(136 days)
No
The document describes a standard endoscopic imaging system with visible and near-infrared fluorescence capabilities. There is no mention of AI, ML, or any advanced image processing that would suggest the use of these technologies. The performance studies focus on basic device functionality, safety, and equivalence to predicate devices, not on algorithmic performance metrics typical of AI/ML systems.
No
The device is an imaging system designed for diagnosis and observation, intended to assist surgeons by providing visual information, but it does not directly treat a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "endoscopic diagnosis" and enables "visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct... using near-infrared imaging." These functions involve identifying or analyzing conditions, which falls under the definition of diagnostic purposes.
No
The device description clearly outlines multiple hardware components including a video system center, light source, camera heads, and telescopes. While software verification and validation are mentioned, the device is not solely software.
Based on the provided information, the VISERA ELITE II Infrared Imaging System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for providing real-time endoscopic visible and near infrared fluorescence imaging during surgery for visual assessment of vessels, blood flow, tissue perfusion, and biliary ducts. This is an in vivo application, meaning it is used within a living organism.
- Device Description: The description details components like a video system center, light source, camera heads, and telescopes, all designed for endoscopic observation and imaging inside the body.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. The VISERA ELITE II system does not perform any analysis on such specimens.
The system is a surgical imaging tool used directly on the patient during a procedure, which falls under the category of medical devices used in vivo.
N/A
Intended Use / Indications for Use
The VISERA ELITE II Infrared Imaging System is intended to provide real-time endoscopic visible and near infrared fluorescence imaging. The VISERA ELITE II Infrared Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels. blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the VISERA ELITE II Infrared Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.
This video system center is intended to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.
The light source has been designed to be used with Olympus endoscopes, video system centers, light guide cables, and other ancillary equipment for endoscopic observation through visible and near-infrared fluorescence imaging with fluorescence agent.
The camera head has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
These endoscopes are intended to be used for endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indication of transanal and transvaginal natural orifice surgery. In combination with a compatible infrared imaging system, the telescope allows for fluorescence imaging.
Product codes (comma separated list FDA assigned to the subject device)
OWN, NWB, GCJ, HET, FET
Device Description
The subject devices OTV-S200, CH-S200-XZ-EA, and CH-S200-XZ-EB were cleared in 510(k) K190449. After clearances, no technological modification for the subject devices were made. Therefore, the above devices have been omitted from the device description in this pre-market notification.
CLV-S200-IR
This device consists of the source circuit, the control circuit, the illumination lamp, and the optical filter. The control circuit connects to the diaphragm to regulate the light intensity, the source circuit supplies the power to the illumination lamp, the operation panel and the rear panel. By switching on the illumination lamp, this device provides the light for endoscopic observation. This device regulates the endoscopic image brightness constantly from the video system center. The observation mode can be switched by the optical filter extracting the specific wavelengths.
WAIR100A, WAIR130A, WAIR500A, WAIR530A
The "IR" Telescopes are rigid endoscopes. An image relay system of rod lenses transmits the endoscopic image. A bundle of optical fibers transmits light from an external light source to illuminate the endoscopic image.
The "IR" Telescopes are delivered non-sterile. They are reusable and fully autoclavable. Before the first and each subsequent use of the device, it must be inspected and reprocessed according to defined reprocessing methods in the Instructions for Use.
The "IR" Telescopes are available with different directions of view to allow use for various applications in accordance with the intended use as submitted with this 510(k).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic visible and near infrared fluorescence imaging.
Anatomical Site
Thoracic and peritoneal cavities including the female reproductive organs, as well as biliary ducts (cystic duct, common bile duct and common hepatic duct). Also, transanal and transvaginal natural orifice surgery.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons performing minimally invasive surgery.
Prescription Use.
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)
The following performance data is provided in support of the substantial equivalence determination.
