(144 days)
Not Found
No
The summary describes a system for centralized control and display of endosurgery equipment, focusing on integration and automation of settings. There is no mention of AI, ML, or any functions that typically involve learning from data or complex pattern recognition beyond basic automation.
No
The device is described as a medical control unit for endosurgery that integrates and centrally operates, displays, and automatically sets ancillary equipment used with an endoscope, rather than directly treating a condition.
No
The device is described as a "MEDICAL CONTROL UNIT FOR ENDOSURGERY" designed for "central operation, central display, automatic initial setting, and interlocking operation of the ancillary equipment" used with an endoscope. Its functions are related to controlling and integrating surgical equipment, not to diagnose a condition or disease.
No
The device description explicitly states it is an "integrated electrosurgical system" and mentions "ancillary equipment" and "surgical lights," indicating it controls and interacts with hardware components beyond just software. The upgrade kit also installs software on existing hardware units (UCES-3, MAJ-1831, etc.).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use clearly state that the Systems Integration ENDOALPHA is designed for central operation, display, and control of endoscopic and ancillary equipment used during endosurgery. It manages the workflow and settings of these devices.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples from a patient. Its function is entirely focused on controlling and integrating other medical devices used in a surgical setting.
Therefore, the Systems Integration ENDOALPHA falls under the category of a medical device used in a clinical setting, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SYSTEMS INTEGRATION ENDOALPHA (MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-3) Software Version 2 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. UPGRADE KIT FOR UCES-3 (Version 2) MAJ-1943 This equipment has been designed to install software on the ENDOALPHA UCES-3, MAJ-1831, MAJ-1832, MAJ-1834, and MAJ-1862.
Product codes (comma separated list FDA assigned to the subject device)
ODA, KOG, GCJ
Device Description
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, 2) Centralized control from a sterilized area (by voice or remote switches of endoscope), 3) Centralized display, 4) Message display, 5) Voice reply, 6) Automatic settings, 7) Scene settings, 8) Display customization, 9) Still image viewing, 10) Automatic smoke evacuation. Modifications made to the subject device include: A) Additional medical devices added to list of recommended ancillary equipment, B) Improved interfacing between UCES-3 and the Advanced System, C) Increase in the maximum number of connectable surgical lights, D) Reduction in the startup time for the UCES-3, E) An additional language setting for text indications, F) Addition of the UPGRADE KIT FOR UCES-3 (Version 2) MAJ-1943.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment. A list of the testing included in the design verification tests is as follows: -Operation/verification testing for the improved interfacing between UCES-3 and the Advanced System -Operation/verification testing for the new compatible ancillary equipment -Operation/verification testing for the increase in the maximum number of connectable surgical lights -Performance testing for the startup time of the UCES-3 -Operation testing for additional language setting for text indications. The software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." A list of the testing included in the software validation activities is as follows: -Unit level testing (Module verification) -Integration level testing (Task verification) -System level testing (System verification) -Simulated use testing (Validation).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.
0
510(k) SUMMARY
SYSTEMS INTEGRATION ENDOALPHA
December 7, 2010
FEB 1 5 201
102763
1 General Information
Applicant:
I
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: 484-896-5405 FAX: 484-896-7128 Email: stacy.kluesner@olympus.com Establishment Registration No: 2429304
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:
Manufacturer:
B Common Name:
- I Regulation No:
- I Regulation Name:
- . Regulatory Class:
- . Product Code:
- . Classification Panel:
- . Prescription Status:
- 1 Performance Standards:
SYSTEMS INTEGRATION ENDOALPHA
(MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-3) Software Version 2 Endosurgery system 21 CFR 876.1500
Endoscope and accessories
- ー
ODA, KOG, and GCJ
Gastroenterology/Urology
Prescription device
- None established under Section 514.
1/4
1
3 Predicate Device Information
- Device Name: SYSTEMS INTEGRATION ENDOALPHA
- = 510(k) No: K100345 ·
- Decision Date: 03/22/2010
Device Description 4
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.
-
- 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).
- Centralized control from a non-sterilized area
- 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).
