OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2

K041494 · Olympus Corporation · FET · Jul 1, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K041494
• Device Name: OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2
• Applicant: Olympus Corporation
• Product Code: FET · Gastroenterology, Urology
• Decision Date: Jul 1, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The "OLYMPUS INTEGRATED ENDSURGERY 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

EndoALPHA UCES-2 acts as a central control unit for integrated endosurgery systems. It interfaces with various ancillary equipment (e.g., electrosurgical units, cameras, insufflators, ultrasonic instruments, video recorders) to enable centralized operation, display, and interlocking functions. Operators include nurses and surgeons using a control panel or voice control. Voice control processes spoken commands to operate connected equipment. The system automates initial settings and coordinates equipment interaction during procedures. By centralizing control, it streamlines surgical workflows, potentially reducing manual adjustments and improving efficiency in the operating room. The device does not perform clinical procedures itself; its utility is defined by the connected ancillary devices.

Clinical Evidence

Bench testing only. Verification included voice recognition testing using sample voice data to confirm correct command execution and noise immunity in an operating room environment. Control panel and surgeon controller functionality were verified against specifications.

Technological Characteristics

Central control unit for endosurgical ancillary equipment. Features voice recognition and physical control panel interfaces. Connectivity via system interface cables. Software-based control of ancillary equipment (UES-40, OTV-SP1C, LUS-2, DSR-45, UPA-P100MD, SonoSurg-IU). Risk management per ISO 14971:2000.

Indications for Use

Indicated for use with Olympus endoscopes and ancillary equipment to provide central control, display, and automated settings for surgical procedures. Patient population is not specified; use is determined by the indications for the connected ancillary equipment.

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) (K022270)

Submission Summary (Full Text)

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K041494

# SMDA 510(k) SUMMARY

pg 1 of 3

This summary of 510(k) safety and effective information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR Section 807.93.

### A. General Information

| 1. Applicant: | Olympus Corporation<br>34-3 Hirai Hinode-machi<br>Nishitama-gun, Tokyo 190-0182, Japan<br>Registration No.: 3003637092 |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Initial Importer: | Olympus America Inc.<br>Two Corporate Center Drive, Melville, NY 11747-3157<br>Registration No.: 2429304 |
| 3. Submission Correspondent: | Tina Steffanie-Oak<br>Associate Manager, Regulatory Affairs/Clinical Monitor<br>Olympus America Inc.<br>Two Corporate Center Drive, Melville, NY 11747-3157<br>TEL: [phone]<br>FAX: [phone]<br>Registration No.: 2429304 |

## B. Device Identification

| 1. Trade Name: | OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES- 2) Software Version 2 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------|
| 2. Common Name: | ENDOSURGERY SYSTEM |

- 3. Classification:

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

4. Class:

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# No41494 Bager 2 ag 3

#### C. Predicate Device Information

- 1. Trade Name:
#K022270 OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) ENDOSURGERY SYSTEM

- 2. Common Name:
- 3. Classification:

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

4. Class: Class II

#### D. Device Description

The "OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) Software Version 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.

Addition of the operating function for ancillary equipment (UES-40, OTV-SP1C, LUS-2, DSR-45, UPA-P100MD and SonoSuro-IU) enables the following:

- The operating function for ancillary equipment operates the additional ancillary equipment (UES-40, OTV-SP1C, LUS-2, DSR-45, UPA-P100MD and SonoSurg-IU) by Nurse's control panel and voice control.
The voice control function enables the subject device to control the ancillary equipment by voice. You will find the details for voice commands and voice controllable equipment in "Standard set and ancillary equipment" and "Operation by voice control" in G. Device Description and Comparison.

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 anciliary piece of equipment.

#### E. Intended Use of the Device

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

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This is the same intended use as previously cleared one for the "OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2)".

#### 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: 2000. The design verifications that were performed as a result of this risk analysis assessment are listed below. Refer to Attachment 3 for more details.

| Modification | Test performed | Acceptance criteria |
|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Voice<br>operation<br>function for<br>additional<br>ancillary<br>equipment | 1. Voice recognition test<br>We confirmed whether the voice<br>recognition is performed correctly by<br>some sample voice data. | 1. Recognize all words that are<br>in specifications. |
| | 2. Wrong recognition test<br>We confirmed whether EndoALPHA<br>doesn't work by some noise in<br>operation room. | 2. Never do wrong recognition. |
| Operating<br>function for<br>additional<br>ancillary<br>equipment | 1.Nurse's control panel operation test<br>We confirmed whether the Nurse's<br>control panel operation is performed<br>correctly. | 1.All the operations that are in<br>specification operate. |
| | 2.Surgeon's controller operation test<br>We confirmed whether the Nurse's<br>control panel operation is performed<br>correctly. | 2.All the operations that are in<br>specification operate. |

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem featuring an eagle with its wings spread, symbolizing protection and strength. The eagle is a stylized representation, with flowing lines suggesting movement and dynamism.

#### Public Health Service

# JUL 0 1 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Tina Steffanie-Oak Associate Manager, Regulatory Affairs/Clinical Monitor Olympus America, Inc. Two Corporate Center Drive MELVILLE NY 11747-3157

Re: K041494

Trade/Device Name: OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) Software Version 2 See Attachment 1 Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories

Regulatory Class: II Product Code: 78 KOG and GCJ Dated: May 24, 2004 Received: June 4, 2004

Dear Ms. Steffanie-Oak:

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.

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 nean 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); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) i his letter will anow you to begin market. By bstantial equivalence of your device to a legally premaired predication. The PDF ancing
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), please If you desire specific advice to: your don't the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, 101 questions on the promote the regulation entitled, "Misbranding Other of Compliance at (301) 57 × (027.97) you may obtain. Other general by reletence to premarket nonitode (r the Act may be obtained from the Division of Small Information on your responsional and Consumer Assistance at its toll-free number [phone] or Manufacturers, International and Socies.
[phone] or at its Internet address http://www.fda.gov/cdch/dsmaldsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### ATTACHMENT 1

## K041494 OLYMPUS ENDOALPHA INTEGRATED ENDOSURGCRY SYSTEM

Regulatory Class: II 21 CFR 876.1500; Procode: 78 KOG, GCJ,

- UCES-2 Software Version 2, .
- MAJ-1347 EndoALPHA system cable for UPA-P100MD .
- MAJ-1175 Nurse's control panel for EndoALPHA .
- MAJ-1176 Universal display for EndoALPHA .
- MAJ-1140 Surgeon's controller for EndoALPHA .
- MAJ-1141 System Interface cable for EndoALPHA .
- MAJ-1142 I/F cable; .
- . MAJ-1143 EndoALPHA system cable for electrosurgical unit
- MAJ-1144 Surgeon's controller holder for EndoALPHA; ●
- . MAJ-972 Long communication cable for boom mount EndoALPHA
- MAPC-10 PC card adapter .
- M-XD512PIXD256P/128P/64P132P/16P: xD-Picture Card .
- DSR-45 Sony Digital video recorder .

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K 041494

## 841494 510(k) Number(if known): Not assigned yet Device Name: OLYMPUS INTEGRATED ENDSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) Software Version 2

Indications for Use:

The "OLYMPUS INTEGRATED ENDSURGERY 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, interfocking 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)

OR

Prescription Use J

(Per 21 CFR 801.109)

Over-The-Counter Use J

David lh. Lyram

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K041494