(291 days)
No
The summary describes a standard colonovideoscope and its accessories. There is no mention of AI, ML, or any advanced image processing that would suggest the use of such technologies. The clinical performance section focuses on the endoscopist's interpretation using NBI and the NICE classification, not on automated analysis by the device.
No
The device is a colonovideoscope used for visualization and diagnosis within the lower digestive tract, and for facilitating endoscopic surgery with accessories. It is not designed to directly treat or cure diseases itself.
Yes
The device is a colonovideoscope used for visualizing the lower digestive tract, which is a diagnostic function for identifying abnormalities. The performance studies also mention the ability to differentiate colorectal polyps as neoplastic or non-neoplastic, indicating a diagnostic capability.
No
The device description clearly states it consists of three physical parts: the control section, the insertion section, and the connector section. It is a physical endoscope, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic purposes. This typically involves tests performed on samples like blood, urine, tissue, etc., outside of the body.
- Device Function: The description clearly states that the EVIS EXERA III COLONOVIDEOSCOPE is an instrument used for endoscopy and endoscopic surgery within the lower digestive tract. It is inserted into the body to visualize internal structures and potentially perform procedures.
- Lack of Specimen Testing: There is no mention of this device being used to test or analyze specimens in vitro. Its primary function is visualization and access for procedures in vivo.
Therefore, the device's intended use and function align with an endoscopic instrument for direct visualization and intervention within the body, not with the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190TL/I
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 COLONOVIDEOSCOPE PCF-H190TL/I is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).
EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-HQ190L/I
This instrument is intended to be used with an Olympus video system center, endoscope position detecting unit, 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 COLONOVIDEOSCOPE PCF-HO190L/I is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).
Product codes
FDF, NWB
Device Description
The EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190TL/I and PCF-HQ190L/I are intended to be used with an Olympus video system center, light source, endoscope position detecting unit (for PCF-HQ190L/I only), documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. The PCF-H190TL/I and PCF-HQ190L/I are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).
The following items are components and accessories to be marketed with the EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190TL/I and PCF-HQ190L/I.
- Single use combination cleaning brush (BW-412T)
- Injection tube (MH-946)
- Channel plug (MH-944)
- AW channel cleaning adapter (MH-948)
- Suction cleaning adapter (MH-856)
- Auxiliary water tube (MAJ-855)
- ETO cap (MB-156)
Available imaging modes are listed below:
WLI
NBI
The EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190TL/I and PCF-HQ190L/I consist 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 PCF-H190TL/I and PCF-HQ190L/I are identical to that of the predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
WLI, NBI
Anatomical Site
lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve)
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 for the EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190TL/I and PCF-HQ190L/I 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 EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190TL/I and PCF-HQ190L/I 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 EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190TL/I and PCF-HQ190L/I 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 EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190TL/I and PCF-HQ190L/I. The system complies with the ANSVAAMI ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-18:2009 standards for safety and the IEC 60601-1-2:2014 standards for EMC.
- Performance testing - Bench: Bench testing for the EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190TL/I and PCF-HQ190L/I as listed below was conducted to ensure that the subject device performs as intended and meet design specifications.
- Thermal Safety Test
- Composite Durability Test
- Photobiological Safety Test
- Retroflexed Withdrawal and Detection of Hidden Polyps (for PCF-H190TL/L only)
- Performance testing - Animal: No animal study was performed to demonstrate substantial equivalence.
- Performance testing - Clinical: A meta-analysis of the clinical performance of NBI for differentiation of diminutive colorectal polyps has been provided in Section 20.1. The clinical literature represents independent studies performed by clinicians with the exception of two Olympus-sponsored studies. The objective of the meta-analysis was to determine the predictive accuracy of endoscopists utilizing NBI and the NBI International Colorectal Endoscopic (NICE) classification or all available classification criteria in general to differentiate diminutive colorectal polyps as neoplastic or non-neoplastic lesions. The evidence being presented in this premarket notification supports our labeling change of the subject device for the use of Narrow Band Imaging as an adjunctive tool to assist the endoscopist in making predictions of the underlying histology of diminutive polyps. This application does not seek to show superiority or non-inferiority of NBI to the gold standard histopathology. The results show that pooled data from NBI-experienced and inexperienced endoscopists making high confidence predictions of diminutive polyp histology in real-time provide reasonable certainty of neoplastic vs. non-neoplastic identity. The NICE classification, simplified criteria for distinguishing neoplastic from non-neoplastic polyps, helps the endoscopist achieve similar performance.
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.
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July 17, 2020
Olympus Medical Systems Corp. % Lisa M. Boyle Regulatory Affairs Specialist II Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610
Re: K192793
Trade/Device Name: Evis Exera III Colonovideoscope Olympus PCF-H190TL Evis Exera III Colonovideoscope Olympus PCF-H190TI Evis Exera III Colonovideoscope Olympus PCF-HQ190L Evis Exera III Colonovideoscope Olympus PCF-HQ190I Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF, NWB Dated: September 26, 2019 Received: September 30, 2019
Dear Lisa M. Boyle:
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.
