(71 days)
No
The document describes a standard duodenoscope with image capture and processing capabilities, but there is no mention of AI or ML being used for image analysis, diagnosis, or any other function.
Yes
The device aids in endoscopic surgery and allows for the insertion of "EndoTherapy accessories" for "endoscopic treatment," indicating a therapeutic purpose beyond just diagnosis.
Yes
The device is described as an endoscope that delivers images for observation, which is a diagnostic function. It also explicitly mentions "normal observation and narrow band imaging (NBI)" as functions. While it can also be used for "endoscopic surgery," the capability to provide images for observation through the CCD chip and light source firmly establishes its diagnostic purpose.
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 a forceps elevator. It is a physical endoscope, not a software-only 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 directly visualizing and potentially manipulating tissue within the body.
- Device Description: The device is a duodenoscope, which is a flexible instrument inserted into the body to visualize internal structures. It uses optical imaging (white light and narrow band imaging) to capture images of the duodenum.
- Lack of In Vitro Activity: IVDs are designed to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health. This device does not perform any tests on specimens outside the body.
The device is an endoscope, which is a medical device used for direct visualization of internal organs and structures.
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 III DUODENOSCOPE 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-Q190V is compatible with Olympus system "Video System Center OLYMPUS CV-190 and XENON LIGHT SOURCE OLYMPUS CLV-190 (K112680)."
The subject device consists of a flexible insertion section, control section and endoscope connector section with equipped charge-coupled device (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 white light for normal observation and narrow band imaging (NBI). The CCD chip transduces the incident light from the objective lens to electrical signal. The video processor transduces the electrical signal to video signal.
There is an instrument channel located inside of the flexible insertion section. EndoTherapy 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.
A sterile, single-use Distal Cover (MAJ-2315) has been designed to be attached to the OLYMPUS TJF-Q190V to cover the distal end of the insertion tube and fit around the forceps elevator. MAJ-2315 is to be discarded after clinical use. MAJ-2315 and TJF-Q190V were previously cleared under 510(k)s K193182 and K202661.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical data were collected.
Verification/validation activities were performed subsequent to a risk assessment evaluation of the device modifications per the Olympus Quality Management System. Results of the following testing demonstrate that the changes to the Distal Cover MAJ-2315 do not adversely affect device performance:
- Performance Testing Bench
- Sterilization Validation and Shelf-Life Testing
- Biocompatibility Evaluation
- Human Factors Evaluation
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.
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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May 11, 2022
Olympus Medical Systems Corp. % Wendy Perreault, Regualtory Consultant Olympus Corporation of the Americas 3500 Corporate Parkway. P.O. Box 610 Center Valley, PA 18034-0610
Re: K220587
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 Dated: February 25, 2022 Received: March 1, 2022
Dear Wendy Perreault:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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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Indications for Use
510(k) Number (if known)
Device Name
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-QI90V
Indications for Use (Describe)
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTberapy 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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K220587 Page 1 of 4
510(k) Summary: K220587
Company Information 1.
- Applicant: OLYMPUS MEDICAL SYSTEMS CORP. ● 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047
- Wendy Perreault ● Official c/o Olympus Corporation of the Americas Correspondent: 3500 Corporate Parkway P.O. Box 610 Center Valley, PA 18034-0610 Phone: 404.542.5854 E-mail: wendy.perreault(@olympus.com
- Manufacturing Site: Aizu Olympus Co., Ltd., ● 3-1-1 Niiderakita, Aizuwakamatsu-shi, Fukushima 965-8520, Japan
- May 2, 2022 Date Prepared: ●
Product Information 2.
- EVIS EXERA III DUODENOVIDEOSCOPE ● Trade Name: OLYMPUS TJF-Q190V Duodenoscope and accessories Common Name: ● Endoscope and Accessories ● Classification Name: Regulation Number: 876.1500 ● ● Regulation Name: Endoscope and Accessories
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| • Regulatory Class: | II |
|---|---|
| • Product Code(s): | FDT (Duodenoscope, Accessories, Flexible/Rigid) |
| NWB (Endoscope, accessories, narrow band spectrum) | |
| • Classification Panel: | Gastroenterology/Urology |
Predicate Device 3.
The subject device is equivalent to the predicate device listed below in Table 1.
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| EVIS EXERA III | ||
| DUODENOVIDEOSCOPE | OLYMPUS MEDICAL | |
| SYSTEMS CORP. | K202661 | |
| OLYMPUS TJF TYPE Q190V |
Table 1: Predicate device on TJF-O190V
Device Description 4.
The EVIS EXERA III DUODENOSCOPE 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-Q190V is compatible with Olympus system "Video System Center OLYMPUS CV-190 and XENON LIGHT SOURCE OLYMPUS CLV-190 (K112680)."
The subject device consists of a flexible insertion section, control section and endoscope connector section with equipped charge-coupled device (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 white light for normal observation and narrow band imaging (NBI). The CCD chip transduces the incident light from the objective lens to electrical signal. The video processor transduces the electrical signal to video signal.
There is an instrument channel located inside of the flexible insertion section. EndoTherapy accessories can be inserted through the instrument channel. A forceps elevator is located at the distal end of the insertion to elevate EndoTherapy
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accessories for endoscopic treatment.
A sterile, single-use Distal Cover (MAJ-2315) has been designed to be attached to the OLYMPUS TJF-Q190V to cover the distal end of the insertion tube and fit around the forceps elevator. MAJ-2315 is to be discarded after clinical use. MAJ-2315 and TJF-Q190V were previously cleared under 510(k)s K193182 and K202661.
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.
Comparison of Technological Characteristics 6.
Compared to the predicate device, the changes are limited to design modifications to the sterile, single-use Distal Cover MAJ-2315 used with the TJF-Q190V and labeling updates.
There are no other changes to either the MAJ-2315 or TJF-Q190V devices, including changes to indications for use, conditions of use, compatible components and accessories to be marketed/used with the device, or patient-contacting materials. There are no changes to the device specifications for TJF-Q190V, including optical or electrical performance.
7. Summary of Non-clinical Performance Data
Verification/validation activities were performed subsequent to a risk assessment evaluation of the device modifications per the Olympus Quality Management System. Results of the following testing demonstrate that the changes to the Distal Cover MAJ-2315 do not adversely affect device performance:
- · Performance Testing Bench
- · Sterilization Validation and Shelf-Life Testing
- · Biocompatibility Evaluation
- Human Factors Evaluation
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K220587 Page 4 of 4
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8. Summary of Clinical Performance Data
No clinical data were collected.
9. Conclusion
Based on the results of the comparison of the indications for use, technological characteristics, and performance testing of the subject and predicate device, the modified Distal Cover MAJ-2315 used with the TJF-Q190V duodenoscope raises no new issues of safety and effectiveness and the device is substantially equivalent to the predicate device and is as safe, as effective, and performs as well as or better than the predicate device.