(271 days)
This instrument is intended 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.
The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-1TH190 is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
The GIF-1TH190 consists of three parts: the control section, the insertion section, and the connector section. The basic principle including user interface and operation for the procedure of the GIF-1TH190 is identical to that of the primary predicate device (K112680) and reference device (K131902).
This document describes the EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 and its substantial equivalence to a predicate device. It appears to be part of a 510(k) submission to the FDA. The information provided heavily focuses on bench testing and comparison to predicate devices rather than clinical studies with defined acceptance criteria for diagnostic performance metrics like sensitivity or specificity.
Here's an analysis based on the provided text, addressing your specific points:
1. A table of acceptance criteria and the reported device performance
The document does not present a single table of "acceptance criteria" alongside specific reported "device performance" in the way one might expect for a diagnostic AI device (e.g., statistical thresholds for sensitivity/specificity). Instead, the "performance data" section details various engineering and safety tests. The acceptance criteria for these tests are generally implied to be meeting design specifications and regulatory standards.
| Acceptance Criteria Category | Specific Tests/Evaluations Performed | Reported Device Performance (Summary) |
|---|---|---|
| Reprocessing | Reprocessing instruction and method validation | Conducted and documentation provided as recommended by FDA guidance. (Implied: met validation standards for cleaning, disinfection, and sterilization) |
| Biocompatibility | Cytotoxicity Study, Intracutaneous Study, Guinea Pig Maximization Sensitization Test | Conducted in accordance with ISO 10993-1. (Implied: device materials are biocompatible) |
| Electrical Safety & EMC | Electrical safety (ANSI AAMI ES 60601-1, IEC 60601-2-18), EMC (IEC 60601-1-2) | Conducted (Implied: device meets electrical safety and electromagnetic compatibility standards) |
| Bench Performance | Thermal safety, Composite Durability, Photobiological safety, Noise and Dynamic Range, Color Performance, Image Intensity Uniformity, Distortion, Field of View, Direction of View, Depth of Field, Video Latency, Resolution | Conducted to ensure the device performs as intended and meets design specifications. (Implied: meets internal engineering specifications for these parameters) |
| Risk Management | Risk management in accordance with ISO 14971:2019 | Design verification tests and their acceptance criteria were identified and performed as a result of this risk management. (Implied: Risks are acceptably mitigated) |
2. Sample size used for the test set and the data provenance
The document explicitly states:
- "No animal study was performed to demonstrate substantial equivalence."
- "No clinical study was performed to demonstrate substantial equivalence."
This indicates that there was no formal test set in the sense of patient data or clinical samples used to evaluate diagnostic performance. The "tests" mentioned are primarily engineering bench tests on the device itself or material and reprocessing validation studies. Therefore, sample size and data provenance are not applicable in the context of clinical/diagnostic performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Since no clinical or diagnostic performance study was conducted on patient data, there was no "ground truth" to be established by experts in this context. The evaluation relies on technical comparisons and non-clinical validations.
4. Adjudication method for the test set
Not applicable, as no clinical or diagnostic performance test set was used that would require adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a gastrointestinal videoscope, not an AI-powered diagnostic system or an assistance tool for human readers. It's a hardware device designed for direct human operation for visualization.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device for direct visualization by a human, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No "ground truth" for diagnostic purposes was established as no clinical or diagnostic performance study was conducted. The "ground truth" for the various engineering tests would be the established industry standards, regulatory requirements, and internal design specifications.
8. The sample size for the training set
Not applicable, as this is a hardware device and not an AI/machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable, as this is a hardware device and not an AI/machine learning algorithm.
Summary Conclusion from the Document:
The document focuses on demonstrating substantial equivalence of the EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 to a legally marketed predicate device (EVIS EXERA III GIF-H190 and referenced PENTAX Video Upper G.I. Scopes EG-3490K) primarily through:
- Comparison of technological characteristics: Highlighting similarities and justifying differences through non-clinical testing.