-
Reprocessing validation testing
Reprocessing instruction and reprocessing method validation testing for the WAIR100A/130A/500A/530A was conducted and documentation is 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 WAIR100A/130A/530A was 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
- Systemic Toxicity Study in Mice
- Material mediated pyrogenicity
-
Software verification and validation testing
Software verification and validation testing for the OTV-S200 and CLV-S200-IR was conducted and documentation is 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 was conducted. The subject devices comply with the ANSI/AAMI 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 as listed below was conducted to ensure that the subject device performs as intended and meet design specifications.
[VISERA ELITE II Infrared Imaging System]
- Verification for photobiological safety of the illumination light
- [WAIR100A/130A/500A/530A] -DOV -FOV -MTF -Distortion -Ghost Image -Internal reflections -Spectral transmission of imaging system -Expected Service Life -Transport Drop -Design Validation / Usability -Illumination System performance Data -Comparison of Optical Properties of Subject Device and predicate Device
-
Performance testing - Animal
The animal study using canines and swines was performed by taking videos that validate the performance of subject device in simulated body environment. The videos were evaluated by an independent Health Care Professional to demonstrate substantial equivalence in terms of IR observation. -
Performance testing - Clinical
No clinical study was performed to demonstrate substantial equivalence. -
Risk analysis
A Risk analysis for the CLV-S200-IR and WAIR100A/130A/500A/530A was conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K161792, K141077, K152583, K162882, K171238
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The text is in a sans-serif font, with "FDA" in a blue square and the rest of the text in blue.
Olympus Medical Systems Corp. % Lisa Boyle Regulatory Affairs Specialist II Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, Pennsylvania 18034-0610
July 17, 2020
Re: K200542
Trade/Device Name: Visera Elite II Xenon Light Source, Telescope Ultra. Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: OWN, NWB, GCJ, HET, FET Dated: June 19, 2020 Received: June 19, 2020
Dear Lisa 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Neil R.P. Ogden, MS Assistant Director, THT4A4 DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K200542
Device Name VISERA ELITE II Infrared Imaging System
Indications for Use (Describe)
[VISERA ELITE II Infrared Imaging System]
The VISERA ELITE II Infrared Imaging System is intended to provide real-time endoscopic visible and near infrared fluorescence imaging. The VISERA ELITE II Infrared Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels. blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the VISERA ELITE II Infrared Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.
[VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S200]
This video system center is intended to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.
[VISERA ELITE II XENON LIGHT SOURCE OLYMPUS CLV-S200-IR]
The light source has been designed to be used with Olympus endoscopes, video system centers, light guide cables, and other ancillary equipment for endoscopic observation through visible and near-infrared fluorescence imaging with fluorescence agent.
[HD 3CMOS AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S200-XZ-EA]
The camera head has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
[HD 3CMOS CAMERA HEAD OLYMPUS CH-S200-XZ-EB]
The camera head has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
[TELESCOPE IR/ULTRA WAIR500A,WAIR530A,WAIR100A,WAIR130A]
These endoscopes are intended to be used for endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indication of transanal and transvaginal natural orifice surgery. In combination with a compatible infrared imaging system, the telescope allows for fluorescence imaging.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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Image /page/4/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are closely spaced together, creating a solid block of text. A thin, horizontal, yellow line is located beneath the word. The registered trademark symbol is located to the right of the letter "S".
