(85 days)
No
The summary describes a standard endoscope and its accessories, focusing on image capture and reprocessing. There is no mention of AI or ML for image analysis, diagnosis, or any other function.
No.
The device is an endoscope used for observation and can be equipped with accessories for therapeutic procedures, but it is not inherently a therapeutic device itself. Its primary function is imaging and visualization within the duodenum.
Yes
The device is designed for endoscopy and endoscopic surgery within the duodenum, and its components include a CCD chip to deliver images and a light source providing both white light for normal observation and narrow band imaging (NBI). These features are indicative of a device used to visualize internal structures, which is a diagnostic function. The "Intended Use / Indications for Use" section also states "endoscopy...within the duodenum," where endoscopy is inherently a diagnostic procedure (though it also supports therapeutic procedures).
No
The device description clearly outlines hardware components such as a flexible insertion section, control section, endoscope connector section with a CCD chip, light guide, objective lens, instrument channel, and forceps elevator. It also describes physical accessories like a single-use distal cover and a connecting tube for reprocessing. While it mentions a video processor that transduces electrical signals to video signals, this is part of a larger hardware system, not a standalone software device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for endoscopy and endoscopic surgery within the duodenum. This involves direct visualization and potential intervention within the body, not the examination of specimens in vitro (outside the body).
- Device Description: The description details a flexible endoscope with a CCD chip for imaging, an instrument channel for accessories, and a forceps elevator. These are all components of a device used for internal examination and procedures, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), reagents, or any processes typically associated with IVD devices. The device captures images of the internal anatomy.
Therefore, this device is a medical device used for endoscopic procedures, not an In Vitro Diagnostic device.
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
FDT, NWB, FEB
Device Description
The TJF-Q190V 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. The TJF-0190V is compatible with Olympus system "Video System Center OLYMPUS CV-190 and XENON LIGHT SOURCE OLYMPUS CLV-190 (K112680)".
The subject device consists of flexible insertion section, control section and endoscope connector section with equipped CCD chip which delivers images.
The light from the light source travels through the light guide to the light guide lens at the distal end. The light source can offer both the white light for the normal observation and the narrow band imaging (NBI). The CCD chip transduces the incident light from the objective lens to electrical signal. The video processor transduces electrical signal to video signal.
There is an instrument channel entirely inside of the flexible insertion section. Endo Therapy accessories can be inserted through the instrument channel. A forceps elevator is located at the distal end of the insertion to elevate EndoTherapy accessories for endoscopic treatment.
The TJF-Q190V consists of a single-use distal cover, MAJ-2315 which has been designed to be attached to OLYMPUS TJF-O190V to cover the distal end of the insertion tube and around the forceps elevator. MAJ-2315 is to be discarded after clinical use. MAJ-2315 and TJF-Q190V were previously 510(k) cleared via premarket notification, K193182.
The following new reprocessing accessory has also been designed for use with TJF-O190V:
CONNECTING TUBE MAJ-2358
The MAJ-2358 has been designed to be used when reprocessing TJF-Q190V using the Olympus endoscope reprocessor.
The MAJ-2358 is a connecting tube to connect Olympus endoscope reprocessor and TJF-O190V. The endoscope side connector is attached to the distal end of the endoscope to directly deliver fluid to the elevator area.
Mentions image processing
Yes
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
-
Reprocessing validation testing
Reprocessing instruction and reprocessing method validation testing for the TJF-Q190V using OER-Pro and MAJ-2358 were conducted and documentation was provided as recommended by Guidance for Industry and Food and Drug Administration Staff, "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling". -
Performance testing - Bench
Bench testing for the TJF-Q190V and its accessories as listed below was conducted to ensure that the subject device performs as intended and meet design specifications. Device performance assessed the design requirements, and included process verification, design verification, and design validation.
- Connecting Tube Validation (MAJ-2358)
- Risk analysis
Risk analysis for the MAJ-2358 when used with the TJF-Q190V was conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007 and the human factors validation was conducted in accordance with the FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices".
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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December 8, 2020
Olympus Medical Systems Corp. % Sheri Musgnung Regulatory Affairs Manager Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, Pennsylvania 18034-0610
Re: K202661
Trade/Device Name: Evis Exera III Duodenovideoscope Olympus TJF-Q190V Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FDT, NWB, FEB Dated: September 11, 2020 Received: September 14, 2020
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K202661
Device Name
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TIF-Q190V
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)
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Image /page/3/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, dark blue letters. The letters are closely spaced together, creating a solid block of text. Below the word "OLYMPUS" is a horizontal gold bar. The gold bar is slightly wider than the word "OLYMPUS" above it.
