(438 days)
Not Found
No
The summary describes a standard flexible video endoscope with mechanical features (sealed elevator wire channel, dual guidewire locking mechanism) and mentions standard performance testing, reprocessing validation, biocompatibility, software validation, and risk analysis. There is no mention of AI, ML, image processing beyond basic video capture, or any data training/testing related to AI/ML algorithms.
Yes
The device is used for "endoscopic diagnosis and treatment," indicating a therapeutic purpose in addition to diagnosis.
Yes
The "Device Description" explicitly states that the device is "used for endoscopic diagnosis and treatment within the duodenum."
No
The device description clearly states it is a "flexible video endoscope" and mentions physical components like a "sealed elevator wire channel" and "dual guidewire locking mechanism," indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "endoscopy and endoscopic surgery within the duodenum." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The device is described as a "flexible video endoscope used for endoscopic diagnosis and treatment within the duodenum." This is a tool for visualizing and potentially treating the inside of the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The focus is on direct visualization and intervention within the body.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
Product codes (comma separated list FDA assigned to the subject device)
FDT, NWB
Device Description
The EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V is a flexible video endoscope used for endoscopic diagnosis and treatment within the duodenum. The device has a sealed elevator wire channel and a dual guidewire locking mechanism.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
duodenum
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)
- Performance testing and design analysis was carried out to demonstrate the safety and effectiveness of the sealed elevator wire channel and the dual guidewire locking mechanism.
- The validation test on the reprocessing is performed in accordance with the FDA guidance "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance - April 1996". The FDA guidance "Draft Guidance for Industry and FDA Staff - Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling -May 2011" is also taken into consideration.
- Biocompatibility testing is performed in accordance with the FDA Guidance, Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" dated on May 1 1995.
- 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."
- Electromagnetic compatibility, electric safety, and thermal safety had been confirmed.
- 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.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, layered on top of each other to create a sense of depth. The profiles are black and are positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 15, 2016
Olympus Medical Systems Corp. % Sheri Musgnung Manager, Regulatory Affairs Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610
Re: K143153
Trade/Device Name: EVIS EXERA II Duodenovideoscope Olympus TJF Type Q180V Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDT. NWB Dated: December 8, 2015 Received: December 11, 2015
Dear Sheri 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 Industry and Consumer Education 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" (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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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
Indications for Use
Device Name
EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V
Indications for Use (Describe)
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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Image /page/3/Picture/1 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Underneath the word is a yellow line, and below that is the text "Your Vision, Our Future" in a smaller, blue font.
510(k) SUMMARY DUODENOVIDEOSCOPE EVIS MPUS TJF TYPE Q180
January 6, 2016
General Information I.
| Applicant: | OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan
192-8507
Establishment Registration No: 8010047 |
| ------------ | -------------------------------------------------------------------------------------------------------------------------------------- |
|---|
- Sheri L. Musgnung Official Correspondent: . Manager, Regulatory Affairs Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-3147 FAX: 484-896-7128 Email: sheri.musgnung@olympus.com
- AIZU OLYMPUS CO., LTD. . Manufacturer: 500 Aza Muranishi Ooaza-Iidera Monden-cho Aizuwakamatsu-Shi Fukushima, JAPAN 965-8520 Registration Number: 9610595
Device Identification II.
| ■ | Device Trade Name: | EVIS EXERA II DUODENOVIDEOSCOPE
OLYMPUS TJF TYPE Q180V |
|---|--------------------|-----------------------------------------------------------|
| ■ | Common Name: | Duodenoscope |
| ■ | Regulation Number: | 876.1500 |
| ■ | Regulation Name: | Endoscope and Accessories |
| ■ | Regulatory Class: | II |
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Image /page/4/Picture/0 description: The image displays the logo for Olympus, a company specializing in optics and imaging. The word "OLYMPUS" is written in large, bold, blue letters. A thin, horizontal, yellow line is underneath the company name. Below the line, the company's slogan, "Your Vision, Our Future," is written in a smaller font.
- Classification Panel: Gastroenterology and urology . FDT; Duodenoscope, accessories, flexible/rigid ■ Product Code: NWB; Endoscope, accessories, narrow band spectrum
Predicate Device Information III.
- Device Trade Name: XTJF Q160VF1 DUODENOVIDEOSCOPE
- . 510(k) Number K080403
- . Decision Date 05/20/2008
- . Manufacturer AIZU OLYMPUS CO., LTD
Device Description IV.
The EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V is a flexible video endoscope used for endoscopic diagnosis and treatment within the duodenum. The device has a sealed elevator wire channel and a dual guidewire locking mechanism.
V. Indications for Use
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
VI. Comparison of Technological Characteristics
The difference between the subject device and the predicate device is as follows:
- Consists of a sealed elevator wire channel ●
- Consists of a dual guidewire locking mechanism
- . Modifications to the device's labeled reprocessing procedure
- . Addition of recommended combination of equipment and accessories
- . Physical dimensions of components at distal end tip
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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, yellow line. Under the line, the words "Your Vision, Our Future" are written in a smaller, blue font.
VII. Summary of non-clinical testing
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.
- Performance testing and design analysis was carried out to demonstrate the safety and effectiveness of the sealed elevator wire channel and the dual guidewire locking mechanism.
- The validation test on the reprocessing is performed in accordance with the FDA guidance "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance - April 1996". The FDA guidance "Draft Guidance for Industry and FDA Staff - Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling -May 2011" is also taken into consideration.
- Biocompatibility testing is performed in accordance with the FDA Guidance, Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" dated on May 1 1995.
- 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."
- Electromagnetic compatibility, electric safety, and thermal safety had been confirmed.
- 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.
- The following standards have been applied to the TJF-Q180V.
- IEC 60601-1 -
- IEC 60601-1-2 -
- IEC 60601-2-18 -
- ISO 11135-1 -
- -ISO 10993-7
- ISO 10993-1 -
- ISO 10993-5 -
- ISO 10993-10 -
- ISO 14971 -
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Image /page/6/Picture/0 description: The image shows the Olympus logo. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a yellow line. Underneath the line is the text "Your Vision, Our Future".
VIII. Conclusion
Based on the 510(k) submission data, Olympus believes that the subject device and the predicate device selected are substantially equivalent and do not change the fundamental scientific technology and indications for use.