← Product Code [FET](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FET) · K041494 # OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2 (K041494) _Olympus Corporation · FET · Jul 1, 2004 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FET/K041494 ## Device Facts - **Applicant:** Olympus Corporation - **Product Code:** [FET](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FET.md) - **Decision Date:** Jul 1, 2004 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## 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, interlocking operation of the ancillary equipment. ## Device Story EndoALPHA UCES-2 acts as central control unit for endoscopic surgical suites; integrates operation of ancillary equipment (e.g., electrosurgical units, cameras, insufflators, ultrasonic instruments). Inputs include user commands via nurse control panel, surgeon controller, or voice recognition system. Device transforms inputs into control signals for connected ancillary devices; enables automatic initial settings and interlocking operations. Used in OR; operated by nursing staff or surgeons. Benefits include centralized workflow management, reduced manual adjustment of individual devices, and improved procedural efficiency. Output consists of system status displays and coordinated equipment responses. ## 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. ## 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. ## Predicate Devices - OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) ([K022270](/device/K022270.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/). {0} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center – WO66-G609 Silver Spring, MD 20993-0002 Olympus America, Inc. Ms. Tina Steffanie-Oak Associate Manager, Regulatory Affairs/Clinical Monitor Two Corporate Center Drive Melville, NY 11747-3157 JUL 27 2015 Re: K041494 Trade/Device Name: OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) Software Version 2 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET, GCJ Dated (Date on orig SE ltr): May 24, 2004 Received (Date on orig SE ltr): June 4, 2004 Dear Ms. Steffanie-Oak, This letter corrects our substantially equivalent letter of July 1, 2004. 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 {1} Page 2 - 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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 {2} K041494 510(k) Number(if known): Not assigned yet K041494 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, 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) Prescription Use ☑ (Per 21 CFR 801.109) OR Over-The-Counter Use ☐ (Optional Format 1-2-96) (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number K041494 {3} JUL 01 2004 K 041494 Pg 1 of 3 # SMDA 510(k) SUMMARY 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 34-3 Hirai Hinode-machi Nishitama-gun, Tokyo 190-0182, Japan Registration No.: 3003637092 2. Initial Importer: Olympus America Inc. Two Corporate Center Drive, Melville, NY 11747-3157 Registration No.: 2429304 3. Submission Correspondent: Tina Steffanie-Oak Associate Manager, Regulatory Affairs/Clinical Monitor Olympus America Inc. Two Corporate Center Drive, Melville, NY 11747-3157 TEL: 631-844-5477 FAX: 631-844-5416 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 Number | Regulation Name | Product Code | | --- | --- | --- | | 21 CFR 876.1500 | Endoscope and accessories | 78 KOG, GCJ, and 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 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: Class II {4} K041494 Page 2 of 3 # C. Predicate Device Information 1. Trade Name: #K022270 OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) 2. Common Name: ENDOSURGERY SYSTEM 3. Classification: | Regulation Number | Regulation Name | Product Code | | --- | --- | --- | | 21 CFR 876.1500 | Endoscope and accessories | 78 KOG, GCJ, and 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 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 SonoSurg-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 ancillary piece of equipment. # E. Intended Use of the Device 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. {5} Ko41494 3 of 3 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 operation function for additional ancillary equipment | 1. Voice recognition test We confirmed whether the voice recognition is performed correctly by some sample voice data. 2. Wrong recognition test We confirmed whether EndoALPHA doesn't work by some noise in operation room. | 1. Recognize all words that are in specifications. 2. Never do wrong recognition. | | Operating function for additional ancillary equipment | 1. Nurse's control panel operation test We confirmed whether the Nurse's control panel operation is performed correctly. 2. Surgeon's controller operation test We confirmed whether the Nurse's control panel operation is performed correctly. | 1. All the operations that are in specification operate. 2. All the operations that are in specification operate. | --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FET/K041494](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FET/K041494) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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