Date Prepared: July 16, 2020
510(k) Summary
5.1 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
5.2 DEVICE IDENTIFICATION
5.2.1 VISERA ELITE II Infrared Imaging System
-
Device Name VISERA ELITE II Infrared Imaging System
-
Model Name [System components]
- VISERA ELITE II XENON LIGHT SOURCE OLYMPUS CLV-S200-IR
- TELESCOPE IR WAIR100A, WAIR130A
- TELESCOPE ULTRA WAIR500A,WAIR530A
- VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S200
- HD 3CMOS AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S200-XZ-EA
- HD 3CMOS CAMERA HEAD OLYMPUS CH-S200-XZ-EB
- Indocyanine Green
-
Common Name
-
876.1500 ■ Regulation Number
-
Endoscope and accessories ■ Regulation Name
5
OLYMPUS®
| ■ Regulatory Class | II |
|---|---|
| ■ Product Code | - |
| ■ Classification Panel | General & Plastic Surgery |
| ■ Manufacturing site: | - |
| 5.2.2 CLV-S200-IR | |
| ■ Device Name | VISERA ELITE II XENON LIGHT SOURCE |
| ■ Model Name | |
| ■ Common Name | CLV-S200-IR |
| Endoscopic Video Imaging System/Component | |
| ■ Regulation Number | 876.1500 |
| ■ Regulation Name | Endoscope and accessories |
| ■ Regulatory Class | II |
| ■ Product Code | OWN; Confocal optical imaging |
| NWB; Endoscope, Accessories, Narrow Band Spectrum | |
| ■ Classification Panel | General & Plastic Surgery |
| ■ Manufacturing site: | Shirakawa Olympus Co., Ltd. |
| 3-1 Okamiyama, Odakura, Nishigo-mura, Nishishirakawa-gun, | |
| Fukushima 961-8061, Japan | |
| 5.2.3 WAIR100A, WAIR130A, WAIR500A, WAIR530A | |
| ■ Device Name | TELESCOPE "ULTRA" |
| TELESCOPE "IR" | |
| ■ Model Name | WAIR100A, WAIR130A,WAIR500A,WAIR530A |
| ■ Common Name | Laparoscopes |
| ■ Regulation Number | 876.1500 |
| 884.1720 | |
| ■ Regulation Name | Endoscope and accessories |
| Gynecologic laparoscope and accessories | |
| ■ Regulatory Class | II |
| ■ Product Code | GCJ; Laparoscope, general & plastic surgery |
| HET; Laparoscope, gynecologic (and accessories) | |
| ■ Classification Panel | General & Plastic Surgery |
| ■ Manufacturing site: | Olympus Winter & Ibe GmbH |
| Kuehnstr.61, 22045 Hamburg, Germany | |
| 5.2.4 OTV-S200 | |
| ■ Device Name | VISERA ELITE II VIDEO SYSTEM CENTER |
| ■ Model Name | OTV-S200 |
| ■ Common Name | Endoscopic Video Imaging System/Component |
| ■ Regulation Number | 876.1500 |
| ■ Regulation Name | Endoscope and accessories |
| ■ Regulatory Class | II |
| ■ Product Code | OWN; Confocal optical imaging |
| FET; Endoscopic Video Imaging System/Component, | |
| Gastroenterology-Urology | |
| ■ Classification Panel | NWB; Endoscope, Accessories, Narrow Band Spectrum |
| General & Plastic Surgery | |
| ■ Manufacturing site: | Shirakawa Olympus Co., Ltd. |
| 3-1 Okamiyama, Odakura, Nishigo-mura, Nishishirakawa-gun | |
| Fukushima 961-8061, Japan | |
| 5.2.5 CH-S200-XZ-EA/ CH-S200-XZ-EB | |
| ■ Device Name | HD 3CMOS AUTOCLAVABLE CAMERA HEAD |
| HD 3CMOS CAMERA HEAD | |
| ■ Model Name | CH-S200-XZ-EA |
| CH-S200-XZ-EB | |
| ■ Common Name | Endoscopic Video Imaging System/Component |
| ■ Regulation Number | 876.1500 |
| ■ Regulation Name | Endoscope and accessories |
| ■ Regulatory Class | II |
| ■ Product Code | OWN; Confocal optical imaging |
| FET; Endoscopic Video Imaging System/Component, | |
| Gastroenterology-Urology | |
| NWB; Endoscope, Accessories, Narrow Band Spectrum | |
| ■ Classification Panel | General & Plastic Surgery |
| ■ Manufacturing site: | Shirakawa Olympus Co., Ltd. |
| 3-1 Okamiyama, Odakura, Nishigo-mura, Nishishirakawa-gun | |
| Fukushima 961-8061, Japan |
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Image /page/7/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The font is sans-serif and the letters are closely spaced together. A registered trademark symbol is located to the right of the word.
