(271 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies do not mention any AI/ML related features or evaluations.
No
The device is described as an instrument for endoscopy and endoscopic surgery, and its intended use is for observation and accessing internal organs, not for treating a disease or condition. It is used with other accessories like biopsy forceps, suggesting it's primarily for diagnostic or interventional procedures facilitated by visualization, rather than direct therapy.
No
The "Intended Use" states that the device is for endoscopy and endoscopic surgery, and is used with accessories like biopsy forceps. While endoscopy can aid in diagnosis, the device itself is not described as analyzing or interpreting images to provide a diagnostic output. It acts as a tool for visualization and intervention, which can inform a physician's diagnosis, but is not a diagnostic device on its own.
No
The device description explicitly states it consists of three physical parts (control section, insertion section, and connector section) and is a videoscope, which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the instrument is for use within the upper digestive tract for endoscopy and endoscopic surgery. This involves direct visualization and intervention within the body.
- Device Description: The description details a videoscope with an insertion section, designed for internal examination.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information about a physiological state, health, or disease. IVDs are typically used in laboratories or point-of-care settings for diagnostic testing of biological samples.
The device described is an endoscope, which is an in vivo (within the living body) diagnostic and therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / 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).
Product codes
FDS, NWB
Device Description
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).
- The Control Section
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.
-
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). -
The Connector Section
The connector section connects the endoscope with the light source (CLV-190) through the universal cord.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper digestive tract (including the esophagus, stomach, and 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)
- 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".
- 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.
- 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.
- 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
- 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
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"
1
(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).
2
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
3
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 SYSTEM | ||
| ENDOSCOPIC VIDEO IMAGING | ||
| SYSTEM | OLYMPUS MEDICAL | |
| SYSTEMS CORP. | K112680 |
■ Reference device
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| PENTAX Video Upper G.I. Scopes (EG- | ||
| 3490K) | PENTAX Medical | |
| Company | 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
7
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 ON
DIFFERENCE(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 II
21 CFR §876.1500 | SAME | SAME | SAME |
| Product Code | FDS - Gastroscope And
Accessories, Flexible/Rigid,
NWB - Endoscope,
Accessories, Narrow Band
Spectrum | FDF – Colonoscope And
Accessories, Flexible/Rigid
FDS - Gastroscope And
Accessories, Flexible/Rigid,
NWB - Endoscope,
Accessories, Narrow Band
Spectrum | FDS - Gastroscope And
Accessories, Flexible/Rigid | All devices share the same
primary product code FDS |
| Intended Use | Intended to be used with an
Olympus video system center, | Intended to be used with an
Olympus video system center, | Intended to be used with a | All devices share the same
indications 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 ON
DIFFERENCE(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 ON
DIFFERENCE(S) |
| Optimum
Working 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 ON
DIFFERENCE(S) |
| Distortion
(at
maximum
field
of
view) | 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 ON
DIFFERENCE(S) |
| image Pixels | | | | |
| Size of Pixels | 2.1 μm x 2.1 μm | SAME | Unknown | Same as Primary Predicate |
| Number of Image
Sensor Chip | 1 | SAME | Unknown | Same as Primary Predicate |
| NBI observation | Available | SAME | Unknown | The Subject device and primary
predicate device have the same
imaging units (including image
sensor and objective lens) and
are compatible imaging systems.
NBI
function
depends
on
image sensor and objective lens
factors, so the effectiveness of
the NBI feature is the same
between subject device and
primary 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 ON
DIFFERENCE(S) |
| Insertion Tube
Diameter | Distal end: 10.0 mm
Insertion tube: 10.9 mm
Insertion tube (Maximum):
13.0 mm | Distal end: 9.2 mm
Insertion tube: 9.2 mm
Insertion tube (Maximum):
11.2 mm | Distal end: 11.5 mm
Insertion tube: 11.6mm
Insertion tube
(Maximum): 12.85 mm | The subject device has a larger
diameter for the instrument
channel compared to the
predicate device. To ensure that
this difference does not affect
the safe reprocessing of the
subject device, new validation
testing was conducted. Please
see Section 14 for the details of
the reprocessing validation.
