(60 days)
No
The summary describes a standard endoscope 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. The performance studies focus on safety, reprocessing, and basic device functionality.
No
The device is described as an instrument for endoscopy and endoscopic surgery, allowing for observation and accessory insertion, but it does not directly apply therapy. It is used with other accessories that might perform therapy.
No
This product is an endoscope designed for visualization and therapeutic interventions within the duodenum, as indicated by its "Intended Use" and "Device Description" sections. While it provides images, its primary purpose is not to diagnose conditions, but rather to facilitate observation and operative procedures. The device itself is a tool for performing endoscopy and endoscopic surgery, not a diagnostic instrument that interprets or analyzes data to conclude a diagnosis.
No
The device description clearly indicates the device is a physical endoscope with hardware components like a flexible insertion section, control section, endoscope connector section with a CCD chip, instrument channel, and forceps elevator. It also includes physical accessories like a single-use distal cover and a distal end flushing adapter. The performance studies include testing related to sterilization, reprocessing, biocompatibility, electrical safety, EMC, and mechanical durability, all of which are associated with hardware devices. While software verification and validation are mentioned, they are for software contained in the medical device, not the device being solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the instrument 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 body.
- Device Description: The description details a flexible insertion section, control section, endoscope connector, CCD chip for imaging, light source, instrument channel for accessories, and a forceps elevator. These are all components of an endoscopic device used for visualization and intervention within 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 device's function is to provide visual access and facilitate procedures within the duodenum.
While the device uses a CCD chip and video processing to generate images, this is for direct visualization during a medical procedure, not for analyzing a sample in vitro to diagnose a condition.
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, OCX
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-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 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.
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)
- Sterilization/Shelf life testing: Sterilization/shelf life testing for the MAJ-2315 were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile". Accelerated aging test for the MAJ-2315 was conducted in accordance with ASTM F1980-16, the standard guide for accelerated aging of sterile barrier systems for medical devices. The real-time aging test for three-years will be performed to demonstrate longer stability and support the results of the accelerated aging test.
- Reprocessing validation testing: Reprocessing instruction and reprocessing method validation testing for the TJF-Q190V 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".
- Biocompatibility testing: Biocompatibility testing for the TJF-Q190V and MAJ-2315 were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility testing included the following tests: Cytotoxicity Study Using the Colony Assay, Intracutaneous Study in Rabbits, Guinea Pig Maximization Sensitization Test.
- Software verification and validation testing: Software verification and validation testing for the TJF-Q190V were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
- Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on the TJF-Q190V. The system complies with the AAMI ANSI ES60601-1: 2005/(R)2012 and A1:2012 and IEC 60601-2-18: Edition 3.0 2009-08 standards for safety and the IEC 60601-1-2: Edition 4: 2014-02 standards for EMC.
- 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.
- Thermal Safety test
- Mechanical durability test
- Performance testing for MAJ-2315
- Photobiological safety test
- Accidental Physical Impact testing on distal tip
- Performance testing - Animal: No animal study was performed to demonstrate substantial equivalence.
- Performance testing - Clinical: No clinical study was performed to demonstrate substantial equivalence.
