(96 days)
Not Found
No
The summary does not mention AI, ML, or related concepts, and the device description focuses on control and integration functions.
No
The device's intended use and description state it is a control unit for operating endoscopes and ancillary equipment, not for directly treating a disease or condition. It facilitates procedures rather than performing therapeutic actions itself.
No
The device is described as a "medical control unit" for endosurgery, designed for central operation, display, and interlocking of ancillary equipment. Its function is to control other equipment, not to diagnose a condition.
No
The device description explicitly states it is a "medical control unit" designed to be used with an endoscope and ancillary equipment, implying it is a hardware component that controls other hardware. While it mentions "Software Version 1," the overall description points to a physical control unit, not a standalone software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is a "medical control unit for endosurgery" used with an endoscope and ancillary equipment for central operation, display, and control. This describes a device used during a surgical procedure, not a device used to test samples outside the body to diagnose or monitor a condition.
- Device Description: The description reinforces its function as a control unit for endosurgery equipment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on controlling surgical equipment during an endoscopic procedure.
N/A
Intended Use / Indications for Use
This medical control unit for endosurgery 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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ, ODA
Device Description
The SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1 (hereinafter referred to as "UCES-4") 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.
- System Components
The UCES-4 consists of the following components.
| Model | Device description |
|---|---|
| UCES-4 | MEDICAL CONTROL UNIT FOR ENDOSURGERY |
| MAJ-2191 | EXTENSION UNIT FOR UCES-4 |
| MAJ-2249 | INTERFACE FOR ESU (VIO SERIES) |
| MAJ-2250 | INTERFACE FOR ESU (FORCE SERIES) |
| MAJ-2251 | UNIVERSAL INTERFACE |
| MAJ-2268 | INTERFACE FOR OLYMPUS LINK DEVICE |
Structure
The UCES-4 has built-in power supply circuit, main control circuit, communication control circuit, and data storage device. Through communications with each of the ancillary equipment, it provides central display of the ancillary equipment status and performs centralized operation of the ancillary equipment via the touch panel.
Principle
Communicating with the connected ancillary equipment, the UCES-4 displays the information of the communications on the touch panel. It sends input commands from input devices such as the touch panel to the ancillary equipment to perform centralized control.
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)
Non-clinical testing was not conducted since the basic technological characteristics of the subject device are identical to the predicate device.
The differences of technological characteristics between the predicate device and the subject device are confirmed that they are substantially equivalent through the following tests and standards.
- 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".
- The electromagnetic compatibility and electric safety had been confirmed.
- The risk management was performed in accordance with established in-house acceptance criteria based on ISO 14971:2007.
- The human factors activities were performed in accordance with the FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices".
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
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December 5, 2017
Olympus Medical Systems Corp. % Sheri L. Musgnung Regulatory Affairs Manager Olympus Corporation of the Americas 3500 Corporate Parkway P.O. Box 610 Center Valley, PA 18034-0610
Re: K172618
Trade/Device Name: SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1 Regulation Number: 21 CFR& 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: GCJ, ODA Dated: November 1, 2017 Received: November 2, 2017
Dear Sheri L. Musgnung:
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.
1
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 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and appears to be centered on a white background. The letters are clear and easy to read.
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
Indications for Use
510(k) Number (if known) K172618
Device Name
SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1
Indications for Use (Describe)
This medical control unit for endosurgery 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1
August 30, 2017
I. General Information
- 1 Applicant: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047
- 1 Official Correspondent: Sheri L. Musgnung Regulatory Affairs Manager Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-3147Fax: 484-896-7128 Email: sheri.musgnung@olympus.com
- 1 Manufacturer: SHIRAKAWA OLYMPUS CO., LTD. 3-1, Aza-Ookamiyama, Ooaza-Odakura, Nishigo-mura, Nishishirakawa-gun, Fukushima, 961-8061, Japan Establishment Registration Number: 3002808148
II. Device Identification
- Device Trade Name: SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1
- . Common Name: Endosurgery system
- . Regulation Number: 876.1500
- I Regulation Name: Endoscope and accessories
- . Regulatory Class: II
- . Classification Panel: Gastroenterology and urology
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Image /page/4/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. A thin, yellow line is underneath the word. Below the line, the words "Your Vision. Our Future." are written in a smaller font.
- . Product Code: GCJ and ODA
III. Predicate Device Information
- . Device Name: SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-3 Software Version 4
- . Common Name: Endosurgery system
- . Regulation Number: 876.1500
- . Regulation Name: Endoscope and accessories
- . Regulatory Class: II
- . Applicant: OLYMPUS MEDICAL SYSTEMS CORP.
- . 510(k) Number: K121701
IV. Device Description
The SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1 (hereinafter referred to as "UCES-4") 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.
- System Components
The UCES-4 consists of the following components.
| Model | Device description |
|---|---|
| UCES-4 | MEDICAL CONTROL UNIT FOR ENDOSURGERY |
| MAJ-2191 | EXTENSION UNIT FOR UCES-4 |
| MAJ-2249 | INTERFACE FOR ESU (VIO SERIES) |
| MAJ-2250 | INTERFACE FOR ESU (FORCE SERIES) |
| MAJ-2251 | UNIVERSAL INTERFACE |
| MAJ-2268 | INTERFACE FOR OLYMPUS LINK DEVICE |
Structure
The UCES-4 has built-in power supply circuit, main control circuit, communication control circuit, and data storage device. Through communications with each of the
K172618 Page 2 of 4
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Image /page/5/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, horizontal, yellow line. Under the line are the words "Your Vision. Our Future" in a smaller font.
ancillary equipment, it provides central display of the ancillary equipment status and performs centralized operation of the ancillary equipment via the touch panel.
- Principle
Communicating with the connected ancillary equipment, the UCES-4 displays the information of the communications on the touch panel. It sends input commands from input devices such as the touch panel to the ancillary equipment to perform centralized control.
V. Indications for Use
This medical control unit for endosurgery 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.
VI. Comparison of Technological Characteristics
The UCES-4 has the same technological characteristics as the predicate device as follows:
- · Operating principle
- · Electrical characteristic
- · Mechanical characteristic
- Communication characteristic .
- · Energy source
- · Material (no patient contacting material)
The UCES-4 has modified the software and hardware, and the following technological characteristics are different from the predicate device.
- · Performance
- Graphical user interface
- · Compatibility with other devices
The validation testing demonstrated that these differences do not affect the safety and effectiveness of the subject device.
VII. Summary of Non-Clinical Testing
Non-clinical testing was not conducted since the basic technological characteristics of the subject device are identical to the predicate device.
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Image /page/6/Picture/0 description: The image contains the logo for OLYMPUS. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, yellow line. Underneath the line, the words "Your Vision, Our Future" are written in a smaller, gray font.
The differences of technological characteristics between the predicate device and the subject device are confirmed that they are substantially equivalent through the following tests and standards.
- · 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".
- · The electromagnetic compatibility and electric safety had been confirmed.
- · The risk management was performed in accordance with established in-house acceptance criteria based on ISO 14971:2007.
- · The human factors activities were performed in accordance with the FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices".
The following voluntary standards have been applied to the UCES-4;
- · IEC 60601-1: 2005+A1
- · IEC 60601-1-2: 2014
- · IEC 60601-2-18: 2009
- · ISO 14971: 2007
VIII. Conclusion
Compared to the legally marketed predicate device. the UCES-4 does not incorporate any significant changes in the indications for use, method of operation, material, or design that could affect the safety or effectiveness of the subject device.
K172618 Page 4 of 4