Additionally, while the diameter
of the instrument channel of the
subject device is larger when
compared to the predicate
device, it is smaller than other
devices on the market as is
shown 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 ON
DIFFERENCE(S) |
| | | | | reference device (K131902
Pentax EG-3490K scope) |
| Insertion section
Working Length | 1030 mm | SAME | 1050 mm | Same as Primary Predicate |
| Distal
End
Enlarged | Image: Distal end diagram with labels 1-5 | Image: Distal end diagram with labels 1-5 | Unknown | Similar to predicate. |
| | 1 Air/water nozzle
2 Light guide lens
3 Objective lens
4 Instrument channel outlet | 1 Air/water nozzle
2 Light guide lens
3 Objective lens
4 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 ON
DIFFERENCE(S) |
| | 5 Auxiliary water channel | 5 Auxiliary water channel | | |
| | Instrument Channel | | | |
| Channel
inner
diameter | ${\text{\O}}$ 3.7 mm | ${\text{\O}}$ 2.8 mm | ${\text{\O}}$ 3.8 mm | The subject device has a larger
diameter for the instrument
channel compared to the
predicate device. To ensure that
this difference does not affect
the safe reprocessing of the
subject device, new validation
testing was conducted. Please
see Section 14 for the details of
the reprocessing validation.
Additionally, while the diameter
of the instrument channel of the
subject device is larger when
compared to the predicate
device, 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 ON
DIFFERENCE(S) |
| | | | | devices on the market as is
shown by the identified
reference device (K131902
Pentax 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 not
detachable | 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 the
air/water nozzle was changed to
reduce 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 ON
DIFFERENCE(S) |
| | | | | clogging. This modification only
changes the flow path. The
subject device's air/water
function remains identical to the
predicate device. Therefore, it
doesn't affect the safety and
effectiveness of the subject
device. |
| Suction Function | Provided | SAME | SAME | SAME |
| Suction
Connector | Image: Suction Connector Subject Device | Image: Suction Connector Predicate Device | Unknown | There is a gap inside the Suction
connector of the predicate
device. The gap is completely
removed in the design of the
subject device. By removing the
gap noted in the Suction
Connector, a positive effect is
expected in reprocessing
validation 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 ON
DIFFERENCE(S) |
| | | | | doesn't affect the safety and
effectiveness of the subject
device. |
| | | Patient-Contacting Materials that Differ | | |
| Distal End of
Insertion Section | Polysulfone (P1700-216) | Polysulfone (P1700BK-937) | Unknown | |
| Air/water nozzle
of Insertion End | Stainless Steel (SUS303) | Stainless Steel (SUS304) | Unknown | A complete list of patient
contacting materials is listed in
Section 11.5. |
| Instrument
channel | (1) PTFE/ePTFE (J-HYPER
TUBE)
(2) PTFE (6C-J)
(3) PTFE (6C-J) | (1) PTFE (6C-J) PTFE/ePTFE
(G-HYPER TUBE)
(2) PTFE/ePTFE (G-HYPER
TUBE)
(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 ON
DIFFERENCE(S) |
| | | TUBE) | | |
| | | Compatible Processor / Light Source / Monitor | | |
| Compatible
Processor | CV-190 | SAME | Unknown | Compatibility among the subject
endoscope and the compatible |
| Compatible Light
Source | CLV-190 | SAME | Unknown | processors/light sources/
monitors has been verified
successfully. Refer to sections
below for more detail. |
| Compatible
Monitor | OEV262H | OEV261H
OEV191H
OEV181H
OEV191 | Unknown | Section 16. Software and
Cybersecurity
Section 17 Electrical Safety and
Electromagnetic Compatibility
Section 18. -Performance
Testing - Bench
In addition, the risk analysis has
not identified any new or
significantly modified risks as it
relates 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 ON
DIFFERENCE(S) |
| | | | | Therefore, it is judged that the
safety and effectiveness of the
subject device are substantially
equivalent to the proposed
primary predicate device. |
| Reprocessing Methods | | | | |
| Cleaning | Ultrasonic cleaning/ Detergent
solution | 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.