5.3 PREDICATE DEVICE
5.3.1 CLV-S200-IR
| Subject Device
(Part of this submission) | Predicate Device | Predicate Device
510(k) No. |
|--------------------------------------------------------------|---------------------------------------------|--------------------------------|
| VISERA ELITE II XENON
LIGHT SOURCE OLYMPUS
CLV-S200-IR | Karl Storz Endoscopic ICG
Imaging System | K152583 |
5.3.2 WAIR100A, WAIR130A, WAIR500A, WAIR530A
| Subject Device
(Part of this submission) | Predicate Device | Predicate Device
510(k) No. |
|---------------------------------------------|-------------------|--------------------------------|
| TELESCOPE IR
WAIR100A, WAIR130A | WA4KL100/WA4KL130 | K150633 |
| TELESCOPE ULTRA
WAIR500A,WAIR530A | WA4KL500/WA4KL530 | |
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5.3.3 OTV-S200
| Subject Device
(Part of this submission) | Predicate Device | Predicate Device
510(k) No. |
|------------------------------------------------------------|------------------------------------------------------------|--------------------------------|
| VISERA ELITE II VIDEO
SYSTEM CENTER
OLYMPUS OTV-S200 | VISERA ELITE II VIDEO
SYSTEM CENTER OLYMPUS
OTV-S200 | K190449 |
5.3.4 CH-S200-XZ-EA/ CH-S200-XZ-EB
| Subject Device
(Part of this submission) | Predicate Device | Predicate Device
510(k) No. |
|------------------------------------------------------------------|------------------------------------------------------------------|--------------------------------|
| HD 3CMOS
AUTOCLAVABLE CAMERA
HEAD OLYMPUS
CH-S200-XZ-EA | HD 3CMOS
AUTOCLAVABLE CAMERA
HEAD OLYMPUS
CH-S200-XZ-EA | K190449 |
| HD 3CMOS CAMERA HEAD
OLYMPUS CH-S200-XZ-EB | HD 3CMOS CAMERA HEAD
OLYMPUS CH-S200-XZ-EB | K190449 |
5.4 REFERENCE DEVICE 5.4.1 CLV-S200-IR
| Reference Device | Predicate Device
510(k) No. |
|-------------------------------------------------|--------------------------------|
| PINPOINT Endoscopic Fluorescence Imaging System | K161792 |
| daVinci Firefly Imaging System | K141077 |
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5.4.2 WAIR100A, WAIR130A, WAIR500A, WAIR530A
| Reference Device | Reference Device
510(k) No. |
|------------------------------------------|--------------------------------|
| KARL STORZ Endoscopic ICG Imaging System | K152583 |
| KARL STORZ Endoscopic ICG Imaging System | K162882 |
| KARL STORZ Endoscopic ICG Imaging System | K171238 |
5.5 DEVICE DESCRIPTION
The subject devices OTV-S200, CH-S200-XZ-EA, and CH-S200-XZ-EB were cleared in 510(k) K190449. After clearances, no technological modification for the subject devices were made. Therefore, the above devices have been omitted from the device description in this pre-market notification.
5.5.1 CLV-S200-IR
This device consists of the source circuit, the control circuit, the illumination lamp, and the optical filter. The control circuit connects to the diaphragm to regulate the light intensity, the source circuit supplies the power to the illumination lamp, the operation panel and the rear panel. By switching on the illumination lamp, this device provides the light for endoscopic observation. This device regulates the endoscopic image brightness constantly from the video system center. The observation mode can be switched by the optical filter extracting the specific wavelengths.