1
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 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.
for 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
2
Indications for Use
510(k) Number (if known)
K192793
Device Name
EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190TL/I EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-HQ190L/I
Indications for Use (Describe)
EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190TL/I
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 COLONOVIDEOSCOPE PCF-H190TL/I is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).
EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-HQ190L/I
This instrument is intended to be used with an Olympus video system center, endoscope position detecting unit, 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 COLONOVIDEOSCOPE PCF-HO190L/I is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).
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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Date Prepared: May 29, 2020
510(k) Summary
1. GENERAL INFORMATION
- 510(k) Submitter: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507
- Contact Person: Lisa M. Boyle Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-3676 Fax: 484-896-7128 Email: lisa.boyle@olympus.com
- Manufacturing site: Aizu Olympus Co., Ltd., 500 Muranishi, Niidera, Monden-machi, Aizuwakamatsu-shi, Fukushima 965-8520, Japan
2. DEVICE IDENTIFICATION
- Device Name EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190TL/I EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-HQ190L/I
- Model Name PCF-H190TL, PCF-H190TI PCF-HQ190L, PCF-H190I
- Common Name COLONOVIDEOSCOPE
- Regulation Number 21 CFR 876.1500
- Regulation Name Endoscope and accessories
- Regulatory Class II
510(k) Summary Page 1 of 8
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- Product Code FDF, NWB
- Gastroenterology/urology ■ Classification Panel
3. PREDICATE DEVICE
■ Predicate device
PCF-H190TL/I
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| EVIS EXERA III VIDEO SYSTEM | ||
| COLONOVIDEOSCOPE PCF-PH190L/I | OLYMPUS MEDICAL | |
| SYSTEMS CORP. | K131780 |
PCF-HQ190L/I
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| EVIS EXERA III VIDEO SYSTEM | ||
| COLONOVIDEOSCOPE CF-HQ190L/I | OLYMPUS MEDICAL | |
| SYSTEMS CORP. | K131780 |
■ Reference device
PCF-H190TL/I
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| EVIS EXERA III VIDEO SYSTEM | ||
| COLONOVIDEOSCOPE PCF-H190L/I | OLYMPUS MEDICAL | |
| SYSTEMS CORP. | K131780 | |
| PENTAX VIDEO COLONOSCOPES | ||
| EC-3490TLi | PENTAX MEDICAL | |
| COMPANY | K131855 |
PCF-HQ190L/I
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| EVIS EXERA III VIDEO SYSTEM | ||
| COLONOVIDEOSCOPE CF-H190L/I | OLYMPUS MEDICAL | |
| SYSTEMS CORP. | K131780 | |
| PENTAX VIDEO COLONOSCOPES | ||
| EC-3490TLi | PENTAX MEDICAL | |
| COMPANY | K131855 |
4. DEVICE DESCRIPTION
1) General Description of the subject device
The EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190TL/I and
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PCF-HQ190L/I are intended to be used with an Olympus video system center, light source, endoscope position detecting unit (for PCF-HQ190L/I only), documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. The PCF-H190TL/I and PCF-HQ190L/I are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).
The following items are components and accessories to be marketed with the EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190TL/I and PCF-HQ190L/I.
- Single use combination cleaning brush (BW-412T)
- Injection tube (MH-946)
- Channel plug (MH-944)
- AW channel cleaning adapter (MH-948)
- Suction cleaning adapter (MH-856)
- Auxiliary water tube (MAJ-855)
- ETO cap (MB-156)
Available imaging modes are listed below:
| Available imaging modes |
|---|
| WLI |
| NBI |
2) Principle of Operation and Mechanism of Action
The EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190TL/I and PCF-HQ190L/I consist 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 PCF-H190TL/I and PCF-HQ190L/I are identical to that of the predicate devices.
