← Product Code [ODA](/productcode/ODA) · K981993

# OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (K981993)

_The Olympus Optical Co. · ODA · Aug 21, 1998 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K981993

## Device Facts

- **Applicant:** The Olympus Optical Co.
- **Product Code:** [ODA](/productcode/ODA.md)
- **Decision Date:** Aug 21, 1998
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.1500
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Indications for Use

Olympus EndoAlpha Integrated Endoscopy System has been designed to be used with Olympus endoscope ancillary equipment for central operation, central display, automatic initial setting and interlocking operation of the ancillary equipment.

## Device Story

The Olympus EndoAlpha Integrated Endoscopy System acts as a centralized remote control unit for existing Olympus endosurgery ancillary equipment. It does not perform clinical functions itself but enables centralized operation, status display, and memory storage of setup values for connected devices. Used in clinical environments by medical staff, it facilitates workflow by allowing the operator to manage multiple ancillary units from a single interface. The system provides automatic initial settings and interlocking operations, reducing manual adjustments and potentially improving procedural efficiency. It does not introduce new clinical functions but streamlines the control of legally marketed ancillary devices.

## Clinical Evidence

Bench testing only. The device was tested for compliance with voluntary safety standards, specifically IEC 60601-1, IEC 60601-2, and CISPR 11. Software validation was performed to confirm the safety of the centralized control functionality.

## Technological Characteristics

Remote control unit for ancillary endosurgery equipment. Meets IEC 60601-1, IEC 60601-2, and CISPR 11 standards. No new patient-contacting materials. Functions as a centralized interface for operation, display, and memory of setup values for connected ancillary devices.

## Regulatory 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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:

1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
   1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
   2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
   3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

## Predicate Devices

- UES-20 Electrosurgical Unit ([K970184](/device/K970184.md))
- SonoSurg System ([K972114](/device/K972114.md))
- UHI High Flow Insufflation Unit ([K953163](/device/K953163.md))
- Subcutaneous Endoscopy System, OTV-S5C ([K963184](/device/K963184.md))
- OTV-SX ([K971416](/device/K971416.md))
- Laparoscopic Ultrasound System IU-E1 ([K944017](/device/K944017.md))
- Laparoscopic Ultrasound System MB-631 ([K944017](/device/K944017.md))
- 3D Surgical Endoscopy System 3DV ([K943304](/device/K943304.md), [K943305](/device/K943305.md), [K943307](/device/K943307.md))
- Crystal Eye E 3D Surgical Endoscopy System ([K943304](/device/K943304.md), [K943305](/device/K943305.md), [K943307](/device/K943307.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

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# AUG 21 1998

Page 1 of 3

## K 981993 510(k) SUMMARY OLYMPUS INTEGRATED ENDOSCOPY SYSTEM EndoALPHA

A. Submitter's Name, Address, Phone and Fax Numbers 1. Manufacturer of the subject devices

Name & Address of manufacturer:

Registration No .: Address, Phone and Fax Numbers: of R&D Department, Endoscope Division

Olympus Optical Co., Ltd. 22-2 Nishi-Shinjuku, 1-Chome, Shinjuku-ku, Tokyo 163-8610 Japan 8010047 2951 Ishikawa-Cho, Hachioji-shi, Tokyo 192-8507 Japan TEL 0426-42-5101 FAX 0426-46-2786

## B. Name of Contact Person

Name: Address, Phone and Fax Numbers: Ms. Laura Storms-Tyler Olympus America Inc. Endoscope Division Two Corporate Center Drive Melville, New York 11747-3157 TEL: (516) 844-5474 FAX (516) 844 - 5416

C. Trade Name, Common Name, Classification Number, Classification Name and Predicate Devices

Trade Name:

Common Name: Classification Number and Classification Name: Olympus Integrated Endosurgery System Endo ALPHA Control Unit for Endosurgery (UCES)

21CFR876.1500 Endoscope and accessories 21CFR876.4300 Endoscopic electrosurgical unit and accessories

ﺗﻪ: "