- Non-clinical performance testing: Including reprocessing validation, biocompatibility, electrical safety/EMC, and various bench performance tests (e.g., optical properties, mechanical durability).
- Risk management: Assurance that potential risks have been identified and mitigated.
The submission did not involve clinical studies, animal studies, or expert evaluations of diagnostic performance, as is typical for traditional hardware medical devices demonstrating substantial equivalence to a well-established predicate. The acceptance criteria are therefore tied to meeting established engineering specifications, regulatory standards, and demonstrating that any differences from the predicate device do not raise new questions of safety or effectiveness.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
June 19, 2024
Olympus Medical Systems Corporation % Darlene Hull Regulatory Program Manager Olympus Corporation of the Americas 800 West Park Drive Westborough, Massachusetts 01581
Re: K232997
Trade/Device Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDS. NWB Dated: May 17, 2024 Received: May 17, 2024
Dear Darlene Hull:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Shanil P. Haugen -S
Shanil P. Haugen, PhD 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 Gastrointestinal Videoscope GIF-1TH190
Indications for Use (Describe)
This instrument is intended 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.
The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-1TH190 is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5
510(k) Summary
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Date Prepared: 09/22/2023
K232997 Pg 2 of 21
510(k) Summary
1. GENERAL INFORMATION
■ 510(k) Submitter: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo 192-8507, Japan
- Contact Person: Darlene Hull Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: +1(801) 698-1653 Email: Darlene.hull(@olympus.com
- . Manufacturing site: Aizu Olympus Co., Ltd. 3-1-1 Niiderakita, Aizuwakamatsu-shi, Fukushima 965-8520, Japan
2. DEVICE IDENTIFICATION
- Device Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-1TH190
- Model Name: GIF-1TH190
- Common Name: GASTROINTESTINAL VIDEOSCOPE
- Regulation Number: 21 CFR §876.1500
- Regulation Name: Endoscope and accessories
- Regulatory Class: Class II
- Product Code: FDS, NWB
- Classification Panel: Gastroenterology/Urology
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3. PREDICATE DEVICE
■ Predicate device
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| EVIS EXERA III VIDEO SYSTEMENDOSCOPIC VIDEO IMAGINGSYSTEM | OLYMPUS MEDICALSYSTEMS CORP. | K112680 |
■ Reference device
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| PENTAX Video Upper G.I. Scopes (EG-3490K) | PENTAX MedicalCompany | K131902 |
4. DEVICE DESCRIPTION
■ General Description of the subject device
This instrument is intended 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.
The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-1TH190 is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
■ Principle of Operation
The GIF-1TH190 consists of three parts: the control section, the insertion section, and the connector section. The basic principle including user interface and operation for the procedure of the GIF-1TH190 is identical to that of the primary predicate device (K112680) and reference device (K131902).
1. The Control Section
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The UP/DOWN angulation control knob and the RIGHT/LEFT angulation control knob on the control section is connected to the tip of the bending section by a series of wires. By operating the UP/DOWN angulation control knob and the RIGHT/LEFT angulation control knob, the bending section at the distal end bends vertically or parallel to guide the distal end for insertion and observation within the upper digestive tract (including the esophagus, stomach, and duodenum).
The endoscope contains a cylinder to attach a suction valve for suction and air/water valve. Depressing the suction valve will allow the physician to use the endoscope to suction any fluids which are obscuring a good view of the tissue. Therapeutic instruments can be passed through the instrument channel for performing endoscopic biopsy and other therapies. Depressing the air/water valve will allow the doctor to feed water through the endoscope for lens washing. It also can be operated to feed air for removing any fluids or debris adhering to the objective lens.
2. The Insertion Section
The insertion section has main parts including the CCD, light guides that bring light from the light source through the endoscope, and instrument channel where therapeutic tools can be pushed in and out (also the suction channel).
3. The Connector Section
The connector section connects the endoscope with the light source (CLV-190) through the universal cord.
