touch operation for performing them at once.

8) Display customization

The contents of the display of the TOUCH PANEL FOR ENDOALPHA (MAJ-1828) and UNIVERSAL DISPLAY FOR ENDOALPHA (MAJ-1176) can be customized.

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9) Still image viewing

Still images recorded in a USB thumb drive (SDCZ8) can be viewed on the UNIVERSAL DISPLAY FOR ENDOALPHA (MAJ-1176).

10) Automatic smoke evacuation

When a recommended electrosuraical unit and/or SonoSurg Generator (SonoSurg-G2) and an insufflator are connected to the MEDICAL CONTROL UNIT FOR ENDOSURGERY (UCES-3) or EXTENSION UNIT FOR UCES-3 (MAJ-1827), the generated smoke or vapor can be evacuated automatically.

The modifications made to the subject device are as follows:

A) Additional medical devices are added to list of recommended ancillary equipment
B) Improved interfacing between UCES-3 and the Advanced System
C) Increase in the maximum number of connectable surgical lights
D) Reduction in the startup time for the UCES-3
E) An additional lanquage setting for text indications
F) Addition of the UPGRADE KIT FOR UCES-3 (Version 2) MAJ-1943

5 Intended Use

SYSTEMS INTEGRATION ENDOALPHA

(MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-3) Software Version 2

The Systems Integration ENDOALPHA has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, and interlocking operation of the ancillary equipment.

UPGRADE KIT FOR UCES-3 (Version 2) MAJ-1943

This equipment has been designed to install software on the ENDOALPHA UCES-3. MAJ-1831. MAJ-1832. MAJ-1834. and MAJ-1862.

The intended use of the SYSTEMS INTEGRATION ENDOALPHA (MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-3) Software Version 2 as stated above is to enable a central system to control various pieces of ancillary equipment. However, the previously cleared indications for use for each separate ancillary device dictate the type of procedures that may be performed. This information is included in the instruction manual for each ancillary piece of equipment.

The Intended Use of the SYSTEMS INTEGRATION ENDOALPHA (MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-3) Software Version 2 is identical to the Intended Use previously cleared for the SYSTEMS INTEGRATION ENDOALPHA. K100345.

હ Comparison of technological characteristics with the predicate device

The modified SYSTEMS INTEGRATION ENDOALPHA has the same hardware as the predicate device and only software has been modified. Therefore, the modified SYSTEMS INTEGRATION ENDOALPHA has the same technological characteristics as the predicate device as follows:

-Operating principle

-Dimensional specifications

-Electrical characteristics
-Mechanical characteristics
-Communication characteristics

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-Enerav source

-Material (no patient contacting material)

The software modifications are minor and substantially equivalent to the predicate device. Therefore, the modified SYSTEMS INTEGRATION ENDOALPHA has the similar technological characteristics as the predicate device as follows:

-Performance

-Graphical user interface

-Compatibility with other devices as listed in the product labeling

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. A list of the testing included in the design verifications tests is as follows:

-Operation/verification testing for the improved interfacing between UCES-3 and the Advanced System

-Operation/verification testing for the new compatible ancillary equipment

-Operation/verification testing for the increase in the maximum number of connectable surgical lights

-Performance testing for the startup time of the UCES-3

-Operation testing for additional language setting for text indications

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." A list of the testing included in the software validation activities is as follows:

-Unit level testing (Module verification)

-Integration level testing (Task verification)

-System level testing (System verification)

-Simulated use testing (Validation)

8 Conclusion

The modified SYSTEMS INTEGRATION ENDOALPHA has the following similarities to the predicate device:

Has the same intended use, ।

Uses the same operating principle -

In summary, the modified SYSTEMS INTEGRATION ENDOALPHA described in this submission is, in our opinion, substantially equivalent to the predicate device.

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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's logo in the center. The logo is a stylized image of an eagle with three lines extending from its head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the perimeter of the circle.

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 Olympus America Inc. 3500 Corporate Parkway CENTER VALLEY PA 18034

FEB 1 5 201

Re: K102763

Trade/Device Name: Systems Integration Endoalpha (Medical Control Unit for Endosurgery UCES-3) Software Version 2 Regulation Number: 21 CFR 8876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODA and GCJ Dated: January 13, 2011 Received: January 18, 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/vcm1117809.html from the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, mease note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Prev 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.

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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510(k) Number (if known): Device Name: SYSTEMS INTEGRATION ENDOALPHA (MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-3) Software Version 2 .

Indications for Use:

SYSTEMS INTEGRATION ENDOALPHA

(MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-3) Software Version 2

UPGRADE KIT FOR UCES-3 (Version 2) MAJ-1943

This equipment has been designed to install software on the ENDOALPHA UCES-3, MAJ-1831, MAJ-1832, MAJ-1834, and MAJ-1862.

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)

K102763

Page 1 of

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

. 2000 . 2000 . 2000 . 2000 . 200 .

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.