| | Subject Device
CLV-S200-IR | Primary Predicate
Device 1 | Reference Device 1 | Reference Device 2 |
|----------------------|-------------------------------|-------------------------------|-------------------------|-------------------------|
| 510(k)
Number | K200542 | K152583 | K161792 | K141077 |
| Regulation
number | 21 CFR part
876.1500 | 21 CFR part
876.1500 | 21 CFR part
876.1500 | 21 CFR part
876.1500 |
| Regulatory
Class | II | II | II | II |
| Product code | OWN, NWB | OWN | GCJ; IZI | NAY, GCJ, IZI |
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| | Subject Device
CLV-S200-IR | Primary Predicate
Device 1 | Reference Device 1 | Reference Device 2 |
|--------------|------------------------------------|------------------------------------------|------------------------------|------------------------------------|
| Manufacturer | OLYMPUS
MEDICAL
SYSTEMS CORP | Karl Storz
Endoscopy-America,
Inc. | Novadaq
Technologies Inc. | Intuitive Surgical
Incorporated |
| ICG agent | Co package | Co package | Co package | Co package |
| Light source | Xenon | Xenon | Laser | Laser |
| 3D image | Not available | Not available | Not available | Available |
| WLI* | Available | Available | Available | Available |
| NBI* | Available | Not available | Not available | Not available |
| IR* | Available | Available | Available | Available |
- White Light Imaging (WLI), Narrow band imaging (NBI), Infrared Imaging (IR)
5.5.2 WAIR100A, WAIR130A, WAIR500A, WAIR530A
The "IR" Telescopes are rigid endoscopes. An image relay system of rod lenses transmits the endoscopic image. A bundle of optical fibers transmits light from an external light source to illuminate the endoscopic image.
The "IR" Telescopes are delivered non-sterile. They are reusable and fully autoclavable. Before the first and each subsequent use of the device, it must be inspected and reprocessed according to defined reprocessing methods in the Instructions for Use.
The "IR" Telescopes are available with different directions of view to allow use for various applications in accordance with the intended use as submitted with this 510(k).
| Subject device | Predicate device | |
|---|---|---|
| WAIR100A, WAIR130A, | ||
| WAIR500A, WAIR530A | WA4KL100/WA4KL130 | |
| WA4KL500/WA4KL530 | ||
| 510(k) Number | K200542 | K150633 |
| Regulation number | 21 CFR 876.1500 | |
| 21 CFR 884.1720 | 21 CFR 876.1500 | |
| 21 CFR 884.1720 | ||
| Regulatory Class | II | II |
| Product code | GCJ / HET | GCJ / NMH / HET |
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| Subject device | Predicate device | |
|---|---|---|
| Subject device | WAIR100A, WAIR130A, | |
| WAIR500A, WAIR530A | WA4KL100/WA4KL130 | |
| WA4KL500/WA4KL530 | ||
| Manufacturer | OLYMPUS WINTER & | |
| IBE GMBH | OLYMPUS WINTER & | |
| IBE GMBH | ||
| Laparoscope | rigid endoscope | rigid endoscope |
| Ocular coupling (y/n) | yes | yes |
| Integrated filters | IR filter | none |
| Lens coating | Near-infrared (NIR) | |
| optimized anti-reflective | ||
| coating | Standard anti-reflective | |
| coating | ||
| Autoclavability | autoclavable | autoclavable |
| Reprocessing | manual and automated | manual and automated |
| Packaging | Cardboard box | |
| Non-sterile, re-usable | Cardboard box | |
| Non-sterile, re-usable |
5.6 INDICATIONS FOR USE VISERA ELITE II Infrared Imaging System
The VISERA ELITE II Infrared Imaging System is intended to provide real-time endoscopic visible and near infrared fluorescence imaging. The VISERA ELITE II Infrared Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the VISERA ELITE II Infrared Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization
VISERA ELITE II XENON LIGHT SOURCE OLYMPUS CLV-S200-IR
The light source has been designed to be used with Olympus endoscopes, video system centers, light guide cables, and other ancillary equipment for endoscopic observation through visible and near-infrared fluorescence imaging with fluorescence agent.