List of device components ■
The GIF-1TH190 will be packed and offered components listed in the Table below. These devices can be used with commercially available Olympus devices as described within the Instruction Manual.
| Model No. | Device Name |
|---|---|
| MAJ-855 | Auxiliary water tube |
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| MH-946 | Injection tube |
|---|---|
| MH-856 | Suction cleaning adapter |
| MH-948 | AW channel cleaning adapter |
| MB-156 | ETO cap |
| MH-944 | Channel plug |
| MB-142 | Mouthpiece |
| BW-412T | Single-use combination cleaning brush |
5. INDICATIONS FOR USE
This instrument is intended 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.
The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-1TH190 is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
6. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEIVCE
The subject device has the same technological characteristics and design as the predicate device except for the following features:
- Outer Diameter of the Insertion Section
- Inner Diameter of the Instrument Channel
- Materials
- Air/Water Nozzle Flow Path
- Suction Connector Design
Validation from non-clinical testing demonstrated that these technological features do not raise any new issues of safety or effectiveness of the subject device.
A side-by-side comparison of the subject device and the predicate device is provided
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K232997 Pg 6 of 21
below.
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| SUBJECT DEVICE:EVIS EXERA III GIF-1TH190(This Submission) | PREDICATE DEVICE:EVIS EXERA III GIF-H190(K112680) | REFERENCE DEVICE:Upper G.I. Scope EG-3490K (K131902) | COMMENTS ONDIFFERENCE(S) | |
|---|---|---|---|---|
| Manufacturer | Olympus Medical | Olympus Medical | Pentax Medical | - |
| Device Image | Image: Olympus Medical Device | Image: Olympus Medical Device | Image: Pentax Medical Device | - |
| Classification&Regulation # | Class II21 CFR §876.1500 | SAME | SAME | SAME |
| Product Code | FDS - Gastroscope AndAccessories, Flexible/Rigid,NWB - Endoscope,Accessories, Narrow BandSpectrum | FDF – Colonoscope AndAccessories, Flexible/RigidFDS - Gastroscope AndAccessories, Flexible/Rigid,NWB - Endoscope,Accessories, Narrow BandSpectrum | FDS - Gastroscope AndAccessories, Flexible/Rigid | All devices share the sameprimary product code FDS |
| Intended Use | Intended to be used with anOlympus video system center, | Intended to be used with anOlympus video system center, | Intended to be used with a | All devices share the sameindications for use. |
| SUBJECT DEVICE:EVIS EXERA III GIF-1TH190(This Submission) | PREDICATE DEVICE:EVIS EXERA III GIF-H190(K112680) | REFERENCE DEVICE:Upper G.I. Scope EG-3490K (K131902) | COMMENTS ONDIFFERENCE(S) | |
| light source, documentation | light source, documentation | PENTAX video processor | ||
| equipment, monitor, | equipment, monitor, | (including light source), | ||
| EndoTherapy accessories (such | EndoTherapy accessories (such | documentation equipment, | ||
| as a biopsy forceps), and other | as a biopsy forceps), and other | monitor, Endotherapy | ||
| ancillary equipment for | ancillary equipment for | Device such as a Biopsy | ||
| endoscopy and endoscopic | endoscopy and endoscopic | Forceps, and other ancillary | ||
| surgery. | surgery. | equipment for endoscopy | ||
| The EVIS EXERA III | The EVIS EXERA III | and endoscopic surgery | ||
| GASTROINTESTINAL | GASTROINTESTINAL | within the upper digestive | ||
| VIDEOSCOPE GIF-1TH190 is | VIDEOSCOPE GIF-H190 is | tract including the | ||