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K981993
Page 2 of 3

| MODEL            | NAME                                                | 510(k) Number |
|------------------|-----------------------------------------------------|---------------|
| UES-20           | Electrosurgical Unit and its associated accessories | K970184       |
| SonoSurg         | SonoSurg System                                     | K972114       |
| UHI              | UHI High Flow Insufflation Unit                     | K953163       |
| CLV-S20          | Subcutaneous Endoscopy System, OTV-S5C              | K963184       |
|                  |                                                     | K971416       |
|                  |                                                     | OTV-SX        |
| IU-E1            | Laparoscopic Ultrasound System                      | K944017       |
| MB-631           | Laparoscopic Ultrasound System                      | K944017       |
| 3DV              | 3D Surgical Endoscopy System                        | K943304       |
|                  |                                                     | K943305       |
|                  |                                                     | K943307       |
| Crystal<br>Eye E | 3D Surgical Endoscopy System                        | K943304       |
|                  |                                                     | K943305       |
|                  |                                                     | K943307       |

#### E. Description of the Device

Olympus EndoAlpha Integrated Endoscopy System is the remote control unit of Olympus legally marketed ancillary equipment. No new clinical functions are added to the above ancillary equipment by the proposed device. This subject device enables the remote control of the ancillary equipment, the display of their action status and the memory of the previous set-up values.

#### F. Intended Use of the Device

Olympus EndoAlpha Integrated Endoscopy System has been designed to be used with Olympus endoscope ancillary equipment for central operation, central display, automatic initial setting and interlocking operation of the ancillary equipment.

### G. Summary of the Technological Characteristics of the Device compared to the Predicate Devices

Olympus EndoAlpha Integrated Endoscopy System is the remote control unit of Olympus legally marketed ancillary equipment. No new clinical functions are added to the above ancillary equipment by the proposed device. Therefore, Olympus Endosurgery Integrated Endoscopy System does not affect safety of effectiveness when compared to the predicate devices.

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### Summary including a Brief Discussion of Non-clinical Tests and How their H. Results support Determination of Safety & Efficacy

Design -

Olympus EndoAlpha Integrated Endoscopy System has been designed, manufactured and tested in compliance with Voluntary Safety Standards. It meets the requirements of IEC 60601-1 and IEC 60601-2, as well as CISPR 11.

Materials -There are no new materials and patient-contacting materials.

### Summary including Conclusions drawn from Non-Clinical Tests I.

When compared to the predicate devices, Olympus EndoAlpha Integrated Endoscopy System incorporates a significant change in the operating principle. However, no new clinical functions are added, and software validation has been conducted for the device relative to this change in operating principle. In terms of other issues of intended use, design and electrical safety, the subject device, EndoAlpha, does not incorporate any significant change that could affect the safety of effectiveness.

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Image /page/3/Picture/2 description: The image shows a partial view of a seal or emblem. The visible portion includes the words "DEPARTMENT OF HEALTH & HUM," arranged vertically along the left side of the image. To the right of the text is a stylized graphic consisting of three curved lines that resemble a series of waves or stylized human profiles. The overall impression is that of an official seal, likely from a government or health-related organization.

# AUG 21 1998

Ms. Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. Two Corporate Center Drive Melville, NY 11042-1179

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K981993

Olympus EndoALPHA Integrated Endosurgery System Dated: June 4, 1998 Received: June 8, 1998 Regulatory Class: II 21 CFR 876.1500/Procode: 78 KOG, GCJ, FAL 21 CFR 876.1075/Procode: 78 FCG 21 CFR 876.4300/Procode: 78 FEH 21 CFR 878.4400/Procode: 79 GEI 21 CFR 878.4160/Procode: 79 FWF 21 CFR 884.1730/Procode: 85 HIF 21 CFR 892.1560/Procode: 90 IYO 21 CFR 892.1570/Procode: 90 ITX Unclassified/Procode: 90 LFL

Dear Ms. Storms-Tyler:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantiation assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmam.html".

Sincerely yours,

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K981993

510(k) Number (if known):

Not assigned yet

Device Name:

## Indications for Use:

The Olympus Integrated Endosurgery System EndoALPHA has been designed to be used with an Olympus endoscope ancillary equipment for central operation, central display, automatic initial setting and interlocking operation of the ancillary equipment.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

|  | <i>Robert R. Satiug/</i> |
|--|--------------------------|
|  | (Division Sign-Off)      |

Division of Reproductive, Abdominal, ENT,
and Radiological Devices

| 510(k) Number | <i>K981993</i> |
|---------------|----------------|
|---------------|----------------|

| Prescription Use     |  | OR | Over The Counter Use |  |
|----------------------|--|----|----------------------|--|
| (Per 21 CFR 801.109) |  |    |                      |  |

(Optional Format 1-2-96)

---

**Source:** [https://fda.innolitics.com/device/K981993](https://fda.innolitics.com/device/K981993)

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