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TELESCOPE IR WAIR100A, WAIR130A TELESCOPE ULTRA WAIR500A,WAIR530A
These endoscopes are intended to be used for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indicated for visualization of transanal and transvaginal natural orifice surgery. In combination with a compatible infrared imaging system, the telescope allows for fluorescence imaging.
VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S200
This video system center is intended to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis.treatment, and video observation.
HD 3CMOS AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S200-XZ-EA HD 3CMOS CAMERA HEAD OLYMPUS CH-S200-XZ-EB
The camera head has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
5.7 COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEIVCE
5.7.1 CLV-S200-IR
The CLV-S200-IR has the same technological characteristics and design as the predicate device except for the following new features:
Specified IR color modes –
5.7.2 WAIR100A, WAIR130A, WAIR500A, WAIR530A
The WAIR100A, WAIR130A, WAIR500A, and WAIR530A have the same technological characteristics and design as the predicate device except for the following new features:
An additional filter optimized for fluorescence imaging has been added within the ocular
- । Coating of internal lenses for optimization of infrared imaging
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.
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5.8 PERFORMANCE DATA
The following performance data is provided in support of the substantial equivalence determination.
1) Reprocessing validation testing
Reprocessing instruction and reprocessing method validation testing for the WAIR100A/130A/500A/530A was conducted and documentation is 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 WAIR100A/130A/530A was 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 ।
- Systemic Toxicity Study in Mice i
- Material mediated pyrogenicity ।
3) Software verification and validation testing
Software verification and validation testing for the OTV-S200 and CLV-S200-IR was conducted and documentation is 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 was conducted. The subject devices comply with the ANSI/AAMI 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.
5) Performance testing - Bench
Bench testing as listed below was conducted to ensure that the subject device performs as intended and meet design specifications.
[VISERA ELITE II Infrared Imaging System]
- Verification for photobiological safety of the illumination light
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- [WAIR100A/130A/500A/530A] -DOV -FOV -MTF -Distortion -Ghost Image -Internal reflections -Spectral transmission of imaging system -Expected Service Life -Transport Drop -Design Validation / Usability -Illumination System performance Data -Comparison of Optical Properties of Subject Device and predicate Device
6) Performance testing - Animal
The animal study using canines and swines was performed by taking videos that validate the performance of subject device in simulated body environment. The videos were evaluated by an independent Health Care Professional to demonstrate substantial equivalence in terms of IR observation.
7) Performance testing - Clinical
No clinical study was performed to demonstrate substantial equivalence.
8) Risk analysis
A Risk analysis for the CLV-S200-IR and WAIR100A/130A/500A/530A was conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
The following voluntary standards have been applied to the CLV-S200-IR and WAIR100A/130A/500A/530A respectively;
CLV-S200-IR
- AAMI / ANSI ES 60601-1:2005 and A1:2012, C1:2009 and A2:2010 -
- IEC 60601-1-2:2014 -
- IEC 60601-2-18:2009 -
- -ISO 14971:2007
- -AAMI/ANSI/IEC 62304:2006
WAIR100A/130A/500A/530A
- AAMI / ANSI ES 60601-1:2005 and A1:2012, C1:2009 and A2:2010 -
- IEC 60601-2-18:2009 -
- IEC 60601-1-6:2013 -
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- ISO 8600-1:2015 -
- ISO 8600-3:1997 + AM1(2003) -
- ISO 8600-4:2014 -
- ISO 8600-5:2005 -
- ISO 8600-6:2005 -
- ISO 10993-1:2018 -
- AAMI/ANSI/ISO 10993-5:2009 -
- ISO 10993-12:2012 -
- ISO 14971:2007 -
- AAMI/ANSI/ISO 14937:2009 -
- -ISO 17665:2006
5.9 CONCLUSIONS
Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate devices, the OTV-S200, CH-S200-XZ-EA, CH-S200-XZ-EB, CLV-S200-IR and WAIR100A/130A/500A/530A raise no new issue of safety and effectiveness. They are substantially equivalent to the predicate devices in safety, efficacy, and performance.