-
- Voice reply
The ancillary equipment settings, warning messages, error messages can be fed back in voice.
- Voice reply
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 recistered 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 DISPLAY FOR ENDOALPHA (MAJ-1176) can be customized.
2
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 electrosuraical 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) Additional medical devices are added to list of recommended ancillary equipment
- B) Improved interfacing between UCES-3 and the Advanced System
- C) Increase in the maximum number of connectable surgical lights
- D) Reduction in the startup time for the UCES-3
- E) An additional lanquage setting for text indications
- F) Addition of the UPGRADE KIT FOR UCES-3 (Version 2) MAJ-1943
5 Intended Use
SYSTEMS INTEGRATION ENDOALPHA
(MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-3) Software Version 2
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.
UPGRADE KIT FOR UCES-3 (Version 2) MAJ-1943
This equipment has been designed to install software on the ENDOALPHA UCES-3. MAJ-1831. MAJ-1832. MAJ-1834. and MAJ-1862.
The intended use of the SYSTEMS INTEGRATION ENDOALPHA (MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-3) Software Version 2 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 of the SYSTEMS INTEGRATION ENDOALPHA (MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-3) Software Version 2 is identical to the Intended Use previously cleared for the SYSTEMS INTEGRATION ENDOALPHA. K100345.
હ Comparison of technological characteristics with the predicate device
The modified SYSTEMS INTEGRATION ENDOALPHA has the same hardware as the predicate device and only software has been modified. Therefore, the modified SYSTEMS INTEGRATION ENDOALPHA has the same technological characteristics as the predicate device as follows:
-Operating principle
-Dimensional specifications
- -Electrical characteristics
- -Mechanical characteristics
- -Communication characteristics
3
-Enerav source
-Material (no patient contacting material)
The software modifications are minor and substantially equivalent to the predicate device. Therefore, the modified SYSTEMS INTEGRATION ENDOALPHA has the similar technological characteristics as the predicate device as follows:
-Performance
-Graphical user interface
-Compatibility with other devices as listed in the product labeling
7 Summary of non-clinical testing
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment. A list of the testing included in the design verifications tests is as follows:
-Operation/verification testing for the improved interfacing between UCES-3 and the Advanced System
-Operation/verification testing for the new compatible ancillary equipment
-Operation/verification testing for the increase in the maximum number of connectable surgical lights
-Performance testing for the startup time of the UCES-3
-Operation testing for additional language setting for text indications
The software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." A list of the testing included in the software validation activities is as follows:
-Unit level testing (Module verification)
-Integration level testing (Task verification)
-System level testing (System verification)
-Simulated use testing (Validation)
8 Conclusion
The modified SYSTEMS INTEGRATION ENDOALPHA has the following similarities to the predicate device:
Has the same intended use, ।
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.
4
Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's logo in the center. The logo is a stylized image of an eagle with three lines extending from its head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring. MD 20993-0002
Olympus Medical Systems Corp. c/o Stacy Abbatiello Kluesner, M.S., RAC Regulatory Affairs Project Manager Olympus America Inc. 3500 Corporate Parkway CENTER VALLEY PA 18034
FEB 1 5 201
Re: K102763
Trade/Device Name: Systems Integration Endoalpha (Medical Control Unit for Endosurgery UCES-3) Software Version 2 Regulation Number: 21 CFR 8876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODA and GCJ Dated: January 13, 2011 Received: January 18, 2011
Dear Ms. Kluesner:
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 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 of medical device-related
5
Page 2
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/vcm1117809.html from the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, mease note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Prev 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.
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.
Enclosure
6
510(k) Number (if known): Device Name: SYSTEMS INTEGRATION ENDOALPHA (MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-3) Software Version 2 .
Indications for Use:
SYSTEMS INTEGRATION ENDOALPHA
(MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-3) Software Version 2
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.
UPGRADE KIT FOR UCES-3 (Version 2) MAJ-1943
This equipment has been designed to install software on the ENDOALPHA UCES-3, MAJ-1831, MAJ-1832, MAJ-1834, and MAJ-1862.
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)
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