MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA

K022270 · Olympus Optical Co., Ltd. · ODA · Aug 14, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K022270
• Device Name: MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA
• Applicant: Olympus Optical Co., Ltd.
• Product Code: ODA · Gastroenterology, Urology
• Decision Date: Aug 14, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The "OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2)" has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, interlocking operation of the ancillary equipment.

Device Story

The Olympus EndoALPHA UCES-2 is a central control unit for endosurgery systems; it integrates operation, display, and settings for various ancillary endoscopic equipment. Input includes signals from connected ancillary devices and voice commands from the operator. The system transforms these inputs to provide centralized control, automatic initial settings, and interlocking of equipment. New features include voice control for ancillary equipment, image switching, recording, and playback capabilities. Still images are recorded to a PC card (SmartMedia) and displayed on monitors. Used in the operating room; operated by physicians or clinical staff. The system benefits the patient by streamlining equipment management and reducing manual adjustments during procedures. Healthcare providers use the central display and controls to manage the surgical environment, directly affecting clinical workflow efficiency.

Clinical Evidence

Bench testing only. Risk analysis performed per ISO 14971-1. Verification testing included voice recognition rate testing using sample voice data and wrong recognition testing to ensure immunity to operating room noise.

Technological Characteristics

Central control unit for endoscopic ancillary equipment. Features voice recognition module, image switching/recording/playback circuitry, and PC card (SmartMedia) interface. Connectivity includes integration with Olympus endoscopes and ancillary devices. Software-based control for interlocking and automated settings. Sterilization not applicable to the control unit itself.

Indications for Use

Indicated for use with Olympus endoscopes and ancillary equipment to provide central control, display, automatic initial settings, and interlocking of ancillary devices during endoscopic procedures. Patient population is defined by the approved indications of the specific ancillary equipment used in the procedure.

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) (K981993)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with its wings outstretched.

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

Olympus America, Inc. Two Corporate Center Drive Ms. Laura Storms-Tyler Director, Regulatory Affairs and Quality Assurance Melville, NY 11747-3157

JUL 2 7 2015

Re: K022270

> Trade/Device Name: Olympus Integrated Endosurgery System EndoALPHA (Control Unit for Endosurgery UCES-2), Models MAJ-1177, MA-2E and M-128/64/32/16/8PIE and PIU

Regulation Number: 21 CFR 876.1500

Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODA, GCJ, FAL, FCG, FEH, FWF, GEI, HIF, IYO, ITX and LFL Dated (Date on orig SE ltr): July 12, 2002 Received (Date on orig SE ltr): July 15, 2002

Dear Ms. Storms-Tyler,

This letter corrects our substantially equivalent letter of August 14, 2002.

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 (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 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/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Benjamin R. Fisher -S

Beniamin 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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510(k) Number(if known): __Not.assigned.yet___________________________________________________________________________________________________________________________________

Device Name:

OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2)_

Indications for Use:

The "OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2)" has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, interlocking 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)

| Prescription Use | <div style="text-align:left;">/</div> | OR | Over-The-Counter Use | |
|---------------------------------------------------------------|---------------------------------------|----|----------------------|--------------------------|
| (Per 21 CFR 801.109) | | | | (Optional Format 1-2-96) |
| (Division Sign-Off) | | | | |
| Division of Reproductive, Abdominal, and Radiological Devices | | | | |
| 510(k) Number | K022270 | | | |

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AUG 1 4 2002

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## SMDA 510(k) SUMMARY

# OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2)

## A. Submitter's Name, Address, Phone and Fax Numbers

| Name & Address of manufacturer: | Olympus Optical Co., Ltd.<br>2-3-1 Shinjuku Monolis Nishi-Shinjuku,<br>Shinjuku-ku Tokyo, Tokyo 163-0914<br>Japan |
|-----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Registration No.: | 8010047 |
| Address, Phone and Fax Numbers:<br>of R&D Department, Endoscope<br>Division | 2951 Ishikawa-Cho,<br>Hachioji-shi, Tokyo 192-8507<br>Japan |
| | TEL [phone] |
| | FAX [phone] |

#### B. Name of Contact Person

| Name: | Laura Storms-Tyler |
|---------------------------------|-------------------------------|
| Address, Phone and Fax Numbers: | Olympus America Inc. |
| | Two Corporate Center Drive |
| | Melville, New York 11747-3157 |
| | TEL: [phone] |
| | FAX: [phone] |

## C. Device Name, Common Name, Classification Name and Predicate Devices

| Trade Name: | #K981993 OLYMPUS INTEGRATED ENDOSURGERY SYSTEM<br>EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | ENDOSURGERY SYSTEM |
| Classification: | 21 CFR 876.1500 Endoscope and accessories<br>21 CFR 876.1075 Gastroenterology-urology biopsy instrument<br>21 CFR 876.4300 Endoscopic electrosurgical unit and accessories<br>21 CFR 878.4160 Surgical camera and accessories<br>21 CFR 878.4400 Electrosurgical cutting and coagulation device and<br>accessories<br>21 CFR 884.1730 Laparoscopic insufflator<br>21 CFR 892.1560 Ultrasonic pulsed echo imaging system<br>21 CFR 892 1570 Diagnostic ultrasonic transducer<br>No Class (Ultrasonic Surgical Instrument) |

Predicate Device: OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES) x981993

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### D. Description of the Device(s)

The "OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-21" has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, interlocking operation of the ancillary equipment.

The additional voice control function enables the subject device to control the ancillary equipment by voice, while the conventional products control them manually. You could find the details for voice commands and voice controllable equipment in "Standard set and ancillary equipment" and "Operation by voice control" of this section.

Addition of Image switching, recording and playback functions enables the followings;

- Images input into the UCES-2 and MAJ-1139 are displayed on two monitors by switching from one to another.
- · Images input into the UCES-2 and MAJ-1139 are displayed on the MAJ-1176 as reference images.
- · Still images input into UCES-2 and MAJ-1139 are recorded in a PC card (SmartMedia) The images recorded in the PC card (SmartMedia) are displayed on the MAJ-1176.

The intended use of the EndoALPHA is to enable a central system to control various pieces of ancillary equipment. However, the approved 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.

### E. Intended Use of the Device(s)

The "OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-21" has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, interlocking operation of the ancillary equipment.

This is the same intended use as previously cleared one for the "OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA(CONTROL UNIT FOR ENDOSURGERY UCES)".

#### F. Summary including Conclusions drawn from Non-clinical Tests

The risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO14971-1. The design verification that were performed as a result of this risk analysis assessment are listed below. Refer to Attachment 3 for detail.

| Modification | Test performed | Acceptance Criteria |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Added the<br>Voice<br>Operation | 1. Voice recognition test<br>We confirmed the voice recognition rate<br>by some sample voice data that is<br>recorded by members of Olympus<br>America Inc. | 1. Recognize all words that is in<br>specifications. |
| Function | 2. Wrong recognition test<br>We confirmed whether EndoALPHA<br>doesn't work by noise in operation room. | 2. Never do wrong recognition. |

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## ATTACHMENT

Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Product Code: 78 KOG, GCJ and FAL Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Product Code: 78 FCG Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Product Code: 78 FEH Regulation Number: 21 CFR 878.4160 Regulation Name: Surgical camera and accessories Product Code: 79 FWF Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Product Code: 79 GEI Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic insufflator Product Code: 85 HIF Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Product Code: 90 IYO Regulation Number: 21 CFR 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Product Code: 90 ITX Regulation Number: Unclassified Product Code: 90 LFL