1. General Information
- OLYMPUS MEDICAL SYSTEMS CORP. ■ Applicant: 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047
- Official Correspondent: Sheri L. Musgnung Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-788-3258 Email: sheri.musgnung@olympus.com
- Manufacturing site: Aizu Olympus Co., Ltd., 500 Muranishi, Niidera, Monden-machi, Aizuwakamatsu-shi, Fukushima 965-8520, Japan
2. Device Identification
| ■ Device Name | EVIS EXERA III DUODENOVIDEOSCOPE
OLYMPUS TJF-Q190V |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| ■ Common Name | Duodenoscope and accessories |
| ■ Regulation Number | 876.1500 |
| ■ Regulation Name | Endoscope and Accessories |
| ■ Regulatory Class | II |
| ■ Product Code | FDT; Duodenoscope, Accessories, Flexible/Rigid
NWB; Endoscope, accessories, narrow band spectrum
FEB; Accessories, Cleaning, For Endoscope |
| ■ Classification Panel | Gastroenterology/Urology |
510(k) Summary Page 1 of 4
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3. PREDICATE DEVICE
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| EVIS EXERA III | ||
| DUODENOVIDEOSCOPE | ||
| OLYMPUS TJF TYPE Q190V | OLYMPUS MEDICAL | |
| SYSTEMS CORP. | K193182 |
Table 1 Predicate device on TJF-O190V
4. DEVICE DESCRIPTION
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
The TJF-Q190V 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. The TJF-0190V is compatible with Olympus system "Video System Center OLYMPUS CV-190 and XENON LIGHT SOURCE OLYMPUS CLV-190 (K112680)".
The subject device consists of flexible insertion section, control section and endoscope connector section with equipped CCD chip which delivers images.
The light from the light source travels through the light guide to the light guide lens at the distal end. The light source can offer both the white light for the normal observation and the narrow band imaging (NBI). The CCD chip transduces the incident light from the objective lens to electrical signal. The video processor transduces electrical signal to video signal.
There is an instrument channel entirely inside of the flexible insertion section. Endo Therapy accessories can be inserted through the instrument channel. A forceps elevator is located at the distal end of the insertion to elevate EndoTherapy accessories for endoscopic treatment.
The TJF-Q190V consists of a single-use distal cover, MAJ-2315 which has been designed to be attached to OLYMPUS TJF-O190V to cover the distal end of the insertion tube and around the forceps elevator. MAJ-2315 is to be discarded after clinical use. MAJ-2315 and TJF-Q190V were previously 510(k) cleared via premarket notification, K193182.
The following new reprocessing accessory has also been designed for use with TJF-O190V:
CONNECTING TUBE MAJ-2358
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Image /page/5/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are all capitalized and evenly spaced. There is a registered trademark symbol to the right of the letter "S". A yellow gradient is visible below the word.
The MAJ-2358 has been designed to be used when reprocessing TJF-Q190V using the Olympus endoscope reprocessor.
The MAJ-2358 is a connecting tube to connect Olympus endoscope reprocessor and TJF-O190V. The endoscope side connector is attached to the distal end of the endoscope to directly deliver fluid to the elevator area.
5. 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.
6. Comparison of Technological Characteristics
Compared to the predicate device, HLD reprocessing method using OER-Pro and MAJ-2358 is compatible with the subject device. In addition, compatibility with OER-Elite has been submitted to FDA via an addendum-to-file K190969/A001.
There are no other major differences and the technological characteristics of the subject device TJF-Q190V are functionally equivalent to the predicate device.
5.7 PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
1) Reprocessing validation testing
Reprocessing instruction and reprocessing method validation testing for the TJF-Q190V using OER-Pro and MAJ-2358 were conducted and documentation was provided as recommended by Guidance for Industry and Food and Drug Administration Staff, "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling".
2) Performance testing - Bench
Bench testing for the TJF-Q190V and its accessories as listed below was conducted to ensure that the subject device performs as intended and meet design specifications. Device performance assessed the design requirements, and included process verification, design verification, and design validation.
- Connecting Tube Validation (MAJ-2358)
3) Risk analysis
Risk analysis for the MAJ-2358 when used with the TJF-Q190V was conducted in
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Image /page/6/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are closely spaced and appear to be a sans-serif font. There is a registered trademark symbol to the right of the letter "S". A gradient of yellow is visible below the word.
accordance with established in-house acceptance criteria based on ISO 14971:2007 and the human factors validation was conducted in accordance with the FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices".
8. CONCLUSIONS
Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate devices, the TJF-Q190V raised no new issue of safety and effectiveness and are substantially equivalent to the predicate devices in terms of safety, efficacy and performance.