| indicated for use within the | indicated for use within the | esophagus, stomach, and | ||
| upper digestive tract (including | upper digestive tract (including | duodenum. | ||
| the esophagus, stomach, and | the esophagus, stomach, and | |||
| duodenum) | duodenum). | |||
| Optical System Parameters | ||||
| Field of View | 140° | SAME | SAME | SAME |
| Direction of View | 0° (Forward viewing) | SAME | SAME | SAME |
| Depth of Field | 2-100mm | SAME | 4-100mm | Same as Primary Predicate |
| SUBJECT DEVICE:EVIS EXERA III GIF-1TH190(This Submission) | PREDICATE DEVICE:EVIS EXERA III GIF-H190(K112680) | REFERENCE DEVICE:Upper G.I. Scope EG-3490K (K131902) | COMMENTS ONDIFFERENCE(S) | |
| OptimumWorking Distance | 8.4 mm | SAME | Unknown | Same as Primary Predicate |
| Resolution at each working distance: on-axis | ||||
| • 2 mm | 14.0 lp/mm | SAME | Unknown | |
| • 8 mm | 17.4 lp/mm | SAME | Unknown | Same as Primary Predicate |
| • 100 mm | 1.4 lp/mm | SAME | Unknown | |
| Resolution at each working distance: off-axis (70% of the maximum image height) | ||||
| • 2 mm | 15.6 lp/mm | SAME | Unknown | |
| • 8 mm | 8.7 lp/mm | SAME | Unknown | Same as Primary Predicate |
| • 100 mm | 0.6 lp/mm | SAME | Unknown | |
| SUBJECT DEVICE:EVIS EXERA III GIF-1TH190(This Submission) | PREDICATE DEVICE:EVIS EXERA III GIF-H190(K112680) | REFERENCE DEVICE:Upper G.I. Scope EG-3490K (K131902) | COMMENTS ONDIFFERENCE(S) | |
| Distortion(atmaximumfieldofview) | Image: Distortion graph | Image: Legend for distortion graph | Unknown | Same as Primary Predicate |
| Imaging System | ||||
| Type of Chip | Color CCD | SAME | Unknown | Same as Primary Predicate |
| Number of active | 529,731 | SAME | Unknown | Same as Primary Predicate |
| SUBJECT DEVICE:EVIS EXERA III GIF-1TH190(This Submission) | PREDICATE DEVICE:EVIS EXERA III GIF-H190(K112680) | REFERENCE DEVICE:Upper G.I. Scope EG-3490K (K131902) | COMMENTS ONDIFFERENCE(S) | |
| image Pixels | ||||
| Size of Pixels | 2.1 μm x 2.1 μm | SAME | Unknown | Same as Primary Predicate |
| Number of ImageSensor Chip | 1 | SAME | Unknown | Same as Primary Predicate |
| NBI observation | Available | SAME | Unknown | The Subject device and primarypredicate device have the sameimaging units (including imagesensor and objective lens) andare compatible imaging systems.NBIfunctiondependsonimage sensor and objective lensfactors, so the effectiveness ofthe NBI feature is the samebetween subject device andprimary predicate. |
| Insertion Section | ||||
| SUBJECT DEVICE:EVIS EXERA III GIF-1TH190(This Submission) | PREDICATE DEVICE:EVIS EXERA III GIF-H190(K112680) | REFERENCE DEVICE:Upper G.I. Scope EG-3490K (K131902) | COMMENTS ONDIFFERENCE(S) | |
| Insertion TubeDiameter | Distal end: 10.0 mmInsertion tube: 10.9 mmInsertion tube (Maximum):13.0 mm | Distal end: 9.2 mmInsertion tube: 9.2 mmInsertion tube (Maximum):11.2 mm | Distal end: 11.5 mmInsertion tube: 11.6mmInsertion tube(Maximum): 12.85 mm | The subject device has a largerdiameter for the instrumentchannel compared to thepredicate device. To ensure thatthis difference does not affectthe safe reprocessing of thesubject device, new validationtesting was conducted. Pleasesee Section 14 for the details ofthe reprocessing validation.Additionally, while the diameterof the instrument channel of thesubject device is larger whencompared to the predicatedevice, it is smaller than otherdevices on the market as isshown by the identified |
| SUBJECT DEVICE:EVIS EXERA III GIF-1TH190(This Submission) | PREDICATE DEVICE:EVIS EXERA III GIF-H190(K112680) | REFERENCE DEVICE:Upper G.I. Scope EG-3490K (K131902) | COMMENTS ONDIFFERENCE(S) | |
| reference device (K131902Pentax EG-3490K scope) | ||||
