SYSTEMS INTEGRATION MODEL: ENDOALPHA

K100345 · Olympus Medical Systems Corporation · ODA · Mar 22, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K100345
• Device Name: SYSTEMS INTEGRATION MODEL: ENDOALPHA
• Applicant: Olympus Medical Systems Corporation
• Product Code: ODA · Gastroenterology, Urology
• Decision Date: Mar 22, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

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.

Device Story

Systems Integration ENDOALPHA acts as a central hub for endoscopic suites; connects to Olympus endoscopes and various ancillary equipment (e.g., electrosurgical units, insufflators, SonoSurg generators). Operates via Medical Control Unit (UCES-3) and Extension Unit (MAJ-1827). Provides centralized control via touch panel (MAJ-1828), voice commands, or endoscope remote switches; enables automatic initial settings and scene-based configurations for procedure efficiency. Displays equipment status, warnings, and error messages on universal displays; supports voice feedback and still image viewing from USB drives. Facilitates automatic smoke evacuation when compatible electrosurgical/insufflation units are connected. Used in clinical settings by medical staff to streamline equipment management, reduce manual adjustments, and improve workflow during endoscopic procedures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and design verification of system modifications.

Technological Characteristics

System consists of Medical Control Unit (UCES-3), Extension Unit (MAJ-1827), Touch Panel (MAJ-1828), and Universal Display (MAJ-1176). Functions as a centralized controller for ancillary endoscopic equipment. Connectivity via proprietary communication interfaces. Software-based control system manages interlocking operations, GUI display, and voice feedback. No specific material standards or energy sources beyond standard electrical power for medical equipment are detailed.

Indications for Use

Indicated for use with Olympus endoscopes and ancillary equipment to provide central operation, display, automatic initial settings, and interlocking control of connected equipment during endoscopic procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Olympus Integrated Endosurgery System EndoALPHA (Control Unit for Endosurgery UCES-2) Software Version 3 (K051613)

Submission Summary (Full Text)

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

JUL 2 7 2015

Olympus Medical Systems Corp. % Ms. Stacy Abbatiello Kluesner, M.S., RAC Regulatory Affairs Project Manager Olympus America, Inc. 3500 Corporate Parkway Center Valley, PA 18034-0610

Re: K100345

> Trade/Device Name: SYSTEMS INTEGRATION ENDOALPHA Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODA, GCJ Dated (Date on orig SE Itr): February 5, 2010 Received (Date on orig SE ltr): February 24, 2010

Dear Ms. Kluesner,

This letter corrects our substantially equivalent letter of March 22, 2010.

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

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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 (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 contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/Safetv/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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): x 100 3 4 5 Device Name: SYSTEMS INTEGRATION ENDOALPHA Indications for Use:

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.

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)

Habib Remine

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

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K100345
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## 510(k) SUMMARY

# MAR 2 2 2010

# SYSTEMS INTEGRATION ENDOALPHA

January 29, 2010

#### 1 General Information

1 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: [phone] FAX: [phone] Email: [e-mail] Establishment Registration No: 2429304

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 Name:
- Common Name:
- Regulation No:
- 트 Regulation Name:
- 월 Regulatory Class:
- 내 Product Code:
- Classification Panel: 월출
- Prescription Status: 물

Performance Standards:

## SYSTEMS INTEGRATION ENDOALPHA

Endosurgery system 21 CFR 876.1500

Endoscope and accessories

KOG, GCJ

ll

Gastroenterology/Urology

Prescription device

None established under Section 514.

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#### 3 Predicate Device Information

| Device Name: | Olympus Integrated Endosurgery System EndoALPHA<br>(Control Unit for Endosurgery UCES-2) Software Version 3 |
|--------------|-------------------------------------------------------------------------------------------------------------|
|--------------|-------------------------------------------------------------------------------------------------------------|

- 510(k) No: K051613
Decision Date: 08/15/2005

#### Device Description ব

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.

## 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).

2} 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).

- 5) Voice reply .
The ancillary equipment settings, warning 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 registered 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

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DISPLAY FOR ENDOALPHA (MAJ-11-76) can be customized.

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 electrosurgical 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) Addition or deletion of recommended ancillary equipment
- B) A change involving the communication interface
- C) A change in the design of the Graphical User interface (GUI)
- D) Addition of a voice reply function
- E) Deletion of Surgeon's controller for EndoALPHA (MAJ-1140)
- F) Transfer of Input/Output function for video signals to the Advanced system
- G) Addition of additional connectable touch panel
- H) Addition of Scene settings function
- l) Addition of system components
- Changes to the specifications of system components S

#### ട് Intended Use

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.

The intended use of the ENDOALPHA 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 is identical to the Intended Use previously cleared for the Olympus Integrated Endosurgery System EndoALPHA (Control Unit for Endosurgery UCES-2) Software Version 3, K051613.

#### 6 Conclusion

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

- Has the same intended use, l
- -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.