| Model | Device Name | 510(k) No. |
|---|---|---|
| PCF-H190TL/I | EVIS EXERA III COLONOVIDEOSCOPE | Part of this |
| submission |
■ Components list of PCF-H190TL/I
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Traditional 510(k) Notification COLONOVIDEOSCOPE PCF-H190TL/I COLONOVIDEOSCOPE PCF-HQ190L/I
| MH-856 | Suction cleaning adapter | K131780 |
|---|---|---|
| MH-948 | AW channel cleaning adapter | K131780 |
| MB-156 | ETO cap | K131780 |
| MH-944 | Channel plug | K131780 |
| MH-946 | Injection tube | K131780 |
| MAJ-855 | Auxiliary water tube | K131780 |
| BW-412T | Single use combination cleaning brush | 510(k) exempt |
| (876.1500, MNL) |
■ Components list of PCF-HQ190L/I
| Model | Device Name | 510(k) No. |
|---|---|---|
| PCF-HQ190L/I | EVIS EXERA III COLONOVIDEOSCOPE | Part of this |
| submission | ||
| MH-856 | Suction cleaning adapter | K131780 |
| MH-948 | AW channel cleaning adapter | K131780 |
| MB-156 | ETO cap | K131780 |
| MH-944 | Channel plug | K131780 |
| MH-946 | Injection tube | K131780 |
| MAJ-855 | Auxiliary water tube | K131780 |
| BW-412T | Single use combination cleaning brush | 510(k) exempt |
| (876.1500, MNL) |
Components list in the complete system for PCF-H190TL/I and PCF-HQ190L/I
| Model | Device Name | 510(k) No. |
|---|---|---|
| CV-190 | EVIS EXERA III video system center | K131780 |
| CLV-190 | EVIS EXERA III xenon light source | K131780 |
| OEV262H | High definition LCD monitor | K102379 |
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5. INDICATIONS FOR USE
■ EVIS EXERA III COLONOVIDEOSCOPE PCF-H190TL/I
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 COLONOVIDEOSCOPE PCF-H190TL/I is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).
■ EVIS EXERA III COLONOVIDEOSCOPE PCF-HQ190L/I
This instrument is intended to be used with an Olympus video system center, endoscope position detecting unit, 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 COLONOVIDEOSCOPE PCF-HQ190L/I is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).
6. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEIVCE
The EVIS EXERA III VIDEO SYSTEM COLONOVIDEOSCOPE PCF-H190TL/I has the same technological characteristics and design as the predicate devices except for the following new features:
- Bending section UP Angulation
- Forward water jet
- Insertion section variable stiffness
- Outer Diameter of Distal End
- Outer Diameter of Insertion Tube
- Inner structure of Air/Water nozzle
The EVIS EXERA III VIDEO SYSTEM COLONOVIDEOSCOPE PCF-HQ190L/I has the same technological characteristics and design as the predicate device except for the following new features:
- Outer Diameter of Distal End
- Outer Diameter of Insertion Tube
- Inner Diameter of Instrument Channel
- Inner structure of Air/Water nozzle
- Downsizing of CCD
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K192793 Page 6 of 8
All other technological characteristics of both the subject and predicate devices are identical. Validation from non-clinical testing demonstrated that these technological features do not raise any new issues of safety or effectiveness of the subject device.
7. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
1) Reprocessing validation testing
Reprocessing instruction and reprocessing method validation testing for the EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190TL/I and PCF-HQ190L/I were conducted and documentation was provided as recommended by Guidance for Industry and Food and Drug Administration Staff, "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling".
2) Biocompatibility testing
Biocompatibility testing for the EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190TL/I and PCF-HQ190L/I 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) Software verification and validation testing
Software verification and validation testing for the EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190TL/I and PCF-HQ190L/I 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".
4) Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190TL/I and PCF-HQ190L/I. The system complies with the ANSVAAMI ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-18:2009 standards for safety and the IEC 60601-1-2:2014 standards for EMC.
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5) Performance testing - Bench
Bench testing for the EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190TL/I and PCF-HQ190L/I as listed below was conducted to ensure that the subject device performs as intended and meet design specifications.
- Thermal Safety Test
- Composite Durability Test
- Photobiological Safety Test
- Retroflexed Withdrawal and Detection of Hidden Polyps (for PCF-H190TL/L only)
6) Performance testing - Animal
No animal study was performed to demonstrate substantial equivalence.
7) Performance testing - Clinical
A meta-analysis of the clinical performance of NBI for differentiation of diminutive colorectal polyps has been provided in Section 20.1. The clinical literature represents independent studies performed by clinicians with the exception of two Olympus-sponsored studies. The objective of the meta-analysis was to determine the predictive accuracy of endoscopists utilizing NBI and the NBI International Colorectal Endoscopic (NICE) classification or all available classification criteria in general to differentiate diminutive colorectal polyps as neoplastic or non-neoplastic lesions.
The evidence being presented in this premarket notification supports our labeling change of the subject device for the use of Narrow Band Imaging as an adjunctive tool to assist the endoscopist in making predictions of the underlying histology of diminutive polyps. This application does not seek to show superiority or non-inferiority of NBI to the gold standard histopathology.
The results show that pooled data from NBI-experienced and inexperienced endoscopists making high confidence predictions of diminutive polyp histology in real-time provide reasonable certainty of neoplastic vs. non-neoplastic identity. The NICE classification, simplified criteria for distinguishing neoplastic from non-neoplastic polyps, helps the endoscopist achieve similar performance.
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8. CONCLUSIONS
Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate devices, the EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190TL/I and PCF-HQ190L/I raise no new issue of safety and effectiveness and are substantially equivalent to the predicate devices in terms of safety, effectiveness and performance.