| Insertion sectionWorking Length | 1030 mm | SAME | 1050 mm | Same as Primary Predicate |
| DistalEndEnlarged | Image: Distal end diagram with labels 1-5 | Image: Distal end diagram with labels 1-5 | Unknown | Similar to predicate. |
| 1 Air/water nozzle2 Light guide lens3 Objective lens4 Instrument channel outlet | 1 Air/water nozzle2 Light guide lens3 Objective lens4 Instrument channel outlet | |||
| SUBJECT DEVICE:EVIS EXERA III GIF-1TH190(This Submission) | PREDICATE DEVICE:EVIS EXERA III GIF-H190(K112680) | REFERENCE DEVICE:Upper G.I. Scope EG-3490K (K131902) | COMMENTS ONDIFFERENCE(S) | |
| 5 Auxiliary water channel | 5 Auxiliary water channel | |||
| Instrument Channel | ||||
| Channelinnerdiameter | ${\text{\O}}$ 3.7 mm | ${\text{\O}}$ 2.8 mm | ${\text{\O}}$ 3.8 mm | The subject device has a largerdiameter for the instrumentchannel compared to thepredicate device. To ensure thatthis difference does not affectthe safe reprocessing of thesubject device, new validationtesting was conducted. Pleasesee Section 14 for the details ofthe reprocessing validation.Additionally, while the diameterof the instrument channel of thesubject device is larger whencompared to the predicatedevice, it is smaller than other |
| SUBJECT DEVICE:EVIS EXERA III GIF-1TH190(This Submission) | PREDICATE DEVICE:EVIS EXERA III GIF-H190(K112680) | REFERENCE DEVICE:Upper G.I. Scope EG-3490K (K131902) | COMMENTS ONDIFFERENCE(S) | |
| devices on the market as isshown by the identifiedreference device (K131902Pentax EG-3490K scope) | ||||
| Bending Section | ||||
| Angulation Range | Up 210° / Down 90°Right 100° /Left 100° | SAME | Up 210° / Down 120°Right 120° /Left 120° | Same as Primary Predicate |
| Connection to Light Source | ||||
| Configuration | Light guide (LG) cable is notdetachable | SAME | SAME | Same as Primary Predicate |
| Venting Connector | ||||
| Position | On the endoscope connector | SAME | Unknown | Same as Primary Predicate |
| Others | ||||
| Total length | 1350 mm | SAME | 1383 mm | Same as Primary Predicate |
| Air/Water nozzle | Image: Air/Water nozzle | Image: Air/Water nozzle | Unknown | The internal flow path of theair/water nozzle was changed toreduce the occurrence of nozzle |
| SUBJECT DEVICE:EVIS EXERA III GIF-1TH190(This Submission) | PREDICATE DEVICE:EVIS EXERA III GIF-H190(K112680) | REFERENCE DEVICE:Upper G.I. Scope EG-3490K (K131902) | COMMENTS ONDIFFERENCE(S) | |
| clogging. This modification onlychanges the flow path. Thesubject device's air/waterfunction remains identical to thepredicate device. Therefore, itdoesn't affect the safety andeffectiveness of the subjectdevice. | ||||
| Suction Function | Provided | SAME | SAME | SAME |
| SuctionConnector | Image: Suction Connector Subject Device | Image: Suction Connector Predicate Device | Unknown | There is a gap inside the Suctionconnector of the predicatedevice. The gap is completelyremoved in the design of thesubject device. By removing thegap noted in the SuctionConnector, a positive effect isexpected in reprocessingvalidation tests. Therefore, it |
| SUBJECT DEVICE:EVIS EXERA III GIF-1TH190(This Submission) | PREDICATE DEVICE:EVIS EXERA III GIF-H190(K112680) | REFERENCE DEVICE:Upper G.I. Scope EG-3490K (K131902) | COMMENTS ONDIFFERENCE(S) | |
| doesn't affect the safety andeffectiveness of the subjectdevice. | ||||
| Patient-Contacting Materials that Differ | ||||
| Distal End ofInsertion Section | Polysulfone (P1700-216) | Polysulfone (P1700BK-937) | Unknown | |
| Air/water nozzleof Insertion End | Stainless Steel (SUS303) | Stainless Steel (SUS304) | Unknown | A complete list of patientcontacting materials is listed inSection 11.5. |