- Risk analysis: Risk analysis for 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". 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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 17, 2020
Olympus Medical Systems Corp. % Sheri Musgnung Regulatory Affairs Manager Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610
Re: K193182
Trade/Device Name: Evis Exera III Duodenovideoscope Olympus TJF-Q190V Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDT, NWB, OCX Dated: November 15, 2019 Received: November 18, 2019
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. Acting 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
2
Indications for Use
510(k) Number (if known) K193182
Device Name EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-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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5.1 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 Surgical Technologies America 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
- . Manufacturing site: Aizu Olympus Co., Ltd., 500 Muranishi, Niidera, Monden-machi, Aizuwakamatsu-shi, Fukushima 965-8520, Japan
5.2 Device Identification
| ■ Device Name | - EVIS EXERA III DUODENOVIDEOSCOPE
OLYMPUS TJF-Q190V |
|---------------------|-----------------------------------------------------------------------------------------------------|
| ■ Model Name | 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 |
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Traditional 510(k) Notification DUODENOVIDEOSCOPE TJF-Q190V
OCX; Endoscopic Irrigation/Suction System
■ Classification Panel Gastroenterology/Urology
5.3 PREDICATE DEVICE
| Table 1 Predicate device on TJF-Q190V | ||
|---|---|---|
| Device name | 510(k) Submitter | 510(k) No. |
| EVIS EXERA II | ||
| DUODENOVIDEOSCOPE | OLYMPUS MEDICAL | |
| SYSTEMS CORP. | K143153 | |
| OLYMPUS TJF TYPE Q180V |
5.4 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-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 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.
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The following new reprocessing accessory has also been designed for use with TJF-Q190V:
DISTAL END FLUSHING ADAPTER MAJ-2319
The MAJ-2319 was designed to flush the distal end of the endoscope with reprocessing fluids.
The MAJ-2319 can be attached to the distal end of the endoscope during the manual cleaning and disinfection process to flush the distal end with reprocessing fluids. The reprocessing fluid is flushed through the MAJ-2319 to the distal end using a syringe.
Indications for Use 5.5
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.
5.6 Comparison of Technological Characteristics
Although there are some major differences including those described below, the technological characteristics of the TJF-Q190V are functionally equivalent to the predicate device, TJF-Q180V.
-
New removable SINGLE USE DISTAL COVER MAJ-2315 is introduced to the subject device compared to fixed distal cover of the predicate device. Design modifications were made around the forceps elevator to optimize the movement of the forceps elevator.
-
The reprocessing process of the subject device is modified from the predicate device due to the introduction of SINGLE USE DISTAL COVER MAJ-2315. This includes the use of a DISTAL END FLUSHING ADAPTER MAJ-2319.
5.7 PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
1) Sterilization/Shelf life testing
Sterilization/shelf life testing for the MAJ-2315 were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff,
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Image /page/6/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are sans-serif and appear to be a standard font. Below the word "OLYMPUS" is a thick, horizontal, yellow bar. The bar is slightly shorter than the length of the word "OLYMPUS" above it.
"Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile".
Accelerated aging test for the MAJ-2315 was conducted in accordance with ASTM F1980-16, the standard guide for accelerated aging of sterile barrier systems for medical devices. The real-time aging test for three-years will be performed to demonstrate longer stability and support the results of the accelerated aging test.
2) Reprocessing validation testing
Reprocessing instruction and reprocessing method validation testing for the TJF-Q190V 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".
3) Biocompatibility testing
Biocompatibility testing for the TJF-Q190V and MAJ-2315 were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility testing included the following tests:
- Cytotoxicity Study Using the Colony Assay ।
- Intracutaneous Study in Rabbits ।
- Guinea Pig Maximization Sensitization Test ।
4) Software verification and validation testing
Software verification and validation testing for the TJF-Q190V were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
5) Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the TJF-Q190V. The system complies with the AAMI ANSI ES60601-1: 2005/(R)2012 and A1:2012 and IEC 60601-2-18: Edition 3.0 2009-08 standards for safety and the IEC 60601-1-2: Edition 4: 2014-02 standards for EMC.
6) 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.
7
- Thermal Safety test
- Mechanical durability test
- Performance testing for MAJ-2315
- Photobiological safety test
- Accidental Physical Impact testing on distal tip
7) Performance testing - Animal
No animal study was performed to demonstrate substantial equivalence.
8) Performance testing - Clinical
No clinical study was performed to demonstrate substantial equivalence.
9) Risk analysis
Risk analysis for 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". The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
5.8 CONCLUSIONS
Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate devices, the TJF-Q190V raise no new issue of safety and effectiveness and are substantially equivalent to the predicate devices in terms of safety, efficacy and performance.