| Instrumentchannel | (1) PTFE/ePTFE (J-HYPERTUBE)(2) PTFE (6C-J)(3) PTFE (6C-J) | (1) PTFE (6C-J) PTFE/ePTFE(G-HYPER TUBE)(2) PTFE/ePTFE (G-HYPERTUBE)(3) PTFE/ePTFE (G-HYBRID) | Unknown | |
| SUBJECT DEVICE:EVIS EXERA III GIF-1TH190(This Submission) | PREDICATE DEVICE:EVIS EXERA III GIF-H190(K112680) | REFERENCE DEVICE:Upper G.I. Scope EG-3490K (K131902) | COMMENTS ONDIFFERENCE(S) | |
| TUBE) | ||||
| Compatible Processor / Light Source / Monitor | ||||
| CompatibleProcessor | CV-190 | SAME | Unknown | Compatibility among the subjectendoscope and the compatible |
| Compatible LightSource | CLV-190 | SAME | Unknown | processors/light sources/monitors has been verifiedsuccessfully. Refer to sectionsbelow for more detail. |
| CompatibleMonitor | OEV262H | OEV261HOEV191HOEV181HOEV191 | Unknown | Section 16. Software andCybersecuritySection 17 Electrical Safety andElectromagnetic CompatibilitySection 18. -PerformanceTesting - BenchIn addition, the risk analysis hasnot identified any new orsignificantly modified risks as itrelates to these differences. |
| SUBJECT DEVICE:EVIS EXERA III GIF-1TH190(This Submission) | PREDICATE DEVICE:EVIS EXERA III GIF-H190(K112680) | REFERENCE DEVICE:Upper G.I. Scope EG-3490K (K131902) | COMMENTS ONDIFFERENCE(S) | |
| Therefore, it is judged that thesafety and effectiveness of thesubject device are substantiallyequivalent to the proposedprimary predicate device. | ||||
| Reprocessing Methods | ||||
| Cleaning | Ultrasonic cleaning/ Detergentsolution | SAME | - | Same as Primary Predicate |
| Disinfection | 2 - 3.5% glutaraldehyde /ACECIDE disinfectant solution | SAME | - | Same as Primary Predicate |
| Sterilization | Ethylene oxide gas sterilization(100% ethylene oxide gas) | SAME | - | Same as Primary Predicate |
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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 were conducted and documentation were 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) Biocompatibility testing
Biocompatibility testing 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 -
3) Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing was conducted in accordance with the ANSI AAMI ES 60601-1:2005/ (R)2012L and A1:2012. C1:2009/ (R)2012 and A2:2010/ (R)2012 (Consolidated Text) and IEC 60601-2-18:2009 standards for safety and IEC 60601-1-2:2014+A1:2020 standards for EMC.
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4) Performance testing - Bench
Bench testing as listed below were conducted to ensure that the subject device performs as intended and meet design specifications.
- Thermal safety test
- Composite Durability
- Photobiological safety test
- Noise and Dynamic Range
- Color Performance
- Image Intensity Uniformity
- Distortion
- Field of View
- Direction of View
- Depth of Field
- Video Latency
- Resolution
5) Performance testing - Animal
No animal study was performed to demonstrate substantial equivalence.
6) Performance testing - Clinical
No clinical study was performed to demonstrate substantial equivalence.
7) Risk management
Risk management was performed in accordance with ISO 14971:2019. The design verification tests and their acceptance criteria were identified and performed as a result of this risk management.
8. CONCLUSIONS
Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate device, the EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-1TH190 raise no new issue of safety and effectiveness and are substantially equivalent to the predicate device in terms of safety, effectiveness and performance.
§ 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.